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Acceptance and Commitment Therapy for Moral Injury

Phase 1
Waitlist Available
Led By Lauren Borges, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-treatment (0-7 days after terminating treatment)
Awards & highlights

Summary

This trial is testing a new treatment for moral injury among warzone Veterans. Moral injury is a consequences of exposure to morally injurious events and can include risk for suicide, substance abuse, and refractory symptoms of PTSD and depression. The new treatment is a recovery-oriented, evidence-based treatment approach that will be evaluated for acceptability and feasibility in this study.

Who is the study for?
This trial is for warzone veterans eligible for VHA care who have experienced moral injury affecting their daily lives. They must be willing to try one of two therapies and not be in another psychotherapy study, acutely intoxicated, psychotic, at immediate suicide risk, or unable to consent.Check my eligibility
What is being tested?
The study tests Acceptance and Commitment Therapy (ACT-MI) against Present Centered Therapy (PCT) to see if they help veterans with moral injury live better lives. It's a pilot study checking if the therapy is acceptable and the design works for larger future studies.See study design
What are the potential side effects?
Psychotherapies like ACT-MI and PCT may bring up uncomfortable emotions or memories but are generally considered safe. Participants might experience increased stress during sessions when discussing difficult experiences.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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 trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment (up to 30-days before starting treatment), post-treatment (0-7 days after treatment completion) and 1- and 3-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Client Satisfaction Questionnaire
Narrative Evaluation of Intervention Interview
Reasons for Termination (Client and Therapist Versions)
Secondary outcome measures
Ecological Momentary Assessment
Outcome Questionnaire-45 (OQ-45)
PROMIS Short Form v2.0-Satisfaction with Social Roles and Activities 8a
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Acceptance and Commitment Therapy for Moral Injury (ACT-MI)Experimental Treatment1 Intervention
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.
Group II: Present Centered TherapyActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,905 Total Patients Enrolled
5 Trials studying Moral Injury
407 Patients Enrolled for Moral Injury
VA Palo Alto Health Care SystemFED
88 Previous Clinical Trials
56,829 Total Patients Enrolled
Lauren Borges, PhDPrincipal InvestigatorRocky Mountain Regional VA Medical Center, Aurora, CO

Media Library

Acceptance and Commitment Therapy for Moral Injury (ACT-MI) Clinical Trial Eligibility Overview. Trial Name: NCT03760731 — Phase 1
Moral Injury Research Study Groups: Acceptance and Commitment Therapy for Moral Injury (ACT-MI), Present Centered Therapy
Moral Injury Clinical Trial 2023: Acceptance and Commitment Therapy for Moral Injury (ACT-MI) Highlights & Side Effects. Trial Name: NCT03760731 — Phase 1
Acceptance and Commitment Therapy for Moral Injury (ACT-MI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03760731 — Phase 1
~3 spots leftby Oct 2024