Pilot Study Testing a Web-Based Moral Elevation Intervention for Veterans With PTSD and Moral Injury (NCT03906240) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study Testing a Web-Based Moral Elevation Intervention for Veterans With PTSD and Moral Injury
United States87 participantsStarted 2020-03-02
Plain-language summary
Given the prevalence of posttraumatic stress disorder (PTSD) and moral injury in combat Veterans and the limitations to current treatments, novel approaches are needed to target both PTSD and moral injury and directly impact psychosocial growth and functional recovery. One potential way to address this critical need is through moral elevation-a positive emotional state described as feeling uplifted and inspired by others' virtuous actions. This study will pilot a web-based moral elevation intervention with Operations Enduring Freedom, Iraqi Freedom, and New Dawn Veterans who experienced a morally injurious event and with a PTSD diagnosis. If Veterans are willing and able to complete an online moral elevation intervention and it has beneficial effects, then moral elevation could be feasibly utilized as a tool to reverse the negative effects of trauma and facilitate recovery. Data from this study will be used to develop larger clinical trials to test if this intervention significantly improves PTSD symptoms and moral injury distress and enhances social functioning.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Veteran Participant Inclusion Criteria:
* 18 years of age
* OEF/OIF/OND Veteran enrolled in CTVHCS
* English-speaking and able to provide written informed consent
* Internet access for web-based sessions and measures
* Current PTSD diagnosis based on medical chart review or screen positively for a probable diagnosis based on empirically-validated cutoffs on the PTSD Checklist for DSM-5
* Screen positively for experiencing 1 morally injurious event and endorse some distress (\>4 on any item) related to that event based on the Moral Injury Events Scale (MIES)
* Willing to complete study procedures and identify an SO who will complete observational measures
* Willing to be randomized
Significant Other Participant Inclusion Criteria:
* 18 years of age
* Designated as a Significant Other by the Veteran participant, and the Veteran participant has provided consent for the study team to contact that potential Significant Other
* English-speaking
* Internet access for web-based observational measures
* Interact with the Veteran \>1 time per week
* Willing to complete study procedures
Exclusion Criteria:
Veteran Participant Exclusion Criteria:
* History of severe traumatic brain injury indicated by medical review and the Ohio State Traumatic Brain Injury Identification Method (OSU TBI-ID)
* Psychosis or current substance use disorder indicated by medical review and the Mini International Neuropsychiatric Interview (MINI)
* Current suicide risk based on the B…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment Evaluation Inventory-Short Form (TEI-SF)
Timeframe: Follow-up assessment within 1 week of study completion.
2
Exercise-Specific Satisfaction Survey (ESSS)
Timeframe: Repeated measure administered during online sessions 1-8 (every Monday & Thursday for 4 weeks of study participation). Participant scores for each item were averaged across all 8 sessions/measurements.