ECRP + BCBT for Suicide Risk Reduction

Overseen By Michael S Esterman, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Psychotic, Manic, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 19

Duration: 12 weeks

136 Participants Needed

Trial Summary

What is the purpose of this trial?

The suicide rate among active duty service members and Veterans increased substantially following the onset of post-9/11 conflicts in Iraq and Afghanistan. Accordingly, Veteran suicide prevention has been identified as a national healthcare and research priority. The investigators will recruit 136 female and male Veterans who have been hospitalized for suicide risk and randomly assign them to receive one of two psychotherapy treatments for suicide risk after they leave the hospital. The goals of this study are to examine if a) a longer psychotherapy causes greater improvements in coping skills and reductions in negative suicidal thinking, b) a longer psychotherapy is more effective in reducing suicide risk, and c) if Veterans with a history of multiple suicide attempts are more likely to benefit from the longer psychotherapy. Additionally, this study will use magnetic resonance imaging (MRI) neuroimaging scans of Veterans shortly after they leave the hospital and again 4- and 12-months later. This study will explore a) if brain markers can predict suicide attempts, b) if brain markers change over time as suicide risk changes, and c) if brain markers change differently for the two types of psychotherapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment ECRP + BCBT for Suicide Risk Reduction?

Research shows that Brief Cognitive Behavioral Therapy (BCBT) is effective in reducing suicide attempts among military personnel, such as U.S. Army soldiers, and has shown preliminary success in other military groups. Additionally, behavior therapy, which includes components similar to BCBT, has been found to be more effective than other therapies in reducing repeated suicide attempts. ^{1 2 3 4 5}

Is the ECRP + BCBT treatment generally safe for humans?

The available research does not specifically address the safety of ECRP + BCBT, but Brief Cognitive Behavioral Therapy (BCBT) has been studied in military settings and is generally considered safe for reducing suicide risk without reported harmful effects. ^{1 2 4 6 7}

How does the ECRP + BCBT treatment for suicide risk reduction differ from other treatments?

The ECRP + BCBT treatment is unique because it combines elements of brief cognitive behavioral therapy (BCBT), which has shown effectiveness in reducing suicide attempts among military personnel, with other components that may enhance its efficacy. This approach is designed to be resource-efficient while specifically targeting suicidal behaviors, unlike more generalized treatments. ^{1 2 3 4 8}

Research Team

Michael S Esterman, PhD

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Eligibility Criteria

This trial is for English-speaking Veterans who've been hospitalized due to recent suicidal thoughts or attempts. They must be able to attend 12 therapy sessions and 3 MRI scans post-discharge. It's not suitable for those with significant cognitive impairments or current psychotic/manic features.

Inclusion Criteria

Veteran status

I can attend 15 sessions after leaving the hospital.

I can understand and agree to the study's consent form.

Exclusion Criteria

Significant cognitive impairment

Current psychotic or manic features

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Enhanced Crisis Response Planning (ECRP) or Brief Cognitive Behavioral Therapy (BCBT) for suicide prevention

12 weeks

12 visits (in-person)

Neuroimaging

MRI neuroimaging scans are conducted shortly after hospital discharge and again at 4- and 12-months post-discharge

12 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 2, 4, 8, and 12 months post-discharge

12 months

4 visits (in-person)

Treatment Details

Interventions

• Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT)
• Enhanced Crisis Response Planning (ECRP)

Trial Overview The study compares two psychotherapies: Brief Cognitive Behavioral Therapy (BCBT) and Enhanced Crisis Response Planning (ECRP), assessing their effectiveness in improving coping skills, reducing negative thinking, and lowering suicide risk among Veterans.

Participant Groups

Group I: Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT) Active Control 1 Intervention

This weekly, 12-session intervention involves completion of an enhanced crisis response plan, as well as emotion regulation skills training, learning strategies to identify and challenge thinking patterns that contribute to suicide risk, and increased engagement in personally meaningful activities.

Group II: Enhanced Crisis Response Planning Active Control 1 Intervention

Using supportive listening, a therapist conducts a brief interview to gather information about lifetime suicide attempt history and recent SI. The therapist then works with the client to identify a) warning signs for being in crisis, b) self-management/distraction strategies, c) reasons for living, d) sources of social support the client could contact in the event of a crisis, and e) crisis resources (e.g., veterans crisis line, contact information for current providers and local emergency resources). Steps for each of these, as well as specific contacts for social support and professional services are written on an index card provided to the patient and the patient is encouraged to keep the card in an accessible place (e.g., wallet) so it can be utilized in the event of a crisis.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Brief cognitive behavioral therapy (BCBT) is projected to prevent 23 to 25 more suicide attempts and 1 to 3 more suicide deaths per 100 patients compared to standard treatment for suicidal US Army soldiers, indicating its efficacy in reducing suicide risk.

BCBT is estimated to save the Department of Defense between $15,000 to $16,630 per patient compared to usual treatment, suggesting it may be a cost-effective intervention for addressing suicide risk among active-duty soldiers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic Evaluation of Brief Cognitive Behavioral Therapy vs Treatment as Usual for Suicidal US Army Soldiers. Bernecker, SL., Zuromski, KL., Curry, JC., et al.[2022]

The article reviews various ultra-brief and brief suicide-specific interventions, highlighting their potential to quickly stabilize individuals at risk of suicide, which is crucial given the rising suicide rates.

Several interventions, such as the Safety Planning Intervention and Cognitive Therapy for Suicide Prevention, have shown promising evidence for effectiveness, indicating a need for continued research to optimize these approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief and Ultra-Brief Suicide-Specific Interventions. Stanley, B., Brodsky, B., Monahan, M.[2023]

A clinical trial comparing behavior therapy to insight-oriented therapy for repeated suicide attempters showed that behavior therapy was more effective in reducing depression, anxiety, and suicidal ideation over a nine-month follow-up period.

The success of the behavior therapy package was attributed to its structured approach and assertive follow-up, which likely enhanced patient outcomes during the ten-day inpatient treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior therapy vs insight-oriented therapy for repeated suicide attempters. Liberman, RP., Eckman, T.[2019]

In a study of 108 active duty US Army personnel with PTSD, both group cognitive processing therapy-cognitive only version (CPT-C) and group present-centered therapy (PCT) significantly reduced rates of suicide ideation, with improvements maintained for up to 12 months post-treatment.

There were no reported suicide attempts during or after treatment in either group, and exacerbation of preexisting suicide ideation was uncommon, suggesting that group CPT-C is safe and does not increase suicide risk among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EVALUATING POTENTIAL IATROGENIC SUICIDE RISK IN TRAUMA-FOCUSED GROUP COGNITIVE BEHAVIORAL THERAPY FOR THE TREATMENT OF PTSD IN ACTIVE DUTY MILITARY PERSONNEL. Bryan, CJ., Clemans, TA., Hernandez, AM., et al.[2019]

The Safety Planning Intervention (SPI) is effective in reducing suicidal ideation and behavior, as well as improving depression and treatment engagement among adults experiencing suicide-related distress, based on a systematic review of 26 studies.

The SPI is adaptable and can be delivered in various formats (in-person or online) and as a standalone or combined intervention, making it a flexible tool in suicide prevention practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. Ferguson, M., Rhodes, K., Loughhead, M., et al.[2022]

A manual-based cognitive-behavioral therapy for suicide prevention (CBT-SP) was developed and tested on 110 adolescents aged 13 to 19 who recently attempted suicide, focusing on risk reduction and relapse prevention.

The therapy was well-received, with 72.4% of participants completing 12 or more sessions, indicating its feasibility for preventing recurrence of suicidal behavior in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for suicide prevention (CBT-SP): treatment model, feasibility, and acceptability. Stanley, B., Brown, G., Brent, DA., et al.[2022]

References

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

Economic Evaluation of Brief Cognitive Behavioral Therapy vs Treatment as Usual for Suicidal US Army Soldiers. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The Marine Suicide Prevention and Intervention REsearch (M-SPIRE) study: A randomized clinical trial investigating potential treatment mechanisms for reducing suicidal behaviors among military personnel. [2021]

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

Brief and Ultra-Brief Suicide-Specific Interventions. [2023]

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

Brief cognitive-behavioral therapy effects on post-treatment suicide attempts in a military sample: results of a randomized clinical trial with 2-year follow-up. [2022]

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

Behavior therapy vs insight-oriented therapy for repeated suicide attempters. [2019]

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

EVALUATING POTENTIAL IATROGENIC SUICIDE RISK IN TRAUMA-FOCUSED GROUP COGNITIVE BEHAVIORAL THERAPY FOR THE TREATMENT OF PTSD IN ACTIVE DUTY MILITARY PERSONNEL. [2019]

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

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. [2022]

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

Cognitive-behavioral therapy for suicide prevention (CBT-SP): treatment model, feasibility, and acceptability. [2022]