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Mood disorders can have a negative impact on daily functioning because cognitive deficits are exacerbated when individuals experience associated symptoms. Nevertheless, yoga therapy has been found to have enhancing features to well-being and quality of life. Occupational therapists are well positioned to include yoga as a modality to benefit clients experiencing mood disorders. However, literature on yoga interventions for mood disorders is underdeveloped causing an inadequate understanding of the health benefits. Thus, the aim of this study is to gain further knowledge associated with the implications of yoga as an intervention to increase participation in activities of daily living and enhance the quality of life of individuals experiencing mood disorders. This review will answer the following research question: can yoga therapy be used as an effective modality in occupational therapy practice to manage symptomatology related to mood disorders through increasing engagement in daily tasks?
OVID Medline, Embase as well as CINAHL Plus, Cochrane Library (Wiley), APA PsycINFO and Scopus will be explored to adhere to the following criteria: (1) studies discussing adults diagnosed with mood disorders, specifically bipolar and related disorders or depressive disorders as stated in the Diagnostic Statistical Manual of Mental Disorders-5; (2) studies discussing implementation of yoga therapy; (3) a correlation between mood disorders and effectiveness of yoga therapy.
Ethics approval is not applicable for this study, due to obtaining data from existing research articles. The completed manuscript will be submitted in a peer-reviewed journal for publication.
CRD42021283157
Bariatric surgery is an effective treatment for severe obesity that leads to significant physical health improvements. Few studies have prospectively described the short-term impact of surgery on mental health using standardised case-finding measures for anxiety or depressive disorders. This study describes the prevalence and short-term course of these conditions following surgery.
Prospective observational cohort study.
12 National Health Service centres in England.
Participants studied took part in the By-Band-Sleeve study, a multicentre randomised controlled trial evaluating the surgical management of severe obesity. We included participants who had undergone surgery (gastric bypass, gastric band or sleeve gastrectomy) within 6 months of randomisation.
Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline and 12 months post-randomisation. Sociodemographic variables collected at prerandomisation included body mass index, age, sex, ethnicity, marital status, tobacco use, employment status and income band.
In our sample of 758 participants, 94.5% (n 716) and 93.9% (n 712) had completed baseline anxiety (HADS-A) and depression (HADS-D) subscales. At pre-randomisation 46.1% (n 330/716, 95% CI 42.4% to 49.7%) met clinical case criteria for anxiety and 48.2% (n 343/712, 95% CI 44.5% to 51.8%) for depression. Among participants returning completed 12 months post-randomisation questionnaires (HADS-A n 503/716, HADS-D n 498/712), there was a significant reduction in the proportion of clinical cases with anxiety (–9.5%, 95% CI –14.3% to -4.8% p
Almost half of people undergoing bariatric surgery had underlying anxiety or depressive symptoms. In the short term, these symptoms appear to substantially improve. Future work must identify whether these effects are sustained beyond the first post-randomisation year.
Depression is highly prevalent in outpatients receiving treatment for mental disorders. Treatment as usual (TAU) usually consists of either psychotherapy and/or antidepressant medication and often takes several weeks before clinical effect. Chronotherapy, consisting of sleep deprivation, sleep-wake phase advancement and stabilisation, and light therapy, is a possible addition to TAU that may decrease the time to treatment response. This randomised controlled trial will examine the benefits of adding chronotherapy to TAU compared with TAU alone.
The trial will include 76 participants with a depressive episode who initiate outpatient treatment at a secondary mental healthcare outpatient clinic at St. Olavs University Hospital. Participants will be randomly allocated 1:1 to either chronotherapy in addition to TAU or TAU alone. Assessments will be performed at baseline, day 3, day 4, day 7, day 14 and weeks 4, 8, 24 and 52, in addition to longer-term follow ups. The main outcome is difference in levels of depressive symptoms after week 1 using the Inventory of Depressive Symptomatology Self-Report. Secondary outcomes include levels of depressive symptoms at other time points, as well as anxiety, health-related quality of life and sleep assessed through subjective and objective measures.
The study protocol has been approved by the Regional Committee for Medical Research Ethics Central Norway (ref: 480812) and preregistered at ClinicalTrials.gov (ref: NCT05691647). Results will be published via peer-reviewed publications, presentations at research conferences and presentations for clinicians and other relevant groups. The main outcomes will be provided separately from exploratory analysis.
This study aimed to investigate the knowledge, attitudes and practical experiences of cardiac surgery nurses regarding kinesiophobia management during early mobilisation.
Using a descriptive qualitative research method, 21 cardiac surgery nurses participated in this study from October 2022 to January 2023, and the interview data were analysed using the Colaizzi 7-step analysis method.
Data were collected through in-depth face-to-face or online interviews in a tertiary hospital located in Nanjing, China.
21 cardiac surgery nurses were interviewed from October 2022 to January 2023.
Two themes were summarised: knowledge, attitude and practice of nurses (high recognition and low participation; low knowledge reserve; low willingness); the promotion and essential elements of kinesiophobia management (efficient health education model; stable medical staff–family caregiver collaboration; simplified clinical protocol; specialist nursing team; clarify the multidisciplinary division of labour).
The management of kinesiophobia in patients undergoing cardiac surgery is currently in the developmental phase. It is advisable to give due consideration to emotional support and cognitive training for medical staff. In addition, a workable management plan, consistent with clinical practice, should be formulated through multidisciplinary and medical staff–family caregiver collaboration to optimise patient outcomes.
Higher education institutions face challenges in providing effective mental health services for diverse student needs. In the UK, discrepancies between healthcare and education service provision create barriers for students and require stronger alignment through partnerships.
This study aimed to identify risks, barriers and enablers to developing service partnerships between universities and the National Health Service (NHS) in England. It investigated existing partnerships and strategies that facilitate effective collaborative working.
A case study approach was employed, including coproduction and stakeholder involvement with staff and service users, to gather information from eight English universities developing regional student mental health hubs. This research received appropriate ethical approval.
In total, 27 professional staff from counselling, mental health, disability and well-being services participated and represented their respective services.
Descriptive information was collected from service websites, handbooks, reports and 11 focus groups using a standardised data collection template. Inter-rater reliability was used to determine the agreement between coders and finalise focus group themes. EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Standards for Reporting Qualitative Research were adopted.
Using inductive thematic analysis, five themes were identified for developing partnerships: building blocks, facing barriers, achieving positive outcomes, shaping student services and developing coordinated care. Fleiss’ kappa showed strong agreement between raters regarding the partnership factors (k=0.84 (95% CI 0.81 to 0.87), p
Stronger partnerships between universities and NHS are needed to meet increasing student mental health demands. Addressing barriers and implementing strategies to develop partnerships can enhance student services.
There is burgeoning evidence for the potential of nature-based interventions to improve wellbeing. However, the role of nature in enhancing maternal mental health, child development and early relationships remains relatively unexplored. This study aimed to develop a co-designed nature-based intervention to improve postnatal mothers’ and infants’ wellbeing.
Person-based and co-design approaches informed the planning and design of the postnatal nature-based intervention. In stage 1, a multidisciplinary team was formed to agree research questions and appropriate methodology, and a scoping review was conducted. Six qualitative focus groups were then held with 30 mothers and 15 professional stakeholders. In stage 2, intervention guiding principles and a logic model were developed, and a stakeholder consensus meeting was convened to finalise the prototype intervention. The research was conducted in Bristol, UK, across voluntary, educational and community-based healthcare settings.
Stakeholder consultation indicated significant enthusiasm for a postnatal nature-based intervention. A scoping review identified little existing research in this area. Focus group data are reported according to four broad themes: (1) perceived benefits of a group postnatal nature-based intervention, (2) potential drawbacks and barriers to access, (3) supporting attendance and implementation, and (4) ideas for intervention content. The developed intervention was tailored for mothers experiencing, or at risk of, postnatal mental health difficulties. It was identified that the intervention should facilitate engagement with the natural world through the senses, while taking into account a broad range of postnatal-specific practical and psychological needs.
To our knowledge, this is the first reported use of person-based and co-design approaches to develop a postnatal nature-based intervention. The resulting intervention was perceived by target users to address their needs and preferences. Further research is needed to determine the feasibility, clinical and cost-effectiveness of this approach.
To ascertain the prevalence and associated factors of anxiety symptoms among middle and high school students in Zhejiang after 2 years of the COVID-19 pandemic.
A school-based cross-sectional study.
30 counties/districts in Zhejiang Province, China.
27 019 students attending middle and high schools.
Anxiety symptoms were assessed using the Generalised Anxiety Disorder 7-item scale (GAD-7). A total score of 10 or more is considered indicative of anxiety symptoms.
The overall prevalence (95% CI) of anxiety symptoms was 14.2% (13.4 to 15.0), higher among girls (18.6%, 95% CI: 17.5 to 19.7) than boys (10.2%, 95% CI: 9.5 to 10.9) (p
Anxiety symptoms prevailed among middle and high school students in China. A variety of factors, containing sociodemographic factors, lifestyle behaviours, mental health, academic performance and physical fight should be taken in consideration in addressing prevention and intervention of anxiety symptoms.
This study aims to map existing literature describing how people with lived experience of self-harm have engaged in codesigning self-harm interventions, understand barriers and facilitators to this engagement, and how the meaningfulness of codesign has been evaluated.
Scoping review by Joanna Briggs Institute methodology. A protocol was published online (http://dx.doi.org/10.17605/OSF.IO/P52UD).
PubMed, Embase, PsycINFO, Web of Science, Cochrane Library, PROSPERO, ClinicalTrials.gov and relevant websites were searched on 24 December 2022 (repeated 4 November 2023).
We included studies where individuals with lived experience of self-harm (first-hand or caregiver) have codesigned self-harm interventions.
Results were screened at title and abstract level, then full-text level by two researchers independently. Prespecified data were extracted, charted and sorted into themes.
We included 22 codesigned interventions across mobile health, educational settings, prisons and emergency departments. Involvement varied from designing content to multistage involvement in planning, delivery and dissemination. Included papers described the contribution of 159 female, 39 male and 21 transgender or gender diverse codesigners. Few studies included contributors from a minoritised ethnic or LGBTQIA+ group. Six studies evaluated how meaningfully people with lived experience were engaged in codesign: by documenting the impact of contributions on intervention design or through postdesign reflections. Barriers included difficulties recruiting inclusively, making time for meaningful engagement in stretched services and safeguarding concerns for codesigners. Explicit processes for ensuring safety and well-being, flexible schedules, and adequate funding facilitated codesign.
To realise the potential of codesign to improve self-harm interventions, people with lived experience must be representative of those who use services. This requires processes that reassure potential contributors and referrers that codesigners will be safeguarded, remunerated, and their contributions used and valued.
Quantify the risk of mental health (MH)-related emergency department visits (EDVs) due to heat, in the city of Curitiba, Brazil.
Daily time series analysis, using quasi-Poisson combined with distributed lag non-linear model on EDV for MH disorders, from 2017 to 2021.
All nine emergency centres from the public health system, in Curitiba.
101 452 EDVs for MH disorders and suicide attempts over 5 years, from patients residing inside the territory of Curitiba.
Relative risk of EDV (RREDV) due to extreme mean temperature (24.5°C, 99th percentile) relative to the median (18.02°C), controlling for long-term trends, air pollution and humidity, and measuring effects delayed up to 10 days.
Extreme heat was associated with higher single-lag EDV risk of RREDV 1.03(95% CI 1.01 to 1.05—single-lag 2), and cumulatively of RREDV 1.15 (95% CI 1.05 to 1.26—lag-cumulative 0–6). Strong risk was observed for patients with suicide attempts (RREDV 1.85, 95% CI 1.08 to 3.16) and neurotic disorders (RREDV 1.18, 95% CI 1.06 to 1.31). As to demographic subgroups, females (RREDV 1.20, 95% CI 1.08 to 1.34) and patients aged 18–64 (RREDV 1.18, 95% CI 1.07 to 1.30) were significantly endangered. Extreme heat resulted in lower risks of EDV for patients with organic disorders (RREDV 0.60, 95% CI 0.40 to 0.89), personality disorders (RREDV 0.48, 95% CI 0.26 to 0.91) and MH in general in the elderly ≥65 (RREDV 0.77, 95% CI 0.60 to 0.98). We found no significant RREDV among males and patients aged 0–17.
The risk of MH-related EDV due to heat is elevated for the entire study population, but very differentiated by subgroups. This opens avenue for adaptation policies in healthcare: such as monitoring populations at risk and establishing an early warning systems to prevent exacerbation of MH episodes and to reduce suicide attempts. Further studies are welcome, why the reported risk differences occur and what, if any, role healthcare seeking barriers might play.
Depression as well as suicidal ideation and behaviours share several precipitating and maintaining factors and are subject to the influence of overlapping constructs. One of these transdiagnostic constructs is rumination. For the treatment of rumination, a variety of interventions are already available. However, not everyone with a need receives psychotherapeutic treatment. And even if they do: implementing learnt strategies alone at home can be challenging for patients. Therefore, this study aims to test the feasibility of delivering microinterventions for the reduction of rumination in a smartphone-based setting with the goal to make these interventions accessible to a larger number of people and support their use in everyday life.
The study’s design is an uncontrolled-within-group design. Participants with at least mild depressive symptoms and reported rumination will be included and recruited via outpatient clinics as well as in the general population. The aim is to recruit at least N=70 participants. Participants first undergo a short telephone screening, a baseline assessment, a 7-day smartphone-based assessment including microinterventions in case participants report rumination and a postassessment. For feasibility purposes, primary outcomes relate to participants’ compliance, their evaluation of the smartphone-based assessment as well as the microinterventions delivered during the assessment. As a secondary goal, clinical utility will be examined. Clinical outcomes (eg, depressive symptoms, rumination) will be measured at baseline and postassessment.
The ethics committee of the institute of psychology of the university of Duisburg-Essen and University of Leipzig has approved the study. Study results will be disseminated to healthcare communities, in peer-reviewed science journals and at conferences.
DRKS00031743.
In routine psychiatric care in Stockholm, Sweden, a comprehensive therapist-guided intervention for clinically significant health anxiety is implemented. However, there is a need for more easily accessible self-care interventions to improve treatment dissemination. This study aimed to transform an existing therapist-guided digital intervention into a self-care intervention, reducing patient burden and used clinical resources while maintaining quality and safety.
An uncontrolled feasibility study.
Conducted at Karolinska Institutet, a medical university in Sweden, with nationwide recruitment trough online advertisements.
Twenty-five adults used the self-care intervention and underwent telephone assessments, along with completing self-rated questionnaires.
The newly developed 8-week self-care intervention was designed to be user-friendly without therapist guidance, and to facilitate high levels of behavioural engagement.
Indicators of quality and safety, including changes in health anxiety severity (primary), clinician time, participant adherence, perceived credibility/satisfaction with the intervention and adverse events, were benchmarked against a previous study of the more comprehensive intervention it was based on.
Compared with the original guided intervention, the self-care intervention was condensed in terms of text (up to 70% less reading), duration (8 weeks instead of 12) and number of exercises. Quality indicators were similar to the original version. Most participants worked actively with core components in the self-care intervention. Within-group effects on health anxiety from pretreatment to the 3-month follow-up were large (g=1.37; 95% CI 0.74 to 2.00). No serious adverse events were reported.
This brief digital self-care intervention shows potential for increasing access to treatment for individuals with health anxiety while reducing the burden on patients and clinical resources. Future studies should investigate the optimal type of intervention and support for different individuals, and if non-inferiority can be established.
The study evaluated the association of academic environment, lifestyle, sense of coherence (SOC) and social support with self-reported mental health status among dental students.
Secondary analysis of data from a cross-sectional, questionnaire-based survey conducted from August to October 2018.
Dental school of a public-funded university in the south-eastern region of Brazil.
233 undergraduate dental students recruited across all years of the course.
Socioeconomic and demographic characteristics, city of origin and student’s academic semester were obtained through self-completed questionnaires. Perception of the academic environment (Dundee Ready Education Environment Measure (DREEM)), individual lifestyle (Individual Lifestyle Profile Questionnaire (ILPQ)), SOC (SOC Scale (SOC-13)), social support (Medical Outcomes Study Scale (MOS)), and depression, anxiety and stress (Depression, Anxiety and Stress Scale-21 (DASS-21)) were assessed using validated instruments. The relationships between variables were investigated through multivariable negative binomial regression to obtain the rate ratios (RRs) and 95% CIs.
Female sex was associated with greater scores of anxiety (RR 1.74, 95% CI 1.10 to 1.97) and stress (RR 1.52, 95% CI 1.12 to 2.06). Students who perceived a better academic environment and those reporting a greater SOC had a lower probability of depression, anxiety and stress. Furthermore, a favourable lifestyle was associated with lower depression scores (RR 0.99, 95% CI 0.97 to 0.99). Social support did not remain associated with depression, anxiety and stress after adjustment.
The present findings suggest that self-reported mental health status is associated with students’ sex, academic environment, SOC and lifestyle. Enhancing the educational environment and SOC, and promoting a healthy lifestyle may improve the psychological health of dental students.
To describe patterns of virtual and in-person outpatient mental health service use and factors that may influence the choice of modality in a child and adolescent service.
A pragmatic mixed-methods approach using routinely collected administrative data between 1 April 2020 and 31 March 2022 and semi-structured interviews with clients, caregivers, clinicians and staff. Interview data were coded according to the Consolidated Framework for Implementation Research (CFIR) and examined for patterns of similarity or divergence across data sources, respondents or other relevant characteristics.
Child and adolescent outpatient mental health service, Nova Scotia, Canada.
IWK Health clinicians and staff who had participated in virtual mental healthcare following its implementation in March 2020 and clients (aged 12–18 years) and caregivers of clients (aged 3–18 years) who had received treatment from an IWK outpatient clinic between 1 April 2020 and 31 March 2022 (n=1300). Participants (n=48) in semi-structured interviews included nine clients aged 13–18 years (mean 15.7 years), 10 caregivers of clients aged 5–17 years (mean 12.7 years), eight Community Mental Health and Addictions booking and registration or administrative staff and 21 clinicians.
During peak pandemic activity, upwards of 90% of visits (first or return) were conducted virtually. Between waves, return appointments were more likely to be virtual than first appointments. Interview participants (n=48) reported facilitators and barriers to virtual care within the CFIR domains of ‘outer setting’ (eg, external policies, client needs and resources), ‘inner setting’ (eg, communications within the service), ‘individual characteristics’ (eg, personal attributes, knowledge and beliefs about virtual care) and ‘intervention characteristics’ (eg, relative advantage of virtual or in-person care).
Shared decision-making regarding treatment modality (virtual vs in-person) requires consideration of client, caregiver, clinician, appointment, health system and public health factors across episodes of care to ensure accessible, safe and high-quality mental healthcare.
Commentary on: Yurtbasi MK, Melvin G, Pavlou C, Gordon M. Staff perspectives on the effects of seclusion in adolescent psychiatric inpatient care. Int J Ment Health Nurs. 2023 Apr;32(2):567–578. doi: 10.1111/inm.13102. Epub 2022 Dec 15.
Nursing staff find adolescent seclusions necessary but also experience related guilt and self-doubt. Seclusion protocols in adolescent psychiatric units should include alternatives to seclusion and debriefing processes.
Seclusions cause distress in patients and lead to negative outcomes, including death. Growing research demonstrates that seclusion rates vary by age, sex, race, diagnosis and personal history of adverse events.
Commentary on: Verhoeven JE, Han LKM, Lever-van Milligen BA, et al. Antidepressants or running therapy: comparing effects on mental and physical health in patients with depression and anxiety disorders. J Affect Disord 2023;329:19–29. doi: 10.1016/j.jad.2023.02.064.
Supervised outdoor running at vigorous intensity leads to antidepressant and physical health benefits in outpatients with major depression or anxiety disorders. More pragmatic exercise trials for mental health outpatients with heterogeneous symptomatology are needed.
Exercise is associated with antidepressant effects in clinical settings but relevant research in pragmatic (real-life) settings is scarce.
Participants were physically inactive adult outpatients with a current major depression or an anxiety disorder and were treated with...
Commentary on: López-Del-Hoyo Y, Fernández-Martínez S, Pérez-Aranda A, Barceló-Soler A, Bani M, Russo S, Urcola-Pardo F, Strepparava MG, García-Campayo J. Effects of eHealth interventions on stress reduction and mental health promotion in healthcare professionals: A systematic review. J Clin Nurs. 2023 Jan 26. doi: 10.1111/jocn.16634. Epub ahead of print.
eHealth interventions can potentially provide cost-effective and easily accessible support for stress-related problems, and reducing sick leave occurrences in healthcare professionals. To establish the effectiveness of interventions targeting healthcare professionals, researchers should prioritise conducting additional studies with larger sample sizes in order to conduct meta-analytic synthesis for more robust and comprehensive conclusions.
Healthcare professionals (HCPs) encounter work-related challenges that elevate the risk of mental health issues like anxiety, depression and stress. The escalating number of sick leaves due to work-induced stress exacerbates the shortage of active HCPs. Employing digitisation...
Calm rooms have been developed and implemented in psychiatric inpatient care settings to offer patients a dedicated space for relaxation in a convenient and safe environment. Recent technology developments have enabled virtual reality (VR) equivalents of calm rooms that can be feasibly deployed in psychiatric care settings. While research has shown VR environments to be efficacious in inducing relaxation, little is known how these virtual calm rooms are perceived by patients. The aim of this study was to elucidate patient experiences of using a VR calm room in a psychiatric inpatient setting.
Qualitative interview study. Semi-structured interviews were analysed using qualitive inductive content analysis, which focuses on the interpretation of texts for making replicable and valid inferences.
Swedish hospital psychiatric inpatient care setting with a wireless, three degrees-of-freedom VR head-mounted display running a calm room application simulating nature environment.
20 adult patients (12 women) with bipolar disorder (n=18) or unipolar depression (n=2).
Participants experienced the use of the VR calm room as having a positive impact on them, inducing awareness, calmness and well-being. They were thankful to be offered a non-pharmacological alternative for anxiety relief. Participants also expressed that they had some concerns about how they would react emotionally before using the VR device. However, after use, they highlighted that their overall experience was positive. They also expressed that they could see potential for further development of VR technology in psychiatric care.
VR technology has the potential to solve pressing logistic issues in offering calm rooms in psychiatric inpatient care. VR calm rooms appear to be appreciated by psychiatric inpatients, who value their accessibility, convenience and variety of modalities offered. Participants perceived an increase in their well-being after use.
More than three-fourths of adverse perinatal outcomes (preterm, small for gestational age, low birth weight, congenital anomalies, stillbirth and neonatal death) occur in low-income and middle-income countries. These adverse perinatal outcomes can have both short-term and long-term consequences on maternal mental health. Even though there are few empirical studies on the effect of perinatal loss on maternal mental illness, comprehensive information on the impact of adverse perinatal outcomes in resource-limited settings is scarce. Therefore, we aim to systematically review and synthesise evidence on the effect of adverse perinatal outcomes on maternal mental health.
The primary outcome of our review will be postpartum maternal mental illness (anxiety, depression, post-traumatic stress disorder and postpartum psychosis) following adverse perinatal outcomes. All peer-reviewed primary studies published in English will be retrieved from databases: PubMed, MEDLINE, CINAHL Ultimate (EBSCO), PsycINFO, Embase, Scopus and Global Health through the three main searching terms—adverse perinatal outcomes, maternal mental illness and settings, with a variant of subject headings and keywords. We will follow the Joanna Briggs Institute critical appraisal checklist to assess the quality of the studies we are including. The review findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 statement. Estimate-based meta-analysis will be performed. We will assess heterogeneity between studies using the I2 statistics and publication bias will be checked using funnel plots and Egger’s test. A subgroup analysis will be conducted to explore potential sources of heterogeneity (if available). Finally, the certainty of the evidence will be evaluated using the Grading of Recommendations, Assessment, Development and Evaluation approach.
Since this systematic review does not involve human participants, ethical approval is not required. The review will be submitted for publication in a peer-reviewed journal.
CRD42023405980.
Adolescent depression has been shown to be associated with many devastating psychosocial outcomes. However, there are many barriers that may prevent depressed individuals from receiving specialised treatment. Virtual reality (VR) technology has shown promise as one avenue for overcoming these challenges. This study first aims to evaluate the effectiveness of VR intervention on adolescent depression symptoms, and second, to determine the intervention’s underlying mechanism of effect using functional near-infrared spectroscopy (fNIRS).
This is a single-centre, prospective, randomised controlled clinical trial. Sixty-six eligible adolescents aged 12–18 years with a diagnosis of depression will be randomised in a 1:1 ratio to either the VR treatment group or the conventional treatment group. All patients for both groups will receive usual treatment during a 4-week intervention period. In addition, patients randomised to VR treatment group (n=33) will complete three 20 min VR sessions including attention, executive function and relaxation training per week. Moreover, 33 healthy adolescents will be recruited as the general population. Primary outcome (ie, depressive symptoms) and secondary outcomes (ie, anxiety symptoms, executive function, treatment emergent symptoms, haemoglobin changes measured by fNIRS) will be collected at preintervention, immediately postintervention and at 4 weeks follow-up. The data assessor and analyst will be blinded to group membership.
Ethical approval has been obtained from the Ethics Committee of Lishui Second People’s Hospital. Written informed consent will be obtained for all participants. Results will be disseminated through peer-reviewed journals, national or international conference presentations, media outlets, the internet and various community activities.
ChiCTR2300067747.
Individual cognitive behavioural therapy (CBT) with exposure and response prevention is an effective treatment for obsessive–compulsive disorder (OCD). However, individual CBT is costly and time-consuming, requiring weekly therapy sessions for 3–4 months. A 4-day intensive version of CBT for OCD delivered in group format has been recently developed in Norway (Bergen 4-day treatment, B4DT). B4DT has shown promising results in several uncontrolled and one small, randomised trial, but its non-inferiority to the gold standard treatment has not been established.
This single-blind, randomised controlled trial including 120 patients (60 per arm) will compare B4DT to individual CBT. The primary outcome is the blind assessor-rated Yale-Brown Obsessive Compulsive Scale (Y-BOCS). We hypothesise that B4DT will be non-inferior to gold standard CBT 15 weeks after treatment start. The non-inferiority margin is set at four points on the Y-BOCS. Secondary outcomes include time to treatment response, cost-effectiveness, response and remission rates, drop-out rates and adverse events.
This study has been approved by the Swedish Ethical Review Authority. Hypotheses were specified and analysis code published before data collection started. Results from all analyses will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials and Consolidated Health Economic Evaluation Reporting Standards irrespective of outcome.
FreshRSS 