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A pre-post pilot feasibility study of the MindBia web-based nutrition intervention for individuals with severe mental illness: Study protocol.3 days agoPeople living with severe mental illness experience substantial health inequalities and high rates of premature mortality, largely driven by modifiable lifestyle-related risk factors, including poor diet quality. Digital technologies may provide scalable and flexible opportunities to support healthier behaviours; however, few interventions have specifically targeted nutrition-related outcomes as a primary focus in this population. MindBia is a co-designed, web-based digital nutrition intervention consisting of six structured modules developed for individuals residing in high-support mental health hostels. The intervention was informed by prior studies with service users and mental health staff. This pilot study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of the MindBia intervention over eight weeks. A mixed-method pre-post design will be employed. Participants will complete baseline and post-intervention assessments examining dietary behaviours, digital literacy, and general wellbeing. Engagement with the web-based application will be monitored using embedded usage analytics. Semi-structured interviews conducted post-intervention will explore participants' experiences, perceived impact, and barriers to engagement. Findings from this pilot study will inform refinement of the MindBia web-based application and guide the design of a larger scale trial evaluating its overall effectiveness.Mental HealthAccess
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Possible Role and Function of AI Conversational Agents in Dialectical Behavior Therapy for Borderline Personality Disorder: Qualitative Interview Study.3 days agoBorderline personality disorder (BPD) is associated with substantial distress and a high risk for suicide. Individuals with BPD may be unable to access evidence-based treatments like dialectical behavior therapy (DBT). Artificial intelligence conversational agents (AI-CA) are increasingly discussed as scalable tools for mental health support, but little is known about how DBT clinicians understand the possible role of AI-CA in treatment.
This study aimed to explore DBT psychologists' perspectives on integrating AI-CA into DBT for BPD in the future.
Seventeen psychologists in Sweden, each with at least 1 year of clinical DBT experience (mean 6.4 years, SD 5.6), participated in semistructured interviews as part of this qualitative study. Interviews were conducted in Swedish, transcribed verbatim, and analyzed using reflexive thematic analysis within a constructivist framework. Participants did not test a specific AI-CA.
Three main themes were developed from the data. The first main theme, "Who Are We in Therapy?" explored how participants defined AI-CA relationally, positioning it variously as a tool, team member, or supervisor, and a sometimes harmful competitor. How these positionings were configured shaped what AI-CA was seen as allowed to do. The second main theme, "The Stoic Helper," captured how AI-CA was constructed as an extension of the ideal helper: available, competent, adaptable, and tireless, able to provide support in moments when human therapists could not or preferred not to be present. Participants' hopes for what AI-CA could become often mirrored qualities they found difficult to sustain in their own clinical work. The third main theme, "The Well-Intended Accommodator," captured concerns that AI-CA may reinforce dependency and function as a safety behavior by supporting reassurance-seeking rather than autonomy. A central concern was not whether AI-CA could generate validating responses, but whether it could know when validation supports change and when it becomes maladaptive accommodation (AI functional ambiguity).
Perceived benefits mainly centered on accessibility and support for DBT skills generalization, whereas key concerns involved alliance disruption, reinforcement of behaviors that would ideally be targeted for change, dependency, and questions regarding responsibility in high-risk situations. Integrating AI-CA into DBT is not only a technical question but a relational and ethical one. How AI-CA is positioned in relation to the therapist, person in treatment, and team shapes which tasks are considered acceptable and what form integration can take. The findings highlight the need for implementation frameworks that account for relational dynamics, treatment-specific considerations, and AI functional ambiguity that may arise when AI-CA operates in complex therapeutic contexts.Mental HealthAccessCare/ManagementEducation -
ACTIVATE: A protocol for a randomised controlled evaluation of Thumos: A cognitive-behavioural intervention for medical students.3 days agoMedical students experience high rates of burnout and mental health distress, with approximately half reporting burnout, one-third experiencing depression, and one-tenth having suicidal thoughts. These issues are exacerbated during clinical placements and contribute to workforce attrition after qualification. Existing interventions are largely generic and show limited effectiveness. Thumos, a cognitive-behavioural therapy-based intervention specifically tailored for healthcare professionals and medical students, addresses the stressful situations intrinsic to medical training and practice. This randomised controlled trial will evaluate whether Thumos improves psychological resilience, confidence in dealing with stressful situations, burnout, and depression in medical students compared with services as usual (SAU).
Two hundred and twenty UK medical students in a year that contains a clinical placement of a week or longer will be recruited nationally from UK medical schools. Participants will be randomised 1:1 to receive either Thumos (two online group workshops and one individual video/phone call) or SAU. Assessments will occur at baseline, post-intervention, 4-month, and 9-month follow-up. The primary outcome is psychological resilience measured by the Brief Resilience Scale at 4-month follow-up. A mixed-methods process evaluation will assess acceptability and feasibility.
To our knowledge, this is the first randomised controlled trial of an intervention specifically designed to prepare medical students for stressful clinical events. If effective, Thumos could potentially be adapted for medical students in other countries.
ISRCTN12744098: https://www.isrctn.com/ISRCTN12744098; An evaluation of a cognitive-behavioural intervention for medical students.Mental HealthAccessCare/ManagementAdvocacyEducation -
"I want to take the power back": An interpretative phenomenological analysis of self-management in coexisting physical and mental long-term conditions.3 days agoIndividuals living with both physical and mental health conditions face compounding barriers to self-management. These challenges arise from complex care needs, interactions between long-term conditions symptoms and inequalities resulting in a high treatment burden. While previous research on coexisting conditions has largely focused on those with severe mental illness, there remains an important gap in understanding the factors that help or hinder self-management among adults living with coexisting physical and common mental health conditions (anxiety/depression) in the community.
This study aims to explore the facilitators and barriers to self-management for adults living with a physical long-term condition and coexisting anxiety or depression in the community.
A qualitative study with in-depth semi-structured interviews was conducted between May and August 2025. Eight adults living with coexisting physical and mental health conditions in the UK participated. Interview data was recorded, transcribed and analysed using Interpretative Phenomenological Analysis.
Three main themes were generated; (1) Moving beyond sink or swim: scaffolding support to self-manage (2) Self-managing: a choice or systemic exclusion (3) Unseen struggles: learning to live with my long-term conditions. Participants described the complex, often unsupported reality of self-managing coexisting long-term conditions, where many felt forced to integrate self-management into their lives due to systemic gaps and negative interactions with healthcare professional. Their experiences demonstrated an apparent hinderance to self-management, with age, condition visibility and identity struggles creating compounding barriers. Therefore, a holistic scaffolded support approach promoting integrated care was suggested to meet both their health and social needs.
Our study provides insight into self-management facilitators and barriers among adults living with coexisting physical-mental health long-term conditions, highlighting substantial barriers to self-management and the need for person-centred, flexible, integrated support. The findings emphasise the need for new care models reflecting evolving presentations and domains of coexisting conditions.Mental HealthAccessCare/Management -
Seizure Disorders in Adults: Evaluation of a First Seizure.3 days agoChronic prostatitis/chronic pelvic pain syndrome is a common male genitourinary condition comprising urinary, musculoskeletal, gastrointestinal, and/or psychological concerns with pain as a prominent feature. It is a diagnosis of exclusion. Physicians should use validated patient questionnaires to inventory presenting symptoms and symptom evolution over time. Questionnaires, such as the National Institutes of Health Chronic Prostatitis Symptom Index, can be particularly helpful in monitoring treatment effect on symptoms. Standardized classification systems can prove useful in choosing therapeutic modalities. Treatment should be individualized for each patient and multimodal; it should focus on symptomatic improvement, with a 25% or 6-point reduction in the National Institutes of Health Chronic Prostatitis Symptom Index score being defined as success. Chronic prostatitis/chronic pelvic pain syndrome is a chronic pain condition. Although pharmacologic and nonpharmacologic treatment modalities have variable proven benefit, few are supported by robust evidence. Chronic prostatitis/chronic pelvic pain syndrome does not predispose men to prostate cancer, but it may be associated with male infertility. Physicians should also be alert for its mental health effects on men.Mental HealthAccessCare/ManagementAdvocacy
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What Supports Students' Well-Being? Insights From Veterinary Learners at an Australian University.3 days agoInterventions that support well-being while educating future veterinarians are widely reported and embedded within most veterinary curricula. A key challenge for educators is understanding which interventions veterinary students are most likely to engage with and how these can be effectively embedded within the curriculum. At the University of Sydney, well-being support is provided through university services and is explicitly integrated into the curriculum. Our objective was to explore this for DVM students at the University of Sydney as part of a curriculum review. A cross-sectional anonymous, online survey was distributed to all currently enrolled DVM students over 5 weeks during semester 1 in 2025. Response rate was 26.4% (n = 142). DVM year had a significant effect on engagement with university mentor services (p = .03); perceived barriers to accessing external well-being interventions, including time (p = .03) and location (p = .04); overall satisfaction with well-being curriculum (p = .04); desire for more career management learning (p = .03); and likely engagement with a novel pet therapy program (p = .05). International students were significantly more likely than domestic students to engage with university mental health services (p < .01) and to report lower preference scores for additional time management learning (p = .03). Students indicated a high likelihood of engagement with food-based well-being interventions (mode = 5). Findings suggest that students' preferences for school-supported well-being interventions vary across degree stage. Further research is needed to inform development of targeted well-being initiatives that maximize student engagement.Mental HealthAccess
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Comparing the Feasibility of In-Person and Online Preventive Cognitive Therapy for Major Depressive Disorder After Partial Response to Repetitive Transcranial Magnetic Stimulation: Protocol for a Pilot Randomized Controlled Trial.3 days agoIn recent years, repetitive transcranial magnetic stimulation (rTMS) has become a first-line recommendation in the Netherlands for individuals with major depressive disorder (MDD) who have not responded to a minimum of 2 prior treatments. Although rTMS can be effective, there is a significant risk of relapse after treatment. Currently, there are no standardized treatment options available after rTMS treatment completion aimed at preventing relapse. Preventive cognitive therapy (PCT) is a brief psychological intervention designed to prevent relapse in partially and fully remitted individuals with MDD.
This study aims to establish the feasibility of 2 distinct forms of PCT (online and face-to-face) after intensive rTMS treatment for responding patients.
Participants who demonstrate partial or full response to rTMS, defined as at least 25% reduction in symptoms, as quantified using the Inventory of Depressive Symptomatology-Self-Report (IDS-SR) or an IDS-SR score of 22 or lower will be included. Twenty participants will be randomly allocated to either face-to-face or online PCT, and treatment adherence will be compared between face-to-face and online treatment. The study will be deemed feasible if at least 75% of participants complete PCT during the grant duration of 1.5 years. For PCT, we aim to see which delivery format is the most feasible. Secondarily, changes in affective states, assessed through experience sampling data during PCT, will be studied to establish usefulness for a larger randomized controlled trial aimed at evaluating the effectiveness of PCT after rTMS. Finally, possible MDD relapse will be monitored throughout the intervention and follow-up periods.
This study was funded in November 2023 by the Netherlands Organisation for Health Research and Development. It was reviewed and approved according to the Medical Research Involving Human Subjects Act (Wet Medisch-Wetenschappelijk Onderzoek met Mensen) by the Medical Research Ethics Committee of Amsterdam University Medical Center on June 17, 2024. Data collection started in August 2024 and ended in April 2026, with an inclusion of 11 participants. As of June 2026, data analysis has not yet started. We expect data analysis and manuscript preparation of results to be completed in December 2026.
If this pilot study shows preferred feasibility of a specific format of PCT (either online or face-to-face) following rTMS treatment for depression, a larger-scale randomized controlled clinical trial may be performed to study the effects of PCT on remission duration, relapse rates, and affective states in remitted individuals with MDD after rTMS treatment using this preferred delivery format. This pilot will provide insights into the feasibility of face-to-face or online PCT after successful rTMS treatment in depression.Mental HealthAccessCare/ManagementAdvocacyEducation -
The Use of Waivers of Guardian Permission in the United States for Pediatric Digital Health Intervention Research Since 2020: Systematic Review.3 days agoDigital health interventions (DHIs) offer scalable ways to reach youth. While DHI research often poses minimal risk, guardian permission is typically required for minors to participate. As a result, requiring guardian permission may unintentionally obstruct safe, high-quality research and delay its translation.
This review aims to explore practices related to guardian permission. This study systematically reviewed randomized controlled trials of DHIs with minors from the United States published between January 1, 2020, and June 17, 2026.
PubMed, Embase, PsycINFO, and ACM Digital Library were searched; Cochrane Library and Web of Science yielded only duplicates and were therefore excluded. Included studies had to be: conducted in the United States, randomized controlled trials evaluating DHIs for pediatric mental and/or behavioral health, written in English, and peer-reviewed. Studies were excluded if participation was decided at the school level, included caregivers or pregnant teens as participants, or had a mean sample age of more than 18 years. Two coders independently screened and extracted data, with a third, unique reviewer resolving discrepancies. Risk of bias was assessed using the revised Cochrane risk of bias tool for randomized trials (RoB 2). A narrative framework was used to identify themes. Inverse variance-weighted linear regressions and logistic regressions were conducted to compare studies with and without permission waivers.
Of 7170 screened studies, 49 met inclusion criteria (21 used guardian permission waivers; 28 required permission). The most commonly reported rationale for waiver use was participant privacy. Logistic regressions showed that studies with waivers were more likely to assess gender beyond the binary of male-female (odds ratio [OR] 4.27, 95% CI 1.22-14.93; P=.02) and more likely to recruit online (OR 0.04, 95% CI 0.01-0.17; P<.001). Weighted study-level regression revealed significantly lower follow-up retention in studies with waivers (mean 77.03%, SD 12.32%) compared to those requiring guardian permission (mean 88.61%, SD 17.17%; P=.005). No significant differences emerged across age, race, ethnicity, assessment of suicidality, sensitive topic assessment, intervention focus, or treatment retention.
Though several frameworks exist for evaluating ethics around waiving guardian permission for minors in research, this is the first review to systematically evaluate research in DHI, which often varies in terms of its level of risk. Although small sample sizes and variable reporting practices limited statistical power, the lack of differences in sample characteristics or study features between studies that used waivers and those that did not suggests that institutional review boards may be differentially interpreting regulations and guidance on waiving guardian permission. These findings likely indicate the need for more evidence to guide risk and benefit evaluations-or more education about the existing evidence base, as well as the risks and potential benefits of pediatric DHI research.Mental HealthAccessCare/ManagementAdvocacyEducation -
Screening Questionnaire Modifications and Firearm Access Disclosure Among Adults in Primary Care.3 days agoMental HealthAccess
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A Digital Therapeutic Intervention for Negative Symptoms of Schizophrenia: A Randomized Clinical Trial.3 days agoNegative symptoms of schizophrenia are a major contributor to poor outcomes, yet no US Food and Drug Administration-approved pharmacotherapies are specifically indicated for their treatment. In particular, motivation and pleasure negative symptoms are especially burdensome for patients. Psychosocial interventions can be effective, but access barriers and challenges in sustaining engagement limit their impact. Digital therapeutics are a novel modality that can deliver patient-centered interventions. CT-155/BI 3972080 (CT-155), an investigational smartphone-based digital therapeutic integrating evidence-based psychosocial strategies, is designed to address negative symptoms of schizophrenia adjunctive to pharmacotherapy.
To evaluate the effectiveness and safety of CT-155 as an adjunct to pharmacotherapy for negative symptoms of schizophrenia.
CONVOKE was a phase 3, multicenter, double-blind, parallel-group, randomized clinical trial conducted between March 31, 2023, and June 20, 2025, at 66 clinical sites in the US among adults with negative symptoms of schizophrenia who were receiving up to 2 antipsychotic medications.
Participants were randomized 1:1 to CT-155 or a digital control for 16 weeks.
The primary end point was change from baseline to week 16 in Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure subscale (CAINS-MAP) score. Secondary end points included change from baseline to week 16 in Positive and Negative Syndrome Scale positive subscale scores. All baseline demographic and clinical characteristic, effectiveness, and engagement analyses were performed using the intention-to-treat set.
Overall, 457 participants were randomized (227 to CT-155 and 230 to digital control; mean [SD] age, 45.8 [12.5] years; 277 male [60.6%]). Retention analyses showed that most participants stayed active in CT-155 (70.4%; [160 of 227]) or digital control (76.5% [176 of 230]) through the end of week 15. At week 16, CT-155 significantly reduced mean (SE) CAINS-MAP total score vs digital control (CT-155 [n = 196], -6.8 (0.5); digital control [n = 204], -4.2 (0.5); least-squares difference, -2.6 [95% CI, -4.0 to -1.2]; P < .001; Cohen d, -0.36 [95% CI, -0.56 to -0.17]). During the 16-week intervention and 4-week follow-up, serious adverse events occurred in 3 of 228 participants (1.3%) receiving CT-155 and 5 of 231 (2.2%) receiving digital control; none were treatment related.
In this randomized clinical trial, CT-155 improved motivation and pleasure negative symptoms with a small-to-moderate effect size comparable with psychosocial interventions and pharmacologic treatment in psychiatry and was well tolerated and safe, thus representing a novel adjunctive therapy for schizophrenia. CT-155 may represent a scalable, accessible option for improving schizophrenia negative symptoms.
ClinicalTrials.gov Identifier: NCT05838625.Mental HealthAccessCare/ManagementAdvocacyEducation