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Adaptation of Mindfulness Training to Treat Moral Injury in Veterans

Primary Purpose

Mindfulness, Educational Support

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Mindfulness
Educational Support
Sponsored by
Old Dominion University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mindfulness focused on measuring Mindfulness, Veterans, Moral Injury, Educational Support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Old Dominion University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness

Educational Support

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Semi-Structured Interviews
Semi-structured interview to obtain input on the study programs

Secondary Outcome Measures

Full Information

First Posted
September 14, 2021
Last Updated
June 2, 2023
Sponsor
Old Dominion University
Collaborators
College of William & Mary, H. Lee Moffitt Cancer Center and Research Institute, University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT05341882
Brief Title
Adaptation of Mindfulness Training to Treat Moral Injury in Veterans
Official Title
Adaptation of Mindfulness Training to Treat Moral Injury in Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
October 19, 2022 (Actual)
Study Completion Date
October 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Old Dominion University
Collaborators
College of William & Mary, H. Lee Moffitt Cancer Center and Research Institute, University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mindfulness, Educational Support
Keywords
Mindfulness, Veterans, Moral Injury, Educational Support

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
In Study 2, we randomized 19 participants to either the Mindfulness or Educational Support condition. In Study 3, we randomized 56 participants to the Mindfulness or Educational Support condition.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
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.
Arm Title
Educational Support
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational Support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Semi-Structured Interviews
Description
Semi-structured interview to obtain input on the study programs
Time Frame
1 hour

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Self-identify as male or female.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Post 9/11 veterans who were deployed to Iraq/Afghanistan regions 1 or more times Report 2 or more symptoms of moral injury Exclusion Criteria: They have a probable psychotic disorder (as determined by the Diagnostic and Statistical Manual-5 Level 1 Cross-Cutting Symptom Measure-Adult) or They have a current suicide plan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle L Kelley, Ph.D.
Organizational Affiliation
Old Dominion University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Old Dominion University
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23529-0267
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
36340697
Citation
Kelley ML, Strowger M, Chentsova VO, Bravo AJ, Gaylord SA, Burgin EE, Vinci C, Ayers KL, Agha E. Mindfulness to Manage Moral Injury: Rationale and development of a live online 7-week group intervention for veterans with moral injury. Contemp Clin Trials Commun. 2022 Oct 14;30:101011. doi: 10.1016/j.conctc.2022.101011. eCollection 2022 Dec.
Results Reference
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Adaptation of Mindfulness Training to Treat Moral Injury in Veterans

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