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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Suicide

Intervention / Treatment
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* Behavioral: Project Life Force
* Behavioral: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to one of two groups in parallel for the duration of the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Project Life Force<br>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<br>* 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.<br>* Other names: PLF;|
| Active Comparator: Treatment-As-Usual<br>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<br>* 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.<br>* Other names: TAU;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suicide, Safety Plan, Group Treatment, Veterans