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): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • 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	Depression will be measured with the Beck Depression Inventory-II. This scale consisting of 21 items and scored based on a Likert scale, has high internal consistency (Cronbach coefficient = .92). 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 then the total score is used to quantify the participant's degree of depression from 0 = no depression to 63 = maximally severe depression.	Baseline, 3 Month, 6 Month, 12 Month
Beck Hopelessness Scale Change	Hopelessness is assessed with the Beck Hopelessness Scale, a 20-item self-report measure with true-false items that assess hopelessness and the extent of positive and negative beliefs about the future. Summed scores range from 0 to 20. Scores provide a measure of the severity of self-reported hopelessness: 0-3 minimal, 4-8 mild, 9-14 moderate, and 15-20 severe. Adequate reliability and concurrent validity data exist for this measure, which has been shown to be predictive of eventual suicide in psychiatric inpatients.	Baseline, 3 Month, 6 Month, 12 Month
Suicide-related Coping Scale Change	Suicide-related coping will be evaluated by the Suicide-related Coping Scale, a 21-item self-report measure developed by Stanley and colleagues to evaluate appraisal of one's ability to cope with suicidal ideation and urges, as well as ability to use the Safety Plan. Examples of items include: "I am at the mercy of my suicidal thoughts", "I have several things I can do to get through a suicidal crisis". The scale has high internal consistency reliability (Cronbach's = 0.88) and demonstrated sensitivity to change in SAFEVET (t(65) = 6.8, p < .001;Dr. Stanley, personal communication).	Baseline, 3 Month, 6 Month, 12 Month
Outpatient Mental Health Treatment Utilization	Outpatient Mental Health Treatment Utilization will be quantified Using CPRS investigators will count the number of outpatient non-PLF mental health visits attended by participants three months prior to the intervention and compare it to the number of outpatient visits attended during and three months post intervention.	12 Month
Drug Abuse Screening Test 10 (DAST-10)	The DAST-10 is a brief, 10-item self-report assesses consequences related to drug abuse, excluding alcohol and tobacco. This is a 10-item questionnaire with no-yes answers (0-1). Higher scores are positively correlated with higher levels of drug dependence. Minimum score = 0 : maximum score = 10.	12 Month
Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)	The AUDIT-C is a widely used 3-item self-report screen for hazardous or harmful alcohol consumption that is based off of the 10-item original AUDIT.	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
Interpersonal Needs Questionnaire Change	The Interpersonal Needs Questionnaire will be used to measure thwarted belongingness. While several versions exist, the investigators will use the 10-item version as it demonstrated the best, most consistent model fit in confirmatory factor analyses and consistently predicted concurrent suicidal ideation.	Baseline, 3 Month, 6 Month, 12 Month
Buss-Perry Aggression Questionnaire Change	The Buss-Perry Aggression Questionnaire assesses four aspects of aggressive behavior: physical aggression, verbal aggression, anger and hostility. Participants rank statements about their temperament using a 7-point Likert scale ranging from 1 (extremely uncharacteristic of me) to 7 (extremely characteristic of me).	Baseline, 3 Month, 6 Month, 12 Month
Insomnia Severity Index Change	The 7-item Insomnia Severity Index will be used to assess important health domains. It is used to assess the severity of both nighttime and daytime components of insomnia. The seven answers are added up to get a total score.	Baseline, 3 Month, 6 Month, 12 Month
Beck Lethality Scale Change	Medical seriousness of attempts was assessed using the Beck Lethality Scale. It measures the degree of the severity of medical injury resulting from the suicide attempt. The Beck Lethality Scales includes eight items that measure the medical lethality of previous suicide attempts (e.g., shooting, jumping, and drug overdose). Each scale is rated from 0 to 10, based on an examination of the patient's physical condition on admission, review of the medical charts, and consultation with the attending physician.	Baseline, 3 Month, 6 Month, 12 Month
Beck Suicide Intent Scale Change	Suicidal intent associated with suicide attempts was assessed using Beck's Suicide Intent Scale. Beck's SIS contains 20 items each scoring from 1 to 3 points. Total score of 15-19 was recorded as low intent, score 20-28 was recorded as medium intent, and score 29 and above was recorded as high intent.	Baseline, 3 Month, 6 Month, 12 Month
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 International Neuropsychiatric Interview	The Mini International Neuropsychiatric Interview is a short diagnostic structured interview developed to explore disorders according to Diagnostic and Statistical Manual diagnostic criteria. The Mini International Neuropsychiatric Interview will be used to determine the presence/absence of (lifetime) psychiatric symptoms.	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

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 (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Veterans; Suicide; Group Treatment; Safety Plan
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide
• 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