Background: There is a growing interest in using cognitive behavioural therapy with people who have Asperger Syndrome and comorbid mental health problems. Aims: To examine whether modified group CBT for clinically significant anxiety in an AS population is feasible and likely to be efficacious. Method: Using a randomised assessor-blind trial, 52 individuals with AS were randomised into a treatment arm or a waiting-list control arm. After 24 weeks, those in the waiting-list control arm received treatment, while those initially (...) randomised to treatment were followed-up for 24 weeks. Results: The conversion rate for this trial was high, while attrition was 13%. After 24 weeks, there was no significant difference between those randomised to the treatment arm compared to those randomised to the waiting-list control arm on the primary outcome measure, the Hamilton Rating Scale for Anxiety. Conclusions: Trials of psychological therapies with this population are feasible. Larger definitive trials are now needed. Declaration of Interest: None Trial Registration: ISRCTN 30265294, UKCRN 8370. (shrink)

BackgroundAcrophobia is a specific phobia characterized by a severe fear of heights. The purpose of the present study was to investigate the efficacy of two therapies that may ameliorate symptoms of acrophobia and anxiety sensitivity, i.e., virtual reality exposure therapy (VRET) and eye movement desensitization and reprocessing (EMDR) therapy with a Waiting List Control Condition (WLCC).MethodsWe applied a three-armed randomized controlled pre-post-test design with 45 female adolescent students. Students who met DSM-5 criteria for acrophobia were randomly assigned to either (...) VRET (N = 15;Mage = 17.26; SD = 1.32), EMDR (N = 15;Mage = 17.15; SD = 1.57), or a WLCC (N = 15;Mage = 17.50; SD = 1.26). The study groups were evaluated one week before the intervention and one week after the last intervention session regarding symptoms of acrophobia (Severity Measure for Acrophobia) and anxiety sensitivity (Anxiety Sensitivity Index).ResultsThe data showed that both the application of VRET and EMDR therapy were associated with significantly reduced symptoms of acrophobia (d = 1.03 for VRET and d = 1.08 for EMDR) and anxiety sensitivity (d = 1.15 for VRET and d = 1.13 for EMDR) in comparison to the Waiting List.LimitationsThe sample consisted only of adolescent women. Due to the recognizable differences between the two interventions, the therapists and the participants were not blind to the conditions.ConclusionThe results suggest that both VRET and EMDR are interventions that can significantly improve symptoms of acrophobia and anxiety sensitivity in female adolescents.Clinical Trial Registrationhttps://www.irct.ir/trial/57391, identifier: IRCT20210213050343N1. (shrink)

ObjectivePost-traumatic stress disorder may affect individuals exposed to adversity. Eye Movement Desensitization and Reprocessing is an evidence-based trauma-focused psychotherapy for PTSD. There is still some debate whether the eye movements are an effective component of EMDR. The primary aim of this study was to investigate the effectiveness of Eye Movement Desensitization treatment in reducing PTSD symptoms compared to a retrieval-only active control condition. We also investigated whether PTSD symptom reduction was associated with reductions in depression and anxiety, and improvements (...) in quality of life.MethodologyAdult PTSD patients were recruited at public psychological services in Jakarta, Bandung and Cimahi, Indonesia. PTSD was diagnosed with the Structured Clinical Interview for DSM-5 disorders. Participants were randomized into: EMD or retrieval-only. EMD consisted of clinical history and treatment planning, preparation, assessment, EMs, closure, whereas retrieval-only consisted of the same elements except EMs. Data were collected at baseline, 1-week post-treatment, 1-month follow-up, and 3-months follow-up. Outcome measures included the PTSD Checklist for DSM-5, Hopkins Symptoms Checklist-25, and the World Health Organization Quality of Life–BREF. Data were analyzed with linear mixed model analysis in R Statistics.ResultsAlthough there were main effects of time indicating reductions for both EMD and retrieval-only in PCL-5 and HSCL-25 scores, and improvements in WHOQoL-BREF scores at T1, T2, and T3, no significant differences in PCL-5, HSCL-25, and WHOQoL-BREF total scores between the EMD and retrieval-only groups at T1, T2, and T3 were found.ConclusionWithin a clinical sample of PTSD patients in Indonesia, both EMD and retrieval-only was associated with reductions in symptoms of PTSD, anxiety and depression, and improvements in quality of life, although EMs did not add to the efficacy of the treatments. Further research to examine the underlying mechanisms of EMDR’s effective treatment elements in clinical samples is needed.Clinical Trial Registration[www.ClinicalTrials.gov], identifier [ISRCTN55239132]. (shrink)

BackgroundCognitive Behavioral Therapy is delivered in most of the early intervention services for psychosis in different countries around the world. This approach has been demonstrated to be effective in decreasing or at least delaying the onset of psychosis. However, none of them directly affect the comorbidity of these types of patients that is often the main cause of distress and dysfunctionality. The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders is a psychological intervention that combines cognitive-behavioral and third-generation techniques (...) that address emotional dysregulation as an underlying mechanism that these disorders have in common. The application of this intervention could improve the comorbid emotional symptoms of these patients.Materials and methodsThe study is a randomized controlled trial in which one group receives immediate UP plus standard intervention and the other is placed on a waiting list to receive UP 7 months later, in addition to standard care in one of our early psychosis programs. The sample will be 42 patients with UHR for psychosis with comorbid emotional symptoms. The assessment is performed at baseline, at the end of treatment, and at 3-months’ follow-up, and includes: general psychopathology, anxiety and depression, positive and negative emotions, emotional dysregulation, personality, functionality, quality of life, cognitive distortions, insight, and satisfaction with the UP intervention.DiscussionThis will be the first study of the efficacy, acceptability, and viability of the UP in a sample of young adults with UHR. The results of this study may have clinical implications, contributing to improving the model of care for young people who consult for underlying psychotic, anxiety, and/or depressive symptoms that can lead to high distress and dysfunctionality.Clinical trial registration[https://clinicaltrials.gov/], identifier [NCT04929938]. (shrink)

The use of placebo as a control condition in clinical trials of major depressive disorder and anxiety disorders continues to be an area of ethical concern. Typically, opponents of placebo controls argue that they violate the beneficent-based, “best proven diagnostic and therapeutic method” that the original Helsinki Declaration of 1964 famously asserted participants are owed. A more consequentialist, oppositional argument is that participants receiving placebo might suffer enormously by being deprived of their usual medication(s). Nevertheless, recent findings of potential (...) for suicidality in young people treated with antidepressants, along with meta-analyses suggesting that antidepressants add no significant clinical benefit over placebos, warrant a re-evaluation of the arguments against placebo. Furthermore, the nature of placebo treatment in short-term clinical trials is often not well understood, and lack of understanding can foster opposition to it. This paper will show how scientific justifications for placebo use are morally relevant. The fundamental ethical importance of placebo controls is discussed in relation to several aspects of clinical trials, including detection of adverse events, accurate assessment of clinical benefit, advancing understanding of the heterogeneity of depression and anxiety disorders and respecting informed consent requirements. Prohibiting the use of placebo controls is morally concerning in that such prohibitions allow for the possibility of serious adverse public health consequences. Moral worries that research participants receiving placebo are being unduly jeopardised will be shown to be exaggerated, especially in relation to the net benefits for end-users to be gained from the quality of data resulting from using placebo controls. (shrink)

Social anxiety disorders are among the most prevalent mental disorders, with high impact on the life of an affected social system and its individual social system members. We developed a manualized disorder-specific integrative systemic and family therapy for SAD, and evaluated its feasibility in a pilot randomized controlled trial. The ISFT is inspired by Helm Stierlin’s concept of related individuation developed during the early 1980s, which has since continued to be refined. It integrates solution-focused language, social network diagnostics, (...) and genogram work, as well as resource- and problem orientation for both case conceptualization and therapy planning. Post-Milan symptom prescription to fluidize the presented symptoms is one of the core interventions in the ISFT. Theoretically, the IFST is grounded in radical constructivism and “Cybern-Ethics,” multi-directional partiality, and a both/and attitude toward a disorder-specific vs. non-disorder-specific therapy approach. SAD is understood from the viewpoint of social systems theory, especially in adaptation to a socio-psycho-biological explanatory model of social anxiety. In a prospective multicenter, assessor-blind pilot RCT, we included 38 clients with SAD : 18 patients participated in the ISFT, and 20 patients in Cognitive Behavioral Therapy. Within-group, simple-effect intention-to-treat analyses showed significant reduction in social anxiety, while intention-to-treat mixed-design ANOVA demonstrated the advantage of ISFT. Per-protocol analyses supported these results. The remission rate based on blind diagnosticians’ ratings was good to satisfactory ; this has yet to be verified in a subsequent confirmatory RCT. The article will present the ISFT rationale and manual, including a special focus on multi-person settings, and the central findings from our pilot RCT. (shrink)

Individuals with social anxiety disorder engage in post-event processing, a form of perseverative thinking. Given that deficits in working memory might underlie perseverative thinking, we examined working memory in SAD with a particular focus on the effects of stimulus valence. SAD and healthy control participants either maintained or reversed in working memory the order of four emotional or four neutral pictures, and we examined sorting costs, which reflect the extent to which performance deteriorated on the backward trials compared to (...) the forward trials. Emotionality of stimuli affected performance of the two groups differently. Whereas control participants exhibited higher sorting costs for emotional stimuli compared to neutral stimuli, SAD participants exhibited the opposite pattern. Greater attention to emotional stimuli in SAD might facilitate the processing of emotional stimuli in working memory. (shrink)

ObjectivesThis study aims to systematically analyze the effects of mind–body exercises on post-traumatic stress disorder symptoms, depression, and anxiety in patients with PTSD. Furthermore, it intends to provide scientific evidence-based exercise prescriptions.MethodsChinese and English databases were used as data sources to search for studies on the effects of mind–body exercises on symptoms associated with patients with PTSD from January 1980 to November 2020. After a rigorous screening, 16 eligible randomized controlled trials were included in the meta-analysis.ResultsMind–body exercises exerted a (...) significant effect on PTSD symptoms [standard mean difference = −0.41, 95% confidence interval −0.64 to −0.19, p < 0.001], depression, and anxiety among patients with PTSD. Subgroup analysis demonstrated that 60–150 min per session for 8–16 weeks of mindfulness was more effective in improving symptoms in patients with PTSD under 45 years of age compared with other subgroups. For depression, 150–180 min of yoga exercises once per week was effective. For anxiety, the frequency, timing, duration, and type of mind–body exercises that are most effective in relieving anxiety in patients with PTSD cannot be determined at this time due to the limited number of eligible RCTs.ConclusionsMind–body exercises were found to be significantly effective in improving PTSD symptoms, depression, and anxiety in patients with PTSD. Therefore, they can be used as an adjunct to intervention for symptoms of patients with PTSD. However, this conclusion requires further confirmation through additional scientific and objective RCTs.Systematic Review Registration:Unique Identifier: INPLASY2020120072. (shrink)

Introduction: Parental postpartum bonding has been studied by many researchers focusing on maternal bonding. The objective of this study was to examine the psychological and socio-demographic predictors of paternal postpartum bonding in the early postpartum period.Methods: In this cross-sectional study, 131 couples (fathers median age of 32.37 years,SD= 4.59; mothers median age of 30.23 years,SD= 3.90) of newborns from full-term pregnancies were recruited from November 2019 until March 2020. The primary outcome was paternal postpartum bonding as measured by the Postpartum (...) Bonding Questionnaire (PBQ). Secondary outcomes included: maternal and paternal anxiety [with the Generalized Anxiety Disorder (GAD) Assessment]; maternal and paternal stress [with the Parental Stress Scale (PSS)]; maternal depressive symptoms [with the Edinburgh Postpartum Depression Scale (EPDS)]; and maternal and paternal socio-demographic variables as fathers’ presence at childbirth, education level, age, and parental experience.Results: Paternal postpartum bonding was significantly correlated with paternal anxiety (moderate strength), maternal stress (strong correlation), and maternal postpartum bonding. No significant correlations between paternal postpartum bonding, maternal depression symptoms, and maternal anxiety were found. The mediating role of paternal stress in paternal postpartum bonding was proven. Paternal anxiety strengthens paternal stress (b= 0.98). Further, a high level of paternal stress disrupts paternal postpartum bonding (b= 0.41). Results of regression analyses have revelated that maternal infant bonding (p< 0.01) and paternal stress (p< 0.01) are the only predictors of parental postpartum bonding across all included variables. None of investigated socio-demographic variables were associated with paternal postpartum bonding.Conclusion: Notwithstanding limitations, the current findings add to a growing body of literature on paternal postpartum bonding. The results have shown that paternal mental health is related to parental postpartum bonding directly after delivery.Clinical Trial Registration:ClinicalTrials.govIdentifier: NCT04118751. (shrink)

Introduction: Schools have become a primary setting for providing mental health care to youths in the U.S. School-based interventions have proliferated, but their effects on mental health and academic outcomes remain understudied. In this study we will implement and evaluate the effects of a flexible multidiagnostic treatment called Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems on students' mental health and academic outcomes.Methods and Analysis: This is an assessor-blind randomized controlled effectiveness trial conducted (...) across five school districts. School clinicians are randomized to either MATCH or usual care treatment conditions. The target sample includes 168 youths referred for mental health services and presenting with elevated symptoms of anxiety, depression, trauma, and/or conduct problems. Clinicians randomly assigned to MATCH or UC treat the youths who are assigned to them through normal school referral procedures. The project will evaluate the effectiveness of MATCH compared to UC on youths' mental health and school related outcomes and assess whether changes in school outcomes are mediated by changes in youth mental health.Ethics and Dissemination: This study was approved by the Harvard University Institutional Review Board. We plan to publish the findings in peer-reviewed journals and present them at academic conferences.Clinical Trial Registration:ClinicalTrials.gov ID: NCT02877875. Registered on August 24, 2016. (shrink)

IntroductionThe COVID-19 pandemic has led to unprecedented strain to healthcare systems worldwide and posed unique challenges to the healthcare professionals and the general public.ObjectivesThe aim of this study is to evaluate the impact of COVID-19 on the mental health, behavioral, and physical wellbeing of HCPs in the early and mid-term periods of the pandemic in comparison to non-HCPs. Thus, facilitating and guiding optimum planning and delivery of support to HCPs.Methods and AnalysisAn observational cross-sectional survey and cohort study aiming to enroll (...) over 1050 participants. Study questionnaires will be completed at baseline and after 6-weeks and 4-months. Recruitment initiated July 2020. The study was designed in London, United Kingdom, but open to participants worldwide. Baseline: Questionnaires comprising of validated self-administered screening tools for depression, anxiety, sleep-related issues, wellbeing, and burnout. The questionnaires also explore changes in behavior and physical wellbeing of the participants. In addition, associations of these mental health and behavioral factors with work-related factors and support will be explored. Six-weeks and 4-months follow-up: Follow-up questionnaires will assess change in symptoms of anxiety and depression, sleep disorders, use of alcohol and other substances, behavioral or interpersonal relationship changes. Physical wellbeing will be assessed through the presence of suspected or confirmed COVID-19 infection and absence from work. We will also evaluate the impact of variable provision of personal protection equipment, extended working hours, and concern for the wellbeing of family members, anxiety levels, and evidence of burnout.Statistical ConsiderationsThe study has 80% power to detect a 10% difference of combined depression and/or anxiety symptoms between the groups using two-sided type 1 error at 0.05 at baseline. Assuming that only 50% of these HCPs agree to be a part of a cohort survey, we will have 80% power to detect around 12% difference in the two groups in reported physical symptoms, or prevalence of depression and/or anxiety at the end of the study.EthicsThe study was approved by the Cambridge East, Research Ethics Committee.Trial Registration NumberClinicalTrials.gov, NCT04433260. (shrink)

Background: COVID-19 has taken many lives worldwide and due to this, millions of persons are in grief. When the grief process lasts longer than 6 months, the person is in risk of developing Complicated Grief Disorder. The CGD is related to serious health consequences. To reduce the probability of developing CGD a preventive intervention could be applied. In developing countries like Mexico, the psychological services are scarce, self-applied interventions could provide support to solve this problem and reduce the health impact (...) even after the pandemic has already finished.Aims: To design and implement a self-applied intervention composed of 12 modules focused on the decrease of the risk of developing CGD, and increasing the life quality, and as a secondary objective to reduce the symptomatology of anxiety, depression, and increase of sleep quality. The Intervention Duelo COVID follows the principles of User Experience and is designed according to the needs and desires of a sample of the objective participants, to increase the adherence to the self-applied intervention, considered one of the main weaknesses of online interventions.Methods: A Randomized Controlled Trial will be conducted from the 22nd of December of 2020 to the first of June 2021. The participants will be assigned to an intervention with elements of Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, Mindfulness and Positive Psychology. The control group will be a wait-list condition, that will receive the intervention 1.5–2 months after the pre-measurement were taken. The Power Size Calculation conducted through G*Power indicated the need for a total of 42 participants, which will be divided by 21 participants in each group. The platform will be delivered through responsive design assuring with this that the intervention will adapt to the screen size of cellphones, tablets, and computers.Ethics and Dissemination: The study counts with the approval of the Research Ethics Committee of the Autonomous University of Ciudad Juárez, México, and it is registered in Clinical Trials. The article is sent and registered in clinical trials before the recruitment started. The results will be reported in future conferences, scientific publications, and media. (shrink)

Background and objectives: Developmental coordination disorder is a neurodevelopmental motor disorder occurring in 5-6% of school-aged children. It is suggested that children with DCD show deficits in motor learning. Transcranial direct current stimulation enhances motor learning in adults and children but is unstudied in DCD. We aimed to investigate if tDCS, paired with motor skill training, facilitates motor learning in a pediatric sample with DCD.Methods: Twenty-eight children with diagnosed DCD were randomized and placed into a treatment or sham group. Anodal (...) tDCS was applied in conjunction with fine manual training over 5 consecutive days. Children's motor functioning was assessed with the Purdue Pegboard Test and Jebsen-Taylor Hand Function Test at baseline, post-intervention and 6 weeks following intervention. Group differences in rates of motor learning and skill transfer/retention were examined using linear mixed modeling and repeated measures ANOVAs, respectively.Results: There were no serious adverse events or drop-outs and procedures were well-tolerated. Independent of group, all participants demonstrated improved motor scores over the 5 training days [F, p < 0.001, 95% CI ], with no skill decay observed at retention. There was no interaction between intervention group and day [F, p = 0.086, 95% CI ].Conclusion: Children with DCD demonstrate motor learning with long-term retention of acquired skill. Motor cortex tDCS did not enhance motor learning as seen in other populations. Before conclusions of tDCS efficacy can be drawn, additional carefully designed trials with reproducible results are required.Clinical Trial Registration:ClinicalTrials.gov: NCT03453983. (shrink)

Introduction: Probationers, offenders with less serious and non-violent offences, and under statutory supervision, have low levels of self-esteem and physical health, and high level of family conflict, and poorer quality of family relationships. This study examined the effectiveness of the existing probation service and the additional use of a positive family holistic health intervention to enhance physical, psychological, and family well-being in probationers and relationships with probation officers.Methods: Probationers under the care of the Hong Kong Social Welfare Department were randomized (...) into a care-as-usual control group, a brief intervention group receiving two 1-h individual sessions [of a brief theory-based positive family holistic health intervention integrating Zero-time Exercise and positive psychology themes of “Praise and Gratitude” in the existing probation service], or a combined intervention group receiving BI and a 1-day group activity with family members. The outcomes were physical activity, fitness performance, self-esteem, happiness, anxiety and depression symptoms, life satisfaction, quality of life, family communication and well-being, and relationships with probation officers. Self-administered questionnaires and simple fitness tests were used at baseline, 1-month and 3-month follow-up. Linear mixed model analysis was used to compare difference in the changes of outcome variables among groups, adjusted of sex, age, and baseline values. Focus group interviews were conducted. Thematic content analysis was used.Results: 318 probationers were randomized into CAU, BI, or CI group. CAU showed enhanced physical activity, fitness performance and psychological health, and family communication with small effect sizes. BI and CI showed further improved physical activity, family communication and family well-being. Additionally, CI reported greater improvements in the relationships with probation officers than CAU with a small effect size. CI also reported greater increases in physical activity and family communication than BI with small to moderate effect sizes. Qualitative feedbacks corroborated the quantitative findings.Conclusion: Our trial provided the first evidence of the effectiveness of probation service and the additional use of an innovative, relatively low-cost, theory-based brief positive family holistic health intervention. This intervention may offer a new model for enhancing probation service.Trial Registration: The research protocol was registered at the National Institutes of Health. (shrink)

Background We report a randomised controlled clinical trial of neurofeedback therapy intervention for ADHD/ADD in adults. We focus on internal mechanics of neurofeedback learning, to elucidate the primary role of cortical self-regulation in neurofeedback. We report initial results; more extensive analysis will follow. Methods Trial has two phases: intervention and follow-up. The intervention consisted of neurofeedback treatment, including intake and outtake measurements, using a waiting-list control group. Treatment involved $\sim$40 hour-long sessions 2-5 times per week. Training involved either (...) theta/beta or sensorimotor-rhythm regimes, adapted by adding a novel 'inverse-training' condition to promote self-regulation. Follow-up (ongoing) will consist of self-report and executive function tests. Setting Intake and outtake measurements were conducted at University of Helsinki. Treatment was administered at partner clinic Mental Capital Care, Helsinki. Randomisation We randomly allocated half the sample then adaptively allocated the remainder to minimise baseline differences in prognostic variables. Blinding Waiting-list control design meant trial was not blinded. Participants 54 adult Finnish participants (mean age 36 years; 29 females) were recruited after screening by psychiatric review. 44 had ADHD diagnoses, 10 had ADD. Measurements Symptoms were assessed by computerised attention test (T.O.V.A.) and self-report scales, at intake and outtake. Performance during neurofeedback trials was recorded. Results Participants were recruited and completed intake measurements during summer 2012, before assignment to treatment and control, September 2012. Outtake measurements ran April-August 2013. After dropouts, 23 treatment and 21 waiting-list participants remained for analysis. Initial analysis showed that, compared to waiting-list control, neurofeedback promoted improvement of self-reported ADHD symptoms, but did not show transfer of learning to T.O.V.A. Comprehensive analysis will be reported elsewhere. Trial Registration "Computer Enabled Neuroplasticity Treatment (CENT)", ISRCTN13915109. Partly funded by Finnish science agency TEKES, project #440078. (shrink)

The aims of this study were to examine the effectiveness of a range of smartphone apps for managing symptoms of anxiety and depression and to assess the utility of a single-case research design for enhancing the evidence base for this mode of treatment delivery. The study was serendipitously impacted by the COVID-19 pandemic, which allowed for effectiveness to be additionally observed in the context of significant community distress. A pilot study was initially conducted using theSuperBetter app to evaluate the (...) proposed methodology, which proved successful with the four finishing participants. In the main study, 39 participants commenced, with 29 finishing the intervention phase and completing post-intervention measures. At 6-month follow-up, a further three participants could not be contacted. This study used a digitally enhanced, multiple baseline across-individuals single-case research design. Participants were randomly assigned to the following apps:SuperBetter,Smiling Mind,MoodMission,MindShift, andDestressify. Symptomatology and life functioning were measured at five different time points: pre-baseline/screening, baseline, intervention, 3-week post-intervention, and 6-month follow-up. Detailed individual perceptions and subjective ratings of the apps were also obtained from participants following the study’s completion. Data were analyzed using visual inspection, time-series analysis, and methods of statistical and clinical significance. Positive results were observed for all apps. Overall, more favorable outcomes were achieved by younger participants, those concurrently undertaking psychotherapy and/or psychotropic medication, those with anxiety and mixed anxiety and depression rather than stand-alone depression, and those with a shorter history of mental illness. Outcomes were generally maintained at 6-month follow-up. It was concluded that a diverse range of evidence-based therapies offered via apps can be effective in managing mental health and improving life functioning even during times of significant global unrest and, like all psychotherapies, are influenced by client features. Additionally, this single-case research design is a low-cost/high value means of assessing the effectiveness of mental health apps.Clinical Trial Registration: The study is registered with the Australian and New Zealand Clinical Trials Registry, which is a primary registry in the World Health Organization Registry Network, registration number ACTRN12619001302145p. (shrink)

Background: In this study, we aimed to investigate the effects of a mindfulness program including Mindfulness-Based Stress Reduction on the mental health of student teachers when offered at their educational institution in a real-life context.Methods: A parallel randomized controlled trial was conducted among self-selected student teachers at a Danish undergraduate program for teacher education in the autumns of 2019 and 2020. Participation was not recommended in case of clinical depression or a diagnosis of psychosis or schizophrenia, abuse of alcohol, (...) drugs, and/or medicine. Randomization was performed by a Statistician who was blinded to the identity of the students. Data was collected using self-reported questionnaires. The primary outcome was a change in perceived stress 3 months from baseline. Secondary outcome measures were symptoms of anxiety and depression, well-being, resilience, mindfulness, and thoughts and feelings during rest. The effects were analyzed according to the intention-to-treat principle using mixed-effect linear regression models. Mediating effects of mindfulness skills on the mental health outcomes were explored using structural equation modeling.Results: The study group included 67 student teachers with 34 allocated to the intervention group ; and 33 students allocated to a waiting list control group. At baseline, mean Perceived Stress Scale scores were 18.88 in the intervention group and 17.91 in the waiting list control group. A total of 56 students completed the questionnaire at a 3-month follow-up. Statistically significant effects of the intervention were found on perceived stress, symptoms of anxiety and depression, well-being, and on three of seven resting-state dimensions. No effects were found on resilience or mindfulness. Statistically significant mediated effects via resting-state dimensions were found.Conclusion The findings suggested that offering a mindfulness program at an undergraduate program for teacher education could significantly improve the mental health among self-selected students within 3 months. Results of mediation analysis supported the hypothesis that some of the effects might be explained by reduced distracting thoughts.Clinical Trial Registration: [www.ClinicalTrials.gov], identifier [NCT04558099]. (shrink)

Psychological flexibility is a key concept of acceptation and commitment therapy. This factor has been linked with psychological wellbeing and associated factors, such as quality of life, in cancer patients. These and other positive results of acceptation and commitment therapy in cancer patients found in previous research could be enhanced by using mhealth tools. A three-arm randomized superiority clinical trial, with a pre-post-follow-up repeated measures intergroup design with a 1:1:1 allocation ratio is proposed. A hundred and twenty cancer patients (...) will be randomly assigned to one of the following interventions: face-to-face ACT + mobile application, face-to-face ACT, and Waitlist control group. The primary expected outcome is to observe significant improvements in psychological flexibility acceptance and action questionnaire- II in the face-to-face ACT + app group, after comparing baseline and post-treatment scores, and the scores will remain stable in the two assessment points, 3 and 6 months after the intervention. Secondary expected outcomes are significant increasing scores in quality of life and post-traumatic-growth, and significant decreasing scores in anxiety and depression, insomnia and fatigue at the same assessment points. Also, it is expected that the scores of this group will be higher than the scores of the face-to-face ACT group and the waitlist control group. This study aims to assess the efficacy of a combined intervention for psychological flexibility and associated symptoms in cancer patients. The results of this protocol may help to consider the use of acceptation and commitment therapy and mhealth applications in cancer settings as a valid therapeutic choice.Clinical Trial Registration[www.ClinicalTrials.gov], identifier [NCT05126823]. (shrink)

Background Thorough information of the patient is an integral part of the process of shared decision making. We aimed to investigate if detailed information about medication may induce nocebo effects. Methods We conducted a randomized, single-blind, pilot-study including n = 51 psychiatric in-patients aged between 18 and 80 years with a depressive disorder and accompanying sleeping disorders. In the intervention group we provided thorough information about adverse effects, while the control group received only a simple consent procedure. In both groups, (...) patients received an open-label placebo pill instead of their sleeping medication. Results No statistically significant differences between the intervention group and the control group were found regarding the main outcome parameter. Conclusion In this study, we were not able detect an effect of informed consent vs. simple consent on the emergence of placebo or nocebo effects. This finding is contrary to most assumptions and publications about this topic. Trial registration Trial registration number: DRKS00017653, registered August 30th 2018. Retrosprectively registered. (shrink)

Deficits in gestures act as early signs of impairment in social interaction and communication in children with autism spectrum disorder. However, the pieces of literature on atypical gesture patterns in ASD children are contradictory. This investigation aimed to explore the atypical gesture pattern of ASD children from the dimensions of quantity, communicative function, and integration ability; and its relationship with social ability and adaptive behavior. We used a semi-structured interactive play to evaluate gestures of 33 ASD children and 24 typically (...) developing children. And we evaluated the social ability, adaptive behavior, and productive language of ASD and TD children by using the Adaptive Behavior Assessment System version II and Chinese Communication Development Inventory. No matter the total score of CCDI was corrected or not, the relative frequency of total gestures, behavior regulation gestures, SI gestures, and joint attention gestures of ASD children were lower than that of TD children, as well as the proportion of JA gestures. However, there was no significant group difference in the proportion of BR and SI gestures. Before adjusting for the total score of CCDI, the relative frequency of gestures without vocalization/verbalization integration and vocalization/verbalization-integrated gestures in ASD children was lower than that in TD children. However, after matching the total score of CCDI, only the relative frequency of gestures without vocalization/verbalization integration was lower. Regardless of the fact that the total score of CCDI was corrected or not, the relative frequency and the proportion of eye-gaze-integrated gestures in ASD children were lower than that in TD children. And the proportion of gestures without eye-gaze integration in ASD children was higher than that in TD children. For ASD children, the social skills score in ABAS-II was positively correlated with the relative frequency of SI gesture and eye-gaze-integrated gestures; the total score of ABAS-II was positively correlated with the relative frequency of total gestures and eye-gaze-integrated gestures. In conclusion, ASD children produce fewer gestures and have deficits in JA gestures. The deficiency of integrating eye gaze and gesture is the core deficit of ASD children’s gesture communication. Relatively, ASD children might be capable of integrating vocalization/verbalization into gestures. SI gestures and the ability to integrate gesture and eye gaze are related to social ability. The quantity of gestures and the ability to integrate gesture with eye gaze are related to adaptive behavior.Clinical Trial Registration:www.ClinicalTrials.gov, identifier ChiCTR1800019679. (shrink)

BackgroundAlthough a large number of clinical trials on interventions demonstrating efficacy (or lack thereof) are conducted annually, much of this evidence is not accessible to scientists and clinicians.ObjectivesWe aimed to determine the publication rate of posttraumatic stress disorder (PTSD) trials that have been registered in clinical trial registries, and the factors associated with publication.MethodsTrials, completed on January 15, 2015, were identified via the US National Institutes of Health clinical trials registry, the European Union Clinical Trials Register and the WHO (...) International Clinical Trials Registry Platform. A systematic search for publications (published by the end of March 2018) related to each of the registered trials were then performed.ResultsFour hundred and thirty-eight of 1982 potentially eligible trials were included. Only 34% of interventional trials were registered prior to initiation, 9% were registered within 2 months of starting and 20% after trial completion. Of the 438 included trials, 72% had generated peer-reviewed publications, while an additional 7% had disseminated results in some other form (such as on the trial database), 26 months after trial completion. Randomisation of a trial was the only factor individually associated with publication, in logistic regression analysis (p < 0.001). Intervention type, university as sponsor and study registration prior to completion were factors that influenced the time to publication, using Cox regression (p < 0.001).ConclusionsThis study underscores the importance of timely and accurate publication and dissemination of trial results, in order to avoid the potential waste of resources and to ensure research integrity and patient safety. We suggest that authors and journal editors adhere to conditions set out by the International Committee of Medical Journal Editors and that more diligent data sharing is encouraged through prospective trial registration and trial reporting websites. (shrink)

Children who live on the margins of society are disadvantaged in achieving their developmental potential because of the lack of a necessary stable environment and nurturing care. Many early prevention programs aim at mitigating such effects, but often the evaluation of their long-term effect is missing. The aim of the study presented here was to evaluate such long-term effects in two prevention programs for children-at-risk growing up in deprived social environments focusing on child attachment representation as the primary outcome as (...) well as on self-reflective capacities of teachers taking care of these children. The latter was a key component for promoting resilient behavior in children. Five hundred and twenty-six children aged 36 to 60 months at risk due to immigration status, low family socio-economic status and child behavior were examined in a cluster-randomized study comparing two preventions, the psychodynamic, attachment-based holistic approach EARLY STEPS (ES) with the classroom based FAUSTLOS (FA) for their efficacy. Primary outcome was the child attachment representation measured by the Manchester Child Attachment Story Task (MCAST). Secondary outcomes were derived from (a) the Caregiver-Teacher Report Form (C-TRF: problem behaviors, including anxiety/depressive symptoms, emotional-reactive and somatic problems, social withdrawal, aggressive behavior, and attention deficit), from (b) the Strength and Difficulties Questionnaire (SDQ, parent version: resilience and wellbeing) and (c) Self-Reflective Scales for teachers (SRS: self-reflective capacities of teachers). Compared to baseline, attachment and behavioral problems improved in both programs. ES led to more secure and more organized attachment representations (medium effect sizes). Aggressive behavior and externalizing problems were reduced in the FA group compared with ES, particularly in boys (medium effect sizes). Self-reflective capacities of the teachers increased only in the ES group. High correlation between children’s attachment type with the number of social risk factors and the increase of problematic social behavior strongly indicate that an increase in teachers’ self-reflective capacities helps to change children’s attachment patterns which thus strengthens the resilience of these children-at-risk [An ethical vote from LPPKJP 2009-02-25 was obtained and the trial registered; Clinical trial registration information: The trial was registered 14.02.2012 (DRKS00003500;https://www.drks.de)]. (shrink)

BackgroundThe participant recruitment process is a key ethical pivot point when conducting robust research. There is a need to continuously review and improve recruitment processes in research trials and to build fair and effective partnerships between researchers and participants as an important core element in ensuring the ethical delivery of high-quality research. When participants make a fair, informed, and voluntary decision to enroll in a study, they agree to fulfill their roles. However, supporting study participants to fulfill study requirements is (...) an important ethical obligation for researchers, yet evidenced as challenging to achieve. This paper reports on participants’ motivations to volunteer and remain part of a dietary study conducted in Kasungu District, Malawi.MethodsWe conducted twenty in-depth interviews (with chiefs, religious leaders, trial participants, and health surveillance assistants), five systematic ethnographic observations, and fourteen focus group discussions with trial participants and their partners. Interviews were audio-recorded and transcribed verbatim. We used a grounded theory methodology to analyse data that included coding, detailed memo writing, and data interpretation.FindingsThe findings reveal that many participants had concerns during the trial. Thematically, experiences included anxieties, mistrust of researchers, rumours, fears of exploitation, and misconceptions. Anonymous concerns collected from the participants were reported to the trial team which enabled the researchers to appropriately support participants. Despite initial concerns, participants described being supported and expressed motivation to take up their role.ConclusionThese findings highlight a diverse map of multiple notions of what is ethically relevant and what can impact participation and retention within a study. The study has revealed how embedding a responsive approach to address participants’ concerns and ethical issues can support trust relationships. We argue for the need to employ embedded ethics strategies that enhance informed consent, focus on participants’ needs and positive experiences, and support researchers to fulfill their roles. This work highlights the need for research ethics committees to focus on the risks of undue influence and prevent exploitation especially in settings with a high asymmetry in resources and power between researcher and participant groups.Trial Registration: The Addressing Hidden Hunger with Agronomy (Malawi) trial was registered on 5th March 2019 (ISCRTN85899451). (shrink)

Next SectionObjectives To evaluate the adequacy of paediatric informed consent and its augmentation by a supplemental computer-based module in paediatric endoscopy. Methods The Consent-20 instrument was developed and piloted on 47 subjects. Subsequently, parents of 101 children undergoing first-time, diagnostic upper endoscopy performed under moderate IV sedation were prospectively and consecutively, blinded, randomised and enrolled into two groups that received either standard form-based informed consent or standard form-based informed consent plus a commercial (Emmi Solutions, Inc, Chicago, Il), sixth grade level, (...) interactive learning module (electronic assisted consent). Anonymously and electronically, the subjects' anxiety (State Trait Anxiety Inventory), satisfaction (Modified Group Health Association of America), number of questions asked, and attainment of informed consent were assessed (Consent-20). Statistics were calculated using t test, paired t test, and Mann Whitney tests. Results The ability to achieve informed consent, as measured by the new instrument, was 10% in the control form-based consent group and 33% in the electronic assisted consent group (p<0.0001). Electronically assisting form-based informed consent did not alter secondary outcome measures of subject satisfaction, anxiety or number of questions asked in a paediatric endoscopy unit. Conclusions This study demonstrates the limitations of form-based informed consent methods for paediatric endoscopy. It also shows that even when necessary information was repeated electronically in a comprehensive and standardised video, informed consent as measured by our instrument was incompletely achieved. The supplemental information did, however, significantly improve understanding in a manner that did not negatively impact workflow, subject anxiety or subject satisfaction. Additional study of informed consent is required. Clinical trial registration number ClinicalTrials.gov Identifier NCT00899392. (shrink)

ObjectivesResearch has linked mindfulness to improved mental health, yet the mechanisms underlying this relationship are not well understood. This study explored the mediating role of emotion regulation strategies and sleep in the relationship between mindfulness and symptoms of depression, anxiety and psychological distress during the COVID-19 pandemic.MethodsAs detailed in this study’s pre-registration, a cross-sectional research design was used to investigate the impact of mindfulness on mental health and the mediating role of emotion regulation strategies and insomnia. A total (...) of 493 participants from the general population answered an online survey and were included in the final analysis. The online survey consisted of the short form of the Five-Facets Mindfulness Questionnaire, the Impact of Event Scale-revised, the Generalised Anxiety Disorder Scale, the Patient Health Questionnaire, the Emotion Regulation Questionnaire, the short form of the Rumination Response Scale, and the Insomnia Severity Index.ResultsStructural equation modelling revealed that mindfulness was related to lower symptoms of depression, anxiety and psychological distress, both directly and indirectly. Mindfulness was negatively associated with rumination and insomnia. As hypothesised, models revealed that the associations between mindfulness and depression, anxiety and psychological distress were significantly mediated by its negative associations with rumination and insomnia. Our findings also demonstrated that rumination was related to increased insomnia symptoms, which in turn was associated with increased mental health problems, indicating a mediated mediation. Mindfulness was also positively associated with cognitive reappraisal and negatively associated with suppression, which were, respectively, negatively and positively associated with depressive symptoms, and thus functioned as specific mediators of the association between mindfulness and depression.ConclusionOur findings suggest that rumination and insomnia operate transdiagnostically as interrelated mediators of the effects of mindfulness on mental health, whereas cognitive reappraisal and suppression function as specific mediators for depression. These insights emphasise the importance of targeting emotion regulation and sleep in mindfulness interventions for improving mental health. Limitations and implications for practice are discussed. (shrink)

The emergence of the new coronavirus at the beginning of 2020, considered a public health emergency due to its high transmission rate and lack of specific treatment, led many countries to adhere to social isolation. Although necessary, social isolation causes important psychological changes, negatively affecting the health of the population, including the older population. The aim of this study is to propose a 4-week, home-based physical exercise protocol for older people in social isolation and evaluate whether will promote positive changes (...) in psychological variables such as anxiety, mood, depression, and stress, and in the variables sleep, quality of life, and physical capacities in the older adults. The sample will be selected in a probabilistic way from individuals aged 60 years or more from the city of Itajaí. Of these, half will perform a home-based resistance training protocol, with 3 weekly sessions, for 4 consecutive weeks. For group allocation, patients will be randomized with a computer-generated 1:1 allocation to the physical exercise group or control group. Outcomes will be depressive symptoms, sleep quality, quality of life, stress, mood states, anxiety, and functional capacity, evaluated at baseline, after 4 weeks, and after 15 days of follow-up. This study will offer a home-based exercise protocol for older adults, with load progression and remote monitoring, thus filling a gap in the provision of PE in this population. The results will be able to identify possible improvements not only in physical health, but also in quality of life and mental health.Clinical Trial Registration: The trial registration was carried out in the Brazil Clinical Trials Registry.. (shrink)

Worrying is the central feature of generalized anxiety disorder . Many people worry from time to time, but in GAD the worrying is prolonged and difficult to control. Worrying is a specific way of coping with perceived threats and feared situations. Meanwhile, it is not considered to be a helpful coping strategy, and the phenomenological account developed in this paper aims to show why. It builds on several phenomenological notions and in particular on Michael Wheeler's application of these notions (...) to artificial intelligence and the cognitive sciences. Wheeler emphasizes the value of 'online intelligence' as contrasted to 'offline intelligence'. I discuss and apply these concepts with respect to worrying as it occurs in GAD, suggesting that GAD patients overrate the value of detached contemplation , while underrating their embodied-embedded adaptive skills . I argue that this phenomenological account does not only help explaining why worrying is used as a coping strategy, but also why cognitive behavioral therapy is successful in treating GAD. (shrink)

Background: An association between gaming disorder and the symptoms of common mental disorders is unraveled yet. In this preregistered study, we quantitatively synthesized reliability, convergent and discriminant validity of GD scales to examine association between GD and other constructs.Methods: Five representative GD instruments were chosen based on recommendations by the previous systematic review study to conduct correlation meta-analyses and reliability generalization. A systematic literature search was conducted through Pubmed, Proquest, Embase, and Google Scholar to identify studies that reported information on (...) either reliability or correlation with related variables. 2,124 studies were full-text assessed as of October 2020, and 184 were quantitatively synthesized. Conventional Hedges two-level meta-analytic method was utilized.Results: The result of reliability generalization reported a mean coefficient alpha of 0.86 and a mean test-retest estimate of 0.86. Estimated effect sizes of correlation between GD and the variables were as follows: 0.33 with depression, 0.29 with anxiety, 0.30 with aggression, –0.22 with quality of life, 0.29 with loneliness, 0.56 with internet addiction, and 0.40 with game playtime, respectively. The result of moderator analyses, funnel and forest plots, and publication bias analyses were also presented.Discussion and Conclusion: All five GD instruments have good internal consistency and test-retest reliability. Relatively few studies reported the test-retest reliability. The result of correlation meta-analysis revealed that GD scores were only moderately associated with game playtime. Common psychological problems such as depression and anxiety were found to have a slightly smaller association with GD than the gaming behavior. GD scores were strongly correlated with internet addiction. Further studies should adopt a rigorous methodological procedure to unravel the bidirectional relationship between GD and other psychopathologies.Limitations: The current study did not include gray literature. The representativeness of the five tools included in the current study could be questioned. High heterogeneity is another limitation of the study.Systematic Review Registration: [https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42020219781]. (shrink)

BackgroundThe present study examined the efficacy of the Michigan Model of Infant Mental Health-Home Visiting infant mental health treatment to promote the socioemotional wellbeing of infants and young children. Science illuminates the role of parental “co-regulation” of infant emotion as a pathway to young children’s capacity for self-regulation. The synchrony of parent–infant interaction begins to shape the infant’s own nascent regulatory capacities. Parents with a history of childhood adversity, such as maltreatment or witnessing family violence, and who struggle with symptoms (...) of post-traumatic stress may have greater challenges in co-regulating their infant, thus increasing the risk of their children exhibiting social and emotional problems such as anxiety, aggression, and depression. Early intervention that targets the infant–parent relationship may help buffer the effect of parental risk on child outcomes.MethodsParticipants were 58 mother–infant/toddler dyads enrolled in a longitudinal randomized control trial testing the efficacy of the relationship-based IMH-HV treatment model. Families were eligible based on child age and endorsement of at least two of four socio-demographic factors commonly endorsed in community mental health settings: elevated depression symptoms, three or more Adverse Childhood Experiences parenting stress, and/or child behavior or development concerns. This study included dyads whose children were born at the time of study enrollment and completed 12-month post-baseline follow-up visits. Parents reported on their own history of ACEs and current posttraumatic stress disorder symptoms, as well as their toddler’s socioemotional development.ResultsMaternal ACEs predicted more toddler emotional problems through their effect on maternal PTSD symptoms. Parents who received IMH-HV treatment reported more positive toddler socioemotional wellbeing at follow-up relative to the control condition. The most positive socioemotional outcomes were for toddlers of mothers with low to moderate PTSD symptoms who received IMH-HV treatment.ConclusionResults indicate the efficacy of IMH-HV services in promoting more optimal child socioemotional wellbeing even when mothers reported mild to moderate PTSD symptoms. Results also highlight the need to assess parental trauma when infants and young children present with socioemotional difficulties. (shrink)

Reduced Environmental Stimulation Therapy (REST) alters the balance of sensory input to the nervous system by systematically attenuating sensory signals from visual, auditory, thermal, tactile, vestibular, and proprioceptive channels. Previous research from our group has shown that REST via floatation acutely reduces anxiety and blood pressure while simultaneously heightening interoceptive awareness in clinically anxious populations. Anorexia nervosa (AN) is an eating disorder characterized by elevated anxiety, distorted body representation, and abnormal interoception, raising the question of whether REST might (...) positively impact these symptoms. However, this approach has never been studied in eating disorders and it is unknown whether exposure to REST might worsen AN symptoms. To examine these possibilities we conducted an open-label study to investigate the safety and tolerability of REST in AN. We also explored the impact of REST on affective symptoms, body image disturbance, and interoception. Twenty-one partially weight-restored AN outpatients completed a protocol involving four sequential sessions of REST: reclining in a zero-gravity chair, floating in an open pool, and two sessions of floating in an enclosed pool. All sessions were 90 minutes, approximately one week apart. We measured orthostatic blood pressure before and immediately after each session (primary outcome), in addition to collecting blood pressure readings every 10 minutes during the session using a wireless waterproof system as a secondary outcome measure. Each participant's affective state, awareness of interoceptive sensations, and body image was assessed before and after every session (exploratory outcomes). There was no evidence of orthostatic hypotension following floating, and no adverse events (primary outcome). Secondary analyses revealed that REST induced statistically significant reductions in blood pressure, anxiety and negative affect, heightened awareness of cardiorespiratory but not gastrointestinal sensations, and reduced body image dissatisfaction. The findings from this initial trial suggest that individuals with AN can safely tolerate the physical effects of REST via floatation. Future randomized controlled trials will need to investigate whether these initial observations of improved anxiety, interoception, and body image disturbance can be effectively extended to acutely ill AN populations. (shrink)

Would metaphors used in the context of psychotherapy by people who experience various forms of anxiety disorders differ from those used by people who experience stress? We investigated this question with the help of the Motivation & Sedimentation Model (MSM), a theory of meaning-making developed within the synthetic new discipline of cognitive semiotics. The analysis of a sample of ten transcripts of psychotherapy sessions concerning the topic of anxiety, and a comparable sample concerning stress, showed a significantly stronger (...) proportion of conventionalized metaphors in the stress sample, and a marginally significant difference in the number of innovative metaphors in the anxiety sample. These results suggest that lived experience of an anxiety disorder or another form of maladaptive anxiety affects metaphorical meaning-making, and manifests itself in spontaneous metaphor use. Furthermore, as a result of the conceptual and the empirical investigations of the topic, we propose novel theoretical and operational definitions of the notion of metaphoricity. (shrink)

This study evaluated the biological dimension of meditation and self-transcendent states. A convenience sample of 513 participants was drawn from attendees at a 4-day guided meditation workshop. Half were randomly assigned to an active placebo control intervention. All were assessed on a variety of measures, both psychological [anxiety, pain, posttraumatic stress disorder, positive emotions, and transcendent states], and physiological. Additional biological assessments including salivary immunoglobulin-A, cortisol, and Quantitative Electroencephalography were obtained from subset of the Experimental group. No significant difference (...) in psychological symptoms or positive emotions was observed between Experimental and placebo groups at baseline. At post-test, significant improvements were noted in the Experimental group, including a 49.5% median increase in SIgA, though cortisol remained unchanged. qEEG z-score analysis identified sustained stress reduction, including delta frequency band amplitude increases, high beta decreases, and faster acquisition of sustained alpha states. Psychological symptoms also improved on all measures. At 6-month follow-up, PTSD and somatic symptoms significantly improved from baseline, and post-test versus 6-month follow-up results indicated significant increases in happiness and spiritual and physical oneness, along with decreases in depressive symptoms. These findings suggest that autonomic self-regulation and transcendent states may be measured in both biological and psychological dimensions and are associated with pervasive health benefits. (shrink)

Although the role of emotion in socioeconomic decision making is increasingly recognised, the impact of specific emotional disorders, such as anxiety disorders, on these decisions has been surprisingly neglected. Twenty anxious patients and twenty matched controls completed a commonly used socioeconomic task (the Ultimatum Game), in which they had to accept or reject monetary offers from other players. Anxious patients accepted significantly more unfair offers than controls. We discuss the implications of these findings in light of recent models of (...) anxiety, in particular the importance of interpersonal factors and assertiveness in an integrated model of decision making. Finally, we were able to show that pharmacological serotonin used to treat anxious symptomatology tended to normalise decision making, further confirming and extending the role of serotonin in co-operation, prosocial behaviour, and social decision making. These results show, for the first time, a different pattern of socioeconomic behaviour in anxiety disordered patients, in addition to the known memory, attentional and emotional biases that are part of this pathological condition. (shrink)

This study reviews the existing literature on psychiatric interventions for individuals affected by the COVID-19 epidemic. My article cumulates previous research on how extreme stressors associated with COVID-19 may aggravate or cause psychiatric problems. The unpredictability of the COVID-19 epidemic progression may result in significant psychological pressure on vulnerable populations. Persons with psychiatric illnesses may experience worsening symptoms or may develop an altered mental state related to an increased suicide risk. The inspected findings prove that psychological intervention measures for patients (...) affected by the epidemic should be designed and personalized adequately. Preventive measures seek to decrease infection rates and cut down the risk of the public healthcare system to eventually be overburdened. Throughout the COVID-19 crisis, people with psychiatric illnesses may confront a decrease in mental health services. As limitations in the current review, by focusing only on articles published in journals indexed in Web of Science, Scopus, and ProQuest, I inevitably disregarded other valuable sources. Subsequent research directions should clarify the effectiveness of online mental health services in providing remote psychiatric interventions to individuals affected by the COVID-19 epidemic. (shrink)

Glas's article is one of several in an interesting special issue focused on applying concepts from enactivism to psychiatry; his focuses on anxiety in particular. Given ongoing developments in work on enactivism, and ongoing debates about how to progress psychiatry, this application is timely. Here, I make three general points about the application of enactivism to psychiatry; I exemplify these with occasional comments on social anxiety disorder.First, as de Haan notes in her introduction, the term enactivism encompasses a (...) number of authors and ideas. Wilson and Foglia note that enactivism falls within a broader literature on "embodied cognition." This literature is partly conceptual, but also relies on... (shrink)

Enactive approaches to emotion are rare and to anxiety and anxiety disorder even more. This article aims to show how an enactive paradigm might be helpful in solving some problems in the clinical and scientific understanding of anxiety and anxiety disorder. I begin by pointing at a number of relevant clinical features of anxiety and anxiety disorder and by sketching how and why anxiety theories have difficulties with doing justice to these features. I (...) specifically focus on two themes: a) how to conceptualize anxiety as the expression of a dynamical interaction with the environment instead of as just a reaction to the environment (or to... (shrink)

Background: Meditation is gaining recognition as a tool to impact health and well-being. Samyama is an 8-day intensive residential meditation experience conducted by Isha Foundation requiring several months of extensive preparation and vegan diet. The health effects of Samyama have not been previously studied. The objective was to assess physical and emotional well-being before and after Samyama participation by evaluating psychological surveys and objective health biomarkers.Methods: This was an observational study of 632 adults before and after the Isha Samyama retreat. (...) All participants were invited to complete surveys. Controls included household significant others. Surveys were completed at baseline, just before Samyama, immediately after Samyama, and 3 months later to assess anxiety, depression, mindfulness, joy, vitality, and resilience through validated psychometric scales. Voluntary blood sampling for biomarker analysis was done to assess hemoglobin, HbA1c, lipid profile, and C-reactive protein. Primary outcomes were changes in psychometric scores, body weight, and blood biomarkers.Results: Depression and anxiety scores decreased from T1 to T3, with the effect most pronounced in participants with baseline depression or anxiety. Scores at T4 remained below baseline for those with pre-existing depression or anxiety. Vitality, resilience, joy, and mindfulness increased from T1 to T3. Body weight decreased by 3% from T1 to T3. Triglycerides were lower from T2 to T3. Participants had lower HbA1c and HDL at T2, and lower CRP at all timepoints compared with controls.Conclusions: Participation in the Isha Samyama program led to multiple benefits. The 2-month preparation reduced anxiety, and participants maintained lower anxiety levels at 3 months post-retreat. Physical health improved over the course of the program as evidenced by weight loss and improved HbA1C and lipid profile. Practices associated with the Samyama preparation phase and the retreat may serve as an effective way to improve physical and mental health. Future studies may examine their use as an alternative therapy in patients with depression and/or anxiety.Clinical Trial Registration:www.ClinicalTrials.gov, Identifier: 1801728792. Registered retrospectively on 4/17/2020. (shrink)

IntroductionGeneralized Anxiety Disorder is a prevalent emotional disorder associated with increased dysfunctionality, which has a lasting impact on the individual’s quality of life. Besides medication, Cognitive-Behavioral Therapy represents the golden standard psychotherapeutic approach for GAD, integrating multilevel techniques and various delivery formats that enable the development of tailored treatment protocols. The objective of this study was to compare the efficiency of a standard CBT protocol targeting worries, dysfunctional beliefs, and intolerance of uncertainty with an integrative and multimodal CBT intervention (...) augmented with Virtual Reality.Materials and methodsThis study included 66 participants with moderate GAD symptoms that were randomized to the standard CBT group and the Integrative and Multimodal CBT augmented with VR group. The interventions comprised 10 weekly sessions conducted by trained CBT therapists, including cognitive restructuring, problem-solving, behavioral exposure, and relaxation techniques. Baseline and post-assessments were conducted with both groups. Primary outcome measures included the Hamilton Anxiety Rating Scale and Penn-State Worry Questionnaire to evaluate the severity of GAD symptoms and worries, respectively. Secondary outcomes involved the administration of Automatic Thoughts Questionnaire, Dysfunctional Attitudes Scale and Unconditional Self-Acceptance Questionnaire.ResultsBoth interventions determined statistically significant effects on both primary and secondary outcomes in the expected direction. However, CBTs was associated with higher effect sizes for anxiety and worries, in contrast to IM-VRCBT. Also, secondary analyses revealed positive correlations between changes in anxiety and worries level and the reduction of dysfunctional cognitive processes.ConclusionThis research emphasized the effectiveness of CBT interventions for treating adults with moderate GAD symptomatology. Specifically, both interventions were efficient for reducing anxiety symptomatology present at individuals with GAD. However, regarding cognitive dysfunctions like worries, the standard CBT protocol performed better, as compared to the IM-VRCBT. In addition, we conclude that VR could be integrated within CBT interventions in a single protocol for GAD treatment. (shrink)

Generalized anxiety disorder is under-treated yet prevalent among young adults. Identifying early risk factors for GAD would contribute to its etiological model and identify potential targets for intervention. Insecure attachment patterns, specifically ambivalent and disorganized, have long been proposed as childhood risk factors for GAD. Similarly, childhood behavioral inhibition has been consistently associated with anxiety disorders in adulthood, including GAD. Intolerance of uncertainty, the tendency to react negatively to uncertain situations, has also been shown to be a crucial (...) component of GAD. Furthermore, maternal anxiety is an important feature of developmental models of anxiety including GAD. Yet, to date, no study has examined, within a comprehensive model, how attachment and behavioral inhibition in childhood, maternal anxiety in adolescence, and IU in emerging adulthood contribute to GAD in adulthood. The present study thus examines these links using a longitudinal design with 62 Canadian participants and their mothers. At age 6, participants' attachment and behavioral inhibition were assessed observationally. Maternal anxiety was measured when participants were 14 years of age. IU and GAD were assessed when participants were 21 and 23 years of age, respectively. Structural equation modeling showed that IU mediates the relationships between behavioral inhibition and GAD, while controlling for maternal anxiety. Ambivalent and disorganized-controlling attachment patterns are also indirectly associated with increased GAD symptoms via greater IU scores. Furthermore, a direct and positive effect of behaviorally disorganized attachment was found on GAD symptoms. This longitudinal study supports integrating attachment, behavioral inhibition, and IU in a model of GAD. (shrink)

The study had two main goals: Firstly, the authors aimed to verify the validity and reliability of the Slovak adaptation of the Coronavirus Anxiety Scale (CAS). Secondly, the authors examined the associations between the CAS and mental health indicators – depression, insomnia and generalized anxiety disorder. The representative sample consisted of 1625 Slovak participants from the general population (793 men and 832 women, Mage = 42.77 ±12.84). The data were collected in October 2020. The data were analyzed using (...) confirmatory factor analysis and multiple hierarchical regression analysis. The authors confirmed that the psychometric properties of the CAS were adequate. Furthermore, they identified predictors of depression (gender, income, change in economic situation, subjective poverty, CAS), generalized anxiety disorder (gender, age, change in economic situation, subjective poverty, CAS) and insomnia (change in economic situation, subjective poverty, CAS). The results may contribute to our understanding of the pandemic’s impact on mental health. (shrink)