Retreat-Based Program for Violence-Exposed Women Veterans

NCT07738445 | Not Yet Recruiting Phase 2

• 2 other identifiers: RRD4-001-25M1I21RD000358-01A1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Suicide Prevention

Keywords

Loneliness; perceived social support

Outcome Measures

Primary Outcomes (3)

• Feasibility (study created metrics)

  Feasibility will be assessed by collecting information on the number of Veterans screened, enrolled, dropout rates, number of GRIT/GRI sessions completed. Determination of feasibility will be made by comparing the obtained metrics to the following metrics: * Recruit and enroll 12 participants per condition per year. * Dropout rate is \< 25% * 75% of participants complete ≥75% each condition sessions

  2 months

• Client Satisfaction Questionnaire

  An 8-item self-report measure assessing participants' satisfaction with services received. Items are rated on a 4-point Likert scale with higher scores indicating greater satisfaction with services.

  2 months

• UCLA Loneliness scale

  A 20-item self-report measure assessing subjective feelings of loneliness and social isolation. Items are rated on 4-point Likert scale ranging from 1 to 4 with higher scores indicated greater loneliness

  2 months

Secondary Outcomes (3)

• Social Functioning Questionnaire

  2 months

• Social Connectedness Scale, revised

  2 months

• Thwarted belongingness subscale of the Interpersonal Needs Questionnaire

  2 months

Study Arms (2)

GRIT

EXPERIMENTAL

GRIT is a 3-day retreat-based program designed to enhance social functioning for women Veterans as an upstream suicide prevention strategy. The intervention includes an initial 90-minute group introduction session (approximately 7 days before the retreat) and a 90-minute group wrap up session (one week after completion of the retreat.

Behavioral: GRIT

GRI

ACTIVE COMPARATOR

GRI is a self-guided version of the retreat-program which includes writing, psychoeducational videos, reflection, worksheets, and activity prompts along with pre-recorded mindfulness activities to complete during the same 3-day timeframe. GRI participants are similarly introduced to Whole Health personal health planning during the initial virtual session and guided toward completing a personal health inventory and setting personal health goals that are followed up on in the post-program virtual wrap-up session. GRI is self-guided over 3 days and participants complete the workbook but do not participate in the group retreat.

Behavioral: GRI

Interventions

GRIT BEHAVIORAL

3-day retreat conducted in person, in a group setting.

GRIT

GRI BEHAVIORAL

3-day self paced program. Conducted individually with group pre- and post-program sessions.

GRI

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734, United States

Location

MeSH Terms

Conditions

Suicide Prevention

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Jennifer Marie Primack, PhD MA

  Providence VA Medical Center, Providence, RI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer M Primack, PhD MA

CONTACT

(401) 273-7100; Jennifer.Primack@va.gov

Kimberly Marcolivio, MEd CCRP

CONTACT

(401) 273-7100; Kimberly.Marcolivio@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Women Veterans will be randomized to either the GRIT retreat-based condition or GRI, a self-guided version of the program that does not include a retreat. Participants will be randomized using a computer-generated block randomization sequence into one of the two conditions, with 24 participants randomized to each group. Random block sizes of 4 and 6 will be used to maintain allocation balance while reducing predictability of assignment. Veteran participants will be assessed at baseline, during the intervention, post-intervention, 2-month follow up using a combination of self-report measures, interview-administered measures, and a semi-structured interview to obtain data on feasibility, acceptability, and preliminary efficacy.

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)