Clinical trial NCT03906240: Pilot Study Testing a Web-Based Moral Elevation Intervention for Veterans With PTSD and Moral Injury
Official title: Using Moral Elevation to Improve Functioning in Veterans With PTSD and Moral Injury: A Pilot Study of a Web-Based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Moral Injury
Keywords: Web-Based Intervention
Pilot Study
Moral Elevation
Veterans
PTSD
Moral Injury
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-04-08
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: The goal of this proposed study is to conduct a pilot trial of a web-based moral elevation intervention to determine if such an intervention is a feasible and acceptable therapeutic approach for Operations Enduring Freedom, Iraqi Freedom, and New Dawn Veterans with distress related to posttraumatic stress disorder (PTSD) and moral injury (MI). This study will also assess the feasibility of randomization, retention, and completion of a no-treatment condition (i.e., comparison group) in preparation for future randomized controlled trials (RCTs). The sample will include 24 Veterans (12 per group). The online intervention consists of two exercises per week for one month, totaling eight sessions. Sessions will include watching validated videos that elicit moral elevation and recalling moments when one experienced moral elevation in daily life, paired with journaling about one's reactions to witnessed virtuous behavior. Participants in the intervention condition will also be presented with a brief goal to be completed prior to the next session to facilitate greater social engagement. Participants randomized to the no-treatment condition will access the same online portal twice per week, but will not be exposed to any intervention components. All participants will complete brief self-report measures at each online session. All participants will also complete self-report measures at baseline and 1-month follow-up that will assess PTSD symptoms, MI distress, prosocial behavior, and quality of social relationships. At the follow-up assessment, participants randomized to the intervention condition will complete an individual qualitative interview with a member of the study team to assess acceptability and satisfaction with the intervention and proposed methodology, which will be coded and analyzed to inform future clinical trials. To supplement self-report measures, all participants will invite a significant other (e.g., spouse, close friend) to complete measures based on observations of the Veteran's behavior and social functioning at baseline and 1-month follow-up. Feasibility of recruitment, retention, and completion of the intervention will be analyzed by tracking the number of participants retained at each stage of the study, as well as the number of sessions completed in the intervention. Results from this study will be used to develop an RCT with a larger sample size to determine the efficacy of a moral elevation intervention and assess whether this novel approach leads to unique beneficial outcomes regarding PTSD and moral injury distress.

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

Primary outcomes:
measure: Treatment Evaluation Inventory-Short Form (TEI-SF)
timeFrame: Follow-up assessment within 1 week of study completion.
measure: 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.
Secondary outcomes:
measure: Elevation Scale (ES)
timeFrame: 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:
measure: Change From Baseline in Posttraumatic Checklist for DSM-5 (PCL-5)
timeFrame: Administered at baseline and follow-up assessment within 1 week of study completion.
measure: Changes From Baseline in Expression of Moral Injury Scale-Military Version (EMIS-M)
timeFrame: Administered at baseline and follow-up assessment within 1 week of study completion.
measure: Changes From Baseline in World Health Organization Quality of Life (WHOQOL-BREF)
timeFrame: Administered at baseline and follow-up assessment within 1 week of study completion.
measure: Changes From Baseline in Prosocialness Scale (PS) - Self-report
timeFrame: Administered at baseline and follow-up assessment within 1 week of study completion.
Locations:
city: Temple
country: United States
facility: Central Texas Veterans Health Care System, Temple, TX
state: Texas
Study officials:
affiliation: Central Texas Veterans Health Care System, Temple, TX
name: Adam P. McGuire, PhD
role: PRINCIPAL_INVESTIGATOR
References: