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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

Study 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 weeks3 visits

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

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,612 Previous Clinical Trials

3,305,669 Total Patients Enrolled

5 Trials studying Moral Injury

394 Patients Enrolled for Moral Injury

VA Palo Alto Health Care SystemFED

87 Previous Clinical Trials

56,789 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for individuals to join this medical experiment?

"Affirmative. According to data on clinicaltrials.gov, this study is currently searching for suitable candidates; it was first posted in April 2019 and last updated in January 2022. A total of 72 people are needed to be recruited from a single medical site."

Answered by AI

How many volunteers have been recruited for this trial?

"Affirmative. Clinicaltrials.gov confirms that this medical experiment, initially posted on April 1st 2019, is currently seeking participants. Approximately 72 patients are required from a solitary research centre."

Answered by AI

Is Acceptance and Commitment Therapy for Moral Injury (ACT-MI) a reliable form of treatment?

"Due to the phase 1 status of this trial, limited data exists concerning the efficacy and safety of Acceptance and Commitment Therapy for Moral Injury (ACT-MI), thus receiving a score of 1."

Answered by AI

What is the primary objective of this medical experiment?

"The principle aim of this trial, whose results will be observed over the Post-treatment period (0 to 7 days after completion), is to assess Reasons for Termination from both a Client and Therapist point of view. Auxiliary outcomes include Outcome Questionnaire-45 (OQ-45) - a self-report which gauges psychosocial symptoms distress, social relations and role functioning on a scale ranging 0 to 100; PROMIS v2.0 Social Isolation - wherein scores between 4 and 20 indicate an individual's level of seclusion; as well as PROMIS Short Form v2 Satisfaction with Social R"

Answered by AI

Are minors of any age allowed to participate in this experiment?

"This study demands that participants be aged 18 to 89, with a total of 153 trials targeting patients younger than 18 and 848 designed for persons over 65."

Answered by AI

May I enroll in this clinical research study?

"The prerequisites for this clinical trial demand that potential participants must suffer from moral injury and be between 18-89 years of age. This study seeks to recruit approximately 72 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Thriving in the Midst of Moral Pain: The Acceptability and Feasibility of Acceptance and Commitment Therapy for Moral Injury (ACT-MI) Among Warzone Veterans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03760731.

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