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



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 89
Updated:11/8/2018
Start Date:October 15, 2018
End Date:March 3, 2023
Contact:Sarah R Sullivan
Email:Sarah.Sullivan@va.gov
Phone:(718) 584-9000

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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.

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.

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
We found this trial at
2
sites
Bronx, New York 10468
Principal Investigator: Marianne S. Goodman, MD
Phone: 718-584-9000
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3900 Woodland Avenue
Philadelphia, Pennsylvania 19104
Phone: 215-823-6029
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Philadelphia, PA
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