Menu
Not yet recruiting NCT07738445

Retreat-Based Program for Violence-Exposed Women Veterans

Phase II Interventional Suicide Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GRIT, GRI.
Who it may be relevant to
Registry conditions: Suicide Prevention. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Pilot Study to Examine Acceptability and Feasibility of Growth, Resilience, Insight, and Togetherness (GRIT), a Retreat-Based Program for Violence-Exposed Women Veterans

Overview

Given their elevated risk for suicide and barriers to engaging in VHA healthcare, violence-exposed women Veterans represent a specialized population for which expansions to current VHA programming are needed. This pilot study is to assess the feasibility, acceptability, and preliminary efficacy of the Growth, Resilience, Insight, and Togetherness (GRIT), a therapeutic retreat program developed with and for Veteran women, to improve social functioning as a potential upstream suicide prevention strategy in comparison to a self-guided program. If found acceptable and feasible, data gathered will inform subsequent program development and identify avenues for further research on use of retreats grounded in Whole Health principles for additional subpopulations of women Veterans and/or other high-risk populations that may benefit.

Detailed description

Women Veterans are exposed to interpersonal violence at high rates throughout their lifespans which may escalate risk for psychosocial impairment and suicidal behavior. Facets of social functioning such as connectedness and social support can mitigate suicide risk. Given their risk for suicide and barriers to engaging in Veterans Administration (VHA) healthcare, violence-exposed women Veterans represent a specialized population for which expansion of VHA programming to include opportunities for socialization and community building as a key component of holistic health are needed. Coinciding with a congressional mandate for women-only retreat-based rehabilitation following military service, retreats are increasingly offered by community organizations. Retreats are associated with significant improvements in mental health and quality of life; however, no research to date has examined retreat programming as an upstream suicide prevention strategy for a high priority, high risk population of Veterans.

The primary aim of this multi-site, two-year, pilot study is to evaluate the feasibility, acceptability, and preliminary efficacy of "Growth, Resilience, Insight, and Togetherness" (GRIT), a retreat-based intervention designed for women Veterans who have experienced intimate partner violence (IPV). GRIT is a retreat-based program designed to enhance social functioning for women Veterans as an upstream suicide prevention strategy. Grounded in Whole Health principles, this holistic complementary program offered in a nature-based, tranquil setting was created for, and with input from, women Veterans known to be at heightened suicide risk due to experiences of interpersonal violence. Through participation in group activities, experiential learning, and envisioning and planning for the future post-retreat, GRIT seeks to combat loneliness and isolation while fostering connection to self and others to support longer term recovery from the sequelae of violence exposure(s).

Using a selective suicide prevention strategy, 48 women Veterans (N = 48) who have experienced interpersonal violence and endorse difficulties in at least two areas of social functioning will be recruited from two VA medical centers: VA Providence Healthcare system and VA Connecticut healthcare system. Eligible participants will be randomly assigned to the GRIT retreat or Growth, Resilience, and Insight (GRI), a self-guided version of the program that does not include a retreat. Participants will receive the GRIT in cohorts of approximately 12. Retreats will be co-led by pairs of VHA trained facilitators from VA Connecticut. A mixed methods approach will be used to evaluate feasibility and acceptability of GRIT and study procedures. Feasibility metrics will include ease of recruitment, program and study completion, and number of adverse events. Acceptability metrics will include participant ratings of satisfaction, credibility, perceived usefulness, and low burdensomeness of study procedures and GRIT/GRI programs. Preliminary efficacy data will be collected on social functioning and mental health impairment, and suicide risk pre-, post-, and two months following program completion.

Interventions

  • Behavioral GRIT
    3-day retreat conducted in person, in a group setting.
  • Behavioral GRI
    3-day self paced program. Conducted individually with group pre- and post-program sessions.

Primary outcome measures

  • Feasibility (study created metrics) [Time frame: 2 months]
  • Client Satisfaction Questionnaire [Time frame: 2 months]
  • UCLA Loneliness scale [Time frame: 2 months]
Secondary outcome measures (3)
  • Social Functioning Questionnaire [Time frame: 2 months]
  • Social Connectedness Scale, revised [Time frame: 2 months]
  • Thwarted belongingness subscale of the Interpersonal Needs Questionnaire [Time frame: 2 months]

Eligibility criteria

Inclusion criteria

  • Experienced interpersonal violence as evidenced by endorsement of items 6, 7, 8, 9, or 11 from the Life Events Checklist for DSM-5®
  • Are willing and able to participate in a two overnight, three-day, retreat and complete pre- and post-retreat surveys
  • Are actively engaged in VHA mental healthcare (i.e., have a documented mental health visit with a VA provider within the last 90 days
  • Endorse some difficulties in social functioning as indicated by a score >2 on at least two items of the social functioning questionnaire
  • Ability to speak, read, and understand spoken English sufficiently well to complete the procedures of the study
  • Have access to a mobile phone or computer device that will enable participation in virtual video sessions

Exclusion criteria

  • Current suicidal thoughts and intent (using the Columbia Suicide Severity Rating Scale; C-SSRS, (i.e., endorses items 1, 2, and 4 or 5)
  • Diagnosis of alcohol or substance use dependence in medical record. In cases where alcohol or substance use is identified as problematic but not reaching the threshold for diagnosis of SUD dependence, additional consultation with mental health providers and chart review by the PI will be used to determine suitability for participation
  • Current psychosis or mania as indicated by electronic health records, or as identified during baseline administration of Quick SCID

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven
  • Providence VA Medical Center, Providence, RI — Providence

Identifiers

NCT: NCT07738445 · RRD4-001-25M · 1I21RD000358-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗