Group (Project Life Force) vs. Individual Suicide Safety Planning RCT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Suicide
- Sponsor
- VA Office of Research and Development
- Enrollment
- 294
- Locations
- 2
- Primary Endpoint
- Columbia Suicide Rating Scale (C-SSRS)
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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.
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
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.
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
- 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)
- Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)(12 Month)