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

NCT05020587 | Active Not Recruiting DMC

• 2 other identifiers: D3495-WRX003495
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moral Injury; Functional Impairment

Keywords

Moral Injury; Group Psychotherapy; Veterans

Outcome Measures

Primary Outcomes (3)

• Acceptability of Intervention Measure (AIM)

  The AIM will be descriptively analyzed, and the mean and standard deviation; mean scores \>/ 4 will indicate acceptability.

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

• Implementation Appropriateness Measure (IAM)

  The IAM is a 4-item measure. The IAM will be descriptively analyzed, and the mean and standard deviation will be reported; mean scores \>/ 4 will indicate appropriateness (via the IAM).

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

• Feasibility of Intervention Measure (FIM)

  The FIM is a 4-item measure. The FIM will be descriptively analyzed, and the mean and standard deviation will be reported; mean scores \>/ 4 will indicate feasibility (via the FIM).

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

Secondary Outcomes (9)

• Moral Injury Outcome Scale (MIOS)

  Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months

• Change in Posttraumatic Stress Disorder Checklist-5 (PCL-5)

  Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months

• Change in Beck Depression Inventory-II (BDI-II)

  Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months

• Change in Beck Scale for Suicide Ideation (BSS)

  Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months

• Change in Religious and Spiritual Struggles Scale (RSSS)

  Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months

Other Outcomes (1)

• Columbia Suicide Severity Rating Scale (C-SSRS)

  Eligibility screening (pre-intervention)

Study Arms (1)

Open Pilot Trial

OTHER

Open pilot trial of a group therapy manual.

Behavioral: Open pilot trial of a group therapy manual.

Interventions

Open pilot trial of a group therapy manual. BEHAVIORAL

Open pilot trial of a group therapy manual.

Open Pilot Trial

Eligibility Criteria

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

You may qualify if:

• male and female
• English-speaking Veterans
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Central Texas Veterans Health Care System, Temple, TX

Temple, Texas, 76504-7451, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Sheila Beth Frankfurt O'Brien, PhD

  Central Texas Veterans Health Care System, Temple, TX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Two open pilot trials of a novel time-limited potentially morally injurious event (PMIE)-focused therapy group (N \~= 12), led by two therapists.

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: August 25, 2021
• Study Start: February 1, 2022
• Primary Completion: February 9, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)