Moral InjuryCACNCT05020587
Consulting After Combat: Interviewing Veterans to Develop a Therapy to Restore Functioning and Reintegration After Moral Injury Events
A study testing Open pilot trial of a group therapy manual. in people with Moral Injury and Functional Impairment, run by VA Office of Research and Development at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moral Injury, Functional Impairment
- What is being tested?
- Open pilot trial of a group therapy manual.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 30 Oct 2026
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Texas Veterans Health Care System, Temple, TX
Temple, Texas, 76504-7451
About this study
Official title: Consulting After Combat: Interviewing Service Members and Veterans to Develop a Therapy to Restore Functioning and Reintegration After Moral Injury Events
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.
Read the detailed 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.
- Conditions
- Moral Injury, Functional Impairment
- Being tested
- Open pilot trial of a group therapy manual.
- Keywords
- Moral Injury, Group Psychotherapy, Veterans
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open pilot trial of a group therapy manual.Behavioural
Open pilot trial of a group therapy manual.
| Study group | Role | What they receive |
|---|---|---|
| Open Pilot Trial | Other | Open pilot trial of a group therapy manual. Receives: Behavioral: Open pilot trial of a group therapy manual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Measure (AIM)
The AIM will be descriptively analyzed, and the mean and standard deviation; mean scores >/ 4 will indicate acceptability.
Measured: 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).
Measured: 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).
Measured: 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)
The 14-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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
The 26-item RSSS assesses six domains including moral and doubt struggles using a Likert-style scale ranging from 0 to 5.
Measured: Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
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.
Measured: Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
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.
Measured: Post intervention (approximately 6 weeks)
Change in Brief Expressions of Moral Injury Scale (EMIS)
The Brief EMIS is a 6-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.
Measured: Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Brief Inventory of Psychosocial Functioning (bIPF), as part of the MIOS
The bIPF, in the MIOS, is a 7-item measures that assesses the impact of morally injurious experiences on domains of psychosocial functioning (i.e., romantic relationships, relationships with children, relationships with family, work, activities of daily living, training/education) on a 7-point Likert-style 0 (not at all) - 6 (extremely) scale. Items that are not applicable are indicated as N/A.
Measured: Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Feb 2022
- Primary completion9 Feb 2026
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moral InjuryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Two open pilot trials of a novel time-limited potentially morally injurious event (PMIE)-focused therapy group (N \~= 12), led by two therapists.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sheila Beth Frankfurt O'Brien, PhD, Principal investigator, Central Texas Veterans Health Care System, Temple, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020587
- Sponsor's protocol ID
- D3495-W
- Other IDs
- RX003495
- Acronym
- CAC
- Status last verified
- Apr 2026
- First submitted
- 12 Jul 2021
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Brien S, Goodman M, Litz B, Boulanger G, Finley E. Development of a Group Psychotherapy for Combat Veterans With Moral Injury: Protocol for a User-Centered Study. JMIR Res Protoc. 2026 May 27;15:e87756. doi: 10.2196/87756.
PubMed 42202476
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consulting After Combat: Interviewing Service Members and Veterans to Develop a Therapy to Restore Functioning and Reintegration After Moral Injury Events
- ClinicalTrials.gov ID
- NCT05020587
- Acronym / sponsor ID
- CAC / D3495-W
- Conditions
- Moral Injury, Functional Impairment
- Keywords
- Moral Injury, Group Psychotherapy, Veterans
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 25 Aug 2021 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two open pilot trials of a novel time-limited potentially morally injurious event (PMIE)-focused therapy group (N ~= 12), led by two therapists.
| Arm | Type | Receives |
|---|---|---|
| Open Pilot Trial | Other | Behavioral: Open pilot trial of a group therapy manual.Open pilot trial of a group therapy manual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- Veterans will be excluded from the study if they have either:
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 |
|---|---|---|
| Open pilot trial of a group therapy manual.Open pilot trial of a group therapy manual. | Behavioural | Open Pilot Trial |
Primary outcome
Acceptability of Intervention Measure (AIM)
Time frame: One-month following the conclusion of the pilot trial and 6-months following the conclusion of the pilot trial.
The AIM will be descriptively analyzed, and the mean and standard deviation; mean scores >/ 4 will indicate acceptability.
Implementation Appropriateness Measure (IAM)
Time frame: One-month following the conclusion of the pilot trial and 6-months following the conclusion of the pilot trial.
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).
Feasibility of Intervention Measure (FIM)
Time frame: One-month following the conclusion of the pilot trial and 6-months following the conclusion of the pilot trial.
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).
9 secondary outcomes
Moral Injury Outcome Scale (MIOS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Change in Moral Injury Events Scale (MIES)
Time frame: Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Group Cohesion Scale-Revised (GCS)
Time frame: Post intervention (approximately 6 weeks)
Change in Brief Expressions of Moral Injury Scale (EMIS)
Time frame: Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Brief Inventory of Psychosocial Functioning (bIPF), as part of the MIOS
Time frame: Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 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 14 Apr 2026.
- Derived from this study: PubMed 42202476O'Brien S, Goodman M, Litz B, Boulanger G, Finley E. Development of a Group Psychotherapy for Combat Veterans With Moral Injury: Protocol for a User-Centered Study. JMIR Res Protoc. 2026 May 27;15:e87756. doi: 10.2196/87756.
- Individual participant dataSharing planned: No
Related trials for Moral Injury
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A Study of Moral Distress, Moral Injury and Post-Traumatic Stress for Nurses
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A Randomized Controlled Trial of a Web-Based Moral Elevation Intervention for Veterans With PTSD
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Implementation of Innovative Treatment for Moral Injury Syndrome: A Hybrid Type 2 Study
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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. This study is not recruiting at the moment.
Sheila Beth Frankfurt O'Brien, PhD principal investigator
Central Texas Veterans Health Care System, Temple, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open pilot trial of a group therapy manual. in people with Moral Injury and Functional Impairment, run by VA Office of Research and Development at 1 site 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 10 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (AIM) (time frame: One-month following the conclusion of the pilot trial and 6-months following the conclusion of the pilot trial.). 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?
On the ClinicalTrials.gov record for NCT05020587, which also lists 1 linked publication.
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 14 Apr 2026.