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Suicidal ideation involves thoughts about or planning for self-harm or suicide and is a critical focus area for mental health research. Clinical trials in this area often explore treatment evaluations, including medications and therapeutic approaches...

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Found 425 Actively Recruiting clinical trials

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Actively Recruiting

Young adults aged 18 to 25 who experience frequent thoughts about killing themselves are the focus of this study, which evaluates the cost-effectiveness of Attachment Based Family Therapy ABFT compared to Treatment As Usual TAU. Suicide is a leading cause of death among young adults, and current treatments have limited success. This trial aims to determine if involving family through ABFT can better reduce suicidality and improve outcomes, informing clinical guidelines and care practices in Belgium and the Netherlands. Participants are randomly assigned to one of two groups the experimental group receives ABFT as an add-on to TAU, which includes treatments like antidepressants, CBT, or DBT, with weekly ABFT sessions lasting about 16 weeks. The control group receives TAU alone, allowing up to four sessions of systemic family therapy. ABFT focuses on strengthening parent-child attachment bonds to provide a supportive base for young adults, involving parents or caregivers actively in therapy. Throughout the study, suicidality is measured at baseline, immediately after intervention, and at follow-ups 3, 6, and 12 months post-intervention using tools like the Suicidal Ideation Questionnaire Junior. Researchers also assess depressive symptoms, family functioning, attachment, quality of life, and healthcare costs. The trial includes 138 participants across multiple sites, with double-blind randomized allocation. Safety, adherence, and cost-effectiveness are closely monitored during and after the treatment period.

Age: 18Years - 25YearsAll GendersPhase Not Applicable
13 locations
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Actively Recruiting

Suicide is the second leading cause of death among youth, and rates in the US are rising despite prevention efforts. Researchers are evaluating a digital platform called Vira to improve how care is delivered to adolescents at high risk for suicide. This platform aims to use smartphone data and secure communication tools to better understand and manage risk factors like psychological distress, anhedonia, behavioral withdrawal, and sleep problems in young people receiving intensive outpatient treatment. The study compares two groups of adolescent patients aged 13 to 18 years old who are in an intensive outpatient Dialectical Behavior Therapy DBT program. One group uses the Vira platform, which collects data passively from smartphone sensors about activity, sleep, mobility, and mood-related language. Vira also prompts daily check-ins and supports practitioners with reminders to encourage behavior changes. The other group receives the usual treatment with the addition of a passive monitoring app called EARS. Participants will use their assigned app during their intensive outpatient treatment. Researchers will assess outcomes using tools like the Columbia Suicide Severity Rating Scale and Scale for Suicidal Ideation over six months. Other measures include anxiety, risky behaviors, sleep quality, mood, and pleasure scales at three and six months. The study monitors clinical outcomes to determine if the digital platform enhances care for youth at risk of suicide.

Age: 13Years - 18YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating the effectiveness and feasibility of Narrative Enhancement and Cognitive Therapy NECT, a group-based treatment designed to reduce self-stigma in people with mental disorders. Self-stigma involves internalizing negative stereotypes which can harm treatment adherence, self-esteem, quality of life, and increase despair or suicide risk. This pragmatic, multicenter, randomized controlled trial includes 416 patients from 26 mental health centers in Northeast Italy, aiming to improve psychological outcomes like self-esteem, hope, empowerment, recovery perception, and mental well-being. Participants in the intervention group will attend 20 one-hour NECT group sessions divided into five parts orientation, psychoeducation, cognitive restructuring, narrative enhancement, and conclusion. The therapy helps challenge stigmatizing beliefs and fosters a positive self-narrative. This group therapy is provided alongside participants usual care, which may include medication and psychosocial treatments. The control group will continue their standard care without NECT. The study lasts about 12 months, with a 2-month recruitment phase, 5 months of intervention, and 5 months for data analysis and publication. Participants will undergo assessments at enrollment and after the 20-week intervention to measure changes in self-stigma, self-esteem, hope, empowerment, recovery perception, mental well-being, and stigma-related stress. Treatment fidelity will be monitored through session recordings. The study also tracks feasibility by evaluating participation rates and feedback. All participants remain under their usual care throughout the study, and data collection includes monitoring care received during the trial.

Age: 18Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating the ViraSafe app, an enhanced version of the BRITE suicide safety planning app, to improve engagement with coping skills and safety planning among suicidal adolescents aged 13 to 24. This pragmatic randomized trial compares the new ViraSafe app integrated into the Vira behavior change platform with the original BRITE app, aiming to address rising youth suicide rates by using digital tools for intervention. The study focuses on youth who have experienced recent suicidal thoughts or attempts and are receiving care in clinical settings. Participants are randomly assigned to use either ViraSafe or BRITE. ViraSafe integrates safety planning and coping skills into a smartphone app with automated just-in-time reminders and daily distress ratings, supported by clinicians who can send additional nudges. The BRITE app offers self-monitoring, a safety plan, distress level ratings, and suggested coping activities based on distress. Both groups onboard the assigned app with a trained clinician or research staff. The trial lasts three months with assessments at baseline, one month, and three months. Participants complete virtual assessments including interviews and self-report measures at baseline, one month, and three months. Some participants using ViraSafe will take part in qualitative exit interviews for feedback. The study collects data on app engagement, technology acceptance, and suicide risk factors using standardized tools. Safety plans remain accessible throughout, and mental health indicators are monitored through self-reports and passive smartphone data. The total participation time is about three months, with ongoing support from clinical providers.

Age: 13Years - 24YearsAll GendersPhase Not Applicable
3 locations
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating a mentalization-based prevention program aimed at improving well-being and mental health in children aged 8 to 10 years and their families across four European countries Germany, Lithuania, Spain, and Switzerland. The study is designed as a partially randomized controlled trial and investigates how multi-level interventions involving children, parents, and teachers can promote mental health, reduce stigma, enhance help-seeking behavior, and improve classroom climate and parenting skills. The program includes a universal prevention workshop delivered at schools for all children, focusing on mental health awareness and peer support skills. Parents receive one of two different intervention trainings or a parenting guidebook one group attends 10 weekly sessions of the Lighthouse Program targeting secure attachment and reflective parenting behaviors, and another group participates in 6 bi-weekly Mentalization Based Skills Training sessions focusing on attentional control and emotion regulation. An active control group receives a parenting guidebook, while a passive control group participates in follow-up assessments without intervention. Participants will be involved in data collection at multiple time points baseline, post-intervention at 3 months, and follow-ups at 6 and 12 months. Assessments include questionnaires measuring childrens and parents well-being and mental health, parental efficacy and stress, classroom climate, teaching efficacy, and mental health stigma. Focus groups after the post-assessment will gather feedback on implementation and satisfaction. The study aims to follow 5,000 children, their parents, and teachers over a year to evaluate long-term program effects.

Age: 8Years +All GendersPhase Not Applicable
4 locations
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Actively Recruiting

Healthy Volunteer

Veterans face a heightened risk of suicide during the first year after leaving military service, especially those not connected to VA healthcare. This research aims to improve reintegration and reduce suicide risk for recently transitioned Veterans by evaluating STEP-Home-SP, a skills-based, video telehealth workshop. It is designed to provide suicide prevention education, support for accessing VA care, and tools to manage the transition effectively during this critical period. The study compares two groups one participating in the STEP-Home-SP workshop and the other receiving Enhanced Usual Care EUC, which includes standard care plus an educational packet on suicide risk and VA care connection. STEP-Home-SP involves weekly 1.5-hour group sessions over 12 weeks, focusing on emotional regulation, problem solving, and attention training, with up to six additional 30-minute individual sessions tailored to each Veterans needs. EUC involves existing transition support programs such as the Transition Assistance Program and VA Solid Start outreach. Participants will be assessed at multiple points over a year, including baseline, 12 weeks, and 24 weeks. Researchers will measure feasibility factors like recruitment and adherence, satisfaction with the program, and changes in reintegration status using the Military-to-Civilian Questionnaire. They will also monitor engagement with VA care and collect qualitative feedback. The study will help inform future larger trials and aims to address social isolation and suicide risk during Veterans transition to civilian life.

Age: 18Years - 65YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are investigating the effects of a multidomain lifestyle intervention to slow cognitive decline and dementia risk in elderly residents aged 60 to 80 in Zhejiang Province, China. The study builds on findings from Finland, where a similar approach combining physical activity, nutrition, cognitive training, social activities, and vascular risk management showed promise in healthy older adults at risk of cognitive decline. This trial aims to explore how such an intervention may change brain structure and function as well as cognitive abilities in an Asian population. Participants are randomly assigned to either a structured multidomain intervention group or a self-guided control group. The intervention group receives tailored nutritional guidance, cognitive training, physical exercises, and vascular risk monitoring, all adapted to Chinese cultural norms. The control group receives regular health education campaigns and basic health monitoring every 6 to 12 months. This trial runs for two years with ongoing assessments to evaluate the impact of these lifestyle changes. During the study, participants undergo various evaluations including cognitive tests measuring global and domain-specific cognition, neuroimaging scans like MRI and fMRI, laboratory blood tests, and physical performance measures such as grip strength and gait speed. Questionnaires assess quality of life, depression, sleep quality, and daily activities. Researchers also monitor cardiovascular health, dementia onset, and falls. This comprehensive monitoring will help determine the interventions effects on brain health and daily functioning over the 24-month period.

Age: 60Years - 80YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the effects of a smartphone-based Healthy Lifestyle HLS intervention on the mental and physical health of firefighters in Tainan, Taiwan. This cluster randomized controlled trial aims to determine if the Traditional Chinese version of the HLS mobile app can improve firefighters health compared to usual care. The study also seeks to find out whether the intervention can promote a healthier lifestyle and reduce the risk of chronic non-communicable diseases among firefighters. Participants will be randomly assigned to either the intervention group, which uses the Traditional Chinese HLS mobile app designed specifically for firefighters, or the control group, which receives usual care. The intervention period lasts from 3 to 6 months, during which firefighters in the intervention group will use the app to support healthier behaviors. The control group will continue with their standard practices without the app. Throughout the study, firefighters will undergo health and fitness assessments at the start and again 3 to 6 months after the intervention begins. Measurements include blood pressure, depressive symptoms, PTSD symptoms, body mass index, smoking habits, diet patterns, physical activity levels, sitting time, sleep duration and napping frequency, glycated hemoglobin, lipid profiles, C-reactive protein, and physical performance. The study will monitor these outcomes to assess changes in mental and physical health. Safety and progress will be observed through these regular evaluations during the study period.

Age: 20Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating a new clinical approach to support LatinxHispanic youth aged 12 to 18 who experience suicidal thoughts and behaviors, along with their caregivers. The study aims to test a culturally relevant treatment called Socio-Cognitive Behavioral Therapy for Suicidal Behavior SCBT-SB, which is tailored to address the unique cultural and developmental needs of these youth. The study compares the standard SCBT-SB treatment to a new model that includes additional support from community health workers CHWs, trusted community members who help families access resources and reduce stigma. Participants will receive the SCBT-SB treatment, which includes individual, caregiver, and family sessions conducted in English or Spanish. The therapy has two phases an initial crisis module with nine core sessions, followed by flexible coping skills sessions. Half of the families will also receive support from a CHW who will assess social needs, provide referrals, psychoeducation, and ongoing follow-up at least once a month. The clinician and CHW coordinate care to enhance family engagement. Youth and their families will be followed for nine months, with assessments of suicidal thoughts, suicide attempts, and depressive symptoms at baseline, six months, and nine months. Data will be collected through self-reports and clinical interviews to measure changes in these symptoms. The study uses a randomized, double-blind design to evaluate the impact of adding CHWs to standard therapy. Participation involves regular treatment sessions and monitoring of mental health outcomes over the study period.

Age: 12Years - 18YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating a peer-delivered recovery program called SUPPORT for Veterans with serious mental illness SMI, such as psychotic or bipolar disorders, who are at increased risk for suicide. The study aims to refine and pilot this intervention, which focuses on helping Veterans identify warning signs, develop wellness tools, and create personalized recovery plans to improve functional and social recovery and reduce suicidal thoughts. This study is conducted in two phases, including a pilot randomized controlled trial comparing SUPPORT with enhanced standard care. The SUPPORT intervention involves weekly 50-minute sessions led by a Peer Specialist who works closely with Veterans after a mental health evaluation. The Peer Specialist helps create a personalized suicide-focused recovery plan tailored to the Veterans experiences, using cognitive learning strategies to enhance safety plan recall and recovery. The comparison group receives enhanced standard care, which includes suicide risk assessments, safety planning, mental health referrals, and follow-up contacts. The study includes training Peer Specialists and gathering feedback from both Veterans and Peer Specialists. Participants will be assessed at baseline, mid-treatment, post-treatment, and three months after treatment using various questionnaires and interviews to measure recovery progress, suicidal ideation severity, and satisfaction with the intervention. Outcomes include feasibility of recruitment and retention, acceptability of SUPPORT, and changes in suicide ideation and personal recovery. The study lasts approximately five years, with ongoing monitoring and data collection throughout the intervention and follow-up periods.

Age: 18Years +All GendersPhase Not Applicable
1 location

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