Adaptation of Mindfulness Training to Treat Moral Injury in Veterans

NCT05341882 | Completed Phase 3

• 1 other identifier: 0414484650000
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Mindfulness; Educational Support

Keywords

Mindfulness; Veterans; Moral Injury; Educational Support

Outcome Measures

Primary Outcomes (1)

• Semi-Structured Interviews

  Semi-structured interview to obtain input on the study programs

  1 hour

Study Arms (2)

Mindfulness

EXPERIMENTAL

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

Educational Support

ACTIVE COMPARATOR

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

Interventions

Mindfulness BEHAVIORAL

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.

Mindfulness

Educational Support BEHAVIORAL

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.

Educational Support

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identify as male or female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Old Dominion University

Norfolk, Virginia, 23529-0267, United States

Location

Related Publications (1)

• 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.

  PMID: 36340697 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Mindfulness; Training Support

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Financial Support; Economics; Health Care Economics and Organizations

Study Officials

• Michelle L Kelley, Ph.D.

  Old Dominion University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: April 22, 2022
• Study Start: June 1, 2021
• Primary Completion: October 19, 2022
• Study Completion: October 19, 2022
• Last Updated: June 5, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)