CLASP for Suicide Prevention

(3C Trial)

Recruiting at 9 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

850 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Coping Long Term with Active Suicide Program (CLASP) for suicide prevention?

Preliminary evidence from pilot studies suggests that CLASP is a feasible and effective treatment to reduce suicidal behavior, especially among high-risk individuals. Additionally, research indicates that CLASP may help reduce suicide outcomes in people with severe mental illness following an emergency department visit. ^{1 2 3 4 5}

Is the CLASP program safe for humans?

The CLASP program has been described as feasible and acceptable, with no specific safety concerns reported in the available pilot data. However, there is a general issue in suicide prevention trials with inconsistent reporting of adverse events, making it difficult to fully assess safety. ^{1 3 5 6 7}

How is the CLASP treatment different from other suicide prevention treatments?

The CLASP treatment is unique because it combines in-person meetings with phone contacts involving both the patient and their significant other, making it a more personalized and supportive approach compared to other treatments that may not involve family or significant others. ^{1 3 5 7 8}

What is the purpose of this trial?

This trial will test a program called CLASP, which helps veterans at high risk for suicide after leaving the hospital. The program offers extra support and coping strategies, sometimes involving a loved one.

Research Team

Lauren Weinstock, PhD

Principal Investigator

Brown University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Longitudinal risk of suicide outcomes in people with severe mental illness following an emergency department visit and the effects of suicide prevention treatment. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Provision of a Multidisciplinary Post-Suicidal, Community-Based Aftercare Program: A Longitudinal Study. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Suicide Prevention Programs. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Reducing short term suicide risk after hospitalization: A randomized controlled trial of the Collaborative Assessment and Management of Suicidality. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The Coping Long Term with Active Suicide Program: Description and Pilot Data. [2022]

6. England 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Long-term outcomes for the promoting CARE suicide prevention program. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A comparison of multi-component systems approaches to suicide prevention. [2022]