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

NCT03653637 | Completed Results DMC

• 2 other identifiers: MHBB-025-17F1I01CX001705-01A1
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 2

Brief Summary

The management of suicide risk is a pressing national public health issue especially among Veterans. This grant consists of two arms: the novel treatment and treatment-as-usual. "Project Life Force" (PLF), a novel suicide safety planning group intervention has been developed to provide a mechanism to develop and enhance the Suicide Safety Plan (SSP) over time. PLF, a 10-session, group intervention, combines cognitive behavior therapy (CBT)/dialectical behavior therapy (DBT) skill based, and psychoeducational approaches, to maximize suicide safety planning development and implementation. Veterans revise their plans over several weeks while learning coping, emotion regulation, and interpersonal skills to incorporate into their safety plans.

Conditions

Suicide

Keywords

Suicide; Safety Plan; Group Treatment; Veterans

Outcome Measures

Primary Outcomes (3)

• Columbia Suicide Rating Scale (C-SSRS)

  Columbia Suicide Rating Scale (C-SSRS) will be used to count prospective or treatment emergent suicidal behaviors. The CSSRS has been used in many treatment trials, and to measure treatment emergent suicidal events during pharmacotherapy. C-SSRS contains a subscale on suicidal ideation which is scored from 1-5; higher numbers indicate increased suicidal thinking. The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt according to the CSSR-S.

  Baseline, 3 Month, 6 Month, 12 Month

• Suicidal Behavior by Chart Abstraction

  An independent research assessor who is blinded to study condition will complete all outcome assessments. Data for all types of suicidal behavior including suicides, suicide attempts, interrupted attempts, aborted attempts, and preparatory behavior for suicide, will be obtained. The nomenclature and definitions for suicide-related behaviors will follow the Center for Disease Control and Prevention's (CDC) definitions. Suicidal behavior over the 12-month time frame is a cumulative outcome such that detection of suicidal behavior at any of the outcome points, or by any method, leads to a "positive" indication for the suicidal behavior composite.

  12 Month

• Death by Suicide by National Death Index Survey Findings

  At month 42, each site's research assistant will query the site's state vital statistics registry for all individuals on this list. For all those who are found to be deceased, data will be abstracted pertaining to his/her death and the probability of suicide from the Death Certificate. The 12-month delay in review is necessary because of the well-known lag in recording deaths in state vital statistics registries.

  12 Month

Secondary Outcomes (6)

• Beck Depression Inventory-II Change

  Baseline, 3 Month, 6 Month, 12 Month

• Beck Hopelessness Scale Change

  Baseline, 3 Month, 6 Month, 12 Month

• Suicide-related Coping Scale Change

  Baseline, 3 Month, 6 Month, 12 Month

• Outpatient Mental Health Treatment Utilization

  12 Month

• Drug Abuse Screening Test 10 (DAST-10)

  12 Month

Other Outcomes (9)

• The Group Cohesion Scale-Revised Change

  Weeks 1, 5, 10

• Interpersonal Needs Questionnaire Change

  Baseline, 3 Month, 6 Month, 12 Month

• Buss-Perry Aggression Questionnaire Change

  Baseline, 3 Month, 6 Month, 12 Month

Study Arms (2)

Project Life Force

EXPERIMENTAL

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.

Behavioral: Project Life Force

Treatment-As-Usual

ACTIVE COMPARATOR

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.

Behavioral: Treatment as Usual

Interventions

Project Life Force BEHAVIORAL

A novel, 10-session group intervention to enhance currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicidal. The PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.

Also known as: PLF

Project Life Force

Treatment as Usual BEHAVIORAL

The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.

Also known as: TAU

Treatment-As-Usual

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Discharge from inpatient unit for suicidal ideation or attempts, or placement on the high-risk suicide list maintained by suicide prevention coordinators
• Completion of a safety plan during the past 6 months prior to entry
• Concurrence from the patient's mental health provider for the Veteran to participate in the study and the provider is willing to work with the research team.

You may not qualify if:

• Unable to provide informed consent or complete study requirements
• Unable to speak English
• Cognitive difficulties that impair consent capacity
• Unable or unwilling to provide at least one verifiable contact for emergency or tracking purposes
• Unable to attend outpatient group treatment program or tolerate group therapy format
• Active alcohol or opiate dependence requiring medically supervised withdrawal
• Schizophrenia diagnosis
• Participation in another intervention RCT

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Corporal Michael J. Crescenz VA Medical Center: collaborator

Study Sites (2)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

Location

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Suicide

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Limitations and Caveats

Primarily, we experienced disruption in the planned procedures due to COVID-19 (e.g., necessitating a shift to remote treatment). This context limits the conclusions that can be drawn from this trial, as the in-person group setting was hypothesized to be an important mechanism of change and improvement in study outcomes.

Results Point of Contact

• Title: Dr. Marianne Goodman
• Organization: James J. Peters VA Medical Center

mggoodman2001@yahoo.com

6462457071

Study Officials

• Marianne S. Goodman, MD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The individual who evaluates the outcomes of interest will not know the assigned condition of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: October 15, 2018
• Primary Completion: December 31, 2023
• Study Completion: March 30, 2024
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)