Clinical Research Directory

Neural-Derived Plasma Exosomal MicroRNAs As Promising Novel Biomarkers for Suicidality and Treatment Outcome in Adolescents

This study is dedicated to help identify biomarkers for depression and suicide. The purpose of the study is to better understand these links to improve medical and psychiatric care in the future. This research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. miRNA) for these disorders.

A Novel Peer-Delivered Recovery-Focused Suicide Prevention Intervention for Veterans With Serious Mental Illness

Suicide is a major public health concern, particularly among Veterans with serious mental illness (SMI, i.e., psychotic disorders or bipolar disorders). Wellness Recovery Action Plan (WRAP) is a well-established evidence-based practice for those with SMI that centers on identifying warning signs of mental illness, developing wellness tools for functional independence, planning for day-to-day effective living within one's community, and building an action plan to create a valued life worth living. This proposed study will refine and pilot SUicide Prevention by Peers Offering Recovery Tactics (SUPPORT), a novel integrated recovery program that is an adaptation of peer-delivered WRAP for Veterans with SMI. In SUPPORT, a Peer Specialist leads a Veteran at increased risk for suicide through recovery planning that is tailored to the Veteran's suicidal experiences with cognitive learning strategies to enhance safety plan recall and improve functioning.

Sleep Treatment for Teens

The purpose of this research study is to test a brief (6-session), empirically supported, and highly disseminable version of digital (i.e., smartphone or web-based) cognitive behavioral therapy for insomnia (dCBT-I), called SleepioTM, in suicidal adolescents with co-occurring insomnia during the high-risk post-hospitalization period. Suicide is the 2nd leading cause of death among adolescents. Sleep problems, such as insomnia symptoms-the most common sleep problem in youth-may be a particularly promising treatment target to reduce suicide risk in adolescents. The investigators propose to test the feasibility, acceptability, and effectiveness of dCBT-I in a two-site (Rutgers and Old Dominion University) pilot study trial. Adolescents, 14-18 years-old, recently hospitalized for suicide risk with co-occurring insomnia (n=20 pilot, 50% at each site), will receive dCBT-I (six weekly, 20-minute sessions) plus post-hospitalization treatment-as-usual (TAU). Adolescents will complete assessments pre-treatment, during the treatment phase including at the end of treatment, and 1-month follow-up post-treatment.

Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings

The study will compare the effectiveness of two relatively brief and scalable evidence-based interventions: the Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+), a suicide-specific intervention that helps people prevent suicidal crises from escalating, and Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI), a psychotherapeutic crisis intervention treatment for suicidal adolescents that teaches youth skills to prevent suicidal crises and addresses interpersonal problems that lead to suicidal crises. The results will inform the future standard of care for youth at risk for suicide presenting in the ED setting. This project focuses on suicidal youth ages 12-24 in five ethnically and racially diverse urban areas: Philadelphia, Pennsylvania; Baltimore, Maryland; Chapel Hill, North Carolina; St. Petersburg, Florida; and Northern Manhattan/lower Bronx/eastern Queens communities in New York City, New York.

Brief Admission by Self-referral for Individuals With Self-harm: Effects on Compulsory Care

Brief Admission by self-referral (BA) is a standardized treatment model, providing patient-controlled and person-centered care. It was developed to reduce self-harm and compulsory care by promoting autonomy. Randomized clinical trials have not yielded significant between group differences with respect to inpatient care, including compulsory care. The major difficulty in evaluating BA is preventing the control group from cross-contamination, as in the implementation process of BA, all physicians, all inpatient and outpatient staff as well as managers need to be informed and undergo basic education regarding the intervention. As BA addresses a prevalent and frustrating issue in psychiatric health care, there is considerable risk that the approach leaks to the control group, reducing the possibility to detect between-group differences. In the current study this will be addressed through a register-based approach, comparing similar clinics, implementing BA at different timepoints over time. Individuals with traits of borderline personality disorder will be included and comparisons will be made with respect to compulsory care, voluntary inpatient care and mortality.

Enhancing the Effectiveness of Prolonged Exposure Among Suicidal Individuals With PTSD

The long-term goal of this study is to reduce suicidal thoughts and behaviors among treatment-seeking individuals who also have posttraumatic stress disorder (PTSD). Prolonged exposure (PE) and crisis response plan (CRP) have demonstrated empirical support for reducing suicide attempts as compared to treatment as usual. However, no studies to date have assessed their effectiveness when used in combination. In light of this knowledge gap, the primary objective of this study will be to test the effectiveness of PE augmented with CRP as compared to PE with care as usual (self-guided treatment plan), an active comparator, for the reduction of suicide ideations and attempts for individuals with comorbid PTSD.

Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide - Randomized Trial

The primary aim of the present study is leverage existing infrastructure to develop novel technological features for a novel personalized smartphone intervention system, called the Mobile Application to Prevent Suicide (MAPS), and to establish feasibility, acceptability, safety, and estimate key parameters for primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization), and target mechanisms.

Virtual Reality Lethal Means Safety Training

The goal of this randomized clinical trial is to determine whether a virtual reality (VR) training program can help healthcare providers improve their skills in discussing suicide prevention and safe storage of firearms and medications with Veterans. The study will test whether VR training increases providers' self-efficacy, confidence, and comfort in conducting lethal means safety counseling, and whether it improves their intention to use these counseling practices in their clinical work. Researchers will compare healthcare providers who complete the VR training to those who complete a 2D video training to determine whether the VR approach is more effective. Participants will complete online surveys before and after the training and again three months later. They will be randomly assigned to one of two groups: VR training group: Participants use a VR headset to interact with a virtual Veteran patient in a simulated rural clinic and practice suicide prevention counseling skills; Video training group: Participants use the same headset to watch a \~10-minute 2D video depicting the lethal means safety counseling session. After the training, participants will also provide feedback about their experience, including how realistic and useful they found the training.

Effectiveness and Implementation of a Clinician Decision Support System to Prevent Suicidal Behaviors

The primary aim of this project are to evaluate a comprehensive, practice-ready, and deployment-focused strategy for improving the prediction and prevention of suicide attempts among a sample of 4,000 patients presenting to an ED with a psychiatric concern. The first aim is to evaluate the effects of providing information about risk of patient suicidal behavior to ED clinicians. The investigators hypothesize that patients randomly assigned to have their clinician receive their risk score will have a lower rate of suicide attempts during 6-month follow-up and that this effect will be mediated by changes in clinician decision-making.

Written Exposure Therapy for Suicide Prevention

Military service members admitted to inpatient psychiatry for self-injurious thoughts and behaviors (SITBs) represent an at-risk group for continued SITBs and rehospitalizations in the post-discharge period. However, there is an absence of evidence-based interventions designed to be delivered on inpatient psychiatric units to reduce the risk of post-discharge SITBs. To address this gap, the investigator's research group developed Written Exposure Therapy for Suicide Prevention (WET-SP), a brief, scalable, suicide-specific psychotherapy based on the written disclosure paradigm. Written disclosure, in which an individual writes about a personally stressful experience and the related thoughts and feelings, yields improvements across physical and psychiatric domains. Pilot data suggest that written exposure also yields reductions in SITBs. Yet, no study has adapted the written exposure paradigm specifically to target the amelioration of distress associated with suicidal crises and examined whether implementing WET-SP reduces the risk of subsequent SITBs and suicide-related hospitalizations. The primary objective of this randomized controlled trial (RCT) is to evaluate the efficacy of WET-SP, in reducing the incidence and severity of SITBs in active duty military service members following a psychiatric hospitalization due to suicidal ideation, suicide plans, or a suicide attempt. Secondary objectives are to evaluate a potential mechanism of change (i.e., decreases in thwarted belongingness \[cf. social disconnectedness\]) and moderator of outcomes (i.e., arc of narrative \[cf. linguistical parameters of the written narratives generated during treatment\]). Participants randomized to WET-SP + TAU will receive five sessions of WET-SP delivered by the study team during their psychiatric hospitalization plus treatment-as-usual (TAU). Participants randomized to TAU will receive daily contact and patient-centered care delivered by the acute psychiatric inpatient unit provider team (e.g., psychiatrists, therapists, case managers). TAU includes psychiatric assessment, initial stabilization, nurse case management, medication management, treatment of medical comorbidities, group and individual therapy, and discharge planning. Outcome assessments will be administered at pretreatment, posttreatment, and 10-, 20-, and 30-week follow-ups.

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.

Effectiveness of a Case Management Algorithm: ALGOS After a Suicide Attempt

The suicidal behaviors are phenomena eminently multifactorial. It is thus always difficult to define univocal strategies of prevention of suicide repetition, during the emergency stay, i.e. almost in general population. One find 23 clinical trials in this topic in the past 25 years, and 18 are negative. The majority of the positive trials have the concern of being dissociated from an assumption of responsibility of care strictly speaking, to adopt a position "méta", nearer to the concept of "case management": how to remain in contact with the suicide attempter, without forcing it in this every day life, replacing a possible proposing, but assumption of responsibility resources reliable and quickly accessible in the event of at risk situation? Each one of these studies tests devices which seem more appropriate to such or such characteristic of this population, by retaining only simple criteria like the sex, the number of former suicide attempts, the proposal or not for an assumption of responsibility of care, the observance or not with the plan of care. Thus, it would seem interesting to combine these approaches in an algorithm entitled "ALGOS". Main aim: To test the effectiveness of this algorithm of case management, named "ALGOS", in reducing the number of death by suicide, in terms of reduction of suicide re-attempts and the number of loss of contact patients in the ALGOS group during 6 months period, compared to a control group of suicide attempters treated as usual (i.e. primarily transmitted to the attending physician). Secondary objectives: To evaluate, according to the method validated by Beecham in 1992, direct medico-economic impact in the year which follows the introduction of algorithm ALGOS. Reduction of the other suicidal behaviors in 6 months (reduction in the full number of suicidal repetitions in each group, evolution of the score of suicidal ideation, etc…). To evaluate the effect of the algorithm, at the 13th month. To study the possible differences within the time in terms of suicidal repetitions in the 2 groups. To propose different profiles of answers according to psychopathology, the number of suicide attempts, suicidal character, the sex,… Methodology: Comparative simple blind prospective multicentric controlled study

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.

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.

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).

Long-term Follow-up of Depressive Disorders in Psychiatric Care

The project investigates long-term prognosis and predictors of treatment outcomes for difficult-to-treat depression in patients in secondary psychiatric care. The current patient cohort was collected in 2012-2021 in the study "Pharmacogenetics in patients with depression with specific focus on difficult-to-treat depression, suicide attempt and CYP2D6". The cohort consists of 415 patients, examined carefully regarding diagnostic assessment and earlier treatment. All participants were also genotyped for the drug metabolizing enzymes CYP2D6 and CYP2C19. Blood samples were stored in biobank for other analyses linked to prognostic markers. The patient cohort will now be followed up with a review of medical records and extraction of register data for a period of 5 years after their participation in the original study. The purpose of the study is to improve treatment and increase knowledge about long-term prognosis in difficult-to-treat depression. This is done by examining symptom profiles, monitoring clinical course and suicidality, and examining prognostic markers.

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.

Suicide Preventive Psychosocial Treatment for Youths

Suicide is the leading cause of death amongst 10-18-year-olds in Sweden. Suicide attempts are the strongest predictor of subsequent death by suicide, often lead to inpatient care, and are associated with substantial societal costs, making suicide attempts a critical target in psychiatric intervention research. Although youths attempting suicide are typically assessed and treated for potential comorbid psychiatric conditions, there is currently no trans-diagnostic evidence-based treatment specifically targeting suicidal behavior. To fill this gap, the Safe Alternatives for Teens and Youths (SAFETY) was developed. SAFETY is a transdiagnostic family-based cognitive-behavioral suicide prevention program that has shown promise but more studies are needed. The overall objective of this project is to evaluate the efficacy, durability, and cost-effectiveness of the SAFETY intervention, a scalable suicide prevention intervention that can be offered immediately following a youth suicide attempt, in a fully powered single-blind randomized controlled superiority trial. Our primary hypothesis is that the SAFETY intervention will be superior to Enhanced Treatment As Usual (enhanced with the evidence-based intervention safety planning) in reducing the proportion of suicide reattempts. Moreover, we predict that these improvements will be maintained for up to 60 months post-treatment. Finally, we expect that SAFETY will be cost-effective compared to the control intervention, both at the primary endpoint and in the longer term.

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.

Efficacy of EBPSI on Future Suicide Risk Among Adolescent Suicide Attempters

Our study is designed to study the efficacy of an Electronic based psycho-social intervention targeting healthy coping and problem solving skills to mitigate suicidal behaviour. This would integrate existing systems and bridge the gap in accessibility to care for suicidal behaviour.

Improving Coping to Reduce Suicide Risk Following ED Discharge

The researchers hope to learn whether an electronic safety plan (ESP) and a supportive text messaging program are feasible and acceptable to adult patients with recent suicidal thoughts or behavior after emergency department (ED) discharge. From this study, the researchers also hope to learn how to best carry out the ESP and text messaging program to improve outcomes for patients after ED discharge.

Ketamine + Cognitive Training for Suicidality in the Medical Setting

This project seeks to identify the acute and longer-term impact of a single dose of intravenous ketamine among suicidal patients referred for psychiatric consultation/liaison in the medical inpatient setting. The investigators will then test whether ketamine's rapid effects can be extended by introducing helpful information delivered by a computer-based training protocol. This work could ultimately lead to the ability to treat suicidality more efficiently and with broader dissemination by rapidly priming the brain for helpful forms of learning.

Ketamine Treatment of Youth Suicide Attempters

Ketamine, an NMDA antagonist, has been shown to have rapid anti- suicidal effects. However, its safety and efficacy and special populations has not been investigated and documented. Several reports in adults suggest rapid decrease of suicidal ideation. In the last decade there is an alarming increase of the number of suicide attempts in patients ages 14-30. Suicide is the second leading cause of death in this population. Patients with previous history of suicide attempt, are even in a higher risk category. The present study focus in this high risk group of suicide attempters. This will be a randomized controlled trial enrolling 60 youth between the ages 14-30 after a suicide attempt; patients will be randomized to receive Ketamine 0.5 mg/kg over 40 minutes or normal saline. Patients will receive all Ketamine or placebo infusions while admitted in the Inpatient Psychiatry Service. Patients will receive up to 6 ketamine or placebo infusions until, for 3 consecutive sessions, they have a clinician rated Scale for Suicidal Ideation (SSI) score of\<4, and \>50% decrease from baseline, and clinical assessment of patient not being suicidal, or they have been discharged from the inpatient unit. Patients will participate in weekly sessions of Collaborative Assessment for the management of Suicidality (CAMS), from the first week of the study while admitted to the hospital and will continue it on a weekly basis post-discharge until the patient has three consecutive outpatient CAMS sessions with an overall risk \< 2 (# 6 on the SSF Core Assessment) along with a positive response regarding their thoughts/feelings and clinician indicating behavioral stability (suicidal behavior).

SAFETY-Parent: Online Learning Module to Support Parents of Suicidal Youth

This project aims to adapt the parent component of Safe Alternatives for Teens and Youth (SAFETY) outpatient intervention to SAFETY-Parent (SAFETY-P), a self-paced interactive learning module for parents, to be implemented as an augmentation for youth being seen for suicidal ideation, suicidal behavior, or recent suicide attempts across multiple settings at Nationwide Children's Hospital (NCH, Columbus, Ohio).