Adaptation of Mindfulness Training to Treat Moral Injury in Veterans

Sponsor
Old Dominion University (Other)
Overall Status
Completed
CT.gov ID
NCT05341882
Collaborator
College of William & Mary (Other), H. Lee Moffitt Cancer Center and Research Institute (Other), University of North Carolina, Chapel Hill (Other)
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mindfulness

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 combat wounded 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) combat wounded 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 Design

Study Type:
Observational
Actual Enrollment :
8 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Adaptation of Mindfulness Training to Treat Moral Injury in Veterans
Actual Study Start Date :
Jun 21, 2021
Actual Primary Completion Date :
Aug 9, 2021
Actual Study Completion Date :
Aug 9, 2021

Outcome Measures

Primary Outcome Measures

  1. Semi-Structured Interviews [1 hour]

    Participants were administered a semi-structured interview to obtain their input on the study program and individual aspects of training.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Old Dominion University Norfolk Virginia United States 23529-0267

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michelle L. Kelley, Professor of Psychology, Old Dominion University
ClinicalTrials.gov Identifier:
NCT05341882
Other Study ID Numbers:
  • 0414484650000
First Posted:
Apr 22, 2022
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Michelle L. Kelley, Professor of Psychology, Old Dominion University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 22, 2022