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

NCT03760731 | Completed Results

• 2 other identifiers: D2854-R1I01RX002854-01A1
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Moral Injury

Keywords

Psychosocial Rehabilitation; Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (6)

• Valued Living Questionnaire

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

• Outcome Questionnaire-45 (OQ-45)

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

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

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

• PROMIS v2.0-Social Isolation

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

• Ecological Momentary Assessment

  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)

Study Arms (2)

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

EXPERIMENTAL

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 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.

Behavioral: Acceptance and Commitment Therapy for Moral Injury (ACT-MI)

Present Centered Therapy for Moral Injury (PCT-MI)

ACTIVE COMPARATOR

Present 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.

Behavioral: Present Centered Therapy for Moral Injury (PCT-MI)

Interventions

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

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.

Also known as: ACT-MI

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

Present Centered Therapy for Moral Injury (PCT-MI) BEHAVIORAL

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.

Also known as: PCT-MI

Present Centered Therapy for Moral Injury (PCT-MI)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to provide informed consent
• Inability to complete study measures, e.g.:
• due to significant acute intoxication/withdrawal symptoms
• mania
• psychosis
• aggression
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Palo Alto Health Care System: collaborator

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Outcome data are provided, but should not be used to draw conclusions about the efficacy of ACT-MI given recommendations for pilot study best practices (e.g., Eldridge et al., 2016) and data lost to follow up.

Results Point of Contact

• Title: Lauren Michelle Borges, PhD
• Organization: Rocky Mountain Regional VA Medical Center

lauren.borges2@va.gov

303-916-0128

Study Officials

• Lauren Borges, PhD

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will be blind to treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: November 30, 2018
• Study Start: April 1, 2019
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: December 29, 2025
• Results First Posted: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)