Pilot Study Testing a Web-Based Moral Elevation Intervention for Veterans With PTSD and Moral Injury

NCT03906240 | Completed Results

• 1 other identifier: D3035-P
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder; Moral Injury

Keywords

Web-Based Intervention; Pilot Study; Moral Elevation; Veterans; PTSD; Moral Injury

Outcome Measures

Primary Outcomes (2)

• Treatment Evaluation Inventory-Short Form (TEI-SF)

  The TEI-SF is a 9-item self-report measure that assessed acceptability of the moral elevation intervention and its procedure. Items were scored from 1 to 5, with higher scores indicating greater acceptability. To assess the acceptability of the treatment in this study, we calculated descriptive statistics to determine the average score for each item across the intervention condition. The mid-point item score for this measure (range = 1-5, mid-point = 3) was used as an indicator for adequate acceptability (e.g., average/medium levels of acceptability, or higher). Thus, item scores that were greater than 3 are interpreted as supporting medium to high perceived acceptability of the intervention.

  Follow-up assessment within 1 week of study completion.

• Exercise-Specific Satisfaction Survey (ESSS)

  The ESSS is a 4-item self-report measure that assessed acceptability of and satisfaction with the moral elevation exercises within the intervention condition. Items are scored from 0 to 8 with higher scores indicate greater perceived helpfulness and satisfaction with moral elevation exercises. To assess the satisfaction of the session components, we calculated descriptive statistics to determine the average score for each item across all 8 sessions (e.g., average score of item #1 for 8 repeated measurements across 8 sessions). The mid-point item score for this measure (range = 0-8, mid-point = 4) was used as an indicator for adequate satisfaction. Thus, item scores that were greater than 4 are interpreted as supporting medium to high perceived satisfaction of the intervention.

  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.

Secondary Outcomes (1)

• Elevation Scale (ES)

  Repeated measure administered during online sessions 1-8 (every Monday & Thursday for 4 weeks of study participation). Participant scores were averaged across all 8 sessions/measurements.

Other Outcomes (4)

• Change From Baseline in Posttraumatic Checklist for DSM-5 (PCL-5)

  Administered at baseline and follow-up assessment within 1 week of study completion.

• Changes From Baseline in Expression of Moral Injury Scale-Military Version (EMIS-M)

  Administered at baseline and follow-up assessment within 1 week of study completion.

• Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF)

  Administered at baseline and follow-up assessment within 1 week of study completion.

Study Arms (2)

No intervention

NO INTERVENTION

Veterans will access the online portal and complete session measures, but will not be presented with any intervention content (i.e., videos, journaling exercise, and goal setting exercise)

Moral Elevation Intervention

EXPERIMENTAL

Moral Elevation Intervention (described in intervention section).

Behavioral: Moral Elevation intervention

Interventions

Moral Elevation intervention BEHAVIORAL

The intervention will be administered twice per week for 8 sessions total. The intervention will include two types of moral elevation exercises related to witnessing virtuous behavior and subsequently setting session goals aimed to facilitate social engagement.

Moral Elevation Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• \- None

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Central Texas Veterans Health Care System, Temple, TX

Temple, Texas, 76504, United States

Location

Related Publications (1)

• McGuire AP, Rodenbaugh M, Howard BAN, Contractor AA. Response styles to positive affect during a positive psychology intervention for veterans with PTSD and moral injury: Preliminary results from a moral elevation intervention pilot trial. Psychol Trauma. 2025 Feb;17(2):457-465. doi: 10.1037/tra0001774. Epub 2024 Aug 29.

  PMID: 39207432 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The main aim of this pilot trial was to test the feasibility and acceptability of the intervention. Therefore, statistical tests used for secondary/targeted outcomes should be interpreted with caution given the small sample size. Additionally, larger samples are needed to formally test between-group comparisons in change scores. Lastly, the state elevation measure did not perform optimally in this sample, but newer scales have been developed since this trial and should be used in future studies.

Results Point of Contact

• Title: Dr. Adam McGuire
• Organization: VISN 17 Center of Excellence for Research on Returning War Veterans

adam.mcguire@va.gov

254-297-5173

Study Officials

• Adam P. McGuire, PhD

  Central Texas Veterans Health Care System, Temple, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants are randomized to either an intervention condition or no-treatment condition. The intervention condition is accessed through an online portal and includes the moral elevation intervention with intervention content and session goals to facilitate social engagement. The no-treatment condition includes accessing the same online portal, but without any intervention content and is limited to repeated self-report measures for the duration of the study.

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 8, 2019
• Study Start: March 2, 2020
• Primary Completion: November 30, 2021
• Study Completion: December 1, 2021
• Last Updated: June 13, 2024
• Results First Posted: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: 1 year after publication

Locations

US (1)