Clinical Research Directory

Effect of Clinical Simulation on Suicide Care Competency and Suicide Stigma Levels of Psychiatric Nursing Students

This study aims to examine the effect of a suicide scenario-based clinical simulation on nursing students' suicide care competency and suicide stigma levels. The study uses a single-group pre-test/post-test (quasi-experimental) design. Nursing students enrolled in a Mental Health and Psychiatric Nursing course at a foundation university in Istanbul, Türkiye, who have not previously participated in a similar simulation, are invited to take part. Before the simulation, participants complete a set of questionnaires assessing their suicide care competency and attitudes toward suicide stigma. They then take part in a structured simulation session involving a standardized patient portraying a person with suicidal history and risk. The session includes a prebriefing phase, a 15-minute clinical encounter, and a 60-minute debriefing session guided by the PEARLS model. Immediately afterward, participants complete the same questionnaires again. The purpose of the study is to determine whether simulation-based training improves nursing students' competency in caring for individuals at suicide risk and reduces stigmatizing attitudes toward suicide, and to contribute evidence on the use of simulation in psychiatric nursing education.

Natural History of Depression, Bipolar Disorder and Suicide Risk

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....

Risk and Resilience to Suicide Following Late-Life Spousal Bereavement

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.

Reducing Stigma - A Treatment for Early Psychosis to Prevent Suicide

A mental health program, called RESTEPS, will be developed for patients with early psychosis being treated in outpatient mental health centers, focusing on reducing suicide risk by targeting mental health stigma and social support. Youth (n = 35) with psychosis and current/past suicidal thoughts or behaviors will be recruited from community mental health centers to complete an initial open trial examining the feasibility and acceptability of RESTEPS, an 8-session intervention. Participants will be assessed at baseline, mid-intervention, post-intervention, and at a 6-month follow-up.

Friends/Family of Individuals at Risk of Suicide Training Program

The Friends/Family of Individuals at Risk of Suicide Training (FIRST) program is a six-week program designed to provide knowledge and practical skills to help caregivers care for their loved one while also supporting their own mental health and wellbeing during highly stressful situations. Throughout the program, participants will develop skills to better communicate with their loved one, manage emotions, navigate the health-care system, practice self-care in moments where it feels impossible, and set healthy personal boundaries. FIRST consists of six weekly 90-minute group sessions delivered either online via videoconference or in-person in Toronto, Ontario. Each session is facilitated by a clinician and a peer facilitator with lived experience.

Reducing Firearm Suicide Among Veterans: Evaluating the Effectiveness of Peer-Delivered Lethal Means Counseling

Suicide prevention is a top priority for the Department of Veterans Affairs (VA), with a major emphasis on developing innovative and effective ways to prevent firearm suicide. Research suggests that secure firearm storage can decrease risk for suicide and the current project aims to evaluate a novel approach to increasing secure storage through an experimental design. The intervention takes one-hour or less and involves a peer-to-peer discussion about secure firearm storage, focusing on participants' reasons for and against using more secure firearm storage practices. The project will evaluate whether Veterans who receive this intervention report greater use of secure firearm storage practices than Veterans who receive only psychoeducational materials on this topic. Secure firearm storage practices will be evaluated over the course of one year. It is hypothesized that Veterans who engage in the peer-to-peer intervention will report greater use of secure firearm storage practices than those who receive only psychoeducational materials. Relevant to Veterans' health, secure firearm storage decreases Veteran firearm suicide risk and may help prevent suicide. In addition, this peer-delivered intervention is preferred by Veterans, and has the flexibility to be implemented before suicide risk develops and in settings outside of the VA. This means the intervention has the potential to reach more Veterans, even those who do not receive VA healthcare.

Suicide Prevention Integration Into Task-shifted Mental Health Interventions

Investigators will conduct a pilot clinical trial to assess the feasibility and acceptability of implementing a Suicide Prevention Package (SuPP) within an existing task-shifted depression intervention in rural Pakistan. This pilot research lays the groundwork for a future project to scale a package for multi-level suicide prevention strategies that can be integrated into community based mental health programs, particularly targeting individuals living in low-resourced settings. As the model is designed to be easily adapted and integrated, investigators anticipate the findings will be valuable for all researchers looking to improve population health and mental health services in disadvantaged settings.

THRIVE: A Recovery-Focused Suicide Prevention Intervention in Crisis Stabilization Centers

Suicide is a major public health concern in the United States, with more than 1.4 million adults attempting suicide and nearly 50,000 adults dying by suicide each year. The launch of the national 3-digit 988 Suicide \& Crisis Lifeline in 2022 has strengthened the crisis care system by emphasizing the need for people in crisis to have someone to call, someone to respond, and somewhere to go. Community-based Crisis Stabilization Centers (CSCs) are an important part of the crisis care system, providing short-term crisis stabilization services and an alternative to Emergency Department care. However, suicide risk can remain high after discharge from CSCs, and no brief, effective, recovery-focused interventions are currently available for this setting. This study will evaluate the effectiveness of THRIVE (Toward Hope, Recovery, Interpersonal Growth, Values, and Engagement) in CSCs. THRIVE is a recovery-focused intervention designed for adults receiving care for suicide risk . THRIVE includes one 60-minute psychotherapy group (focused on belonging, giving, meaningful living, and recovery) delivered during the CSC stay and up to six peer-led recovery coaching calls during the weeks following discharge. This multi-site Hybrid Type 1 randomized effectiveness-implementation trial will enroll 552 participants and compare care as usual (CAU) in CSCs to CAU plus THRIVE (CAU + THRIVE). The primary purpose of this study is to determine whether THRIVE reduces suicide risk events (SREs) following CSC discharge, including crisis care re-admissions, escalation to higher levels of care, suicide attempts, and suicide deaths. The study will also examine barriers and facilitators that may influence the adoption and implementation of THRIVE in community-based crisis settings.

Army-SPRING Army-Suicide Prevention Research

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.

Wearable Suicidal Early Warning System for Adolescents

This study is prospectively enrolling a cohort of adolescent patients who present to the Emergency Department and an inpatient psychiatric adolescent unit with acute suicidality.

Proximal Risk for Suicide in Adolescents

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.

CAMS Relational Agent System (CAMS-RAS) for Suicide Prevention

This Phase II study is a continuation of the Phase I feasibility study where the investigators fully met and exceeded project aims to design, build, and test the usability and acceptability of an avatar-based system, Jaspr Health ("Jaspr"), for use by suicidal ED patients and medical personnel responsible for their care. Phase II includes a formative phase, during which the investigators will continue conducting usability and acceptability tests of new features, and a summative phase to conduct a clinical trial. SBIR Phase II project aims include: (1) Complete development of Jaspr, including readiness for electronic health record integration; (2) Cultivate and utilize the advisory board so that Jaspr is positioned to meet the needs of diverse healthcare systems and successful conduct of the proposed research; (3) Conduct usability/acceptability tests of new features with target end-users (suicidal patients, including those in the ED, medical providers) and key stakeholders (i.e., administrators); and (4) Conduct a randomized controlled trial (RCT; n=31) of suicidal ED patients comparing Jaspr (n=14) to Care-As-Usual (CAU; n=17). Participants were assessed at baseline while in the ED, and again at 7, 30, and 90 days. The investigators predicted that Jaspr participants will report a significantly greater decrease in suicidal behaviors and ED/hospital admissions, as well as significantly greater increases in use of behavioral coping skills, self-efficacy in coping with distress, and perceived helpfulness of patients' ED experience and satisfaction with the app. This study, however, was paused due to COVID after February, 2020 with a total of 31 participants recruited. The study later resumed at one site; however, because of COVID there were fewer admissions for suicidal behavior to the ED, only 7 participants were enrolled before the study ended recruitment in December, 2020 (RCT; n=7) (Jaspr; n=4) (CAU; n=3). The Telehealth clinical trial was conducted with suicidal outpatients to compare the Jaspr-At-Home companion mobile app (JAH; n=28) and CAU (in addition to crisis safety planning; n=26). Participants were assessed at baseline, 30- and 90-days after the initial session.

Rapid Personalization of Safety Plans for Psychiatrically Hospitalized Veterans at High-Risk for Suicide

Veterans psychiatrically hospitalized face significantly elevated suicide risk, particularly in the three months post-discharge. While Safety Planning is a required component of discharge planning, many safety plans lack personalization thereby reducing their effectiveness. The proposed intervention, Personalized Safety Plans (PSP), will be developed for rapid delivery on acute inpatient psychiatry units. PSP is a single-session intervention followed by twice monthly brief, personalized coaching sessions during the three-month high-risk discharge period. PSP will be iteratively refined and finalized in a case series (N = 15) then evaluated in a pilot randomized controlled trial (N = 96) comparing PSP to Safety Plans as Usual among psychiatrically hospitalized Veterans. Overall, the study aims to: 1) iteratively refine PSP; 2) examine PSP's preliminary effectiveness in reducing suicide ideation and increasing adaptive coping; 3) identify barriers and facilitators to implementation; and 4) develop a fidelity measure to support future personalization monitoring.

Targeting Emotion Dysregulation to Reduce Suicide in People With Psychosis

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.

Cognitive Reappraisal Intervention for Suicide Prevention (CRISP 70+) for Suicidal Older Adults in a Swedish Geropsychiatric Setting

The overall aim of the project is to develop and test the feasibility and preliminary effect of a manualized psychosocial intervention Cognitive Reappraisal Intervention for Suicide Prevention (CRISP 70+) for older adults with suicidal behavior, an intervention that includes the optional participation of a close relative.

Expanding Access to Evidence-Based Suicide Risk Assessment and Intervention in a Crisis Stabilization Setting

The overarching goal of this project is to expand access to evidence-based suicide risk assessment, safety planning, and intervention among patients at elevated suicide risk by implementing Jaspr in a real-world psychiatric setting.

A Pilot Study of a DBT-Informed Caregiver Risk Management Workshop

The goal of this pilot clinical trial is to explore the feasibility and acceptability of implementing an intervention for caregivers in our health care system. The intervention is intended to provide information and consultation to caregivers of youth ages 12-26 years old who are at risk of self-harm (i.e., suicidal behaviors and/or nonsuicidal self-injury). The intervention is based on principles of Dialectical Behavior Therapy, an evidence-based intervention for youth who engage in suicidal behaviors and nonsuicidal self-injury. Acceptability will be assessed through questionnaires and qualitative feedback. Feasibility will be assessed by tracking the amount of clinician resources needed and how long it takes to identify caregivers who want to participate. A group of caregivers who have lived experience of having a child at risk for self-harm will form an advisory board. The board will review the study methods and data; their advice will guide next steps.

i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression: A Randomized, Midazolam-Controlled Clinical Trial

Approximately four thousand Canadians die by suicide every year, and suicide is the second leading cause of death in youth and young adults (15-34 years). Most people with depression experience thoughts of suicide and many will also plan and/or attempt suicide at some time in their life. There is an urgent need for new scalable treatments that can effectively reduce suicidality in people with depression. Cognitive behavioural therapy (CBT) reduces suicidal thoughts and behaviours, and can be delivered through the internet (i-CBT) making it more accessible and scalable. However, i-CBT has not been shown to rapidly reduce suicidal thoughts and behaviours (suicidality), such as within 24 hours. IV ketamine on the other hand has been shown to rapidly reduce thoughts of suicide, but not suicidal behaviours. Therefore, combining i-CBT with IV ketamine may be more effective reducing suicidality than i-CBT treatment with a control treatment. The investigators propose a 13-week, multi-site, study that looks at how combining i-CBT and IV ketamine treatment will affect suicidality in individuals with depression who have recently experienced suicidal thoughts and/or behaviours, but have not responded to previous treatment. All 76 participants will receive a weekly session of i-CBT for 13 weeks, but half will be randomly assigned to also receive six IV ketamine treatments or six IV midazolam treatments (control treatment) over the first initial 30 days. The investigators will measure changes in suicidal thoughts and behaviours before drug treatment and at the primary endpoint (i.e.,day 30), and after 3 months (i.e. Day 91) of the starting treatment.

A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents

Suicide risk has increased among youth in underserved communities, where access to mental healthcare is limited. To address this need, the investigator team plans to evaluate the preliminary efficacy of a brief, low-cost, culturally responsive digital intervention for ethnically diverse youth at risk for suicide in The Bronx, New York. In collaboration with community stakeholders, suicide recovery narratives, featuring adolescents' experiences related to recovery from suicidal thoughts will be developed. A smartphone ecological momentary assessment (EMA) app will be used to evaluate whether a curriculum of these narratives provides anti-suicidal benefits to at-risk adolescents.

Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression

Background: Major depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective. Researchers want to know if a faster-acting drug, (2R,6R)-hydroxynorketamine (HNK), can better treat the symptoms of MDD. Objective: To test a study drug (HNK) in people with MDD. Eligibility: People aged 18 to 70 years with MDD. They must have had a screening assessment under protocol 01-M-0254. Design: Participants will be tapered off their current MDD drugs over 2 to 5 weeks. They will stay off of the drugs for up to 2 weeks prior to starting the study medication and procedures. They will have a physical exam with blood tests. They will have tests of their heart function, mood, and thinking. They will answer questions about their symptoms. They may choose to have imaging scans and scans of their brain activity. HNK is given through a tube attached to a needle inserted into a vein. Participants will receive infusions on this schedule: They will receive 4 infusions over 2 weeks. They will stay in the clinical center overnight after each infusion or for the duration of the study. They will receive no drugs for 2 to 3 weeks. They will have 4 more infusions over 2 weeks, with overnight stays after each or for the duration of the study. One set of 4 infusions will be the HNK. The other set of 4 infusions will be a placebo. A placebo looks just like the real drug but contains no medicine. Participants will not know when they are getting the HNK or placebo. ...

NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics

This study will adapt and evaluate an evidence-based suicide risk screening and follow-up program in two school-based health centers in West Virginia. The suicide screening program is titled the "NIMH Clinical Pathway" and provides tools and procedures for routinely screening adolescents for suicide risk screening, suicide risk assessment, safety planning, referral procedures, and follow-up care activities for adolescents receiving health services. The study will assess implementation outcomes, including suicide screening practices, identification of suicide risk, safety planning, and follow-up service delivery, as well as participant outcomes including suicidal ideation, depressive symptoms, satisfaction with services, suicidal behavior, safety plan utilization, and acute care utilization. Data collected across participating sites will be combined to evaluate the feasibility, acceptability, and preliminary effectiveness of the adapted Clinical Pathway. Protocol amendments resulted in consolidation of site-specific outcome measures into combined analyses across participating school-based health centers. The ClinicalTrials.gov record was updated to reflect the current protocol, study procedures, and planned statistical analyses.

Ketamine & Crisis Response Plan for Suicidal Ideation in the ED

The goal of this randomized pilot trial is to assess the feasibility of administering a combination of 100mg intramuscular (IM) ketamine and Crisis Response Plan (a short psychosocial intervention) for patients with acute suicidality in the context of the Emergency Department setting. This study will assess a combination of a pharmacologic intervention and a psychosocial one. The pharmacologic intervention is a one-time dose of 100mg ketamine delivered intramuscularly (IM) while the patient is in the ED. The psychosocial intervention under study is a brief, patient-centered therapy which takes, on average, 30 minutes to administer. Both interventions will be administered only once. The main questions this study aims to answer are: * Determine if 100mg of IM ketamine and Crisis Response Plan in combination results in greater short-term reductions in suicidal ideation in adult patients who report acutely elevated suicide risk during an ED visit. * Examine potential weight-based dose response differences in the reductions in suicidal ideation to determine if future treatment protocols with IM ketamine may benefit from weight-based dosing.

Peer Delivered Youth Suicide Prevention in Nepal

South Asia has the highest suicide rate in the world with important risk profile differences from high-income settings. Investigators will conduct formative research to co-design a package of brief interventions and implementation strategies to prevent youth-suicide and then test the package in a pilot feasibility hybrid type 2 cluster randomized controlled trial in Nepal. Potential health impacts may be substantial as results can be applied not only in similar South Asian primary healthcare contexts, but also in low-resource settings in the US and abroad, where the suicide burden remains high. Using experience-based co-design and equity-focused implementation frameworks, this study will assess the feasibility and acceptability of a Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP) integrated within existing mhGAP services in Nepal's decentralized primary healthcare system. This pilot trial will generate preliminary data to inform the design of a future fully powered effectiveness trial and potential scale-up of youth suicide prevention strategies.

Targeted Alternating Current and Cognitive Training Intervention for Cognitive Control in Bipolar Disorders

This study is testing whether a type of gentle brain stimulation, combined with computer-based brain training exercises, can help improve thinking skills in Veterans with bipolar disorder. Veterans with bipolar disorder may have difficulty with skills like stopping to think before acting or adjusting their behavior when things change - problems that can affect daily life and have been linked to a higher risk of serious outcomes. In this study, Veterans with bipolar disorder will complete brain training exercises at home on a computer, paired with a mild electrical brain stimulation called transcranial alternating current stimulation (tACS), delivered through a small headband worn on the forehead. Some participants will receive real stimulation and some will receive an inactive ("sham") version, and neither participants nor most study staff will know which one a person is receiving. All participants will also complete brain wave recordings (EEG), interviews, questionnaires, and various thinking tasks before and after the study to measure any changes. A separate group of Veterans without bipolar disorder will complete the same tests, without any brain stimulation or training, to help researchers understand how much change would happen naturally just from taking the same tests more than once. The goal of this research is to learn whether this combined treatment approach is safe, tolerable, and helpful for improving thinking skills in Veterans with bipolar disorder, and whether Veterans find it an acceptable treatment worth continuing.