Suicide Safety Planning Group Treatment: "Project Life Force"

Suicide Clinical Trial

— PLF  

Official title:

Suicide Safety Planning Group Treatment - "Project Life Force"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02525575
• Other study ID #: D1911-P
• Secondary ID: GOO-15-037
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: March 1, 2018

Study information

• Verified date: October 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Despite the enrichment of VA suicide prevention services and implementation of the national suicide hotline, Veteran suicide completions have risen to 22 per day and suicide attempts numbered over 15,000 in 2012. These data underscore the urgency of developing additional interventions targeting suicidal Veterans. The construction of a Suicide Safety Plan (SSP); a "best practice", is mandated throughout the VA system, and a vital component of the VA's coordinated effort at suicide prevention and recovery. The investigators' pilot data on patterns of SSP use in suicidal Veterans over a 30 day time frame demonstrates that only 65% of Veterans used their safety plans, coping strategies listed on the plan were often mismatched or inadequate to the individual's needs, and limited access to the SSP during times of stress negatively impacted its utility. To the investigators' knowledge, there are currently no recommended guidelines or mechanisms for refinement of the SSP in adult populations beyond its initial development. "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. Importantly, the group format mitigates loneliness and fosters increased "belongingness", both key risk factors for suicide. Additionally, PLF's weekly format facilitates VA-mandated monitoring for any Veteran placed on the suicide "high risk" list.

Data from this project will test the intervention's feasibility, acceptability and preliminary efficacy and provide pilot data for a larger randomized clinical trial. The project is comprised of two phases. In Phase 1, the investigators will finalize the PLF intervention and accompanying manual and handouts. In Phase 2, the investigators will conduct an open label trial of PLF in 50 suicidal Veterans to evaluate the feasibility and acceptability of the intervention. The investigators will also test whether PLF affects outcomes of suicide ideation, depression, hopelessness, and outpatient compliance by examining clinically meaningful differences in these measures before and after PLF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Veterans > 18

• Able to give consent

• Recent Completion of a VA suicide safety plan

Exclusion Criteria:

• IQ<80

• Does not speak English

• Inability to tolerate group therapy format

• There is no exclusion based on medical or psychiatric treatment status.

• There are no special restrictions with regard to gender, ethnic status or race

Related Conditions & MeSH terms

• Suicide

Intervention

Behavioral:
• Project Life Force Group Treatment
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.

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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