CLASP for Suicide Prevention

(3C Trial)

Not currently recruiting at 10 trial locations

Overseen By Todd Bishop, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brown University

Disqualifiers: Impaired decision-making, Limited English, Terminal illness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Coping Long Term with Active Suicide Program (CLASP) to help prevent suicide among veterans recently hospitalized. Participants will receive either their usual care or their usual care plus CLASP, which includes telehealth sessions to support ongoing treatment, problem-solving, and social connections. The study focuses on veterans flagged as high-risk for suicide after leaving the hospital and who have access to a phone. As an unphased trial, this study offers veterans the opportunity to contribute to important research that could enhance suicide prevention strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Coping Long Term with Active Suicide Program (CLASP) is safe for veterans?

Research has shown that the Coping Long Term with Active Suicide Program (CLASP) is designed to assist individuals at high risk for suicide. Early studies suggest it holds promise for those in similar situations. CLASP, a telehealth-based program, is delivered over the phone or internet, and participants generally find it easy to use. The program focuses on keeping people engaged in treatment, solving problems, and building social support. Some participants also address specific issues like substance misuse.

Previous studies have not identified any major safety concerns. As a behavioral program rather than a medication, CLASP is less likely to cause physical side effects. Instead, it provides support and strategies to help reduce suicidal thoughts and behaviors. The program uses communication and counseling, which have proven safe and manageable for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Coping Long Term with Active Suicide Program (CLASP) because it offers a novel, telehealth-based approach to suicide prevention. Unlike traditional treatments that often rely on in-person therapy, CLASP provides flexibility and accessibility through virtual sessions, making it easier for participants to engage consistently. The program targets specific risk factors like treatment engagement, problem-solving, and social support, while also personalizing care by addressing individual issues such as substance misuse. This tailored intervention has the potential to significantly reduce suicidal behavior, especially during critical transition periods post-discharge.

What evidence suggests that the Coping Long Term with Active Suicide Program (CLASP) is effective for suicide prevention?

Research has shown that the Coping Long Term with Active Suicide Program (CLASP), which participants in this trial may receive, is a promising method for helping individuals at high risk of suicide. Early studies indicate that CLASP is practical and effective in reducing suicidal thoughts and actions. The program engages individuals in their treatment, aids in problem-solving, and encourages support from family and friends. It also addresses feelings of hopelessness and other personal risks, such as substance abuse. The varied approach of CLASP has proven particularly effective in preventing suicide. ^{2 3 4 5 6}

Who Is on the Research Team?

Lauren Weinstock, PhD

Principal Investigator

Brown University

Are You a Good Fit for This Trial?

The Veterans Coordinated Community Care (3C) Study is for veterans at least 18 years old who are considered high-risk for suicide after leaving the hospital. They must be able to speak English, make their own decisions, and have access to a phone post-discharge.

Inclusion Criteria

Inpatient Veteran at high-risk for post-discharge suicide (as flagged by the study's validated prediction model)

Access to a telephone after discharge

Exclusion Criteria

Terminal illness

I have difficulty making decisions due to my health condition.

Limited or no English language proficiency

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments are conducted to gather initial data before intervention

1 week

1 visit (in-person or virtual)

Treatment

Participants receive either Treatment As Usual (TAU) or TAU plus the CLASP intervention

6 months

3 initial sessions (inpatient or post-discharge), 12 telehealth sessions over 6 months, 6 SO telehealth sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Coping Long Term with Active Suicide Program (CLASP)

Trial Overview This study tests if adding the Coping Long Term with Active Suicide Program (CLASP) to usual treatment helps reduce suicide-related behaviors in veterans. Participants will either receive standard care or standard plus CLASP and will be monitored for six months.

How Is the Trial Designed?

Group I: Coping Long Term with Active Suicide Program (CLASP) Experimental Treatment 1 Intervention

The CLASP intervention is an adjunctive, telehealth-based behavioral intervention designed to reduce suicidal behavior among individuals at high risk for suicide going through periods of transition. CLASP is designed to intervene on four risk factor targets: ongoing treatment engagement, problem-solving, social and family support, and hopelessness. In addition to these general factors, the CLASP provider also has the flexibility to identify and target certain "patient-specific" risk factors (e.g., substance misuse) for intervention. CLASP will begin after completion of the baseline assessment, and will continue for 6 months post-discharge. CLASP will be comprised of: a) 3 initial sessions while participants are still inpatients (can occur post-discharge if needed); b) 12 brief telehealth sessions over 6-months post-discharge; c) 6 brief SO telehealth sessions.

Group II: Treatment As Usual (TAU) Active Control 1 Intervention

Treatment As Usual (TAU) consists of unrestricted treatment provided as part of routine care in the Veterans Health Administration (VHA) following inpatient hospitalization. Study staff will provide no additional treatment in this arm.

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

Harvard University

Collaborator

Trials

237

Recruited

588,000+

Canandaigua VA Medical Center

Collaborator

Trials

13

Recruited

1,800+

West Virginia University

Collaborator

Trials

192

Recruited

64,700+

The Warren Alpert Foundation

Collaborator

Trials

2

Recruited

1,100+

Published Research Related to This Trial

In a study of 150 individuals discharged after a suicide-related crisis, both the Collaborative Assessment and Management of Suicidality (CAMS) and treatment as usual (TAU) led to improvements in suicidal thoughts and psychological distress over 12 months, but CAMS was not found to be superior to TAU for the primary outcomes.

Participants receiving CAMS reported less psychological distress at 12 months compared to their baseline levels, indicating some benefit, but overall, the study suggests that while CAMS is feasible and acceptable, further research is needed to explore its potential advantages over standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing short term suicide risk after hospitalization: A randomized controlled trial of the Collaborative Assessment and Management of Suicidality. Comtois, KA., Hendricks, KE., DeCou, CR., et al.[2023]

A study involving 31 participants showed that a multidisciplinary, assertive outreach model of post-suicidal care significantly reduced suicidal ideation and distress while improving resilience and well-being at least 6 months after discharge.

Qualitative feedback highlighted the importance of staff support in recovery, suggesting that effective post-suicidal care can enhance protective psychological factors and sustain improvements in mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provision of a Multidisciplinary Post-Suicidal, Community-Based Aftercare Program: A Longitudinal Study. Kehoe, M., Wright, AM., Lee, SJ., et al.[2023]

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5047846/

The Coping with Long Term Active Suicide Program (CLASP) This paper presents a description and pilot data for a new adjunctive intervention designed to reduce suicidal behavior among high-risk individuals.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27038050/

The Coping Long Term with Active Suicide Program - PubMed Open trial and pilot randomized trial data provide preliminary evidence that CLASP is a feasible, acceptable, and efficacious intervention to reduce suicidal ...

3. academic.oup.com academic.oup.com/book/43195/chapter/362835465

CLASP Introduction, Development, and Empirical Support This chapter introduces the Coping Long Term with Active Suicide Program (CLASP), which is a suicide prevention intervention process. Suicide behavior is ...

4. researchgate.net researchgate.net/publication/363004931_The_Coping_Long_Term_with_Active_Suicide_Program_CLASP_A_Multi-Modal_Intervention_for_Suicide_PreventionA_Multi-Modal_Intervention_for_Suicide_Prevention

The Coping Long Term with Active Suicide Program (CLASP) Multifaceted interventions have been found to be particularly effective in reducing suicidal behaviors (Krysinska et al., 2015;Hofstra et al., 2020;Doupnik et ...

5. hsrd.research.va.gov hsrd.research.va.gov/for_researchers/cyber_seminars/archives/video_archive.cfm?SessionID=3590

The Coping Long-Term with Active Suicide Program (CLASP ... Presenters will discuss suicide risk factors, challenges in suicide prevention over care transitions, and will present efficacy data on CLASP. Intended ...

6. suny.edu suny.edu/mental-health/resources/

Find Mental Health Resources Near You Services Offered. Individual counseling; Group counseling; Wellness programming; Consultation; Crisis intervention; Educational programs (classes, dorms) ...