N/A
N=48
Pilot Study Testing a Web-Based Moral Elevation Intervention for Veterans With PTSD and Moral Injury
Posttraumatic Stress Disorder · Moral Injury
Bottom Line
View on ClinicalTrials.gov: NCT03906240 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Treatment Evaluation Inventory-Short Form (TEI-SF) — 3.62; 4.00; 3.94; 3.69 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Moral Elevation intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Evaluation Inventory-Short Form (TEI-SF) |
3.62; 4.00; 3.94; 3.69; 2.75; 3.25 | — |
| PRIMARY Exercise-Specific Satisfaction Survey (ESSS) |
4.95; 4.64; 5.11; 6.22 | — |
| SECONDARY Elevation Scale (ES) |
1.63 | — |
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.
Eligibility Criteria
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 Beck Depression Inventory-II (BDI-II)
Significant Other Participant Exclusion Criteria:
- None
Data sourced from ClinicalTrials.gov (NCT03906240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.