524 Clinical Trials for Various Conditions
Despite the high risk of suicide among LGBTQ+ Veterans, there is currently no suicide-focused intervention for this population. This study will refine and pilot Qnnections, a novel group-based suicide prevention intervention that aims to increase social connection and functioning in this population. The project will involve Veterans with lived experience in further refining Qnnections, and then will examine feasibility and acceptability of Qnnections and of study procedures in a pilot randomized clinical trial.
Suicidal Thoughts and Behaviors, Social Isolation
Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to increase engagement with effective interventions such as suicide safety planning. The BRITE suicide safety planning app was developed on evidence-based principles and has undergone rigorous formative development and effectiveness evaluations. However, to optimize its functionality, commercial viability, and scale its implementation, issues related to user engagement need to be addressed. This 4-week Micro-Randomized Trial (MRT) will optimize specific components of ViraBrite, an augmented version of the BRITE suicide safety planning app that integrates automated algorithms (i.e., just in time adaptive intervention features) to facilitate increased engagement with coping skills and pushes safety planning materials to users at periods of high risk (i.e., increases in emotional distress).
Suicide, Mental Health Disorder, Anhedonia
The study is of high importance to Veterans' health because it will study a suicide prevention intervention in a Veteran population that is at high risk of suicide but has not been a specific focus of the Veteran Affairs' (VA's) suicide prevention efforts. Specifically, a growing number of Veterans are now receiving acute mental health treatment in VA-purchased settings (commonly referred to as Community Care). While these Veterans are at high risk of suicide after discharge, very little is known about how to prevent suicide in these Veterans. This study will directly address this problem by looking at whether a promising suicide prevention strategy called the VA Brief Intervention and Contact Program (VA BIC) can decrease the risk of suicide in Veterans after they are discharged from a non-VA mental health treatment setting. The proposed research is highly pertinent to the VA's top clinical priority-to prevent suicide in Veterans.
Suicide Prevention
Every unit in the Connecticut Army National Guard has a Suicide Intervention Officer to provide suicide intervention education awareness for their unit, monitor for soldiers in crisis and connect soldiers with helping resources and agencies. Suicide Intervention Officers need support in this difficult role, yet there is limited guidance on how to help them. This study will shed light on how to support Suicide Intervention Officers and whether this support results in reduced suicide risk in their units.
Suicide
Few treatments target core features of suicidal thoughts and behaviors in Veterans. Real-time functional magnetic resonance imaging neurofeedback can provide information regarding brain activation associated with suicide-specific rumination, defined as a "repetitive mental fixation on one's suicidal thoughts and intentions." The goal of this feasibility study is for Veterans to learn strategies for modulating activity within brain regions that have been demonstrated to contribute to the maintenance of rumination, as they receive neurofeedback feedback signals from the brain.
Depression, Suicide, Mood Disorders
Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide. People 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254. This study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time. Participants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation.
Behavioral Symptoms, Suicide, Self-Injurious Behavior, Sensory System Agents, Analgesics, Peripheral Nervous System Agents, Physiological Effects of Drugs, Anesthetics, Dissociative, Anesthetics, General, Anesthetics, Central Nervous System Depressants, Excitatory Amino Acid Antagonists, Excitatory Amino Acid Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Ketamine, Depression, Unipolar, Depressive Symptoms, Treatment Resistant Depression, Major Depressive Disorder, Depression, Bipolar
The central hypothesis is that biometric data can continuously monitor and allow for early identification/intervention of escalating suicidal symptoms. The rationale is that improved outpatient monitoring through wearable technology can create a more objective platform to provide the ability to identify a worsening condition and utilize patient-specific just-in-time therapeutics developed with mental health providers for suicidal adolescents.
Suicide, Mental Health Issue
This study plans to learn more about the use of one of two self-guided online cognitive behavioral therapy courses. One is focused on symptoms of depression and one is focused on history of suicidal thoughts and behaviors.
Suicide, Depression
The Culturally Adapted Linking Individuals Needing Care (CA-LINC) study will recruit a sample of Black youth to participate in a two-arm parallel-comparison single-blinded pilot randomized control trial (RCT). For the pilot RCT, 68 Black youth participants ages 14-19 who meet the inclusion criteria will be randomly assigned to one of two conditions: CA-LINC (n=34) or TAU (n=34). CA-LINC is a 90-day culturally adapted LINC intervention developed with and for Black youth. The CA-LINC intervention integrates engagement and follow-up strategies to assess/monitor suicide risk, facilitate service use referrals/linkages, develop/refine safety plans, and create villages of care. The CA-LINC intervention incorporates African-centered principles and empowerment and motivational strategies aimed to support, enhance strengths, promote hope, improve family relationships, and reinforce caring messages. This consumer-, community-, and theory-driven care coordination intervention is designed to reduce suicide ideation and behavior (SIB) by improving service engagement and delivery standards. CA-LINC is implemented by Peer Support Specialists and Community Health Workers assigned to mental health "hubs" in Black Faith-Based Organizations (FBOs) that facilitate standardization and access to care for Black youth/families regardless of religious affiliation. Black FBOs effectively mobilize Black communities to promote positive health behaviors. The RCT will explore the "fit" of the culturally adapted intervention (CA-LINC) in Black communities in Charlotte, North Carolina, and inform a scalable RCT for a future study.
Suicide, Suicide Prevention
The purpose of the RISE study is to examine how the 24-hour rhythm of sleep and social activity relate to mood and suicidal ideation among older adults that recently lost a spouse or life partner.
Suicide, Bereavement
The current study is a clinical trial, meaning a research study in which human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related behavioral outcomes. Specifically, male and female adolescents with current suicidal intent will be randomly assigned to receive either a 1-hour session of virtual crisis response planning (CRP), a 1-hour session of in-person CRP, or a 1-hour session of standard crisis risk management (treatment as usual). The feasibility and acceptability of the virtual CRP, compared to in-person CRP, will be assessed 14 days post-treatment. Additional assessments of changes in mood, behavior, and suicidality will be collected daily for 14 days post-treatment via ecological momentary assessments. The investigators hypothesize the following: 1) Virtual CRP will be rated as more feasible and acceptable compared to traditional CRP and treatment as usual interventions; 2) Both versions of CRP will be associated with changes in frequency and severity of suicidal ideation and behavior compared to treatment as usual; 3) Virtual CRP will be equally as effective as traditional CRP at reducing suicide risk, suggesting that virtual CRP is a promising scalable intervention adaptation.
Suicide Prevention
Pragmatic randomized controlled trial to compare the effectiveness of two-way Caring Contacts text messages vs. one-way Caring Contacts text messages vs. enhanced usual care for suicide prevention in adults and adolescents.
Suicide, Suicide Prevention, Suicide and Self-harm
This clinical trial is part of a series of brief interventions to reduce suicide risk in collaboration with the social media platform RallyPoint, a site specifically designed for U.S. servicemembers and veterans to connect with one another. In this RCT (Intervention 1: Peer Support), the investigators will test a psychoeducational intervention aimed at increasing peer responses to RallyPoint posts that a machine learning risk algorithm developed by the current team has identified for signs of distress (e.g., descriptions of suicidal thoughts and behaviors or other mental health concerns). In this intervention, the investigators will flag these distressed posts and prompt peers to reply to the posts by providing informational blurbs detailing helpful peer responses.
Distress, Emotional, Suicide
This clinical trial is part of a series of brief interventions to reduce suicide risk in collaboration with the social media platform RallyPoint, a site specifically designed for U.S. servicemembers and veterans to connect with one another. In this RCT (Intervention 3: Professional Outreach), the investigators will test a psychoeducational intervention aimed at increasing users' likelihood of reaching out to mental health resources (e.g., suicide hotline) when experiencing distress.
Suicide, Distress, Emotional
The purpose of this study is to identify factors (sleep, psychiatric characteristics, stressful life events, and work environment characteristics) that potentiate or mitigate adverse effects of real-world stressors that predispose nurses to suicidal risk. The specific aims are: Aim 1. To investigate associations between sleep, stressful life events (life stressors, discrimination, lateral violence), psychiatric characteristics (psychiatric diagnosis, subjective mood), work environment characteristics (workload, shift type and duration, overtime, nurse work environment, and team relations) and stress (self-report and heart rate variability) in working nursing professionals while controlling for standard covariates known to influence stress. Aim 2. To determine if stress exposure (self-report and HRV) is associated with predisposing factors (sleep, stressful life events, additional psychiatric characteristics, and work environment characteristics), and to explore whether stress mediates the effect of predisposing factors on suicidal ideation in working nursing professionals. Exploratory Aim. To explore the preliminary impact of an existing sleep intervention (sleep health promotion kit) on self-reported stress, HRV, sleep, and psychiatric health outcomes including depression, burnout, and suicidal ideation. This record will focus on the Exploratory Aim.
Suicide, Nurse's Role, Work Environment Adverse Effects, Sleep, Stress, Mental Health Wellness 1
This project aims to adapt, implement, and evaluate a Dialectical Behavior Therapy skills training group intervention for aging adult family caregivers of person with Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) to reduce suicidality. By adapting this modality, the investigators will provide a scalable intervention tailored for this high-risk population, maximizing the public health impact and improving suicide prevention.
Suicide, Depression, Caregiver Burden, Physical Health, Inflammation
Suicide is the second leading cause of death among young people aged 12-17 years in the United States, yet many youth at risk for suicide are not identified or go untreated. Stepped care approaches have been shown to be effective at reducing suicide risk in clinical settings, including primary care. The goal of this hybrid I stepped wedge effectiveness-implementation study is to test the effectiveness of a population-based quality improvement (QI) intervention, entitled STARRS-PC (Stepped Approach to Reducing Risk of Suicide in Primary Care) compared to treatment as usual (TAU), in reducing the risk of suicidal behavior among youth in the pediatric primary care setting. STARRS-PC implements a clinical pathway for youth at elevated risk for suicide in pediatric primary care clinics. Clinical pathways are tools used by health professionals to guide evidence-informed practice. The STARRS-PC pathway consists of three evidence-based suicide clinical care processes: risk detection, assessment and triage, and, if needed, follow-up transitional care. STARRS-PC is guided by the Practical, Robust Implementation, and Sustainability Model (PRISM), which allows for the study of factors that influence effective implementation of the suicide prevention clinical pathway and is focused on scalability. The main questions the study aims to answer are: * Will STARRS-PC be more effective than TAU at reducing the rate of suicide attempt at 12 months post-baseline (primary outcome)? * Will STARRS-PC be more effective than TAU at reducing suicidal ideation and non-suicidal self-injury, and improving family satisfaction at 12 months post-baseline (secondary outcomes)? * What are the barriers and facilitators of effective implementation and sustainability of STARRS-PC?
Suicidal Ideation, Suicide, Attempted, Suicide Prevention
The suicide rate among active duty service members and Veterans increased substantially following the onset of post-9/11 conflicts in Iraq and Afghanistan. Accordingly, Veteran suicide prevention has been identified as a national healthcare and research priority. The investigators will recruit 136 female and male Veterans who have been hospitalized for suicide risk and randomly assign them to receive one of two psychotherapy treatments for suicide risk after they leave the hospital. The goals of this study are to examine if a) a longer psychotherapy causes greater improvements in coping skills and reductions in negative suicidal thinking, b) a longer psychotherapy is more effective in reducing suicide risk, and c) if Veterans with a history of multiple suicide attempts are more likely to benefit from the longer psychotherapy. Additionally, this study will use magnetic resonance imaging (MRI) neuroimaging scans of Veterans shortly after they leave the hospital and again 4- and 12-months later. This study will explore a) if brain markers can predict suicide attempts, b) if brain markers change over time as suicide risk changes, and c) if brain markers change differently for the two types of psychotherapy.
Suicide
Youth suicide is a serious public health concern. Compared to their heterosexual and cisgender peers, sexual and gender minority (SGM) adolescents report higher rates of suicidal ideation and suicide attempts. Unfortunately, many barriers complicate the implementation of suicide prevention in SGM communities. SGM youth often report feeling unwelcome in traditional behavioral health service organizations. Consequently, treatment attendance and retention remain low. Instead, this population generally seeks mental health services in community organizations for lesbian, gay, bisexual, transgender, and queer (LGBTQ) youth. These organizations are often unprepared for this clinical challenge. The Behavioral Health-Works (BH-Works) suicide risk management system may offer a potential solution to this problem. BH-Works is an evidence-based, comprehensive youth suicide prevention program. It offers support for policy development, staff training, suicide and behavioral health screening, technology-assisted safety planning, an electronic patient referral system, real-time data analytics for program monitoring, and a learning collaborative structure to support sustainability. All functions are supported on a web-based software platform that facilitates cross-system communication, implementation, adoption, and expansion. In this project, the investigators will adapt this program for LGBTQ organizations and test feasibility, acceptability and preliminary effectiveness. This project builds upon robust partnerships with two diverse LGBTQ organizations in Philadelphia, Pennsylvania and rural Southwest, Virginia) and their respective behavioral health (BH) partnering sites. To facilitate BH-Works adaptation for SGM adolescents, the investigators will employ the Enhancing Engagement trajectory from Lau's cultural adaptation framework. To pilot the program within LGBTQ organizations and their partners, the investigators will use an Effectiveness-Implementation Hybrid Type 2 design with a historical comparison group. Informed by the Consolidated Framework for Implementation Research, the investigators will also pilot test a sequenced implementation strategy. This strategy focuses on promoting engagement, building partnerships, and creating sustainability. In Years 1 and 2, the investigators will collect treatment as usual data, and work with their partners to adapt BH-Works policy, content, practices, and workflow. The investigators will also train staff/providers in suicide risk management, family engagement and affirmative care. In Years 3 and 4, the investigators will test the adapted SGM BH-Works Program and examine several essential program targets (training impact, partnership development, software usability) and outcomes (successful referral, program satisfaction, caregiver involvement, suicide identification).
Suicide, Engagement, Patient
Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death among youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to provide a unique understanding of risk factors, including psychological distress, anhedonia and behavioral withdrawal, and sleep disturbance among high-risk individuals. This project aims to enhance the effectiveness of the delivery of preventative health care to youth at risk for suicide by developing a comprehensive digital platform that allows practitioners to integrate mobile sensing data and HIPAA-compliant client communication tools into their management of these young people.
Suicide, Mental Health Disorder, Anhedonia
The overall aim of this study is to reduce suicide among sexual and gender diverse youth ages 18-24 years old. This study will compare the effectiveness of two brief suicide prevention interventions that have been adapted for use with this population to use in primary care via telehealth and will recruit youth from primary care clinics in Texas metropolitan areas. The primary study outcome is suicidal ideation. Each clinic will be randomly assigned to deliver one of the two study interventions.
Suicide, Suicidal Ideation
The aim of this study is to determine whether learning three skills for managing negative emotions and receiving reminders via smartphone to practice these skills reduces how often and how intensely one experiences emotional distress and suicidal thoughts.
Suicidal Ideation, Suicide Attempt
The goal of this study is to test the effects of just-in-time intervention strategies aimed to promote implementation of the safety plan and its components at different levels of suicidal urges and intent. The main questions the investigators aim to answer are: 1. What is the acceptability and feasibility of the just-in-time intervention strategies? 2. What are the proximal effects of just-in-time intervention strategies aimed to promote use of the safety plan and its components? 3. What internal and external contextual factors moderate the just-in-time intervention effects? Participants (adults hospitalized for suicidal thoughts or behaviors) will: * Answer questions about current suicidal thoughts on their smartphone up to 4 times each day during both hospitalization and the 4 weeks after they leave the hospital * Each time they submit a survey, be immediately randomized to receive (or not receive) a just-in-time intervention tailored to their level of current suicidal thoughts * Answer brief follow-up questions on their smartphone within a couple hours of each randomization * Provide feedback on their experience with the just-in-time interventions
Suicide
Suicide rates among Veterans with Serious Mental Illness (SMI) are intractably high, representing a serious public health concern and a critical target for interventions. Yet, at present available treatments offer modest benefits. Thus, there remains an urgent need to identify novel approaches to address suicide risk in this population. Previous reports have linked suicide risk with poor social functioning. Emerging evidence from basic affective neuroscience research has indicated that effective social functioning is contingent on intact emotion awareness. Consistent with these findings, individuals with SMI at risk of suicide display social functioning difficulties along with poor emotion awareness (i.e., alexithymia). Employing a proof-of-concept design, the aim of the present study is to test the feasibility and acceptability of a novel, blended psychoeducation and digital mHealth (mobile health) intervention with smartphones designed to target alexithymia and poor social functioning to reduce suicide risk in Veterans with SMI.
Suicide, Schizophrenia, Bipolar Disorder, Post Traumatic Stress Disorder, Major Depressive Disorder
The overarching goal of this study is to evaluate a newly-developed suicide prevention program for sexual and gender minority youth and emerging adults. After development of the intervention program, a randomized controlled trial will be conducted to test its preliminary efficacy in lowering the risk for suicide attempts.
Suicide
The aim of this study is to develop a manualized suicide prevention intervention to improve the retention and engagement of suicidal clients. (For the purposes of this proposal, engagement is defined as return to treatment after the initial session and retention as treatment attendance in an ongoing manner.) In the prior grant received by the investigators (#R01 MH112139) a large-scale project implementing evidence-based suicide prevention practices in 165 outpatient behavioral health clinics in New York State, it was determined that several aspects of the Zero Suicide model were successfully implemented but that treatment engagement and retention of acutely suicidal clients was far from optimal. This project will have two phases; only the second phase is considered a clinical trial. In the first phase, the investigators will conduct qualitative interviews with clients engaged in outpatient behavioral health for suicide-related reasons, as well as outpatient behavioral health staff (peer specialists and clinicians) with experience working with suicidal clients, to determine to determine client, clinician and situational facilitators and barriers of suicidal clients' engagement in ongoing care. Specifically, interviews will assess if the proposed interventions of shared decision-making (SDM), structured phone outreach (SPO) and peer support are acceptable and feasible from both a client and staff perspective and perceived to be effective in enhancing treatment engagement and retention and decreasing suicidal ideation and behavior. The investigators will also conduct secondary quantitative data analyses with administrative data obtained during the previously-funded project to examine characteristics of those who did not engage or remain in treatment and/or had self-harm behavior during the implementation period, to identify clients who may benefit from additional support or assistance at the outset of treatment and during ongoing care. In the second phase of the study, the investigators will use the findings from the first phase to develop a manualized treatment engagement and retention protocol and conduct a small pilot study to assess the protocol's feasibility and acceptability to clients and staff (peer specialists and clinicians) and preliminary effectiveness, as indicated by client satisfaction and engagement.
Suicide
The primary aim of this study is to design and develop a digital game that models the process of a safety planning intervention. To do so, the investigators will explore and better understand peer or student perceptions around potential warning signs, coping strategies, and seeking help among youth who may be at greater risk of suicide due to misuse of substances. Focus groups/interviews with adolescents, young adults, adults, and school-based behavioral health providers will be conducted. Findings will inform the development of a digital intervention to reduce the risk of suicide among adolescents who misuse substances. Once a prototype of the game is developed, play-test focus groups with adolescents, college-aged youth, and school-based mental health providers will be conducted to finalize the intervention. Once finalized, the investigators will conduct a pilot study with 60 adolescents aged 13-19 to assess user experience, acceptability and feasibility of the digital game.
Substance Misuse, Suicide
People with psychotic disorders are excluded from most suicide-focused clinical trials despite incredibly high rates of completed suicide, and interventions that have been tested for this population have shown limited impact on suicide. Emotion dysregulation is a significant suicidogenic factor that is understudied in people with psychotic disorders. The investigators propose to implement and evaluate an intervention targeting emotion dysregulation in people with psychotic disorders while employing rigorous statistical modeling and measurement techniques including Ecological Momentary Assessment, which will support future advanced research on suicide and suicide prevention for this high-risk group.
Psychosis, Suicide
The central purpose of this project is to evaluate and facilitate access to evidence-based best practices for individuals struggling with suicidal ideation and co-occurring behavioral problems, including alcohol misuse, and provide assistance to the patients while they are waiting to receive care, as they are receiving care, and after they return home. While WisePath is highly innovative in how it delivers these best practices, the content is well-established and known to reduce suicidality and alcohol misuse. We will conduct a 12-week intent-to-treat RCT with 120 suicidal adults 22 years and older who may also be experiencing alcohol misuse. Participants will be randomly assigned to WisePath (n=60) or an active control condition (n=60) including a control suicide prevention self-help app plus an electronic wellness resources brochure containing links to health and wellness materials, psychoeducation about suicide, depression, self-help recovery-focused resources (e.g., Alcoholics Anonymous and other 12-Step programs, Moderation Management, etc.), and phone/text information for the 988 Suicide \& Crisis Lifeline. Participants will be assessed at baseline, 4, 8 and 12 weeks.
Suicide, Suicide, Attempted, Suicidal Ideation, Alcohol Use Disorder, Alcoholism, Alcohol Abuse, Screening and Brief Interventions
For the past 20+ years the investigators have focused on addressing two interrelated public health issues, alcohol use disorder (AUD) and suicide in Alaska. There is no greater source of health disparity in American Indian and Alaska Native (AI/AN) communities than that involving AUD and suicide, and no greater necessity in addressing this disparity than the development of sustained, trusting, collaborative, and non-exploitive research relationships with those who historically experienced forced acculturation and exploitation. Yup'ik community leaders have made addressing AUD and suicide among their highest priorities. Working with Yup'ik community members, the investigators developed a multilevel (individual, family, peer, and community) intervention that uses a culturally-based AUD and suicide prevention framework. The Qungasvik (kung-az-vik; a Yup'ik word meaning 'toolbox') intervention is a Yup'ik AN approach to prevention organized and implemented utilizing a local indigenous theory of change and process model to build protective factors against AUD and suicide. The purposes of the proposed research are to: (a) validate results obtained from previous smaller intervention studies aimed at reducing the incidence of AUD and suicide in 12-18 year old Yup'ik Alaska Native (AN) youth; and (b) learn more about the relative importance of the individual, family, peer, and community variables that underscore the Qungasvik intervention. This study will: (a) assess the efficacy of the Qungasvik intervention through a two group community level trial using an interrupted time series design with wait-listed control, and (b) examine mechanisms of change in response to intervention. Specific aims (SA) of the project are to: (SA1) test the Qungasvik intervention efficacy through impact on the ultimate outcome variables of reasons for life and reflective processes on alcohol use consequences, and on suicidal ideation and alcohol use; (SA2) examine the mechanisms of change in response to the Qungasvik intervention through (a) self-report outcome measures of protective factors (b) social network assessment and (c) process evaluation; (SA3) test levels of fidelity of the implementation of the intervention with regard to the Yup'ik indigenous theory-driven intervention model outlined in the Qungasvik manual of operations.
Suicide, Alcohol Use Disorder