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

April 8, 2026 updated by: VA Office of Research and Development

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Temple, Texas, United States, 76504-7451
        • Central Texas Veterans Health Care System, Temple, TX

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Open Pilot Trial
Open pilot trial of a group therapy manual.
Behavioral: Open pilot trial of a group therapy manual.
Open pilot trial of a group therapy manual.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
One-month following the conclusion of the pilot trial and 6-months following the conclusion of the pilot trial.
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).
One-month following the conclusion of the pilot trial and 6-months following the conclusion of the pilot trial.
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).
One-month following the conclusion of the pilot trial and 6-months following the conclusion of the pilot trial.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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
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
Group Cohesion Scale-Revised (GCS)
Time Frame: Post intervention (approximately 6 weeks)
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)
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
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.
Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
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
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.
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
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.
Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: Eligibility screening (pre-intervention)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sheila Beth Frankfurt O'Brien, PhD, Central Texas Veterans Health Care System, Temple, TX

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 9, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D3495-W
  • RX003495 (Registry Identifier: eRA Commons)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participants will have the option of agreeing to allow their data to be transferred into a secure, deidentified data repository. Individual participant data from those consenting participants will be transferred into a secure, deidentified data repository. Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose may have access. However, data will not be shared directly from this project.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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