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Ayer — Abril 20th 2026Tus fuentes RSS

Implementation of a digital tool for monitoring and managing the emotional and cognitive sequelae of post-intensive care syndrome: ICURA study protocol for a randomised clinical trial

Por: Llabres-Alvarez · E. · Riera-Sagrera · M. · Llompart-Casasnovas · A. · Salva · P. · Castro · A. · Godoy-Gonzalez · M. · Dona-Lopez · E. · Lopez-Aguilar · J. · Jodar · M. · Navarra-Ventura · G. · Gili · M. · Roca · M. · Fernandez-Gonzalo · S.
Introduction

Intensive care units (ICUs) can be a particularly challenging environment for patients who are mentally vulnerable. In addition to the physical stress associated with critical illness and its management, there are physiological and psychosocial factors that can negatively impact a patient’s mental health. Approximately half of ICU survivors will experience post-intensive care syndrome, a set of emotional, neuropsychological and physical sequelae that can significantly affect patients’ functionality and quality of life, both in the short and long term. The main objective of this study is to investigate whether the ICU Recovery Answers (ICURA) digital follow-up platform can effectively detect emotional and cognitive problems in critically ill patients and its impact on functionality and health-related quality of life during the first year after ICU discharge.

Methods and analysis

Multicentre longitudinal prospective study involving ICU adult patients, with randomised follow-up comparing a telemedicine monitoring programme versus usual medical care during 1 year after discharge. A total of 360 participants will be recruited during their ICU admission in two hospitals in Spain. Efficacy outcomes will focus on participants’ level of functioning, assessed with the WHO Short Disability Assessment Schedule, and quality of life, measured with the 12-Item Short Form Survey at 1, 6 and 12 months after ICU discharge. Emotional state and cognitive impairment will be evaluated using the Patient Health Questionnaire-9, Generalised Anxiety Disorder-7 and Treatment-Outcome Post-Traumatic Stress Disorder Scale and the Montreal Cognitive Assessment by telephone at 1, 3, 6, 9 and 12 months after ICU discharge.

Ethics and dissemination

The implementation of this project is expected to have a direct impact on the satisfaction of ICU survivors, improving their well-being, personalised follow-up and quality of life. Results from this study will be disseminated at various scientific conferences, national and international meetings, and will be shared with the general public and other relevant parties. The dissemination of these results will occur through scientific publications, allowing the medical and scientific community to benefit from the study’s findings. Ethics approval from the Ethics Board of Parc Taulí Foundation and Balearic Islands with reference numbers 2022/3031 and IB 5072/22 PI: Protocol version 1 of 18 November 2022.

Trial registration number

NCT06504979.

Negative effects of mindfulness-based cognitive therapy and cognitive behavioural analysis system of psychotherapy for patients with 'difficult to treat depression: protocol for a systematic review and individual participant data meta-analysis

Por: Niemi · M. · Michalak · J. · Velana · M. · Barnhofer · T. · Harrer · M.
Introduction

Mindfulness-based interventions are widely used, yet concerns about potential negative effects—particularly those related to mindfulness meditation practice—have gained increasing attention. Individuals with difficult-to-treat depression (DTD) represent a population of particular relevance due to heightened vulnerability, but comparative evidence on clinically relevant negative outcomes of mindfulness-based cognitive therapy (MBCT) versus established alternative psychotherapies in this group is lacking. This protocol describes a systematic review and individual participant data (IPD) network meta-analysis to assess and compare the incidence of clinically relevant negative outcomes associated with MBCT and the cognitive behavioural analysis system of psychotherapy (CBASP), an established individual psychotherapy for DTD.

Methods and analysis

Randomised controlled trials of MBCT and CBASP for adults with DTD were identified through systematic searches of major databases. Eligible studies must compare MBCT or CBASP (alone or with treatment as usual) to each other or to control groups. The primary outcome is clinically significant deterioration, defined as a ≥6-point increase on the Patient Health Questionnaire-9 or equivalent. Secondary outcomes are suicidality and treatment dropout. IPD will be requested from trial investigators; aggregate data will be used when IPD is unavailable. One-stage random-effects IPD network meta-analyses will be conducted to integrate direct and indirect evidence and to examine participant-level moderators of deterioration. Adverse events reported in the included trials will be summarised descriptively at the study level.

Ethics and dissemination

No local ethical review was required following consultation with the Swedish Ethical Review Authority. Primary trial investigators obtained local ethical approval and will share pseudonymised IPD. Findings will inform clinical decision-making and guideline development by strengthening the evidence base on potential negative effects of MBCT and CBASP in adults with DTD, including identification of subgroups at increased risk. Results will be disseminated through peer-reviewed publication and accessible summaries for relevant stakeholders.

PROSPERO registration number

CRD42022332039

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Regional disparities in insurance-covered cognitive behavioural therapy in Japan: a nationwide cross-sectional study using National Database Open Data, 2015-2023

Por: Fujii · T. · Nogami · Y. · Seo · T.
Objectives

Cognitive behavioural therapy (CBT) is recommended as a first-line treatment for depression and anxiety disorders, but its utilisation under Japan’s national health insurance remains poorly understood. This study aimed to describe CBT utilisation patterns, quantify regional disparities across prefectures and analyse temporal trends from fiscal year (FY)2015 to FY2023.

Design

This was a nationwide repeated cross-sectional study.

Setting

Japan’s National Database of Health Insurance Claims and Specific Health Checkups Open Data (NDB Open Data), FY2015–2023.

Participants

All patients who received insurance-covered CBT in FY2023, with a longitudinal comparison across FY2015–2023.

Primary and secondary outcome measures

The primary outcomes were annual CBT claims and patient counts. The secondary outcomes included prefecture-level distribution, population-adjusted utilisation rates per 100 000 population, distribution by sex and age, monthly trends and temporal changes over 9 years. Regional variation in physician-delivered CBT was assessed using the coefficient of variation (CV) and extremal quotient (EQ).

Results

In FY2023, the total CBT claims numbered 38 045 with 8299 patients, representing only 0.14% of an estimated 6.03 million psychiatric patients. Physician-delivered CBT accounted for 99.6% (37 886 claims), whereas nurse-delivered CBT introduced in 2016 remained at 0.4% (159 claims). 13 of the 47 prefectures (27.7%) had zero or fewer than 10 claims. The population-adjusted physician-delivered CBT claims ranged from 370.96 per 100 000 in Okayama to 0.99 per 100 000 in Kumamoto, yielding an EQ of 375-fold. The CV among the 34 prefectures with measurable physician-delivered CBT was 174.8%. Despite indication expansions in 2016 and 2018, claims decreased by 9.9% from 42 216 in FY2015 to 38 045 in FY2023.

Conclusions

Insurance-covered CBT in Japan remains severely underused, with significant regional disparities. Incremental policy measures, including indication expansions and nurse-delivered CBT, have failed to improve access. Fundamental system reforms, potentially including dedicated psychological therapy services, are needed to ensure equitable access to evidence-based psychological treatments.

Using the suicide audit method to examine trajectories of adolescent girls following a suicide attempt in Quebec, Canada: a study protocol

Por: Kourgiantakis · T. · Mercier · E. · Cote · M. · Tousignant · R.-N. · Dumais Michaud · A.-A. · Maltais · N. · Rassy · J. · Lesage · A.
Introduction

Suicide is a major public health concern among youth in Canada and worldwide. The most rapid increases in suicidal ideation, self-harm, and suicide attempts have been observed among adolescent girls, particularly since the COVID-19 pandemic. Recent studies report disproportionately high rates of emergency department visits and hospitalisations for suicide-related concerns among adolescent girls. Despite these concerning trends, limited evidence exists on the life trajectories, needs, and service pathways of adolescent girls who attempt suicide. This protocol describes a qualitative suicide audit focused on adolescent girls aged 12–17 who were hospitalised following a suicide attempt in two regions of the province of Québec, Canada. The aim is to understand developmental trajectories, document services received and identify individual, relational and systemic factors influencing these trajectories to generate recommendations that inform suicide prevention.

Methods and analysis

Using a narrative qualitative design and a community-based research approach, data will be collected from semi-structured interviews with adolescents and parents, parent questionnaires and hospital health records. These data will be integrated to develop anonymised case vignettes. A multidisciplinary panel, including clinicians, health system stakeholders, community partners and individuals with lived experience, will review each case to identify gaps and strengths in care and generate case-level and cross-case recommendations for clinical practice, health policy and professional training.

Ethics and dissemination

Ethics approval was obtained from the research ethics committee (REC) of the Centre intégré de santé et de services sociaux de Chaudière-Appalaches, which serves as the reviewing REC, with administrative reviews underway at two other health authorities. Findings will be disseminated through peer-reviewed publications, conference presentations and collaborative knowledge-mobilisation activities with clinical and community partners, including practice-oriented tools and accessible materials for adolescents and parents.

Efficacy, moderators and mediators of cognitive behavioural analysis system of psychotherapy (CBASP) versus behavioural activation (BA) in persistently depressed treatment-resistant inpatients: study protocol for the multicentre, randomised controlled cha

Por: Brakemeier · E.-L. · Klein · J. P. · Zimmermann · J. · Hollandt · M. · Reinhard · M. A. · Boger · S. · Daldrup · L. · Eldem · L. · Gebhardt · P. · Heinrich · S. · Hirsmueller · M. · Millerowski · J. · Richter · M. · Ridderbusch · I. C. · Suerig · S. · Schroeter · L. · Velten-Schurian
Introduction

Up to 30% of individuals with depression develop persistent depressive disorder (PDD), an often disabling and difficult to treat condition. The Cognitive Behavioural Analysis System of Psychotherapy (CBASP) is the only psychotherapy developed specifically for treating individuals with PDD. While several randomised controlled trials (RCTs) have demonstrated its efficacy in outpatient settings, evidence for its use in inpatient settings remains limited. Pilot studies of CBASP inpatient programmes in Germany have shown promising feasibility and effectiveness; however, no RCTs to date have systematically evaluated their outcomes. This study represents the first RCT to compare the short- and long-term efficacy and safety of CBASP with Behavioural Activation (BA), a first-line psychotherapy for depression, within an intensive multimodal inpatient setting.

Methods and analysis

In this prospective, multicentre, rater-blinded RCT with an active control group, we aim to recruit 396 adults (aged 18–70 years) with treatment-resistant PDD at eight German university hospitals. Participants will be randomly assigned to receive either (1) CBASP or (2) BA within an intensive treatment programme consisting of 10 weeks acute treatment in an inpatient and/or day clinic setting, followed by 6 weeks of outpatient continuation treatment. Primary and secondary outcome assessments will be conducted at multiple time points: baseline (T0), treatment onset (T1), after 5 and 10 weeks of acute treatment (T2, T3), at the end of continuation treatment (T4, week 16) and every 2 months up to week 64 (T5, naturalistic follow-up).

The primary outcome measure will be the change in depression severity, as assessed by the Hamilton Depression Rating Scale (24-item version), after 16 weeks of treatment (from T0 to T4). Secondary outcomes will include response, remission, deterioration and relapse rates, self-reported depression and anxiety symptoms and additional psychological variables. A cost-benefit analysis will evaluate the health-economic benefits of both interventions. Additionally, this RCT will explore personalised treatment selection and mechanisms of change, including potential moderators and mediators of treatment effects. The findings from this trial are expected to provide clinicians with evidence-based guidance on choosing CBASP versus BA for inpatients with treatment-resistant PDD.

Ethics and dissemination

This study has received ethical approval from the ethics committees of all participating university hospitals. All participants will provide written informed consent before enrolment. Study findings will be published in peer-reviewed journals and presented at national and international conferences. We have involved people with lived experience from the earliest pilots onward, using their feedback to refine our study design. Ongoing consultation at conferences and public events has further ensured that our research remains grounded in patient perspectives.

Trial registration number

NCT04996433.

Mental health patients perceive observation as the least restrictive intervention

Por: Yesodharan · R. · Renjith · V.

Commentary on - Lindekilde CR, Pedersen ML, Birkeland SF, Hvidhjelm J, Baker J, Gildberg FA. Mental health patients' preferences regarding restrictive interventions: an integrative review. J Psychiatr Ment Health Nurs. 2024 May 2. doi: 10.1111/jpm.13057.

Implications for practice and research

  • Mental health patients perceive observation as the least restrictive intervention. Mental health professionals should consider environment, communication and duration that could influence patient preferences for restrictive interventions.

  • More research is needed on developing a global definition for restrictive interventions and also to understand patient preferences and views regarding various restrictive interventions.

  • Context

    Philippe Pinel has been honoured in history for his ‘humane treatment’ and ‘unchaining the mentally ill’.1 However, the use of restrictive interventions (RIs) in psychiatric hospitals continues in the 21st century. Ensuring safety for self and others is one of the major reasons for using these RIs.2...

    Navigating conflict mitigation and reduction: critical insights on Safewards models implementation across healthcare settings

    Por: Sorice · V. · Ekumah · N.-T. D.

    Commentary on: Ward-Stockham, Daniel C, Bujalka H, et al. Implementation and use of the Safewards model in healthcare services: A scoping review. Int J Ment Health Nurs. 2024;00:1–30.

    Implications for practice and research

  • Effective implementation of Safewards interventions could significantly reduce conflict and containment in healthcare services, resulting in a safer environment for patients and professionals.

  • Research is needed on the sustainability and generalisability of Safewards interventions, particularly in non-mental health settings as the model expands to other healthcare contexts.

  • Context

    Conflict behaviours, such as aggression, along with containment practices like seclusion, adversely affect both patients’ well-being and staff safety.1–3 To create safer therapeutic environments, the Safewards model was developed, incorporating ten core interventions to enhance staff-patient interactions.1 3 These encompass strategies such as establishing clear mutual expectations, employing soft words and implementing...

    De-escalating aggression in acute inpatient mental health settings: a fundamental skill

    Por: Citrome · L.

    Commentary on: Price O, Armitage CJ, Bee P, et al. De-escalating aggression in acute inpatient mental health settings: a behaviour change theory-informed, secondary qualitative analysis of staff and patient perspectives. BMC Psychiatry. 2024 Aug 6;24(1):548. doi: 10.1186/s12888-024-05920-y.

    Implications for practice and research

  • Successful de-escalation of agitation requires being mindful of the content of verbal and non-verbal interactions and is a skill that may not come naturally.

  • Training will require changing caregiver perceptions and local culture; leadership is essential.

  • Context

    Agitation is an acute behavioural emergency requiring immediate intervention in order to avoid further escalation to aggression/violence. Verbal de-escalation involves engaging the patient and helping him or her become an active partner in their evaluation and treatment in tandem with nonverbal approaches, such as voluntary medication and environment planning.1 This strategy is in contradistinction with the traditional use of restrictive measures, which...

    Tackling nurses mental health issues: key risk factors, consequences and organisational solutions for improving well-being

    Commentary on: Yang J, Chen Y, Tian Y, Li X, Yu Q, Huang C, Chen Z, Ning M, Li S, He J, Du J, Huang B, and Li Y (2024). Risk factors and consequences of mental health problems in nurses: A scoping review of cohort studies. International Journal of Mental Health Nursing. Advance online publication. https://doi.org/10.1111/inm.13337

    Implications for practice and research

  • Implement interventions to reduce workplace bullying, violence and job demands while promoting healthy lifestyles and social support for nurses.

  • Future research should investigate nurses’ mental health in low-income and middle-income countries, explore gender differences and evaluate the effectiveness of mental health interventions.

  • Context

    Mental health issues among nurses are widespread and jeopardise healthcare systems and patient care.1 Yang et al2 conducted a pioneering scoping review using cohort study evidence to explore the risk factors and consequences...

    Education, training and operational support is required to improve nursing practice for patients living with auditory hallucinations

    Por: Danda · M. C.

    Commentary on: McCluskey A, Watson C, Nugent L, et al. 'Sometimes You Have No Choice but to Give Them Medication': Experiences of Nurses Caring for People With Auditory Hallucinations in an Acute Unit. Int J Ment Health Nurs. 2024 ;33(6):2193-2202. doi: 10.1111/inm.13380.

    Implications for practice and research

  • Nurses require enhanced training in targeted interventions and engagement skills to provide effective, recovery-oriented care for patients experiencing auditory hallucinations.

  • Organizsational support is crucial for re-envisioning ‘"risk’" beyond patient danger, enabling the implementation of recovery-focused therapeutic interventions in high-risk environments.

  • Context

    Auditory hallucinations, commonly associated with schizophrenia, significantly impact individuals’ emotional well-being. With around 24 million people affected globally and notable rates in Ireland, the prevalence is alarming.1 Despite existing guidelines, Ireland lacks specific policies addressing auditory hallucinations, creating a critical practice gap.2 Nurses, the largest group in mental health services, play a...

    Parents of children diagnosed with cancer reveal higher rates of suicide attempts and death by suicide: a population-based study

    Por: Zohn · J. H.

    Commentary on: Liu Q, László KD, Wei D, et al. Suicide attempt and death by suicide among parents of young individuals with cancer: A population-based study in Denmark and Sweden. PLoS Med 2024;21:e1004322. https://doi.org/10.1371/journal.pmed.1004322

    Implications for practice and research

  • Parents of children diagnosed with cancer have high stress rates and higher rates of suicide attempts, particularly in the early years after diagnosis.1

  • Healthcare providers working with parents of children diagnosed with cancer should be vigilant and appropriately respond to psychological distress, psychiatric symptoms and suicide risk in this population.

  • Context

    Parents experience significant psychological stress when a child is diagnosed with cancer. More research is needed regarding stress and suicidal behaviour in this population. The aim of this study was to investigate parents’ risk of suicide attempt and risk of death by suicide in relation to having a child...

    Clear universal clinical and ethical guidelines must be developed to prevent and reduce coercive interventions in various clinical mental health settings aiming at promoting evidenced-based and trauma-informed care

    Por: Ghassemi · A. E.

    Commentary on: Haines S, Stanton R, Anderson C, Welsh A. Ethical challenges for nurses delivering coercive interventions in community mental health setting: a scoping review. Int J Mental Health Nurse. 2023; 33: 750-759. doi: 10.1111/inm.13290.

    Implications for practice and research

  • To prevent and reduce coercive interventions in mental health and community settings, collaborative and continued efforts should target creating policies and ethical and best clinical practice guidelines.

  • Future research should focus on developing clear, consistent and effective global policies and ethical guidelines to prevent and reduce coercive behaviour in clinical and community settings, especially in psychiatry.

  • Context

    While the percentages of coercive interventions in psychiatry vary in different countries and clinical settings, global initiatives are increasingly aimed at preventing and reducing these interventions in the mental health and community settings.1–3 Policymakers, academics, healthcare leaders and clinicians urge...

    Screening tools should not be used to determine suicide risk

    Por: Ougrin · D. · Chappell · A.

    Commentary on: Flores JP, Kahn G, Penfold RB, et al. Adolescents who do not endorse risk via the Patient Health Questionnaire before self-harm or suicide. JAMA Psychiatry. 2024;81(7):717–26

    Implications for practice and research

  • Screening tools should not be used to determine the risk of self-harm and suicide in young people.

  • Research should focus on novel approaches to predicting the risk of self-harm and suicide.

  • Context

    Self-harm is defined as self-injury or self-poisoning, irrespective of the presence or absence of suicidal intent.1 Self-harm could be divided into the following categories: (1) self-harm with suicidal intent (suicide attempts); (2) self-harm without suicidal intent (non-suicidal self-injury and non-suicidal self-poisoning) and (3) self-harm with undetermined or mixed intent. Self-harm resulting in a presentation to an emergency room is the strongest known predictor of death by suicide.1

    The prevalence of self-harm is just under...

    Experiences of internet addiction among junior college students in Taiwan: a qualitative descriptive phenomenological study

    Por: Huang · I.-L. · Li · J.-B. · Chung · M.-h.
    Objectives

    This study explored the lived experiences of internet addiction among Taiwanese junior college students. Specifically, it examined their perceptions of addiction, experiences of excessive use and attempts to manage their online behaviours.

    Design

    A descriptive phenomenological approach involving one-on-one, semi-structured, in-depth interviews was employed. Data analysis was conducted using Giorgi’s phenomenological method assisted by NVivo V.12.

    Setting

    The interviewees were from a junior college with two campuses in northern Taiwan.

    Participants

    Purposive and snowball sampling of 15 junior college students. All participants met the criteria for internet addiction using the Chen Internet Addiction Scale.

    Results

    Three main themes and eight subthemes were identified: continuous provocation (childhood exposure and unexpected pandemic), continuous promotion (irresistible immersion and compensatory self-isolation) and continuous resistance (varied self-awareness, dilemmas, perceived insignificance and futility). This study also explored how junior college students with internet addiction repeatedly struggle to resist a seamless virtual world.

    Conclusions

    From the perspective of adolescents with internet addiction, early exposure to the internet, the boost of the pandemic, the growing demand, and negative beliefs and attitudes all contribute to the inability to overcome internet addiction. These findings offer valuable insights into the underlying mechanisms of internet addiction, providing mental health professionals with a deeper understanding and establishing a foundation for the development of future intervention strategies.

    Bayesian randomised controlled trial of guided parent-delivered cognitive behavioural therapy for children with anxiety disorders via remote sessions in Japan: a study protocol

    Por: Okawa · S. · Blackwell · S. E. · Violato · M. · Creswell · C. · Ishikawa · S.-i. · Obikane · E. · Takahashi · T. · Arai · H. · Nakamura · H. · Ishitsuka · K. · Shimizu · E. · Sasaki · T.
    Introduction

    Guided parent-delivered cognitive behavioural therapy (GPD-CBT) is an evidence-based, low-burden treatment programme for childhood anxiety disorders with demonstrated efficacy, cost-effectiveness and accessibility. However, it has been tested primarily in Western countries, and the efficacy and cost-effectiveness have not been evaluated in Japanese families. The current study aims to examine GPD-CBT’s efficacy and cost-effectiveness in Japanese samples and explore potential cultural adaptations of the programme.

    Method and analysis

    This study is designed as a Bayesian single-blind randomised controlled trial with two parallel groups: GPD-CBT (intervention group) and a waitlist control group. The primary outcome is remission of primary anxiety disorders evaluated through diagnostic interviews by independent evaluators. Secondary outcomes include child and parent-reported child anxiety symptoms, depressive symptoms and life interference. Additionally, measures of parental psychological characteristics, programme acceptability and quality of life are collected. We will conduct qualitative interviews with parents who participated in the programme and therapists who delivered the intervention to explore potential cultural adaptations. We aim to recruit 54–170 families, depending on the results of sequential Bayesian analyses. GPD-CBT consists of seven weekly 20 min sessions and a 1-month follow-up session. Assessments will be conducted at baseline, 13 weeks post randomisation (primary endpoint for between-group comparison), with an additional 25 weeks post randomisation. The waitlist control group will receive GPD-CBT after the 13-week assessment.

    Ethics and dissemination

    This study has been approved by the Ethics Review Committees of Chiba University and the University of Tokyo. We will disseminate results through academic conference presentations and peer-reviewed journal publications. If the GPD-CBT intervention proves efficacious, we will promote wider implementation in Japan through the development of training programmes for mental health professionals and key stakeholders.

    Trial registration numbers

    jRCT1032250421 (https://jrct.mhlw.go.jp/latest-detail/jRCT1032250421) and jRCT1030250422 (https://jrct.mhlw.go.jp/latest-detail/jRCT1030250422) registered on 9 October 2025.

    Open-label randomised controlled trial of aripiprazole/sertraline combination in comparison with quetiapine for the clinical and cost-effectiveness of treatment of bipolar depression (the ASCEnD study): study protocol

    Por: Azim · L. · Al-Ashmori · S. · Butcher · C. · Cipriani · A. · Chew-Graham · C. A. · Clare · E. · Clark · E. · Cole · M. · Carella · S. · Dixon · L. · Evans · J. · Gergel · T. · Gibson · J. · Hancock · H. C. · Hoppe · I. · Kessler · D. · Kabir · T. · Lewis · G. · Mathias · A. · Morris · R. · Nix
    Introduction

    Bipolar disorder affects around 2% of the population and is linked with reduced life expectancy and socioeconomic burden. Depressive episodes are difficult to treat and typically more prevalent, enduring and burdensome than manic episodes. The use of antidepressants alone has limited effect and is associated with significant clinical risk through polarity switch. Current National Institute for Health and Care Excellence guidelines recommend quetiapine, olanzapine (with or without fluoxetine) and lamotrigine; however, these medications have limited efficacy, tolerability and acceptability. The ASCEnD study aims to assess the clinical and cost-effectiveness of aripiprazole plus sertraline compared with quetiapine, offering potential improvements for outcomes in bipolar depression. The study is funded by the National Institute for Health and Care Research Health Technology Assessment programme (NIHR132773).

    Methods and analysis

    ASCEnD is a prospective, two-arm, superiority, individually 1:1 randomised, controlled, pragmatic, parallel group, type A open-label clinical trial of aripiprazole/sertraline medication combination compared with quetiapine for bipolar depression. The study is conducted in the UK National Health Service setting with the aim of recruiting and randomising 270 participants followed-up for 24 weeks. Adults with bipolar disorder self-refer or are recruited through primary and secondary care services. The primary outcome is change in depressive symptoms 12–16 weeks after randomisation. Secondary outcomes include measures of symptom change, treatment satisfaction, tolerability, medication adherence, concomitant medication use, psychosocial functioning, quality of life and cost-effectiveness and informal carer measures of quality of life and costs of caring. The exploratory outcome is change in participant reward and punishment responsiveness. Analysis will follow a prespecified statistical analysis plan. A nested qualitative study is included to examine feasibility and acceptability of the trial design.

    Ethics and dissemination

    A Clinical Trial Authorisation from Medicines and Healthcare products Regulatory Agency, and approval from the Health Research Authority (IRAS 1007468) and North East – Newcastle and North Tyneside 1 Research Ethics Committee (23/NE/0132) were obtained. Results will be disseminated through peer-reviewed publications, conference presentations and lay summaries for participants and patient and public groups.

    Trial registration number

    ISRCTN63917405.

    Brief narrative interventions for adults with chronic illness or psychosocial distress: a scoping review protocol

    Por: Polenz · B. · Rigby · T. · Logue · C. · Krein · S. L. · Powell · V. D.
    Introduction

    Narrative interventions elicit personal stories from participants to impact outcome(s). The process of organising a troublesome experience into a cohesive story may benefit individuals dealing with a variety of complex medical conditions and psychosocial stressors. A better understanding of prior work is a critical step to guide further development, refinement and expansion of this under-recognised therapeutic modality for new populations.

    Methods and analysis

    This scoping review will follow recommendations of the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews to map and summarise the content and context of brief narrative interventions intended for individuals with chronic illness and/or psychosocial distress. Inclusion criteria are records describing brief (≤4 discrete session) interventions eliciting personal stories with the intent of impacting patient-centred outcomes (eg, depression, quality of life) delivered in any context. Participants will be adults (≥18 years old) living with chronic medical or psychiatric conditions (eg, metastatic cancer, chronic pain) or psychosocial distress (eg, grief, loneliness). Studies whose focus is not direct participant benefit or studies conducted in populations without evident illness or psychosocial stressors will be excluded. An initial search of PubMed (MEDLINE) identified sentinel articles; a comprehensive strategy was developed with the assistance of a librarian for systematically searching PubMed (MEDLINE), PsycInfo (EBSCOhost), CINAHL (EBSCOhost) and Embase (Ovid). Bibliographies of relevant articles will also be examined. Two independent reviewers will screen articles; disagreements will be discussed at regular meetings. U-M GPT, an artificial intelligence-powered institutional large language model, will perform initial data abstraction with a human reviewer verifying accuracy. Findings will be qualitatively summarised according to the three research questions, presented in tabular format, and described narratively.

    Ethics and dissemination

    As data will be obtained only from secondary sources, no ethics approval will be sought. Findings will be disseminated via the scoping review Open Science Framework (OSF) project site and submitted for peer review. Results will elucidate promising areas for future research, including narrative intervention development and refinement; these findings will guide expansion into new populations.

    Trial registration number

    https://osf.io/85hjd/

    Cost-benefit analysis of a 24/7 text-based online emotional support platform for at-risk youth in Hong Kong

    Por: Yip · P. S. F. · Chen · J. · Tang · R. L. M. · Chau · C. L. I. · Cheng · W. M. K. · Lui · E. N. C.
    Objectives

    This study was to estimate the potential social value and net benefit of OpenUp, a 24/7 text-based online counselling service for youth in Hong Kong, and draw policy-relevant conclusions for service provision.

    Design

    A retrospective, model-based cost–benefit analysis using social return on investment (SROI) methods. Adopting a societal perspective, service, health and social outcomes were valued over a 1-year period, and productivity gains associated with avoided suicide deaths were valued over a 10-year period. Costs are reported in 2022 HK dollars (HK$; US$1=HK$7.8). Reporting was guided by Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) Statement.

    Setting

    A text-based, synchronous online emotional support counselling platform in Hong Kong was accessible through WhatsApp, Facebook, SMS and the official web portal.

    Participants

    A total of 19 543 users aged 11–35 years accessed OpenUp services during the study period (1 December 2020 to 31 May 2022).

    Primary and secondary outcome measures

    These included total social value (HK$), net social benefit (social value minus investment) and the SROI ratio. The secondary outcomes included monetised savings in medical and social services and productivity gains from avoiding suicide attempts and death.

    Results

    The total social value was estimated to be HK$226 119 729 against an investment of HK$47 655 000 (SROI=4.74). Suicide risk reduction (productivity gains from avoided attempts and deaths) accounted for 75.4% of the social value. Deterministic one-way sensitivity analyses yielded SROI values ranging from 3.62 to 6.99 aggregated across the three groups, with results being most sensitive to assumptions about the duration of productivity impacts for avoided attempts and avoidable mortality.

    Conclusions

    Based on conservative assumptions, OpenUp can generate potential social value by providing an online emotional support service. Given the study’s reliance on modelling and proxy monetisation, these estimates should be interpreted with caution. Further integration of offline services with online intervention strategies requires continuous investment and evaluation.

    Identifying common mental disorders among perinatal and non-perinatal women in northern India: a cross-sectional validation study of the diagnostic accuracy of six self-report measures

    Por: Fellmeth · G. · Sharma · D. · Kanwar · P. · Chawla · K. · Gupta · V. · Thakur · A. · Harrison · S. · Quigley · M. A. · Bharti · O. · Chandra · P. S. · Desai · G. · Thippeswamy · H. · Singh · S. · Nair · M. · Kishore · M. T. · Alderdice · F. · Verma · A. · Perinatal Mental Health Study (P
    Objectives

    To translate and culturally adapt six self-report measures for depression, anxiety, post-traumatic stress disorder (PTSD) and somatic symptom disorder into Hindi and determine their diagnostic accuracy against a diagnostic clinical interview.

    Design

    Cross-sectional validation study.

    Setting

    Rural Kangra, Himachal Pradesh, northern India.

    Participants

    480 perinatal (pregnant or within 12 months postpartum) and non-perinatal (not currently pregnant and not given birth within 12 months) women at one tertiary hospital and district-level Anganwadi (community health) centres.

    Primary and secondary outcome measures

    Symptom endorsement; and discriminant validity, sensitivity, specificity, positive and negative predictive values and area under the receiver operating characteristic curve (AUROC) of the Kessler Scale of Psychological Distress (K10), Patient Health Questionnaire (PHQ9), Edinburgh Postnatal Depression Scale (EPDS), Generalised Anxiety Disorder Scale (GAD7), Perinatal Anxiety Screening Scale (PASS), PTSD Checklist (PCL-5) and Scale for the Assessment of Somatic Symptoms (SASS).

    Results

    Complete data were available for 443 participants. Tiredness and body weakness were the most commonly endorsed symptoms among participants with common mental disorders. Among perinatal participants, the AUROC was highest for the GAD7 (0.88, 95% CI 0.79 to 0.96) and SASS (0.84, 95% CI 0.71 to 0.96). Among non-perinatal participants, the AUROC was highest for the SASS (0.92, 95% CI 0.88 to 0.97) and PHQ9 (0.91, 95% CI 0.86 to 0.96).

    Conclusions

    Measures which assess for fatigue, tiredness and somatic symptoms may help to identify women experiencing common mental disorders in this setting. Small numbers of participants with clinically diagnosed mental disorders in our sample mean results must be interpreted cautiously.

    Trial registration number

    NCT05485701.

    The Montreal model of ketamine-therapy for alcohol use disorder and comorbid treatment-resistant depression: protocol for a feasibility trial

    Por: McAnulty · C. · Lavoie · P. · Cyr · S. · Lavin · P. · Elkrief · L. · Richard-Devantoy · S. · Rizkallah · E. · Lesperance · P. · Gamin · N. · Lembke · A. · Jutras-Aswad · D. · Greenway · K. · Garel · N.
    Background

    Alcohol use disorder and treatment-resistant depression (TRD) often co-occur, presenting a major clinical challenge with limited effective treatments. However, ketamine produces rapid antidepressant effects and has shown promise in reducing alcohol use, and acceptance and commitment therapy (ACT) can be effective for both substance use and mood disorders. This study explores the feasibility and acceptability of combining ACT with ketamine within the framework of the Montreal Model—a structured, integrative psychedelic ketamine therapy developed for severe TRD.

    Methods and analysis

    This study is a single-group, open-label feasibility trial at the Centre hospitalier de l'Université de Montréal (CHUM) Neuromodulation Ketamine Clinic in Montreal, Canada. 30 participants diagnosed with both alcohol use disorder and treatment-resistant depression will receive eight weekly in-person or virtual ACT sessions in addition to six intravenous ketamine infusions. The primary outcome is feasibility, assessed through study completion and protocol adherence. Secondary outcomes include recruitment rate, tolerability, safety, data completeness and healthcare resource use. Exploratory measures will examine changes in depressive symptoms, alcohol use and quality of life using validated tools. A subset of participants will participate in semistructured qualitative interviews to explore their experiences.

    Ethics and dissemination

    This study was approved by the ethics committee of the CHUM on 14 May 2025. The results of the trial, including primary and secondary outcomes, will be published in peer-reviewed scientific journals.

    Trial registration number

    NCT06620276.

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