Suicide Safety Planning Group Treatment: "Project Life Force"

NCT02525575 | Completed Results DMC

• 2 other identifiers: D1911-PGOO-15-037
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

For suicidal individuals, minimizing future risk and fostering recovery are critical public health concerns, especially among Veterans, as very few effective interventions exist. This proposal tests a novel group psychotherapy treatment that combines emotion regulation skill based, and psychoeducational approaches, with suicide safety planning development and implementation. "Project Life Force" (PLF), a novel suicide safety planning group intervention has been designed to fill this critical gap and provide a mechanism to develop and enhance suicide safety planning over time. PLF, a 12-session, group psychotherapy intervention, combines Dialectical Behavioral Therapy (DBT) skill based and psychoeducational approaches, to enhance suicide safety planning development and implementation. Veterans revise their plans over several weeks while learning distress tolerance, emotion regulation, and friendship building/interpersonal skills to incorporate into their safety plans and also receive lessons on gun safety and minimizing access to lethal means. Sessions are augmented with 1) training in the use of a suicide safety planning mobile App to promote accessibility and maximize implementation, and 2) didactic information to bolster recovery, including fostering improved connection with the treatment team, and Veteran's family.

Conditions

Suicide

Outcome Measures

Primary Outcomes (4)

• Beck Scale for Suicide Ideation (BSS)

  Beck Scale for Suicide Ideation is designed to assess severity of suicidal attitudes and plans for suicide. BSS is a 21 item self-report, rated on a scale of 0-2, with a total score range of 0-38 with higher score indicating higher ideation.

  Baseline, 3 Month, 6 Month

• Columbia Suicide Rating Scale (C-SSRS)

  The Columbia Suicide Rating Scale (C-SSRS) will be used to count prospective or treatment emergent suicidal behaviors. The C-SSRS 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 C-SSRS.

  Baseline, 3 Month, 6 Month

• Beck Depression Inventory-II

  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

• Beck Hopelessness Scale

  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

Study Arms (1)

Project Life Force Group Treatment

EXPERIMENTAL

Project Life Force Clinical Intervention: is a manualized, weekly 90-minute group treatment lasting 3 months coinciding with the time frame for enhanced monitoring of Veterans identified as "high-risk". The use of Dialectical Behavior Therapy skills in PLF differs from other DBT interventions in that it focuses primarily on emotion regulation (ER), distress tolerance and interpersonal effectiveness in the specific context of implementing a safety plan. Mindfulness is not covered. PLF is augmented with additional skill modules on strengthening friendships and education pertaining to suicide risk, suicide means restriction and suicide prevention mobile Apps.

Behavioral: Project Life Force Group Treatment

Interventions

Project Life Force Group Treatment BEHAVIORAL

PLF, a 12-session, group psychotherapy intervention, combines Dialectical Behavioral Therapy (DBT) skill based and psychoeducational approaches, to enhance suicide safety planning development and implementation. Veterans revise their plans over several weeks while learning distress tolerance, emotion regulation, and friendship building/interpersonal skills to incorporate into their safety plans and also receive lessons on gun safety and minimizing access to lethal means. Sessions are augmented with 1) training in the use of a suicide safety planning mobile App to promote accessibility and maximize implementation, and 2) didactic information to bolster recovery, including fostering improved connection with the treatment team, and Veteran's family. Importantly, the group format mitigates loneliness and fosters increased "belongingness", both key risk factors for suicide.

Project Life Force Group Treatment

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans \> 18
• Able to give consent
• Recent Completion of a VA suicide safety plan

You may not qualify if:

• IQ\<80
• Does not speak English
• Inability to tolerate group therapy format
• There are no special restrictions with regard to gender, ethnic status or race

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Limitations and Caveats

Limitations are: small sample size; open-label; patients with psychotic disorders who may not benefit from the group format

Results Point of Contact

• Title: Marianne Goodman, MD
• Organization: Department of Veteran Affairs

Marianne.Goodman@va.gov

718-584-9000

Study Officials

• Marianne S Goodman, MD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 17, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: October 25, 2019
• Results First Posted: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)