Clinical Research Directory

Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide

The purpose of this project is to conduct a randomized control trial with 470 Veterans to examine the impact of a revised version of Motivational Interviewing to Address Suicidal Ideation (MI-SI-R) on risk for suicide attempts and suicidal ideation when compared to high quality usual care.

Social Media Concerns Related to Emotional Experiences in Naturalistic Settings (SCREENS)

The objective of this study is to advance understanding of the relationships between social media use (SMU) and internalizing symptoms among a diverse sample of depressed and/or suicidal youth. Youth (ages 13-18) enrolled in the TX-YDSRN registry study will be recruited for participation in SCREENS. After reviewing the Information Sheet, participants will complete baseline measures assessing internalizing symptoms (e.g., depression, anxiety, suicidal ideation/behavior), and trauma history. They will then complete ecological momentary assessments (EMAs) twice daily for 30 days via the mHealth app, capturing internalizing symptoms, emotional responses to social media, and in-person social support. The mHealth app will also collect the amount of social media use during this 30-day period. From Month 1 through Month 6, participants will receive monthly self-report surveys administered through REDCap. 100 participants This study will enroll youth from the TX-YDSRN registry study who meet all the following criteria: * Be between 13 and 18 years of age at the time of enrollment. * Be currently enrolled in the TX-YDSRN registry study and willing to allow sharing of data from that study. * Own a smartphone and agree to download and use the study mHealth application for the duration of study participation. * Be willing and able to participate in all study requirements and allocate sufficient time to complete study questionnaires and measures. Visits include a Screening Visit, Baseline Visit, EMA 2x daily for 30 days, 6 remote follow-up survey visits. Multiple streams of outcome measures will be utilized for this protocol, including self-report measures, research assessor-completed measure, and EMA measures. Adverse event (AE) recording, 9 item Patient Health Questionnaire Adolescent Version (PHQ-A), Concise Health Risk Tracking Self Report (CHRT-SR).

Inhaled DMT for Major Depressive Disorder

This Phase 2b, randomized, double-blind, active-controlled clinical trial will evaluate the efficacy and safety of inhaled N,N-dimethyltryptamine (DMT) in adults with Major Depressive Disorder (MDD). The study will test whether inhaled DMT can rapidly reduce depressive symptoms and suicide risk compared with a low-dose active comparator. A total of 140 participants will be randomized 1:1 to receive either 15 mg followed 1 hour later by 60 mg of inhaled DMT, or 1 mg followed 1 hour later by 4 mg of inhaled DMT. Participants who do not achieve remission at Day 7 will enter an open-label extension and receive a high-dose DMT session on Day 14 (±3 days). All participants will be followed for up to 12 months to evaluate the durability of response, safety, functioning, and quality of life.

Mind After Midnight

This study examines whether wakefulness during the biological night (2:00-4:00 AM) is associated with increased negative mood, impaired decision-making, and suicidal thoughts. Adults with a history of suicidal ideation in the past six months will complete laboratory and home-based assessments under varying levels of sleep pressure. Participants will be evaluated during late-night wakefulness and under conditions of both higher and lower sleep pressure. The goal of the study is to better understand the biological and behavioral mechanisms that may contribute to elevated suicide risk during nocturnal wakefulness.

Understanding and Treating Suicidal Ideation With Ketamine

The goal of this clinical trial is to treat active suicidal ideation in individuals with Major Depressive Disorder (MDD) using ketamine and to understand suicidal ideation by examining biological mechanisms using magnetic resonance imaging (MRI), and psychological mechanisms through validated clinical scales and qualitative interviews. The main questions it aims to answer are: 1. Will ketamine will reduce suicidal ideation in a significant proportion of study participants? 2. Will reduction in suicidal ideation will be accompanied by rapid changes in neuroimaging biomarkers? Participants will receive four intravenous (IV) ketamine infusions administered twice weekly for two weeks. Participants will undergo two identical MRI scans: 1) within 48 hours prior to starting ketamine treatment, and 2) 24 hours after the fourth ketamine infusion. Suicidal ideation and depressive symptoms will be assessed prior to each imaging session alongside additional self-report measures. Qualitative interviews will occur within 72 hours after the fourth ketamine treatment.

Preliminary Trial of an Avatar Guided Digital Intervention for Emerging Adults

The goal of this clinical trial is to learn whether a novel digital avatar (virtual coach) support program can help emerging adults ages 18-29 who present to the emergency department with suicidal thoughts and alcohol misuse (EA-Avatar). The study also aims to learn whether people find the program easy to use and whether daily surveys and the study design are able to be completed by the majority of emerging adult participants. The main questions this study aims to answer are: * Do participants use the digital program and find it helpful? * Is it possible for participants to complete daily surveys for twenty-eight days and follow-up surveys over twelve weeks? * Are there early signs that the program may help lower alcohol use and suicidal thoughts? Researchers will compare participants who receive the new digital avatar program plus supportive text messages to participants who receive a freely available suicide safety planning app to see if there are differences in use, engagement, and early signs of benefit. Participants will: * Receive standard care from the emergency department * Be randomly put into one of two groups (EA-Avatar or a free suicide prevention app) * Depending on their group, use a new avatar-guided digital support program with text message reminders OR use a free suicide safety planning app * Complete surveys at the start of the study and again at four, eight, and twelve weeks * Complete short daily surveys for twenty-eight days

Integrated Suicide Supports and Safety Planning for Youth

The goal of this clinical trial is to evaluate an app to help keep teens and young adults with suicidal thoughts safe. The app includes a safety plan created by adolescents and healthcare providers, and videos to encourage supportive communication and skills for teens and young adults to stay safe. The main question it aims to answer is whether the use of an app can increase youth suicide-related coping for youth with suicidal ideation, parent/caregiver suicide prevention self-efficacy, and healthcare provider self-efficacy in suicide management. Researchers will compare usual care to usual care with the app. Participants, including adolescents, caregivers, and healthcare providers, will use the ISSP app (if assigned to that group) and view video content and complete three online surveys.

Suicide Intervention for Alaska Native Youth

Two interventions will be delivered virtually to American Indian/Alaska Native youth who have been hospitalized with suicidal attempt, suicidal ideation, or associated risk behaviors, including alcohol-related injury.

Task-Shifting Adapted IPT-A for Youth Suicide Prevention

The goal of this randomized pragmatic clinical trial is to examine the feasibility, acceptability, and mechanisms of change of a brief adaptation of Interpersonal Psychotherapy for Adolescents (BIPT-A), adapted and task-shifted to lay providers (mentors, youth trusted adults) in youth community centers (YCCs) as an upstream approach to suicide. It focuses on Hispanic adolescents ages 12-17 enrolled in these YCCs. The pragmatic clinical trial will evaluate the acceptability and feasibility of adapted IPT-A delivered by mentors in YCCs and whether adapted BIPT-A impacts mechanisms of change (depressive symptoms, belongingness, and burdensomeness or feeling like a burden to others). The main questions to answer are: * Is adapted BIPT-A, when delivered by trained lay providers (youth mentors), feasible and acceptable in youth community centers? * Does adapted BIPT-A, delivered by lay providers, change key risk factors (i.e., key mechanisms: depressive symptoms, low belongingness, and perceived burdensomeness) associated with suicide ideation? The investigators will compare adolescents randomized to adapted BIPT-A (6 sessions) delivered by a trained youth mentor with those receiving usual services at the community center (one individual session focused on active listening). Participants will: 1. Be screened for subthreshold depression using the Patient Health Questionnaire Adolescent version (PHQ-A). Adolescent participants will be included if they score between 4 and 9 (mild depression). Participants with a PHQ-A score of 10 or higher (severe depression) will not be eligible and will be referred to a licensed mental health provider for appropriate care. 2. Be randomized to adapted BIPT-A or usual care. Adolescent participants in the intervention arm will participate in 6 weekly, adapted BIPT-A sessions with a trained youth mentor. Intervention focuses on education, affect identification, and interpersonal skills.

Youth Suicide and Self-Harm Intervention: Clinical and Biological Outcomes Study

The goal of this clinical trial is to develop and evaluate youth-focused intervention programs for suicide and self-harm that are tailored to the psychological, developmental, and cultural characteristics of Korean adolescents and young adults. The study examines whether two structured, mindfulness-based intervention programs-one for middle and high school students and one for young adults-reduce suicidal ideation, self-harm behaviors, depressive symptoms, and emotion-regulation difficulties. The study also aims to determine whether these clinical improvements are associated with biological changes, including alterations in resting-state functional brain activity (e.g., ALFF, ReHo, and functional connectivity) and social rhythm patterns. The main questions this study seeks to answer are: * Does the youth suicide and self-harm intervention program reduce suicidal ideation and self-injurious thoughts/behaviors? * Does the program improve mood, sleep, hopelessness, and emotion regulation? * Are improvements in clinical outcomes accompanied by changes in biological markers of suicide risk? * Researchers will compare the intervention program to usual care provided in hospitals, schools, and community mental health settings. Participants will: * Participate in the structured suicide/self-harm intervention program or receive usual care. * Complete standardized assessments of mood, sleep, emotion regulation and suicide/self-harm risk. * Undergo biological assessments, including resting-state fMRI and rhythm-related measures, at baseline and follow-up. * Be followed for up to 12 weeks.

The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects

The purpose of this study is to test the hypothesis that the anti-depressant and anti-suicidal effects of the N-methyl-D-aspartate receptor (NMDAR) antagonist Ketamine is critically dependent on stimulation of Alpha-Amino-3-Hydroxy-5-Methyl-4-Isoxazole Propionic Acid receptors (AMPAR).

Neural Correlates of Suicidal Behavior in Youth

This study, titled "Neural Correlates of Suicidal Behavior in Youth: a Pre and Post CAMS Therapy Neuroimaging Study," aims to better understand the brain mechanisms underlying suicidal thoughts and behaviors in adolescents and young adults (ages 14-24). Suicide is a leading cause of death in this population, and current clinical approaches often fail to accurately predict or prevent suicidal behavior. This study seeks to identify objective neurobiological markers associated with suicide risk and treatment response. Participants will be divided into three groups: (1) high-risk individuals recently hospitalized following a suicide attempt, (2) medium-risk individuals with chronic suicidal ideation but no attempts, and (3) low-risk healthy controls. All participants will undergo advanced neuroimaging, including magnetoencephalography (MEG) and magnetic resonance imaging (MRI), along with comprehensive psychiatric assessments. The study focuses on brain regions and networks implicated in suicidality, including the anterior cingulate cortex and salience network, as well as neurochemical markers such as glutamate. It also examines electrophysiological activity and functional connectivity patterns associated with suicidal thoughts and behaviors. High-risk participants will receive an evidence-based psychotherapy called the Collaborative Assessment and Management of Suicidality (CAMS). This therapeutic approach emphasizes collaboration between patient and clinician to identify and address the underlying drivers of suicidal thoughts, with a focus on increasing hope and reducing psychological distress. Neuroimaging and clinical assessments will be repeated after completion of CAMS to evaluate treatment-related changes. The study's primary goals are to: * Identify neural and electrophysiological correlates of suicide risk. * Distinguish biological differences between individuals with suicidal ideation and those who have attempted suicide. * Determine how CAMS therapy affects brain function and neurochemistry. By integrating clinical and neurobiological data, this research aims to improve understanding of suicidality, enhance risk prediction, and inform more effective, personalized interventions for at-risk youth.

Navigating Mental Health Treatment for Black Youth

This study looks to conduct a systematic adaptation of Suicidal Teens Accessing Treatment (STAT-ED) for Black youth presenting in the emergency department who have suicide risk. A randomized controlled trial of STAT-ED adapted for Black youth and their caregivers will examine whether patient navigation intervention can increase mental health treatment initiation and number of visits.

Youth Depression and Suicide Research Network

The objective of this study is to build the Texas Youth Depression and Suicide Research Network to support the development of a Network Participant Registry and characterization of systems and interventions to examine statewide population health outcomes. All 12-13 sites represented in the Texas Child Mental Health Care Consortium (https://www.utsystem.edu/pophealth/tcmhcc/) have been invited to participate in the Texas Youth Depression and Suicide Research Network as "Nodes." 12 Nodes have been selected for this project. Each Node has obtained support of senior institutional leadership including the department chair. Leadership from each Node provided input and edits in the study design process by committee, with a focus on the inclusion of the "end user" in design decisions. Nodes will work closely with the Network Hub leadership to recruit, monitor, and retain participants. This will require active engagement and sustained relationships with clinics within the academic medical center as well as clinics in the community (i.e., psychiatry, psychology, counselling).

The Group Risk Reduction Intervention Therapy (GRRIT) Project

Investigators will evaluate a group format adaptation of Brief Cognitive-Behavioral Therapy for Suicide (i.e., G-BCBT) on suicide ideation (Aim 1), ability to use coping strategies (Aim 2), and overall mental health (exploratory analysis). The combination of tailored means safety counseling and training in evidence-based emotion regulation and cognitive flexibility skills delivered via a 12-session group therapy treatment will decrease service members' overall suicide risk. The group format will provide opportunities to learn and practice skills, thereby enhancing self-efficacy. G-BCBT outcomes are expected to be no worse than Dialectical Behavior Therapy (DBT) group skills training, an existing gold standard intervention that is twice the length of time as G-BCBT.

Multimodality Adaptive Intervention for Post-Inpatient Hospitalization Suicide Risk Reduction

The goal of this clinical trial is to learn whether a combination of brief digital and clinician-delivered interventions can help adults leaving a psychiatric hospitalization cope with suicidal thoughts and prevent suicide-related events. The main questions it aims to answer are: * Are people who receive automated smartphone messages when they report suicidal thoughts after leaving the hospital less likely to have a suicide-related event than those who do smartphone self-monitoring alone? * Are people who have additional session(s) with a clinician in the four weeks after leaving the hospital less likely to have a suicide-related event than those who receive additional brief self-guided intervention(s)? Participants will be asked to: * Make a personalized safety plan (of coping strategies to use when feeling suicidal) before leaving the hospital * Do self-monitoring of suicidal thoughts and related experiences on their smartphone for four weeks after leaving the hospital * Complete a longer set of research questionnaires at the start of the study and five more times during the 12 weeks after leaving the hospital Depending on which study group they are in and whether they benefit from initial smartphone interventions, participants may or may not: * Receive automated smartphone messages reminding them of coping strategies to use for suicidal thoughts * Receive up to three additional sessions with a study clinician * Receive up to three brief online self-guided interventions The study interventions last for the four weeks after leaving the hospital. Participants will also be asked permission to share information from their health records about care received for 12 weeks after leaving the hospital.

Dynamic Deconstructive Psychotherapy Versus Brief Intervention and Contact for Suicidal Adolescents and Young Adults

The purpose of this clinical trial is to assess whether 6 months of treatment with Dynamic Deconstructive Psychotherapy (DDP) is more effective for reducing thoughts of suicide in suicidal adolescents and young adults than usual care in the community supplemented with Brief Intervention and Contact (BIC). DDP and BIC are two evidence-based practices shown to be more effective than usual care at reducing suicidality. Participants will be randomly assigned to receive DDP treatment with safety planning and optional medication management or BIC treatment with safety planning and optional medication management. Participants in both groups will receive the assigned treatment at SUNY Upstate Medical University's Psychiatry High Risk Program (PHRP). Each participant is anticipated to take part in this trial for up to one year.

Cognitive-Behavioral Therapy for Children With Nightmares

The goal of this clinical trial is to assess the efficacy of CBT-NC intervention to determine its impact on mental health and suicidality in children ages 6-17. The main aims are: Aim 1: Examine CBT-NC efficacy for improving nightmare distress and frequency in youth with chronic nightmares by comparing the treatment and waitlist group. Aim 2: Examine whether improvements in nightmares relate to fewer mental health problems for youth by determining by comparing the treatment and waitlist group.

Evaluation of an App for Young People With Suicidal Thoughts

There are currently very few evidence-based tools specifically designed to support children and adolescents experiencing suicidal thoughts. Digital interventions are increasingly used in suicide prevention and show promise in helping young people improve emotional regulation, coping skills, and manage suicidal thoughts and behaviors. In Flanders, the app BackUp was developed in 2015 by VLESP to support adults with suicidal thoughts. Research showed that while the app led to a small, non-significant reduction in suicidal thoughts after one week, 70% of users found it helpful in daily life. A key feature of the app is the Safety Plan, based on cognitive behavioral therapy, which helps individuals identify coping strategies and sources of support. This approach has proven effective in reducing suicidal behavior and is also suitable for use with children and adolescents. Despite these developments, there is still a need for a digital tool specifically tailored to young people. In 2023, the investigators launched a project to develop a new app in collaboration with youth care professionals, app developers, and adolescents with lived experience of suicidality. Their input ensures the app meets the needs and preferences of young users. This study aims to evaluate the effectiveness and usability of the app through a pilot study involving adolescents aged 12-17 who are currently experiencing suicidal thoughts. Participants and their parents or guardians must provide informed consent before joining the study. The evaluation includes online questionnaires completed before and after using the app. These questionnaires collect information on demographics, coping strategies, and the severity of suicidal thoughts and behaviors. The post-assessment also includes questions about user experience and satisfaction. No interviews are conducted; all data are collected digitally. Participants are recruited through various channels and must meet specific inclusion criteria. After completing the initial questionnaire, they receive a code to access the app, ensuring that only study participants can use it.

A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior

This study aims to evaluate the acceptability, safety, and efficacy of a smartphone-delivered intervention called Therapeutic Evaluative Conditioning for Suicide (TEC-S) in reducing suicidal thoughts and behaviors (STB) among adults with recent and frequent suicide ideation.

Leverage Noninvasive Transcutaneous Vagus Nerve Stimulation to Reduce Suicidal Behaviors in Vulnerable Adolescents

Suicidal thoughts, suicide attempts, and suicide are increasingly common in adolescence. Current face-to-face prevention approaches are of limited effectiveness, rely on extensive resources, and are at odds with adolescents' digital preferences. We will evaluate two unconventional but promising interventions delivered to 13- to 17-year-olds: transcutaneous vagus nerve stimulation to target emotion dysregulation, and a peer-support smartphone app to combat social isolation. If effective, these digitally-delivered interventions could reach far more adolescents at far lower cost than current approaches.

Drivers of Suicide Mobile App Study

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.

Digital Mental Health Intervention for Nonsuicidal Self-Injury in Young Adults

This is a feasibility trial of a digital mental health intervention aimed at young adults (ages 18-25) with nonsuicidal self-injury and who are not currently engaged in mental health treatment. We will pilot three arms: a self-guided DMHI, the DMHI with low-intensity coaching, or an active control which will involve the delivery of non-interactive psychoeducational content via the same app interface. The primary goals of this project are to evaluate the feasibility of the intervention and trial procedures in preparation for a fully-powered randomized-controlled trial.

Feasibility and Safety of Ketamine for Suicidal Patients in the Emergency Department

There is currently no readily available pharmacologic intervention for suicidal ideation, a true psychiatric emergency, in the Emergency Department (ED). Investigators aim to trial low-dose, intravenous ketamine, a drug with well-established use in treatment-resistant depression, for patients who present to the ED with suicidal ideation.