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

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ClinicalTrials.gov Identifier: NCT03760731
Recruitment Status : Not yet recruiting
First Posted : November 30, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
VA Palo Alto Health Care System
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Moral Injury Behavioral: Acceptance and Commitment Therapy for Moral Injury (ACT-MI) Behavioral: Present Centered Therapy (PCT) Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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 twelve, 90-minute 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 (PCT) will include 12 group 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 (Outcomes Assessor)
Masking Description: Outcomes assessor will be blind to treatment condition.
Primary Purpose: Treatment
Official Title: Thriving in the Midst of Moral Pain: The Acceptability and Feasibility of Acceptance and Commitment Therapy for Moral Injury (ACT-MI) Among Warzone Veterans
Estimated Study Start Date : January 2, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Acceptance and Commitment Therapy for Moral Injury (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 intervention is group-based and spans twelve, 90-minute 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)
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 twelve, 90-minute 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.
Other Name: ACT-MI

Active Comparator: Present Centered Therapy
Present Centered Therapy (PCT) will include 12 group 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. 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 could provide another treatment option that might be preferable to some Veterans and promote patient choice. Additionally, PCT would require less clinician training and specialization than ACT-MI. Using PCT 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 (PCT)
Present Centered Therapy (PCT) will include 12 group 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. 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.
Other Name: PCT




Primary Outcome Measures :
  1. Client Satisfaction Questionnaire [ Time Frame: Post-treatment (0-7 days after treatment completion) ]
    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.

  2. Narrative Evaluation of Intervention Interview [ Time Frame: Post-treatment (0-7 days after treatment completion) ]
    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.

  3. Reasons for Termination (Client and Therapist Versions) [ Time Frame: Post-treatment (0-7 days after terminating treatment) ]
    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.


Secondary Outcome Measures :
  1. Valued Living Questionnaire [ Time Frame: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up ]
    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.

  2. Outcome Questionnaire-45 (OQ-45) [ Time Frame: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up ]
    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.

  3. PROMIS Short Form v2.0-Satisfaction with Social Roles and Activities 8a [ Time Frame: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up ]
    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.

  4. PROMIS v2.0-Social Isolation [ Time Frame: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up ]
    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.

  5. Ecological Momentary Assessment [ Time Frame: 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) ]
    Self-report ecological momentary assessment via a smart phone application was developed to assess in the moment experiential avoidance (1 to 5 point rating for experiential avoidance during the assessment period [7 possible items with 2 to 3 administered during each assessment period], higher scores indicate more experiential avoidance), emotions (1 to 5 point rating for each emotion during the assessment period [13 possible items with 2 administered from each category-negative self-directed emotions, negative other-directed emotions, and positive emotions-during each assessment period], higher scores indicate feeling the emotion at an extreme level), and engagement in valued behavior (identify the number of domains from 0 to 10 areas in which they have engaged in the assessment period; qualitative information gathered via audio recording).



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760731


Contacts
Contact: Lauren Borges, PhD (314) 566-4118 lauren.borges2@va.gov
Contact: Sean M Barnes, PhD (303) 399-8020 ext 4237 Sean.Barnes2@va.gov

Locations
United States, Colorado
Rocky Mountain Regional VA Medical Center, Aurora, CO Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Pamela Rice, PhD    303-399-8020 ext 3846    Pamela.Rice@va.gov   
Principal Investigator: Lauren Borges, PhD         
Sponsors and Collaborators
VA Office of Research and Development
VA Palo Alto Health Care System
Investigators
Principal Investigator: Lauren Borges, PhD Rocky Mountain Regional VA Medical Center, Aurora, CO

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03760731     History of Changes
Other Study ID Numbers: D2854-R
1 I01 RX002854-01A1 ( Other Grant/Funding Number: VA Rehabilitation Research and Development )
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by VA Office of Research and Development:
Psychosocial Rehabilitation
Acceptance and Commitment Therapy

Additional relevant MeSH terms:
Wounds and Injuries