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Moral InjuryNCT03760731

Thriving in the Midst of Moral Pain: The Acceptability and Feasibility of Acceptance and Commitment Therapy for Moral Injury (ACT-MI) Among Warzone Veterans

A study testing Acceptance and Commitment Therapy for Moral Injury (ACT-MI) and Present Centered Therapy for Moral Injury (PCT-MI) in people with Moral Injury, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The need for moral injury interventions is increasingly being recognized as a domain in Veteran care that must be addressed. Consequences of exposure to morally injurious events include risk for suicide, substance abuse, and refractory symptoms of PTSD and depression. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Moral Injury
What is being tested?
Acceptance and Commitment Therapy for Moral Injury (ACT-MI) and Present Centered Therapy for Moral Injury (PCT-MI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteUnited States
Study dates
1 Apr 2019to 31 Oct 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligible for VHA care
  • Has been deployed to a warzone
  • Has experienced a morally injurious event which continues to interfere with functioning
  • Willing to be randomized and participate in either of the two conditions

Who cannot join

  • Inability to provide informed consent
  • Inability to complete study measures, e.g.:
  • due to significant acute intoxication/withdrawal symptoms
  • mania
  • psychosis
  • aggression
Show all 14Show fewer
  • catatonia
  • cognitive impairment
  • Imminent suicide risk
  • Membership in a vulnerable population, e.g.:
  • pregnant women
  • History of significant violence towards VA staff
  • Participation in another psychotherapy research study
  • Current participation in an EBP for a condition related to moral injury

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rocky Mountain Regional VA Medical Center, Aurora, CO

    Aurora, Colorado, 80045-7211

Other trials in United States

About this study

The need for moral injury interventions is increasingly being recognized as a domain in Veteran care that must be addressed. Consequences of exposure to morally injurious events include risk for suicide, substance abuse, and refractory symptoms of PTSD and depression. Exposure to morally injurious events is also highly prevalent among Veterans. Thus, interventions addressing moral injury are crucial to helping Veterans build meaningful lives. Psychotherapies explicitly targeting moral injury and functional recovery associated with this construct are limited in VHA. The proposed study serves as a first step in addressing this gap in the literature through the development of a recovery-oriented, evidence-based treatment approach for moral injury among warzone Veterans who report functional impairments related to moral emotions. The proposed pilot study will evaluate the acceptability of this intervention and the feasibility of the design for a future study to test the treatment's capacity to improve patients' functioning.

Read the detailed description

Warzone Veterans exposed to morally injurious events frequently experience numerous difficulties in functioning. These Veterans often report suicidal ideation and behavior, substance abuse, symptoms of depression and PTSD, and problems in resuming valued living (e.g., spiritual practice, close relationships). Despite the transdiagnostic nature of moral injury, there are no moral injury-specific transdiagnostic interventions. Existing interventions tend to be focused on treating moral injury in the context of PTSD. In addition to an emphasis on PTSD, these interventions target beliefs associated with moral injury as causal factors in the development and maintenance of suffering. An emphasis on altering beliefs associated with moral injury may not optimally facilitate functional recovery as moral pain from moral violations may be justified. As one third of warzone Veterans endorse exposure to morally injurious events, it is vital to develop interventions that can be efficiently disseminated in VHA to facilitate functional recovery. The ideal intervention must simultaneously address moral emotions and promote values consistent behavior in the face of these emotions.

Acceptance and Commitment Therapy for moral injury (ACT-MI) is a recovery-based, psychosocial treatment ideally suited for Veterans endorsing difficulties in functioning related to moral injury. ACT teaches skills to help Veterans relate differently to painful thoughts, emotions, urges, and sensations. Rather than focusing on symptom reduction, ACT is an evidence-based intervention that directly targets functional recovery by assisting Veterans in identifying and engaging in values-consistent behavior even in the presence of distress. In Veteran populations specifically, ACT has been demonstrated effective in treating suicidal ideation and depression and as a result, has been "rolled-out" as an evidence based psychotherapy for depression within VHA. ACT-MI operates on the principles of ACT, with an explicit focus on the social functions of moral emotions. ACT-MI is the only intervention for moral injury that is based on social functionalism which purports that moral emotions (e.g., shame, pride) serve evolutionary purposes essential to group survival. Thus learning to interact with moral emotions differently is crucial to recovery. In ACT-MI, a group-based intervention is used to facilitate in-vivo exposure to moral emotions in the context of values. The proposed two arm randomized controlled pilot study will evaluate the acceptability of ACT-MI and an active control treatment, and determine the feasibility of the randomized controlled trial design for a future full-scale efficacy study. To accomplish this goal the investigators will continue to refine ACT-MI. Veterans enrolled will be randomized to: (a) Present Centered Therapy (PCT) or (b) ACT-MI, both of which will consist of 12, 90-minute group sessions. The specific aims of this study are to: (1) Evaluate the acceptability of the ACT-MI intervention for Veterans experiencing impairment in functioning associated with moral injury, (2) Determine the feasibility of the efficacy study design, and to (3) Select measures and calculate the necessary sample size for a future efficacy study. The performance of validated scales will be measured, in addition to selected NIH Patient Reported Outcomes Measurement Information System modules. All participants will complete a baseline assessment, post treatment, and follow-up assessment one and three months after completion of ACT-MI or PCT. Participants in both groups will also complete a post-treatment assessment on the acceptability of the intervention. The proposed study represents a crucial first step in a line of research likely to yield a recovery oriented, empirically-supported intervention for moral injury among Veterans. The objectives of ACT-MI directly align with Rehabilitation Research and Development's goal to improve Veteran functioning, increase community reintegration, and to facilitate Veteran centered care.

Note, as of March 7, 2024: Completed recruitment for baselines, still collecting data for post treatment, 1-month, and 3-month follow-ups

Conditions
Moral Injury
Being tested
Acceptance and Commitment Therapy for Moral Injury (ACT-MI), Present Centered Therapy for Moral Injury (PCT-MI)
Keywords
Psychosocial Rehabilitation, Acceptance and Commitment Therapy
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.

  • Acceptance and Commitment Therapy for Moral Injury (ACT-MI)Behavioural

    Also called ACT-MI

    Acceptance and Commitment Therapy for Moral Injury (ACT-MI) is a novel treatment protocol detailing the application of ACT for recovery from moral injury. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives. The 15-week intervention spans twelve, 90-minute group sessions and 3 30-minute individual case conceptualizing sessions. The current ACT-MI protocol was developed through an iterative process in which authors generated and refined the intervention based on clinical interactions with Veterans currently reporting moral injury.

  • Present Centered Therapy for Moral Injury (PCT-MI)Behavioural

    Also called PCT-MI

    Present Centered Therapy for Moral Injury (PCT-MI) is a 15-week intervention consisting of 12 90-minute group sessions and 3 30-minute individual case conceptualizing sessions, focused on problem solving daily life difficulties related to moral injury rather than the experiential focus on moral emotions presented in ACT-MI. Because PCT has been established as an evidence-based active control condition, it is likely to serve as a beneficial transdiagnostic intervention in its own right.

Study groups in NCT03760731
Study groupRoleWhat they receive
Acceptance and Commitment Therapy for Moral Injury (ACT-MI)ExperimentalAcceptance and Commitment Therapy for Moral Injury (ACT-MI) is a novel treatment protocol detailing the application of ACT for recovery from moral injury. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives. The intervention is group-based and spans fifteen weeks including 12, 90-minute group sessions and 3, 30-minute individual case conceptualizing sessions. The current ACT-MI protocol was developed through an iterative process in which authors generated and refined the intervention based on clinical interactions with Veterans currently reporting moral injury.
Receives: Behavioral: Acceptance and Commitment Therapy for Moral Injury (ACT-MI)
Present Centered Therapy for Moral Injury (PCT-MI)Active comparatorPresent Centered Therapy (PCT-MI) represents a 15-week intervention with 12 90-minute group sessions and 3 30-minute individual case conceptualizing sessions. PCT-MI focuses on problem solving daily life difficulties related to moral injury rather than the experiential focus on moral emotions presented in ACT-MI. Because PCT has been established as an evidence-based active control condition, it is likely to serve as a beneficial transdiagnostic intervention in its own right. PCT-MI could provide another treatment option that might be preferable to some Veterans and promote patient choice. Additionally, PCT-MI would require less clinician training and specialization than ACT-MI. Using PCT-MI as an active comparison condition will determine whether it is necessary to train clinicians in ACT-MI or if therapists with exposure to supportive problem-solving therapy approaches can lead a group that impacts functioning among Veterans reporting moral injury-related distress.
Receives: Behavioral: Present Centered Therapy for Moral Injury (PCT-MI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Client Satisfaction Questionnaire

    The investigators will assess the proportion of participants who find ACT-MI acceptable, defined as 70% of participants scoring 24 on the Client Satisfaction Questionnaire (CSQ). The total for the CSQ can range from 8- to 32-points. Higher scores on the CSQ indicate greater treatment acceptability.

    Measured: Post-treatment (0-7 days after treatment completion)

  2. Narrative Evaluation of Intervention Interview

    The Narrative Evaluation of Intervention Interview (NEII) will be used to inform any necessary revisions to the intervention and refinement of the treatment manual. The NEII is a semi-structured qualitative interview assessing the perspective of each participant about the impact of the intervention, helpful and unhelpful components, and comparison to other interventions. The NEII will be used to assess acceptability and inform revisions to the treatment manuals. The NEII includes domains related to description of intervention process, description of intervention outcome, evaluation of intervention process, and evaluation of intervention outcome. Data provided reflects the number of participants who provided perspective feedback.

    Measured: Post-treatment (0-7 days after treatment completion)

  3. Reasons for Termination (Client and Therapist Versions)

    The Reasons for Termination scale is a self-report measure which assesses the impact of common reasons patients terminate therapy. The scale will be used to assess treatment acceptability. Participants who terminate treatment early and their therapists will be asked to independently rate their reasons for termination in 19 domains. Possible total scores on this scale range from 10 to 190-points. Higher scores indicate that the reason for termination had a very great influence on the participant's termination of therapy.

    Measured: Post-treatment (0-7 days after terminating treatment)

Secondary outcomes (6)

  1. Valued Living Questionnaire

    The Valued Living Questionnaire is a self-report measure that assesses participants' values as well as the consistency with which they believe they have been living life according to their values. This scale will be examined as a candidate outcome measure for a future efficacy trial. A possible of 10 to 100 total points for importance of values and 10 to 100 total points for consistency of action with values is demonstrated on the Valued Living Questionnaire (VLQ). Higher scores on the VLQ are indicative of greater importance of values and greater consistency in acting on values.

    Measured: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up

  2. Outcome Questionnaire-45 (OQ-45)

    The Outcome Questionnaire-45 (OQ-45) is a self-report measure that assesses functioning in the psychosocial domains of symptom distress (0-100 points), social relations (0-44 points), and social role functioning (0-36 points). The OQ-45 will be examined as a candidate outcome measure for a future efficacy trial. Higher scores on the OQ-45 are indicative of more symptom distress, difficulty in social relations, and difficulty in social role functioning.

    Measured: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up

  3. PROMIS Short Form v2.0-Satisfaction With Social Roles and Activities 8a

    This is a self-report measure that assesses ability to perform various social activities. This measure will be examined as a candidate outcome measure for a future efficacy trial. Total scores range from 8 to 40 points on this scale with higher scores associated with greater satisfaction with social roles and activities.

    Measured: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up

  4. PROMIS v2.0-Social Isolation

    This is a self-report measure that assesses experience of social isolation. This measure will be examined as a candidate outcome measure for a future efficacy trial. Total scores range from 4 to 20 points with higher scores on this scale associated with greater social isolation.

    Measured: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up

  5. Ecological Momentary Assessment

    Self-report ecological momentary assessment via a smart phone application was developed to assess in the moment experiential avoidance, emotions, and engagement in valued behavior. However, because VA regulations and use of a new application, analyses will focus on feasibility of completing the EMA and will be reported as number of participants who provided EMA data. Actual EMA responses will only be analyzed if there is sufficient participation. Actual EMA responses will only be analyzed if there are 25% or more reporting participants.

    Measured: Pre-treatment (Up to 30-days before starting treatment for a 1-week period) and post-treatment (0-7 days after treatment completion for a 1-week period)

  6. Inventory of Psychosocial Functioning

    Self-report measure that assesses impairment within the last 30 days across a spectrum of psychosocial domains. Will be examined as a candidate outcome measure for a future efficacy trial. Response options range from 0 = never to 6 = always. The measure yields a mean score for the total scale. Higher scores indicate less functional impairment. The total scale score is reported.

    Measured: Pre-treatment, post-treatment, one-month follow-up, and three-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2018
  2. Study start1 Apr 2019
  3. Primary completion31 Oct 2024
  4. Study completion31 Oct 2024

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Acceptance and Commitment Therapy for Moral Injury (ACT-MI) is a novel treatment protocol detailing the application of ACT to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives. The intervention is group-based and spans fifteen weeks and is a hybrid of twelve, 90-minute psychotherapy group sessions and three, 30-minute individual case conceptualizing sessions. The current ACT-MI protocol was developed through an iterative process in which authors generated and refined the intervention based on clinical interactions with Veterans currently reporting moral injury. Present Centered Therapy for Moral Injury (PCT-MI) represents a 15-week protocol consisting of twelve 90-minute group sessions and three 30-minute individual case conceptualizing sessions, but will focus on problem solving daily life difficulties related to moral injury rather than the experiential focus on moral emotions presented in ACT-MI.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03760731
Sponsor's protocol ID
D2854-R
Other IDs
1I01RX002854-01A1
Status last verified
Dec 2025
First submitted
29 Nov 2018
Last updated
29 Dec 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Borges LM, Farnsworth JK, Walser RD, Drescher KD, Forster JE, Brenner LA, Johnson JPS, Miller CN, Aharoni GE, Rosen CS, Nieuwsma JA, Currier JM, Barnes SM. Acceptance and commitment therapy for moral injury (ACT-MI) and present-centered therapy for moral injury (PCT-MI): Results from a randomized controlled pilot trial with war zone deployed veterans. Psychotherapy (Chic). 2026 Jul 27:10.1037/pst0000632. doi: 10.1037/pst0000632. Online ahead of print.

    PubMed 42507361

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy for Moral Injury (ACT-MI) and Present Centered Therapy for Moral Injury (PCT-MI) in people with Moral Injury, 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 4 inclusion and 14 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: finished, as of the sponsor's last update on 29 Dec 2025. 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?

Yes. Results are posted in the registry (first posted 29 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Client Satisfaction Questionnaire (time frame: Post-treatment (0-7 days after treatment completion)). 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 NCT03760731, 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 29 Dec 2025.

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