JMIR Publications

ABSTRACT

Background:

Approximately 25% of combat Veterans with Posttraumatic Stress Disorder (PTSD) seek treatment for traumas that involve potentially morally injurious events (PMIEs), which involve acts of commissions or omission or betrayal that deeply transgress one’s sense of right and wrong. The sequelae of exposure to PMIEs, called moral injury, are associated with functional and psychiatric impairment and disrupt Veterans’ sense of identity and meaning, ability to connect with and trust others, and engender disturbing guilt, shame, rage, and disgust. Currently, no first-line treatments directly address moral injury and evidence-based treatments for PTSD may be limited because they were derived from civilian contexts, poorly fit the war zone context, and do not allow Veterans to discuss the details of the PMIEs with other Veterans.

Objective:

The objective of this proposal is to develop a depth-oriented group psychotherapy for morally injured U.S. combat Veterans. The treatment development process is guided by user-centered design principles, in which the needs and preferences of potential treatment users (e.g., patients, providers) are systematically incorporated at all design and development phases.

Methods:

This research plan will employ user-centered design methods that continuously gather user experiences during treatment development, with the goal of increased effectiveness and usability. Aim 1 will discover user needs and preferences as well as treatment-engagement barriers and facilitators from the perspectives of PMIE-impacted Veterans and VA trauma clinicians (i.e., mental health providers and chaplains) using semi-structured qualitative interviews. Aim 2 will design a treatment manual and refine it using feedback from Veterans, VA clinicians and chaplains, and an expert clinical advisory board. Aim 3 will conduct two rapid prototyping open trials (i.e., tangibly testing treatment approaches using a prototype manual) with PMIE-impacted Veterans (N = ~12), and iteratively revise the manual based on Veteran, provider, and clinical expert panel feedback, with the following hypothesis: The treatment manual will meet usability, feasibility, learnability, and acceptability criteria.

Results:

This study was funded with a start date of November 2021. Participant recruitment for Aim 3 pilot trials began in October 2023 and ended in January 2025. We anticipate study data collection to be completed in January 2026 and primary data analysis to be completed by April 2026.

Conclusions:

The proposed research has the potential to offer innovative treatment for traumatized combat Veterans who otherwise may not find full relief from PTSD. Clinical research practice will be advanced by employing state-of-the-art methods from design thinking and implementation science, combined with expert clinical feedback, to develop an effective user-centered treatment that will meet the needs of VA consumers, providers, and contexts. Clinical Trial: ClinicalTrials.gov identifier is NCT05020587.