Adaptation of Mindfulness Training to Treat Moral Injury in Veterans

June 2, 2023 updated by: Michelle L. Kelley, Old Dominion University
This project is highly innovative as it will be the first to develop a mindfulness-based treatment as a first-line intervention tailored to target moral injury among combat-wounded veterans. In Study 1, the investigators recruited a small group of veterans to give feedback on the project. In Studies 2 and 3, the investigators will compare the newly developed mindfulness training to an equally intensive Educational Support condition. Further, if successful, this application may have the ability to adapted and extended to address common to other professions that experience moral injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Combat theaters place service members in situations where they make difficult decisions that may transgress deeply held moral beliefs or witness others' acts of betrayal. Although many veterans are resilient to these types of experiences, for others, failure to accommodate these events may result in internal conflict that is theorized to lead to the development of moral injury. Moral injury is distinct from posttraumatic stress disorder and has been associated with poor mental health outcomes (e.g., depression, anxiety, suicidality) and alcohol/drug use among veterans. Few evidence-based interventions have been developed to target symptoms of moral injury. In studies with combat wounded veterans, community veterans, and a predominantly VA treatment-seeking sample, the investigators have demonstrated that mindfulness moderates associations between moral injury symptoms and negative mental health outcomes. In addition, the investigators have demonstrated that combat wounded veterans are willing to take part in a mindfulness-based moral injury intervention, especially if administered in an online interactive web-based program. Using an iterative developmental process, the goal of this project is to adapt an integrative and theory-driven mindfulness-based intervention delivered online to target moral injury in combat wounded veterans. Aim 1 is to modify an evidence-based, online, interactive, instructor-delivered, six-session mindfulness program, originally designed to help active duty members manage physical pain (i.e., Mindfulness to Manage Chronic Pain), such that it addresses the psychologically painful symptoms (e.g., guilt, shame) characteristic of those with moral injury. The newly adapted program, Mindfulness to Manage Moral Injury (MMMI), will then be piloted with one group of eligible veterans (N = 6) to generate qualitative feedback on program content and format; revisions based on this feedback will result in preliminary manualization. Subsequently, in Aim 2 the investigators propose to develop a facilitator-led online interactive Education Support (ES) program designed to serve as a control comparison intervention, and then carry out a non-randomized pilot study comparing the feasibility (i.e., credibility, acceptability, study completion, and adherence (e.g., to homework assignments) of ES to the revised MMMI program with N = 20 (10 MMMI; 10 ES) recent-era veterans. Following this phase of feasibility testing, the investigative team will collect qualitative information and further refine both the MMMI and ES materials. In Aim 3, the investigators propose a small-scale randomized controlled trial (N = 42 combat wounded veterans; 21 MMMI; 21 ES) to collect data on recruitment, credibility and acceptability, completion rates, and adherence in the two newly refined intervention arms at pre-post-test. Aim 3 will assess for potential primary and secondary outcome measures and lay the groundwork for a large-scale randomized R01 controlled efficacy trial. If supported, this work would have the potential to provide a novel and flexible theoretically grounded form of treatment delivered in-home for combat wounded veterans experiencing moral injury symptoms and associated mental health problems.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23529-0267
        • Old Dominion University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Study Population

Participants must be recent-era veterans, deployed 1 or more times to Iraq or Afghanistan regions.

Description

Inclusion Criteria:

  1. Post 9/11 veterans who were deployed to Iraq/Afghanistan regions 1 or more times
  2. Report 2 or more symptoms of moral injury

Exclusion Criteria:

  1. They have a probable psychotic disorder (as determined by the Diagnostic and Statistical Manual-5 Level 1 Cross-Cutting Symptom Measure-Adult)

    or

  2. They have a current suicide plan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness
The seven weekly sessions teach veterans how to use mindfulness techniques in everyday life and when dealing with stress and negative emotions related to moral injury.
Behavioral: Mindfulness
Participants took part in a live, facilitated Zoom-delivered training that involved learning mindfulness and education about moral injury. The participants were interviewed regarding the program.
Active Comparator: Educational Support
As an active control condition, the investigators developed an education support (ES) group, which ran concurrently to the mindfulness intervention group. Within the military community, peer support and psychoeducation are considered critical components of alleviation of suffering from traumatic exposure.
Behavioral: Educational Support
As an active control condition, the investigators developed an education support (ES) group, which ran concurrently to the mindfulness intervention group. Within the military community, peer support and psychoeducation are considered critical components of alleviation of suffering from traumatic exposure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semi-Structured Interviews
Time Frame: 1 hour
Semi-structured interview to obtain input on the study programs
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Old Dominion University

Collaborators

University of North Carolina, Chapel Hill
H. Lee Moffitt Cancer Center and Research Institute
College of William & Mary

Investigators

  • Principal Investigator: Michelle L Kelley, Ph.D., Old Dominion University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

October 19, 2022

Study Completion (Actual)

October 19, 2022

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0414484650000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Given this is an R34 grant, we developed a mindfulness program via an iterative process. We then completed a protocol paper that describes the development process and the mindfulness and active control training programs.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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