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NCT04924088
The legal team in medical-legal partnerships works with healthcare providers to improve their clients' lives. It is unknown whether this approach is better than providing usual legal services, with no special emphasis on non-legal matters and no particular collaboration with healthcare providers. The investigators propose to randomly assign 300 Veterans with housing-related legal problems to either legal help from a medical-legal partnership or help from lawyers in the community. The investigators will follow the randomized Veterans in this study for one year to determine if there is a difference between the two groups of Veterans in their housing situations and their mental health. The investigators will also interview Veterans in both groups about their experience of the legal services they have received.
NCT05211713
The aim of the project is firstly, to develop an app-based mental health intervention for adolescents. Secondly, to evaluate the effect of this app. The overarching goal is to offer a low-threshold intervention, called Opp, that is easily accessible and free to use for all adolescents in Norway.
NCT07576855
The goal of this study is to learn whether a telephone-based program that helps people share life memories can reduce loneliness and improve mental well-being, life satisfaction, and social support in older adults and their caregivers living in rural areas. This study has two parts. In the first part, researchers will gather feedback from a small group of older adults and informal caregivers to see if the updated telephone reminiscence program works well and is easy to use. In the second part, researchers will test the telephone reminiscence program in a clinical trial study to see whether the updated telephone reminiscence program reduces loneliness and improves social support, life satisfaction, and mental well-being in older adults and their caregivers. The researchers will also examine how the program impacts how often and for what reason you reminisce. The main questions this study aims to answer are: * Does the telephone reminiscence program improve social support, life satisfaction, and mental well-being and reduce loneliness in rural older adults and their caregivers? How does the telephone reminiscence impact how often and for what reason participants reminisce? * How often and how long do participants use the program? * How satisfied are older adults and informal caregivers with the program? In this study researchers will compare participants who begin the telephone reminiscence program right away with participants who start the program after a 12-week waiting period to see whether starting the program earlier leads to better outcomes. Participants will: * Take part in telephone calls 3 times a week that invite older adults to talk about their life experiences. * Answer brief survey questions about social support, loneliness, and mental well-being, and life satisfaction over time. * Include both older adults and their informal caregivers, who may also participate by recording questions in their own voice.
NCT07073963
This research study is testing whether Mindfulness-Based Stress Reduction (MBSR) can help reduce fatigue in people with sarcoidosis. The study will also look at whether MBSR can improve symptoms of anxiety and depression. Participants will be placed into one of two groups: * One group will take part in an 8-week virtual MBSR program, attend weekly online sessions, keep a daily mindfulness journal, and complete surveys about fatigue, anxiety, and depression. * The other group will join a virtual support group once a month for 5 months and complete the same surveys. The goal is to see which approach is more helpful for improving fatigue and mental well-being in people with sarcoidosis.
NCT07129070
This study will evaluate the usability, feasibility, and acceptability of a novel multi-level Just-In-Time Training (JITT) implementation strategy (JITT-EBP) that aims to equip mentors and mentor supervisors to implement evidence-based practices (EBPs) with fidelity using methods that are sustainable in rural communities. JITT-EBP integrates (a) self-directed, on-demand, online training modules for mentors and mentor supervisors, (b) synchronous evidence-based supervision strategies, and (c) an apprenticeship delivery model in which EBPs are co-led by an experienced mentor and a novice mentor, providing opportunity for in-the-moment training and support. The study will conduct a pilot hybrid type 2 effectiveness-implementation trial to evaluate the use of JITT-EBP compared to usual training for implementing mentor-delivered Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), an evidence-based depression prevention program. 96 adolescents (age 12-17) and their parents, 8-18 mentors (depending on amount of turnover), and 4 mentor supervisors will be enrolled in the trial.
NCT07545239
Migrant populations experience elevated levels of psychological distress while facing barriers to accessing mental health care. Lifestyle factors such as physical activity, sleep, diet, and social engagement are closely linked to mental health and represent promising targets for preventive interventions. Digital delivery may increase accessibility and reduce structural barriers to care. The aim of this study is to evaluate the feasibility, acceptability, and efficacy of a culturally and linguistically adapted digital lifestyle intervention for migrants experiencing moderate psychological distress in Sweden. Participants (N = 240) will be randomized to an 8-week digital lifestyle intervention or to a wait-list control receiving a general lifestyle module. A nested pilot study (N = 30) will first assess feasibility and acceptability. Outcomes include general psychological health, quality of life, depression, anxiety, stress, and lifestyle behaviors. Assessments will be conducted at baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up.
NCT07544498
This study investigates the effectiveness of an extended reality (XR) based resilience training program designed to support the mental health and well-being of nurses working in hospital settings. Nurses are exposed to high emotional, cognitive, and organizational demands and show elevated levels of work-related stress and stress-associated mental health problems. Strengthening resilience and coping capacities is therefore an important preventive approach to support nurses' well-being and sustain quality of care. The study is conducted as a pragmatic randomized controlled trial with a waitlist control group and includes approximately 232 nurses from hospitals in several European countries. Participants are randomly assigned either to an XR-based resilience training group or to a waitlist control group that continues with care as usual during the waiting period. The XR-based intervention consists of eight immersive training sessions delivered over approximately ten weeks using a head-mounted display. The training focuses on behavioral, cognitive, and emotional coping strategies and aims to enhance key resilience factors such as problem-solving, cognitive reappraisal, emotion regulation, and positive self-care. The primary outcome is perceived stress, assessed using the Perceived Stress Scale. Secondary outcomes include resilience, occupational self-efficacy, quality of life, psychological distress, burnout symptoms, coping strategies, work-related rumination, and turnover intentions. Assessments are conducted at baseline, post-intervention, and at a 20-week follow-up. In addition, a subgroup of participants will optionally provide physiological data during selected XR sessions to explore digital biomarkers related to stress and recovery. The findings of this study will provide evidence on the effectiveness, feasibility, and acceptance of XR-based resilience training for nurses and inform future implementation of digital mental health interventions in healthcare workplaces.
NCT05525676
This study compares two approaches to working with Veterans that have a mix of mental health and relationship concerns in primary care. One approach is a 3-session couple-based program called the Brief Relationship Checkup (BRC). BRC has shown promise improving relationship health in Air Force primary care (including some mental health symptoms related to relationship functioning) but has never been tested for individuals with significant mental health concerns. The other approach is a high-quality delivery of three sessions of Co-Located Collaborative Care (CCC) with the Screened Veteran only. This program is the current standard of care for Veterans reporting mental health concerns in primary care (including mental health concerns related to their relationship) but has never been tested for individuals struggling with relationship concerns. The goal is to compare the benefits of the couples-based program vs. the individual-based program when it comes to reducing suicide risk factors at the relationship level and the individual level.
NCT07525271
The purpose of this study is to evaluate the effectiveness of the Syndemic-Adapted Medly Uganda (SAMU) in improving mental health care among adults living with HIV and hypertension in Uganda. In sub-Saharan Africa (SSA), there is a high prevalence of depression and anxiety among people living with HIV (PLHIV) as well as alcohol use disorder (AUD). PLHIV who experience depression are less likely to link to HIV care, adhere to antiretroviral therapy, and achieve viral suppression. Building on research conducted to adapt Medly Uganda for mental health using a syndemic framework, this study aims to assess the effectiveness of SAMU on mental health screening and diagnosis. This will be accomplished through a two-arm trial in which 1. participants will be enrolled, screened, re-screened, and assessed for diagnosis and linkage to care for depression, anxiety and AUD and 2. evaluate the factors impacting sustained engagement in the SAMU program, through mixed methods.
NCT06805682
A significant number of children are abused or neglected every year. This exposure is associated with short- and long-term consequences for their mental and somatic health. In France, 308,000 minors are benefiting from at least one child protective service or measure. There are few data on the health status of this population, and how it is evolving. Against this backdrop, interventions are needed to address the many needs of these children early and comprehensively, both in the short and long term. The PEGASE program, funded by the French government under Article 51, aims to ensure adequate medical follow-up - both somatic and psychiatric - for children taken into care by child protective services (CPS). An evaluation of the program's effectiveness and efficiency is needed to inform public decision-making on the appropriateness of extending it to all children under CPS's care. This requires the creation of a control cohort of children followed by CPS but not benefiting from the PEGASE program, the ESPER cohort (Prospective cohort study of protected children), which will enable us to carry out a comparative evaluation of the PEGASE program, as well as to provide information on the health of children followed by the CPS at the time of their placement and its evolution over time, data which are rare in France. The main objective is to evaluate the effectiveness of the PEGASE program on the evolution of the mental health of children followed by the CPS after 2 years of follow-up.
NCT07502092
High levels of chronic and recurrent workplace stress can profoundly impact the physical, mental, and emotional health of first responders. A multi-modal evidence-based mindfulness intervention was delivered to cohorts of first responders to evaluate effects on perceived stress, resilience, work engagement, and musculoskeletal pain.
NCT05713695
This 3-year Hybrid Type 1 study will randomize 208 people with co-occurring substance use and mental health disorders (COD) referred from the Worcester Hub. This study seeks to evaluate the effectiveness of MISSION, a multi-component team approach, versus linkage with a Peer Specialist on improving outcomes among individuals with CODs. We expect that individuals receiving MISSION versus linkage only will show greater improvement in treatment engagement, substance use, and mental health outcomes. This study will also concurrently conduct a process evaluation to inform sustainability and future implementation of such interventions.
NCT07509853
The study evaluates the integration of a sexual pleasure-based approach into harm reduction services for MSM and transgender persons engaging in chemsex or substance use in Thailand, using the "Pleasuremeter" tool to improve sexual health and related outcomes.
NCT07512869
This study evaluates the pre-implementation phase of a host-led harm reduction model for men who have sex with men (MSM) engaging in chemsex in Bangkok, Thailand, focusing on understanding harms, contexts, and needs to develop a tailored intervention.
NCT07495839
Addiction is a major public health issue. According to the World Health Organization (2024), approximately 400 million people worldwide suffer from alcohol- or drug-related disorders, resulting in nearly 3.2 million deaths per year. In France, the situation is also cause for concern: approximately three million people engage in risky alcohol consumption, thirteen million smoke daily, and nearly one and a half million use illicit drugs, primarily cannabis. Addiction, defined by the National Institute on Drug Abuse (NIDA) as a chronic, relapsing brain disorder, is characterized by the compulsive pursuit and use of a substance despite knowledge of its harmful effects. Its development depends on multiple factors: personal (trauma, psychiatric disorders, genetic predispositions), environmental (stress, isolation, family context), and those related to the substance itself (addictive potential). The diagnosis of substance use disorders is based on 11 criteria defined in the \*Diagnostic and Statistical Manual of Mental Disorders\* (DSM-5), the main ones being: loss of self-control, interference of substance use with academic or occupational activities, continued use despite awareness of the problems it causes, and a new central criterion, craving, defined as an irresistible urge to use, which serves as both a symptom and a diagnostic and prognostic marker because it is a predictor of relapse. The cumulative total of criteria allows the disorder to be classified as mild (2-3), moderate (4-5), or severe (≤ 6). Since the 2020 health crisis, researchers have observed an increase in the use of psychoactive substances, particularly among vulnerable populations. Despite public policy efforts and treatment programs, relapses remain common after treatment, affecting 60 to 70% of patients within six months of their hospitalization. This phenomenon is also observed at La Musse Hospital, where many patients admitted to the nutrition and alcoholism unit express a sense of emptiness upon returning home: a void in relationships, therapy, and daily activities. This feeling often contributes to a return to substance use. To address these relapses, this study aims to evaluate the impact of a post-hospitalization equine-assisted therapy program on the mental health and addictive behaviors of patients receiving addiction treatment. Already used at La Musse Hospital as part of the care pathway, equine-assisted therapy is based on the interaction between the patient and the horse in a therapeutic setting. Several studies have demonstrated the benefits of this approach on emotional regulation, self-confidence, stress management, and overall well-being. This prospective, single-center, interventional study will include twenty-two patients who have been hospitalized at least once in the nutrition and alcoholism unit at La Musse Hospital or another facility. Participants will be randomly assigned to either a group receiving post-hospitalization equine-assisted therapy or a control group.
NCT05064293
The randomized, two-arm pragmatic trial will test the effectiveness of offering 6-months of telephonic support from a mental health (MH) navigator to promote early access, engagement, coordination, and personalization of mental health treatment and services for children naïve to such treatments and services, and who are identified as being at risk for behavioral health concerns. The model includes: (a) automated identification of early symptoms for children meeting criteria for behavioral health problems using a previously developed Natural Language Processing (NLP) program and predictive algorithm; (b) standardized instruments for assessment and diagnosis of mental health disorders (c) 30 minute assessment appointments with a study psychologist (d) creation of an Epic "reporting workbench" and Epic "smart form" to facilitate the outreach, monitoring and follow-up of families/children by the MH navigator; (e) use of MH Navigators (e.g., clinical social workers) to conduct family outreach, and coordination with and between clinicians; and (f) the offer of one to four clinic-to-home videoconferencing brief therapy sessions to bridge families/children unwilling or unable to access in-person MH services.
NCT06623682
This proposed study aims to evaluate the implementation of integrating the existing services in tertiary education institutions with the JCTH+ platform. The study aims to evaluate the efficacy of JCTH+ on students' mental health outcomes as compared to service as usual, and to assess the cost-utility of the platform to determine whether the benefits of implementing the platform justify the costs associated. It is hypothesized that participants who receive integrated self-help and support services will show (H1) a greater reduction in mental health symptoms, and (H2) better mental well-being compared with participants in the control condition, i.e. service-as-usual (SAU).
NCT07485673
Background: Adolescence is a period of intensified emotional responses and occurs when mental health disorders commonly develop since adolescents are learning how to deal with powerful emotions. Globally, 15% of adolescents experience a mental disorder like depression or anxiety. However, adolescent mental health goes beyond mental disorders. It is state of mental well-being that allows individuals to deal with stressors, recognize their abilities, develop their activities well, and participate in society, providing a holistic approach that highlights the interplay between psychological well-being and other aspects of life. Given this perspective, a Lifestyle Medicine (LM) approach based on a multi-component framework is needed for assessing adolescents' mental health. This study aims to evaluate adolescents' (aged 14-19) mental health, identify and mitigate the risks of developing any mental health disorder as well as formulate comprehensive interventions to promote and increase their emotional wellbeing. Methods: Cross-sectional and longitudinal studies will be performed. Adolescents from Quito, Ecuador will be recruited using a simple random sampling technique. The minimum sample size is 385; however, to increase the precision of the estimates, a target sample of approximately 1000 participants will be established. Main outcome measure will be mental health using social determinants of health and lifestyle medicine factors. Conclusion: This research project will evaluate adolescents' mental health through a holistic and multiapproach evaluation and interrelate social determinants of health and lifestyle medicine variables to propose and design multidisciplinary strategies and interventions to prevent and mitigate mental health outcomes in adolescents. Additionally, the results will be useful in informing public health authorities to evaluate or modify current policies
NCT07473505
This study prospectively evaluates the effects of Integrative Bilateral Cervical Sympathetic Block (BCSB) on trauma-related symptoms in Special Operations Veterans, comparing outcomes in those receiving BCSB alone versus BCSB combined with structured integrative therapy. Using standardized FDA-approved dosing, validated symptom measures, and strict safety criteria, the study aims to determine whether this dual-level autonomic intervention improves PTSD-related and TBI-related symptoms, and whether pairing the procedure with therapy enhances durability and overall clinical benefit.
NCT07137572
This is a parallel-group randomised-controlled trial aiming to assess the effect of exposure to the arts on mental health and wellbeing of community dwelling recipients of mental health care. The trial constitutes a comparison of two arms: An Art Intervention arm, hereby the Active Group (AG), versus a waitlist control arm (WL).