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Completed

NCT Number: NCT03653637

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

James J. Peters VA Medical Center, Bronx, NY, The Bronx, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PLF

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.

Other names: TAU

Primary outcomes

  1. Columbia Suicide Rating Scale (C-SSRS)

    Time frame: Baseline, 3 Month, 6 Month, 12 Month

    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.

  2. Suicidal Behavior by Chart Abstraction

    Time frame: 12 Month

    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.

  3. Death by Suicide by National Death Index Survey Findings

    Time frame: 12 Month

    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.

Secondary outcomes

  1. Beck Depression Inventory-II Change

    Time frame: Baseline, 3 Month, 6 Month, 12 Month

    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.

  2. Beck Hopelessness Scale Change

    Time frame: Baseline, 3 Month, 6 Month, 12 Month

    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.

  3. Suicide-related Coping Scale Change

    Time frame: Baseline, 3 Month, 6 Month, 12 Month

    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.

  4. Outpatient Mental Health Treatment Utilization

    Time frame: 12 Month

    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.

  5. Drug Abuse Screening Test 10 (DAST-10)

    Time frame: 12 Month

    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.

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

    Time frame: 12 Month

    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.

Other outcomes

  1. The Group Cohesion Scale-Revised Change

    Time frame: Weeks 1, 5, 10

    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.

  2. Interpersonal Needs Questionnaire Change

    Time frame: Baseline, 3 Month, 6 Month, 12 Month

    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.

  3. Buss-Perry Aggression Questionnaire Change

    Time frame: Baseline, 3 Month, 6 Month, 12 Month

    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.

  4. Insomnia Severity Index Change

    Time frame: Baseline, 3 Month, 6 Month, 12 Month

    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.

  5. Beck Lethality Scale Change

    Time frame: 12 Month

    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.

  6. Beck Suicide Intent Scale Change

    Time frame: Baseline, 3 Month, 6 Month, 12 Month

    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.

  7. Ohio State University Traumatic Brain Injury Identification Method

    Time frame: Baseline

    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.

  8. Mini International Neuropsychiatric Interview

    Time frame: Baseline

    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).

  9. Mini Mental State Exam

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Corporal Michael J. Crescenz VA Medical Center

Registry information

Official study title

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

Acronym: PLF

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Aug 31, 2018
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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