The Bronx, New York 10468


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02525575


Primary Contact:

Principal Investigator
Marianne S Goodman, MD
VA Office of Research and Development

Marianne S Goodman, MD
Phone: (718) 584-9000 ext. 5188
Email: marianne.goodman@va.gov


Backup Contact:

N/A


Location Contact:

The Bronx, New York 10468
United States

Marianne S Goodman, MD
Phone: 718-584-9000
Email: marianne.goodman@va.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.