• ACTIVATE: A protocol for a randomised controlled evaluation of Thumos: A cognitive-behavioural intervention for medical students.
    4 days ago
    Medical 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.
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  • "I want to take the power back": An interpretative phenomenological analysis of self-management in coexisting physical and mental long-term conditions.
    4 days ago
    Individuals 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.
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  • Seizure Disorders in Adults: Evaluation of a First Seizure.
    4 days ago
    Chronic 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.
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  • What Supports Students' Well-Being? Insights From Veterinary Learners at an Australian University.
    4 days ago
    Interventions 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.
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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.
    4 days ago
    In 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.
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  • The Use of Waivers of Guardian Permission in the United States for Pediatric Digital Health Intervention Research Since 2020: Systematic Review.
    4 days ago
    Digital 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.
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  • A Digital Therapeutic Intervention for Negative Symptoms of Schizophrenia: A Randomized Clinical Trial.
    4 days ago
    Negative 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.
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  • Prepare, don't scare: Rethinking cognitive readiness before epilepsy surgery.
    4 days ago
    Epilepsy surgery is an effective but underutilized treatment for drug-resistant epilepsy, and concerns about postsurgical cognitive change are a prominent barrier. Refinements in surgical technique can reduce cognitive impact, but cognitive change cannot always be avoided, and approaches carrying lower cognitive risk are often less effective for seizure control. Cognitive change therefore needs to be addressed directly rather than minimized through surgical strategy alone. This article proposes cognitive prehabilitation, a structured presurgical intervention combining individualized risk-benefit education, compensatory strategy training, and recovery planning, as a potential advancement in presurgical care. A central conceptual shift is reframing potential postsurgical cognitive decline from an outcome to be feared to a cost that patients can prepare for, adapt to, and weigh against the benefits of seizure freedom. The literature specific to cognitive prehabilitation in epilepsy surgery is too limited to support systematic review; thus, we draw on adjacent evidence bases, including cognitive rehabilitation in epilepsy, prehabilitation in other surgical populations, and literatures on shared decision-making and risk communication, to outline complementary frameworks. We detail theoretical components of cognitive prehabilitation, including risk communication and expectation setting, cognitive compensatory training, attention to mental and physical wellbeing, planning for postsurgical recovery, and peer support. Clinical and structural barriers to implementation are discussed, including patient engagement challenges and healthcare constraints. Priorities for future research include standardization of prehabilitation protocols, identification of patient-level moderators of benefit, and scalable delivery formats. Cognitive prehabilitation represents an opportunity to move toward empowerment-based presurgical care and to expand access to epilepsy surgery. PLAIN LANGUAGE SUMMARY: Many people with drug-resistant epilepsy avoid surgery because of the risks associated with declines in memory and thinking. This article describes the concept of cognitive prehabilitation, which is a presurgical program that gives patients personalized information about what may change with surgery, teaches practical strategies for managing memory and thinking difficulties should they arise, and helps them plan for recovery. The aim is for patients to prepare for possible memory and thinking changes rather than simply fear them. Research is still early, and studies are needed to test whether prehabilitation improves outcomes.
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  • Improving Vocational Rehabilitation for people with Mental Health Problems through Intersectoral Collaboration: A Mixed-Method Implementation Study.
    4 days ago
    Work participation is associated with improved health and wellbeing. Vocational rehabilitation (VR) programs support individuals, including those with mental health problems, in obtaining and maintaining employment. Integrating mental health and work support in VR is considered more effective but requires cross-sector collaboration. In a Dutch region, multiple stakeholders jointly implemented a collaborative initiative, covering the access route to and the delivery of three VR interventions. This study evaluated the implementation process, outcomes, and working mechanisms of this collaborative initiative.

    We conducted a mixed-methods process evaluation, including 37 interviews with 12 clients, 14 professionals, and 11 managers/directors, supplemented by field notes and documents over a 3-year period. Monitoring data included intervention start and end dates, participation ladder (PL) level, and registered outcomes (i.e., paid employment or voluntary work). Data were analysed using the UK MRC guidelines for process evaluations, covering implementation outcomes (according to Proctor), mechanisms of impact, context, and both intended and unintended outcomes.

    Between January 2021 and December 2023, 129 clients were reached. Recruitment was challenging. Referral was hindered by external professionals' limited awareness, knowledge, and belief in clients' potential. Mean duration (dose) of the intervention lasted or exceeded the original setup, aligning with client perceived needs. Monitoring fidelity ranged from 100% at the start to 89% at 12 months, indicating fair to good fidelity. Clients valued informal conversations equally or more than the structured monitoring conversations. Trust between clients and professionals enhanced the intervention experience and perceived effectiveness. From 111 out of 129 participants their outcomes were monitored: 62 (56%) entered voluntary or paid work, after participation in the intervention. Key collaborative mechanisms were mutual trust among professionals and belief in the added value of collaboration. Contextual factors included economic-financial, political-financial, and socio-psychological factors: Governmental support and the meaningfulness of work were facilitating factors, whereas barriers included legislation and stigma, including low expectations regarding the capabilities of individuals with mental health problems.

    Professionals' knowledge and awareness of VR interventions, alongside stigma and existing legislation influenced whether individuals with mental health issues were reached for an intervention that best fits their needs. This may lead to practice variation and unequal opportunities. Clients appreciated the multifaceted support and felt they had more choices although intervention choice was usually directed by professionals. During interventions delivery both clients and professionals valued cross-sector collaboration. Trust between client and professional and among professionals was found to be a crucial mechanism for the collaborative initiative, clients progress and VR intervention success.
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