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临床试验/NCT07738445
NCT07738445尚未招募2 期

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

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年12月1日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
入组人数
48
试验地点
2
主要终点
Feasibility (study created metrics)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Feasibility (study created metrics)

时间窗: 2 months

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

Client Satisfaction Questionnaire

时间窗: 2 months

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.

UCLA Loneliness scale

时间窗: 2 months

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

次要结局

  • Social Functioning Questionnaire(2 months)
  • Social Connectedness Scale, revised(2 months)
  • Thwarted belongingness subscale of the Interpersonal Needs Questionnaire(2 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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