Clinical Research Directory

Deaf CBT-TS to Reduce Suicide Risk

The goal of this clinical trial is to learn if a short, Zoom-based intervention, Cognitive Behavioral Therapy for Treatment-Seeking for Deaf Individuals (Deaf CBT-TS) can change beliefs about mental health treatment and increase treatment-seeking behaviors in Deaf adults with untreated mental health or alcohol use problems. It will also see if Deaf CBT-TS may reduce suicide risk and explore factors that may increase the effectiveness of Deaf CBT-TS. The main questions it aims to answer are: * Does Deaf CBT-TS increase positive beliefs about treatment and increase treatment-seeking behaviors? * Does Deaf CBT-TS increase hope and reduce mental health symptoms, suicide ideation, and alcohol use? * Is Deaf CBT-TS more effective for individuals with less cultural stress compared to those with high levels of cultural stress? * Is Deaf CBT-TS more effective for Deaf individuals in residential areas with more Deaf resources than those with less Deaf resources? Researchers will compare individuals who complete Deaf CBT-TS to those on a waitlist to see if Deaf CBT-TS works to increase positive beliefs about treatment and treatment-seeking behaviors. Participants will: * Complete a baseline assessment including demographic information, measures of hope, general mental health and functioning, alcohol use, suicide ideation, cultural stress, and beliefs about treatment. * Receive Deaf CBT-TS (2 sessions) or be placed on a waitlist with the option of receiving Deaf CBT-Ts after 4 months * Complete two follow-up assessments in 2 and 4 months.

Engage Coaching (R33 Phase)

The purpose of this study is to test whether an individual coaching program helps adults age 60 and older feel more connected to other people in ways that matter to them.

Caring Connections Youth Suicide Detection and Intervention Study

The goal of this pilot randomized control trial (RCT) is to test the feasibility of Caring Connections, a Culturally Adapted Linking Individuals Needing Care (CA-LINC) suicide prevention care coordination intervention for high-risk suicidal youth. This consumer-, community-, and theory-driven care coordination intervention is designed to reduce suicide ideation and behavior (SIB) by improving service engagement. Connections is a 90-day intervention that 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 intervention incorporates cultural promotive factors, empowerment, and motivational strategies aimed at supporting youth, enhancing strengths, promoting hope, improving family relationships, and reinforcing caring messages. Primary research questions include: Is Caring Connections feasible to use for suicidal high-risk youth? Does Caring Connections have the potential to reduce suicide ideation and behaviors among high-risk suicidal youth? For the pilot RCT, 80 youth participants ages 13-19 who meet the inclusion criteria will be randomly assigned to one of two conditions: Caring Connections (n=40) or Treatment as Usual (n=40). Additionally, investigators will enroll 80 caregivers of youth meeting inclusion criteria and 20 Mental Healthcare, Healthcare Providers, Community Stakeholders, and/or Care Coordinators with experience working with suicidal youth. Researchers will compare those receiving Caring Connections with treatment as usual to see if suicidal ideation and behaviors, and engagement.

Nurse and Peer Led Suicide Prevention in Tajikistan

The study takes place in Tajikistan, a postwar country in Central Asia, where Dr. Weine, Dr. Pirova, Dr. Bahromov, and other collaborators successfully implemented a D43 research capacity building project and an R21 and R01 on stepped care for women's mental health in primary care. This study also builds on the team's prior research that demonstrated the effectiveness of nurse- and peer-led interventions, identified risk and protective factors for suicide among women, and on the PREVAIL peer-led suicide prevention model. The specific aims for this new project are: Aim 1: Adapt the evidence-based PREVAIL model into a new SUSTAIN nurse- and peer-led suicide prevention model in primary care for women at moderate or high suicide risk in rural and urban Tajikistan using a participatory co-design process (the Transcreation Framework) with multi-level partners. Aim 2: Evaluate a pilot implementation of the SUSTAIN model in primary care among 96 women with moderate to high suicide risk, 48 randomized to SUSTAIN and 48 to an enhanced usual care condition, with both groups followed for 9 months for suicidal ideations or behaviors, mental health outcomes, and mediators. Aim 3: Assess the acceptability, feasibility, appropriateness, potential for scalability and sustainability, programmatic costs, and partnership of SUSTAIN to inform a future hybrid type 2 effectiveness-implementation pragmatic trial.

Smartphone App Enhanced Facilitation Among Veterans in a Mental Health Inpatient Setting (Project HOPE)

This study will test whether a novel intervention, Virtual Hope Box Enhanced Facilitation (VHB-EF), reduces suicide risk in Veterans after discharge from inpatient psychiatric hospitalization. Additionally, this study will also conduct interviews with Veterans and healthcare providers to explore barriers and facilitators to future adoption of the VHB-EF intervention in healthcare settings.

Plan and Protect: Safety Planning for Teens in Rural Emergency Departments

The goal of this observational study is to determine whether implementing a culturally sensitive, tablet-based safety planning program called Plan \& Protect (P\&P) within rural emergency departments can improve home safety and reduce suicide risk in adolescents presenting with suicidality. The main questions it aims to answer are: * Will implementing P\&P increase caregiver-reported home safety (reduce access to firearms and unsafe medication storage) for adolescents 12-17 years old presenting to rural EDs with suicidal ideation, self-harm, or mental health crisis? * Will implementing P\&P decrease adolescent-reported perceived suicide risk and related outcomes (e.g., suicide events, and attendance at follow-up mental healthcare)? Researchers will compare outcomes for adolescents and caregivers receiving P\&P (implemented as the new standard of care at sites during the intervention periods) to those receiving usual care (prior to P\&P implementation at those hospitals) to see if P\&P increases home safety and decreases suicide risk and related healthcare utilization. Participants will, if clinically appropriate: * Complete the tablet-based P\&P modules during their ED visit * Complete self-report measures at baseline, \~30 days, and \~3 months post-discharge * A subset will also participate in semi-structured interviews

A One-Arm Open Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior

This study aims to evaluate the acceptability, safety, and preliminary 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.

Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy Attempted Suicide Short Intervention Program (ASSIP) on Neuropsychological Correlates and Psychological Process Factors - Project 2

The present study consists of 3 projects in total and aims to investigate the (neuro-) psychological patterns from suicidal ideation to suicidal behavior as well as the effects and feasibility of ASSIP Home Treatment. The overall aim of project 2 is to investigate how the (neuro-) psychological patterns are modulated by the Attempted Suicide Short Intervention Program (ASSIP). Therefore, suicide attempters participating in this project 2 will be randomly assigned to either the intervention group ASSIP or a standard care plus resource interview (STAR) group. The ASSIP and STAR interventions take place at the University Hospital of Psychiatry and Psychotherapy Bern (Switzerland). At the end of the assessment in project 1 participants who reported a history of past suicide attempt (SUAT) will be informed about project 2. Only if participants agreed to take part in project 2 and have signed the informed consent, they are randomized into two conditions: The ASSIP intervention (ASSIP) versus standard of care plus resource interview (STAR). Participants of both groups will be assessed again 4 weeks and 12 months after their first baseline assessment of project 1.

Suicidal Ideation Framework: Grounded Theory Study, Catalonia

This doctoral project aims to develop a comprehensive theoretical model of the process through which the suicidal ideation framework is configured as a symbolic, narrative, and relational expression, adopting a multiperspective approach that spans the suicide attempt and the stages of care and recovery. Moving away from biomedical reductionisms, this investigation seeks to identify shared meaning-making nuclei and discursive fractures that reflect the inherent conflictuality of the suicidal act. Grounded in the integration of the theoretical frameworks previously outlined, this study adopts an interpretive-constructivist approach. Phase 1 will include studies conducted in OECD countries, providing a broad and conceptually diverse interpretive foundation. Phase 2, conducted in Catalonia, will deepen situated configurations, assuming that local sociocultural frameworks act as interpretive prisms for globally relevant phenomena. Overall, this theoretical-methodological architecture not only ensures conceptual robustness and coherence, but also articulates an ethical and epistemic commitment to understanding suicide through the complexity of its human textures. By centering suffering, listening to historically silenced voices, honoring the singularity of each life trajectory, and grounding the inquiry in an ethics of care, this study aims to transcend a merely technical-instrumental logic of knowledge.

Lock and Protect: Reducing Adolescent Access to Lethal Means of Suicide

The primary goal is to determine the acceptability and feasibility of implementing the Lock and Protect decision aid. The secondary goals are to identify the potential short-term impact of Lock and Protect on home firearm and medication storage, parental self-efficacy. Using interviews with caregivers, the study will clarify the acceptability, feasibility, and barriers to implementing the Lock and Protect hone safety plan. This will allow further development of effective strategies to subsequently further test and use Lock and Protect in the ED. NOTE: The study will only recruit guardians and their adolescents from the pediatric ED at Morgan Stanley Children's Hospital NY-Presbyterian.

Randomized Suicide Prevention Trial Using ASSIP and ACT in Suicide Attempters

This is a randomized controlled trial that aims to compare the effectiveness of two psychological treatment approaches: the Attempted Suicide Short Intervention Program (ASSIP) and Acceptance and Commitment Therapy (ACT). The study seeks to determine which of these two methods is more effective in reducing suicidal ideation and mental pain in individuals who have recently attempted suicide. In this study, 60 participants with a history of suicide attempts will be randomly assigned to three groups. One group will receive ASSIP in addition to treatment as usual (TAU), the second group will receive ACT alongside TAU, and the third group will be a control group receiving TAU only. The results will be assessed using the Beck Scale for Suicide Ideation (BSSI) and the Orbach \& Mikulincer Mental Pain Scale (OMMP) at three stages: pre-test, post-test, and follow-up. The ultimate goal of this research is to provide valuable insights into the comparative effectiveness of ASSIP and ACT interventions for suicide attempters and to contribute to evidence-based suicide prevention strategies. The findings are expected to inform clinical practice and guide future research in this field.

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 12-19 in three ethnically and racially diverse urban areas: Philadelphia, Pennsylvania; Baltimore, Maryland; and upper Manhattan/lower Bronx in New York City.

A New Clinical Model for the Engagement of Latinx Youth With Suicidal Behavior

This study will test a model of providing treatment to Latinx/Hispanic youth, who experience suicidal thoughts and behavior, and their caregivers. An affirmative and culturally relevant treatment will be provided to all youth and half of the families will be assigned to the additional support of a community health worker (CHW). Youth symptoms and family engagement to treatment will be followed for nine months. The potential benefit of adding the CHW intervention will be assessed.

Electronic, Self-Guided Safety Plan in Adolescents: Project SAFER

Suicide is a leading cause of death for youth 10-24, and nearly ¼ of adolescents report nonfatal suicidal thoughts and behaviors (STB). However, traditional interventions (e.g., multi-session therapy protocols) are contingent upon (1) access to treatment, (2) involvement of parents/guardians (hereafter parents), and (3) disclosure of risk to treatment providers. Unfortunately, adolescents are frequently hesitant to disclose STB to healthcare providers and parents for reasons including shame, stigma, and fear of hospitalization, with even lower rates of disclosure among queer youth-including those with diverse genders and sexualities- who are at disproportionately high risk for STB. Related to these concerns, most youth at risk for suicide, as well as other mental health challenges, do not access any mental healthcare. Self-guided, brief digital interventions may be a powerful adolescent suicide prevention tool. With their relative accessibility-they can be completed privately, at home, for at no cost-such interventions are well-suited for youth not accessing traditional care. Thus, effective digital adaptation of brief suicide prevention interventions is a promising frontier for adolescent suicide prevention. A strong candidate for digital adaptation is the Safety Planning Intervention (SPI), a brief (\~5-10 minute) single-session intervention shown to significantly reduce STB in adults. In the SPI, people at risk for suicide receive brief education about suicidal thoughts and crises before developing a personalized, one-page plan with skills and resources to use during future suicide crises, when it is difficult to think clearly. There is strong evidence across several randomized control trials (RCTs) that SPI reduce suicidal behaviors in adults compared to those who received treatment as usual. Despite widespread use in outpatient and acute clinical settings across ages, there is a paucity of adequately-powered RCTs testing whether the SPI (in any format) reduces STB in adolescents. Emerging evidence supports the SPI can work well in digital format among adolescents. In qualitative studies, adolescents with a history of STBs reported that they would be comfortable using a digital safety plan and feel it would be helpful to them in a crisis, emphasizing easy access and customizability as useful features. Building on this work, I created a digital, self-guided SPI specifically for use in online studies of high-risk adolescents. Preliminary research (approved by DU IRB# 1505797) suggests that youth find this self-guided digital SPI "very helpful" and nearly half actually use the safety plan in the next month. Moreover, using a standardized coding system, quality of self-guided safety plans mirrored the quality seen in clinician-guided, adult SPI. However, it remains unclear whether the SPI in any format can reduce STB in adolescents. This project will test the ability of a self-guided SPI, compared to a suicide psychoeducational control intervention, to increase self-efficacy to avoid suicidal behaviors and to reduce suicidal thoughts and suicidal behaviors in adolescents over a 3-month follow-up period. The investigators hypothesize that compared to the control condition, adolescents who receive the SPI will report greater self-efficacy to avoid suicidal action and reduced STB at the 3-month follow-up assessment. If hypotheses are supported, this study will provide strong, high-quality evidence in favor of the potential of highly accessible, digital self-guided SPIs to prevent suicidal behavior in adolescents. In this case, distribution of such an intervention at scale could be a powerful tool for reducing STBs in adolescents.

Examining the Efficacy of a Digital Therapeutic to Prevent Suicidal Behaviors

The primary aim of the project is to test the efficacy of BCBT delivered via a digital platform (i.e., smartphone) to Servicemembers with recent suicidal ideation and/or suicide attempts presenting to primary care clinics. Given existing challenges of scaling empirically-supported treatments/interventions for suicidality with fidelity, this project could lead to markedly expanded access to BCBT, along with improving our understanding about what intervention strategies are most effective and how they can be delivered with meaningful fidelity. Aviva, the digital version of BCBT, was developed for use with patients across the full spectrum of healthcare settings, including primary care. Aviva is not an emergency alert system, rather a digital platform for delivery of the full scope of BCBT treatment components. An open-label single group Phase I clinical trial has demonstrated the safety, tolerability, feasibility, fidelity, and potential efficacy of Aviva, with participants completing modules over 8 weeks, and follow-up assessments at weeks 1, 4, and 8. Subsequent refinements included the addition of technical features that would allow patients to revisit and/or repeat previously completed modules, along with integration of more characters for delivering video vignettes and greater opportunities for skills practice and treatment engagement. These modifications have further enhanced Aviva safety, tolerability, and fidelity, consistent with the original BCBT protocol. Not only is it hypothesized that Aviva will result in significantly larger reductions in severity of suicidal ideation than participants randomized to the control condition, but also that greater app engagement will be negatively correlated with severity of suicidal thinking. Moderators and mediators (i.e. suicidal beliefs, wish to live, impulsive decision-making) of intervention effects will also be examined. The study will be conducted at the primary care clinics at Fort Carson, with a goal of enrolling 720 patients across a two-year timeframe. Participants will be identified using each clinic's existing suicide risk assessment methods, including the PHQ-9 suicide risk item and a score of 1 or higher on the CSSRS Screener (Recent). Participants will be randomly assigned to one of two treatment conditions, Aviva or control (i.e., development of a safety plan consistent with local procedures and policies, along with referral for standard mental health care and suicide risk management in accordance with local policies and procedures). In an effort to address potential performance bias specific to smartphone use, participants in the control condition will download the Suicide Safety Plan app to their smartphones. Those in the Aviva condition will also complete weekly check-ins with Project 2 research clinicians to review treatment adherence, identify and respond to any logistical/operational problems, and respond to any unexpected emergencies and/or participant safety concerns. Participants will have up to five data points: baseline, 3, 6, 9, and 12 months. All data available from all participants and all time points will be included in the analyses, consistent with the intent-to-treat principle. Across our two previous clinical trials and our in-progress RCT, attrition during the first 12 months postbaseline was \<30% and we anticipate similar rates in this trial.