Clinical trial NCT03760731: Thriving in the Midst of Moral Pain: The Acceptability and Feasibility of Acceptance and Commitment Therapy for Moral Injury (ACT-MI) Among Warzone Veterans
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Moral Injury
Keywords: Psychosocial Rehabilitation
Acceptance and Commitment Therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Palo Alto Health Care System
First posted: 2018-11-30
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Client Satisfaction Questionnaire
timeFrame: Post-treatment (0-7 days after treatment completion)
measure: Narrative Evaluation of Intervention Interview
timeFrame: Post-treatment (0-7 days after treatment completion)
measure: Reasons for Termination (Client and Therapist Versions)
timeFrame: Post-treatment (0-7 days after terminating treatment)
Secondary outcomes:
measure: Valued Living Questionnaire
timeFrame: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up
measure: Outcome Questionnaire-45 (OQ-45)
timeFrame: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up
measure: PROMIS Short Form v2.0-Satisfaction with Social Roles and Activities 8a
timeFrame: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up
measure: PROMIS v2.0-Social Isolation
timeFrame: Pre-treatment (Up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up
measure: Ecological Momentary Assessment
timeFrame: 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)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Lauren Borges, PhD
role: PRINCIPAL_INVESTIGATOR
References: