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

Moral Injury Clinical Trial

— CAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05020587
• Other study ID #: D3495-W
• Secondary ID: RX003495
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 1, 2022
• Est. completion date: October 30, 2026

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: Sheila Frankfurt, PhD
• Phone: (254) 400-6742
• Email: Sheila.Frankfurt[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Approximately 25% of combat Veterans with Posttraumatic Stress Disorder (PTSD) seek treatment for traumas that involve potentially morally injurious events (PMIE) rather than danger-based traumas. PMIEs are more strongly associated with functional and psychiatric impairment than life-threat-based combat. Veterans report that PMIEs disrupt their sense of identity and meaning, ability to connect with and trust others, and engender disturbing guilt, shame, rage, and disgust. The sequelae of exposure to PMIEs, otherwise known as moral injury, may explain variance in post-deployment recovery and is a potential unaddressed treatment target. Existing first-line treatments may be limited because they were derived from civilian contexts, poorly fit the war zone context, and do not allow Veterans to discuss the details of the PMIEs with other Veterans. This project will develop a relational dynamic-based group therapy treatment manual that will target functioning and quality of life among Veterans who are impacted by high magnitude PMIEs. The goal of this relational dynamic trauma therapy is to help Veterans identify connections between their current symptoms and their experiences in combat/PMIEs, their current life stressors and relationships, and the historical factors that carry person-specific meaning to their trauma/PMIE. These explorations take place in the presence of attuned and sympathetic others who can resonate to the experience and the affect being expressed. Symptom reduction occurs through increasing the Veteran's capacity to consciously reflect on their experiences and develop an integrated self-awareness of the various factors that affect their mental states. The result is greater self-reflection, less avoidance, and greater adaptive incorporation of life experiences and their aftermath and meanings into one's inner world. This CDA-2 will employ innovative user-centered design methods that continuously gather user experiences during treatment development, with the goal of increased effectiveness and usability. User feedback will be synthesized with formative feedback from a clinical expert panel. This objective will be accomplished by pursuing these specific aims: Aim 1: Discover user needs and preferences as well as treatment-engagement barriers and facilitators from the perspectives of PMIE-impacted Veterans and VA trauma clinicians. Aim 2: Design a treatment manual and refine it using feedback from Veterans, trauma clinicians, and an expert clinical advisory board. Aim 3: Conduct two rapid prototyping open trials (i.e., tangibly testing treatment approaches using a prototype manual) with PMIE-impacted Veterans (N = ~12), and iteratively revise the manual based on Veteran, provider, and clinical expert panel feedback, with the following hypothesis: The treatment manual will meet usability, feasibility, learnability, and acceptability criteria.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: October 30, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The investigators will recruit 12 potentially morally injurious event (PMIE)-impaired Veterans.

• Potential participants include:

• 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 the MIOS functional impairment item

• if they score 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

Related Conditions & MeSH terms

• Functional Impairment
• Moral Injury
• Stress Disorders, Post-Traumatic
• Wounds and Injuries

Intervention

Behavioral:
• Open pilot trial of a group therapy manual.
Open pilot trial of a group therapy manual.

Locations

Country	Name	City	State
United States	Central Texas Veterans Health Care System, Temple, TX	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Columbia Suicide Severity Rating Scale (C-SSRS)	The C-SSRS is the VA-mandated suicide screening tool used in primary care and mental health clinics across the VA. The C-SSRS assesses lifetime and past-month suicidal ideation, intent, plans, and behavior.	Eligibility screening (pre-intervention)
Primary	Change in Intervention Usability Scale (IUS)	The 10-item IUS was adapted from the widely used System Usability Scale. It is scored on a Likert-style scale ranging from 0 (strongly disagree) to 4 (strongly agree). The IUS generates a percentile ranking, and scores >68 are considered above average.	After each weekly therapy session and following the conclusion of the intervention, up to 6 months
Primary	Change in Acceptability of Intervention Measure (AIM)	The AIM will be descriptively analyzed, and the mean and standard deviation for each session and for the final session will be reported; mean scores 4 will indicate acceptability.	After each weekly therapy session and following the conclusion of the intervention, up to 6 months
Primary	Change in Implementation Appropriateness Measure (IAM)	The IAM is a 4-item measure. The IAM will be descriptively analyzed, and the mean and standard deviation for each session and for the final session will be reported; mean scores 4 will indicate appropriateness (via the IAM).	After each weekly therapy session and following the conclusion of the intervention, up to 6 months
Primary	Change in Feasibility of Intervention Measure (FIM)	The FIM is a 4-item measure. The FIM will be descriptively analyzed, and the mean and standard deviation for each session and for the final session will be reported; mean scores > 4 will indicate feasibility (via the FIM).	After each weekly therapy session and following the conclusion of the intervention, up to 6 months
Secondary	Change in Sheehan Disability Scale (SDS)	The SDS is a 5-item measure that assess social and occupational functional impairment. Respondents rate the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms on a 10 point visual analog scale. Scores range from 0 (unimpaired) to 30 (highly impaired). Change in disability from pre- to post-intervention will be examined.	Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Secondary	Change in Moral Injury Outcome Scale (MIOS)	The 15-item MIOS assesses exposure to a PMIE, prior month multidimensional outcomes associated with the PMIE, and prior month PMIE-related functional impairment. Items are rated on a Likert-style scale ranging from 0 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of more moral injury. Change in moral injury from pre- to post-intervention will be examined.	Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Secondary	Change in Posttraumatic Stress Disorder Checklist-5 (PCL-5)	PTSD will be measured with the widely used 20-item Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), which assesses severity of each DSM-5 PTSD symptom using a Likert-style ranging from 0 (not at all) to 4 (extremely). A total score of 31-33 is suggestive of a PTSD diagnosis. Change in PTSD symptom severity from pre- to post-intervention will be examined.	Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Secondary	Change in Beck Depression Inventory-II (BDI-II)	Depression will be measured with the 21-item Beck Depression Inventory-II (BDI-II), which uses a Likert-style scale ranging from 0 to 3. Lower scores are indicative of less severe depression. Change in depressive symptoms from pre- to post-intervention will be examined.	Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Secondary	Change in Beck Scale for Suicide Ideation (BSS)	Suicidal ideation will be measured using the Beck Scale for Suicide Ideation (BSS), which is extensively used in treatment studies of suicidal individuals. The BSS is rated on a Likert-style scale ranging from 0 to 3, which lower scores indicative of less severe suicidal ideation. Change in suicidal ideation from pre- to post-intervention will be examined.	Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Secondary	Change in Religious and Spiritual Struggles Scale (RSSS)	The 26-item RSSS assesses six domains including moral and doubt struggles using a Likert-style scale ranging from 0 to 5.	Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Secondary	Change in Group Cohesion Scale-Revised (GCS)	The 25-item Group Cohesion Scale-Revised measures group functioning on a Likert-style ranging from 0 (low) to 4 (strongly agree). Higher scores are indicative of greater group cohesion.	Post intervention (approximately 6 weeks)
Secondary	Change in Moral Injury Events Scale (MIES)	The MIES is a 9-item measure that assess perceptions of potentially morally injurious events. Items are rated on a 1 (Strongly agree) to 6 (strongly disagree) Likert-style scale, and lower scores are indicative of more moral injury. Change in endorsement of moral injury events will be assessed from pre- to post-intervention.	Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Secondary	Change in Expressions of Moral Injury Scale (EMIS)	The EMIS is a 17-item scale that assesses moral injury event-related guilt, shame, and related outcomes. Items are rated on a Likert-style on a 5-point scale (1 = strongly disagree to 5 = strongly agree). Higher scores indicate greater moral injury. Change in moral injury will be assessed from pre- to post-intervention.	Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months