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Group Suicide Safety Planning vs. Individual Therapy for Suicide Risk (PLF Trial)

N/A

Waitlist Available

Led By Marianne S. Goodman, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 month, 6 month, 12 month

Awards & highlights

PLF Trial Summary

This trial will explore whether PLF is more effective than treatment-as-usual in reducing suicide risk among Veterans.

Who is the study for?

This trial is for Veterans who've made a suicide safety plan in the past 6 months, recently left inpatient care for suicidal thoughts or attempts, or are on a high-risk list. They need their mental health provider's approval to join and must be able to attend group therapy sessions without severe language or cognitive barriers.Check my eligibility

What is being tested?

'Project Life Force' (PLF) is being tested against standard treatment. PLF is a group program with 10 sessions that uses CBT/DBT skills and education to help participants improve their Suicide Safety Plans by learning coping strategies and interpersonal skills.See study design

What are the potential side effects?

Since 'Project Life Force' involves psychological therapy rather than medication, side effects may include emotional discomfort due to discussing sensitive topics, potential stress from group interactions, and possible fatigue after sessions.

PLF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 month, 6 month, 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 month, 6 month, 12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 month, 6 month, 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Columbia Suicide Rating Scale (C-SSRS)

Death by suicide by National Death Index Survey Findings

Suicidal behavior by Chart Abstraction

Secondary outcome measures

Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)

Beck Depression Inventory-II Change

Beck Hopelessness Scale Change

+3 more

Other outcome measures

Beck Lethality Scale Change

Beck Suicide Intent Scale Change

Buss-Perry Aggression Questionnaire Change

+6 more

PLF Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Project Life ForceExperimental Treatment1 Intervention

A novel, 10-session intervention to enhance currently mandated VA suicide safety planning in a group setting to support its implementation. PLF is a manualized, weekly 90-minute group treatment lasting 10 weeks coinciding with the time frame for enhanced monitoring of Veterans identified as "high-risk". Session content is described in Table 1 (see appendix A). Six of the PLF sessions correspond to a step of the safety plan and teach skills to maximize the use of that particular step of the plan. The use of emotion regulation skills in PLF differs from other DBT interventions in that it focuses primarily on emotion regulation, distraction and developing social support in the specific context of implementing a safety plan. Mindfulness is not covered. PLF is augmented with additional skill modules on physical health management, education pertaining to suicide risk, promoting positive emotion and suicide prevention mobile apps. PLF patients also receive usual care.

Group II: Treatment-As-UsualActive Control1 Intervention

The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Project Life Force

2018

N/A

~210

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Corporal Michael J. Crescenz VA Medical CenterFED

30 Previous Clinical Trials

10,310 Total Patients Enrolled

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,247 Total Patients Enrolled

38 Trials studying Suicide

5,412 Patients Enrolled for Suicide

Marianne S. Goodman, MDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center

2 Previous Clinical Trials

100 Total Patients Enrolled

1 Trials studying Suicide

78 Patients Enrolled for Suicide

Media Library

Project Life Force Clinical Trial Eligibility Overview. Trial Name: NCT03653637 — N/A

Suicide Research Study Groups: Project Life Force, Treatment-As-Usual

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research team currently seeking participants for this trial?

"Affirmative. The information hosted on clinicaltrials.gov shows that this trial is currently enrolling participants; the study was first published on October 15, 2018 and later modified in June 16th 2022. 265 candidates are needed between two different medical sites."

Answered by AI

Who is eligible to partake in this clinical examination?

"This trial requires 265 participants aged 18-89 who are currently battling with suicidal thoughts. Additionally, they must have been discharged from an inpatient unit or placed on a high-risk list by suicide prevention coordinators within the past six months and their mental health provider must be willing to work collaboratively with researchers during the study."

Answered by AI

How many participants are enrolled in this clinical experiment?

"Correct. Clinicaltrials.gov data affirms that this medical trial is currently recruiting individuals, beginning from the date of October 15th 2018 and with an update on June 16th 2022. The study is seeking 265 participants at two different sites."

Answered by AI

Is the enrollment window for this study open to those aged 55 and above?

"According to the stipulations of this clinical trial, the minimum age requirement for enrollment is 18 while the upper limit stands at 89."

Answered by AI

What is the expected outcome of this trial?

"The primary goal of this medical investigation, which will be monitored over Baseline, 3 Month, 6 Month and 12 Month intervals is to evaluate suicidal behaviour via Chart Abstraction. Secondary objectives include evaluating Beck Depression Inventory-II Change (a measure of depression ranging from 0 = no depression to 63 = maximally severe depression), gauging Beck Hopelessness Scale Change (with scores providing a degree of self-reported hopelessness: 0-3 minimal, 4-8 mild, 9-14 moderate, and 15-20 severe) as well as assessing Outpatient Mental health Treatment Utilization (quantified by counting the number of outpatient"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Group ("Project Life Force") vs. Individual Suicide Safety Planning RCT

2018. "Group ("Project Life Force") vs. Individual Suicide Safety Planning RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03653637.