Clinical trial NCT03653637: Group ("Project Life Force") vs. Individual Suicide Safety Planning RCT
Official title: Group (Project Life Force) vs. Individual Suicide Safety Planning RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Keywords: Suicide
Safety Plan
Group Treatment
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Corporal Michael J. Crescenz VA Medical Center
First posted: 2018-08-31
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Columbia Suicide Rating Scale (C-SSRS)
timeFrame: Baseline, 3 Month, 6 Month, 12 Month
measure: Suicidal behavior by Chart Abstraction
timeFrame: 12 Month
measure: Death by suicide by National Death Index Survey Findings
timeFrame: 12 Month
Secondary outcomes:
measure: Beck Depression Inventory-II Change
timeFrame: Baseline, 3 Month, 6 Month, 12 Month
measure: Beck Hopelessness Scale Change
timeFrame: Baseline, 3 Month, 6 Month, 12 Month
measure: Suicide-related Coping Scale Change
timeFrame: Baseline, 3 Month, 6 Month, 12 Month
measure: Outpatient Mental Health Treatment Utilization
timeFrame: 12 Month
measure: Drug Abuse Screening Test 10 (DAST-10)
timeFrame: 12 Month
measure: Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)
timeFrame: 12 Month
Other outcomes:
measure: The Group Cohesion Scale-Revised Change
timeFrame: Weeks 1, 5, 10
measure: Interpersonal Needs Questionnaire Change
timeFrame: Baseline, 3 Month, 6 Month, 12 Month
measure: Buss-Perry Aggression Questionnaire Change
timeFrame: Baseline, 3 Month, 6 Month, 12 Month
measure: Insomnia Severity Index Change
timeFrame: Baseline, 3 Month, 6 Month, 12 Month
measure: Beck Lethality Scale Change
timeFrame: Baseline, 3 Month, 6 Month, 12 Month
measure: Beck Suicide Intent Scale Change
timeFrame: Baseline, 3 Month, 6 Month, 12 Month
measure: Ohio State University Traumatic Brain Injury Identification Method
timeFrame: Baseline
measure: Mini International Neuropsychiatric Interview
timeFrame: Baseline
measure: Mini Mental State Exam
timeFrame: Baseline
Locations:
city: Bronx
country: United States
facility: James J. Peters VA Medical Center, Bronx, NY
state: New York
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
Study officials:
affiliation: James J. Peters Veterans Affairs Medical Center
name: Marianne S. Goodman, MD
role: PRINCIPAL_INVESTIGATOR
References: