Suicide PreventionPhase 2GRITNCT07738445
Retreat-Based Program for Violence-Exposed Women Veterans
A Phase 2 study testing GRIT and GRI in people with Suicide Prevention, run by VA Office of Research and Development at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Suicide Prevention
- What is being tested?
- GRIT and GRI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Dec 2026to 31 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908-4734
Kate J Barnabe, MHA, (401) 273-7100 ext. 16272, Kate.Barnabe@va.gov
Kimberly Marcolivio, MEd CCRP, (401) 273-7100 ext. 13464, Kimberly.Marcolivio@va.gov
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
Candice Presseau, PhD
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
Candice Presseau, PhD, 203-223-8345, Candice.Presseau@va.gov
Galina Portnoy, PhD, (203) 7023145, Galina.Portnoy@va.gov
About this study
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
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.
Read the 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.
- Conditions
- Suicide Prevention
- Being tested
- GRIT, GRI
- Keywords
- Loneliness, perceived social support
- Medical subject headings
- Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRITBehavioural
3-day retreat conducted in person, in a group setting.
GRIBehavioural
3-day self paced program. Conducted individually with group pre- and post-program sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: GRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 2 months
Secondary outcomes (3)
Social Functioning Questionnaire
The Social Functioning Questionnaire (SFQ) consists of 8 items designed to assess an individual's social functioning across various domains. Each item evaluates key aspects such as interpersonal relationships, work performance, and leisure activities through concise questions. Responses are measured on a 4-point Likert scale ranging from 0 (not at all) to 3 (most of the time), allowing for quantifiable assessment of social engagement and difficulties.
Measured: 2 months
Social Connectedness Scale, revised
The Social Connectedness Scale - Revised (SCS-R) is a 20-item instrument designed to measure an individual's sense of connectedness and belonging within their social environment. The scale consists of 20 items rated on a 6-point Likert scale, where 1 indicates "strongly disagree" and 6 indicates "strongly agree." This allows for a nuanced understanding of an individual's feelings of connectedness. Scores are summed to yield a total score ranging from 20 to 120. A higher score reflects greater feelings of connectedness, while a lower score may indicate feelings of isolation or disconnection
Measured: 2 months
Thwarted belongingness subscale of the Interpersonal Needs Questionnaire
This subscale is a self-report measure of perceived social disconnection, loneliness, and unmet need to belong. The subscale consists of 9 items rated on a 7-point Likert scale. Higher scores indicate greater thwarted belongingness.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jennifer Marie Primack, PhD MA, Principal investigator, Providence VA Medical Center, Providence, RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738445
- Sponsor's protocol ID
- RRD4-001-25M
- Other IDs
- 1I21RD000358-01A1
- Acronym
- GRIT
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07738445
- Acronym / sponsor ID
- GRIT / RRD4-001-25M
- Conditions
- Suicide Prevention
- Keywords
- Loneliness, perceived social support
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| GRIT | Experimental | Behavioral: GRITGRIT 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. |
| GRI | Active comparator | Behavioral: GRIGRI 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRIT3-day retreat conducted in person, in a group setting. | Behavioural | GRIT |
| GRI3-day self paced program. Conducted individually with group pre- and post-program sessions. | Behavioural | GRI |
Primary outcome
Feasibility (study created metrics)
Time frame: 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
Time frame: 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
Time frame: 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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Suicide Prevention
Not yet recruitingPhase 1/2
Reducing Firearm Suicide Among Veterans: Evaluating the Effectiveness of Peer-Delivered Lethal Means Counseling
Suicide, Secure Firearm Storage
Not yet recruitingPhase 2
Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay
Suicidal Ideation, Suicidal Behavior
Recruiting
Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis
Clinical High Risk for Psychosis (CHR), Suicidal Ideation
Recruiting
Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
Depressive Disorder, Major Depressive Disorder, Suicidal Ideation
Not yet recruiting
THRIVE: A Recovery-Focused Suicide Prevention Intervention in Crisis Stabilization Centers
Suicide
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Marie Primack, PhD MA principal investigator
Providence VA Medical Center, Providence, RI
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GRIT and GRI in people with Suicide Prevention, run by VA Office of Research and Development at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer M Primack, PhD MA ((401) 273-7100 ext. 13400, Jennifer.Primack@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (study created metrics) (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.