Active — Not RecruitingNot Applicable

Consulting After Combat: Interviewing Veterans to Develop a Therapy to Restore Functioning and Reintegration After Moral Injury Events

United States14 participantsStarted 2022-02-01

Plain-language summary

Despite the VA's best efforts to treat the psychosocial impact of war, many combat Veterans report lingering difficulty reintegrating into meaningful post-deployment lives. War is among the most extreme forms of human experience but, for many, wartime trauma was treated using models transported from civilian single-incident trauma contexts. Veterans have unique needs and experiences that require culturally responsive and sensitive conceptualizations and treatments. Patient-centered care is improved by providing multiple effective treatment options and this project, if successful, could have a significant impact on VA care. This CDA-2 project has the potential to offer innovative treatment for traumatized combat Veterans who otherwise may not find full relief from PTSD. Clinical research practice will be advanced by employing state-of-the-art user-centered design methods combined with expert clinical feedback to develop an effective and usable group treatment manual that will meet VA needs.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * male and female * English-speaking Veterans * 18 years of age or older * enrolled in Central Texas Veterans Healthcare System * with a service record of combat deployments * Participants must: * comprehend and sign the informed consent form * if they report a PMIE as their worst trauma * \>=3 on a MIOS functional impairment item * \>= 10 on the SDS Exclusion Criteria: * Veterans will be excluded from the study if they have either: * untreated substance abuse disorder * severe suicidal or homicidal ideation, defined using the C-SSRS * \<18 on the MOCA, indicating potential for more than mild cognitive impairment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acceptability of Intervention Measure (AIM)

Timeframe: One-month following the conclusion of the pilot trial and 6-months following the conclusion of the pilot trial.

Implementation Appropriateness Measure (IAM)

Timeframe: One-month following the conclusion of the pilot trial and 6-months following the conclusion of the pilot trial.

Feasibility of Intervention Measure (FIM)

Timeframe: One-month following the conclusion of the pilot trial and 6-months following the conclusion of the pilot trial.

Trial details

NCT IDNCT05020587

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2026-02-09

View on ClinicalTrials.gov More Moral Injury trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Acceptability of Intervention Measure (AIM)

Timeframe: One-month following the conclusion of the pilot trial and 6-months following the conclusion of the pilot trial.

Implementation Appropriateness Measure (IAM)

Timeframe: One-month following the conclusion of the pilot trial and 6-months following the conclusion of the pilot trial.

Feasibility of Intervention Measure (FIM)

Timeframe: One-month following the conclusion of the pilot trial and 6-months following the conclusion of the pilot trial.