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

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

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.

Study Overview

• Status: Completed
• Conditions: Suicide
• Intervention / Treatment: Behavioral: Project Life Force; Behavioral: Treatment as Usual

Detailed Description

Worldwide someone dies by suicide every 40 seconds. In the United States, Veterans exhibit significantly higher suicide risk when compared to the general United States population. One in five suicide deaths is a Veteran and in spite of enhanced suicide prevention services in the Veterans Administration (VA), twenty Veterans commit suicide daily. These very concerning numbers demonstrate an urgent need to develop additional, empirically validated interventions for suicidal Veterans.

One component of the VA's coordinated effort to treat high-risk suicidal Veterans, and diminish suicide risk, is through the construction of a Suicide Safety Plan. Considered a best practice, the SSP instructs one to: recognize personal warning signs of suicide; use internal coping strategies; engage social contacts that can offer support and serve as distraction from suicidal thoughts; contact family members or friends who may help resolve a crisis; provide contact information for VA professionals to help and, specify steps for how to make the immediate environment safer. The patient takes the SSP home for his or her use during (or at the onset of) a suicidal crisis. Safety planning is based on the idea that suicide risk fluctuates over time, and aims to prevent suicidal crises from escalating, and stop individuals from acting on their suicidal thoughts and urges. Research suggests creation of the SSP is effective; one study found that Veterans who present to an emergency room show decreased suicide behavior after creating a SSP.

This study aims to fill this treatment gap by examining a novel intervention integrating skills training with safety planning for high risk suicidal Veterans, "Project Life Force" (PLF). The PLF intervention augments the SSP with skills training, and psychoeducation, to maximize use and effectiveness of the plan in a group setting. This intervention's skill instruction is delivered in a group format. Research suggests groups mitigate loneliness and increase a sense of belonging, which is in line with the extensive literature supporting the interpersonal psychological theory (i.e., that those who die by suicide have a low sense of belonging. More recently, reports on the relation of "military unit cohesion" and suicide risk, suggests that increasing unit cohesion may have a protective effect. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others.

The main objective of this RCT is to examine if Veterans who are at high risk for suicide will benefit from the novel group intervention, PLF, compared to Veterans who receive TAU.The specific aims and hypotheses of PLF are:

Aim 1: To conduct a multi-site randomized clinical trial (RCT) of a group safety planning intervention, "PLF" versus individual safety planning in 265 suicidal Veterans. PLF will be compared with the comparison condition- individual safety planning, the current standard of care, designated as TAU.

Exploratory Aim 2: To test whether increased suicide coping and improved belongingness partially mediates treatment response in PLF>TAU.

Exploratory Aim 3: To test whether group cohesion partially mediates treatment response in PLF.

Exploratory Aim 4: To test whether the change in Safety Plan Quality (post intervention - baseline) is greater PLF>TAU, as well as whether the change in safety plan quality partially mediates treatment response in the follow up period.

Hypothesis A1: Compared to TAU, Veterans who participate in PLF, will demonstrate a decrease in suicidal behavior.

Hypothesis A2: Compared to TAU, Veterans who participate in PLF will show a decrease in depression and hopelessness.

Hypothesis A3: Compared to TAU, Veterans who participate in PLF will have increased compliance and attitudes towards mental health treatment.

• Study Type: Interventional
• Enrollment (Actual): 294
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • The Bronx, New York, United States, 10468-3904
      • James J. Peters VA Medical Center, Bronx, NY
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Project Life Force; 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; 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.; Other Names: PLF
Active Comparator: Treatment-As-Usual; 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; 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.; Other Names: TAU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory-II Change	The Beck Depression Inventory-II (BDI-II) measures depressive severity with 21 items on a Likert scale. It has high internal consistency, construct validity, and test-retest reliability. Each question has a set of at least four possible answer choices ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer, and items are summed for a total score (ranging from 0-63). Higher scores indicate worse depressive severity.	Baseline, 3 Month, 6 Month, 12 Month
Beck Hopelessness Scale Change	The Beck Hopelessness Scale (BHS) measures hopelessness with 20 binary (true/false) items. Items are recoded so that optimistic beliefs equal 0 and pessimistic beliefs equal 1. Recoded items are summed for a total score (ranging from 0-20), and higher scores indicate more severe hopelessness. The BHS demonstrates excellent internal reliability and external validity.	Baseline, 3 Month, 6 Month, 12 Month
Suicide-related Coping Scale Change	The Suicide-Related Coping Scale (SRCS) has 17 items assessing suicide-related coping (knowledge of, and perceived confidence in, using internal coping strategies and external supports to regulate suicidal thoughts and urges). Items are rated on a 5-point scale (Strongly disagree (0) - Strongly agree (4)). All items are summed for a total score (range 0-68), and the first 14 items can also be used for "external coping" and "internal coping" subscales (7 items each; total range 0-28). Higher scores show improved suicide-related coping. The SRCS has acceptable internal and external validity.	Baseline, 3 Month, 6 Month, 12 Month
Outpatient Mental Health Treatment Utilization	Outpatient Mental Health Treatment Utilization was quantified using CPRS. The number of outpatient non-PLF mental health visits from the past three months was counted.	12 Month
Drug Abuse Screening Test 10 (DAST-10)	The DAST-10 measures drug use over the past twelve months to identify potential drug use disorder with 10 binary items (0/1). Total scores range from 0 to 10. Scores of 0 indicate no problems, 1-2 low-level, 3-5 moderate level, 6-8 substantial level, and 9-10 severe level.	12 Month
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)	The Alcohol Use Disorders Identification Test-Concise (AUDIT-C) is a brief 3-item alcohol screening tool used to identify individuals who may be at risk for hazardous drinking or have an alcohol use disorder. Each item is rated from 0 to 4, and total scores range from 0 - 12. Higher scores indicated an increased likelihood that an individual's drinking is endangering his or her safety.	12 Month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Group Cohesion Scale-Revised Change	Group cohesion will be measured by the The Group Cohesion Scale-Revised, a 25-item self-report measure that assesses aspects of group cohesion including communication, interaction, member retention, decision making, vulnerability among group members and consistency between group and individual goals with a four-point scale. This scale will be used for participants randomized to the PLF treatment at 3 times points before a group session. The scale demonstrated high validity and reliability in research settings and was found to be sensitive to change in a psychodrama group treatment.	Weeks 1, 5, 10
Ohio State University Traumatic Brain Injury Identification Method	The Ohio State University Traumatic Brain Injury Identification Method is a standardized, 3-5-minute structured interview designed elicit a person's lifetime history of TBI.	Baseline
Mini Mental State Exam	The Mini Mental State Exam is a questionnaire used to measure cognitive impairment. This scale has good validity and construct validity and will be used to examine if participants are cognitively able to participate in the study.	Baseline
Interpersonal Needs Questionnaire Change	The Interpersonal Needs Questionnaire-15 (INQ-15) consists of 15 items assessing thwarted interpersonal needs along two domains: Thwarted Belongingness (TB, nine items) and Perceived Burdensomeness (PB, six items). All items are rated from one (not at all true for me) to seven (very true for me). Six items from the TB subscale are reverse-keyed and reverse-scored. Items are summed for total scores (TB total score range: 9-63 and PB score range: 6-42). Higher scores indicate increased severity of TB and PB.	Baseline, 3 Month, 6 Month, 12 Month
Buss-Perry Aggression Questionnaire Change	The Buss-Perry Aggression Questionnaire (BPAQ) assesses aggression in four domains (anger, hostility, physical aggression, and verbal aggression) with 29 items on a 4-point scale (Extremely uncharacteristic (0) - Extremely characteristic (3)). Items in each domain are summed for domain scores, and higher scores indicate more aggression severity in the respective domain. Total score ranges are: anger: 7-35, hostility: 8-40, physical aggression: 9-45, verbal aggression: 5-25.	Baseline, 3 Month, 6 Month, 12 Month
Insomnia Severity Index Change	The Insomnia Severity Index (ISI) is a 7-item brief screening measure of insomnia. Items include insomnia severity (falling asleep, staying asleep, and waking too early), satisfaction with sleep, the extent to which sleep difficulties impair daily functioning, how noticeable low quality of life due to sleep difficulties is to others, and distress about sleep difficulties. Item responses range from 0 - 4 and are summed for total scores (range 0-28). Higher scores indicate more severe insomnia. The ISI has good internal consistency and validity for treatment research.	Baseline, 3 Month, 6 Month, 12 Month
Beck Lethality Scale Change	The Beck Lethality Scale (BLS) is an interview-administered measure of medical lethality of a suicide attempt for eight possible methods (i.e., coma-producing drugs, non-coma-producing drugs, shooting, burning, drowning, cutting, jumping, and hanging). The BLS was used following suicidal behavior over the full study duration. Each item (i.e., each method) is rated from "0" (none or minimal damage) to "10" (death) based on an examination of the patient's physical condition on admission, review of the medical charts, and consultation with the attending physician. Higher scores on each method indicate higher lethality for that method. The highest lethality rating across all of the eight methods (none or minimal damage to death) was used as a total score.	12 Month
Beck Suicide Intent Scale Change	The Suicide Intent Scale (SIS) measures the retrospective intensity of the wish to die at the time of a suicide attempt with 20 items. Each item is graded in intensity from 0 to 2, and the first 15 items are summed for a total score (ranging from 0 to 30). Higher scores indicate higher suicide intent. The SIS has high inter-rater reliability and internal consistency.	Baseline, 3 Month, 6 Month, 12 Month
Mini International Neuropsychiatric Interview	The Mini International Neuropsychiatric Interview (MINI) is a structured diagnostic interview that assesses the presence of psychiatric disorders according to DSM-IV or ICD-10 criteria, with good interrater and test-retest reliability. The MINI was used to determine psychiatric diagnoses (lifetime and current).	Baseline

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Corporal Michael J. Crescenz VA Medical Center
• Investigators: Principal Investigator: Marianne S. Goodman, MD, James J. Peters Veterans Affairs Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): March 30, 2024

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Estimated): November 10, 2025
• Last Update Submitted That Met QC Criteria: October 24, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Veterans; Suicide; Group Treatment; Safety Plan
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Behavior; Suicide; Therapeutics
• Other Study ID Numbers: MHBB-025-17F; 1I01CX001705-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No