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

Posttraumatic Stress Disorder Clinical Trial

Official title:

Using Moral Elevation to Improve Functioning in Veterans With PTSD and Moral Injury: A Pilot Study of a Web-Based Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03906240
• Other study ID #: D3035-P
• Status: Completed
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 1, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Moral Injury
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Wounds and Injuries

Intervention

Behavioral:
• Moral Elevation intervention
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.

Locations

Country	Name	City	State
United States	Central Texas Veterans Health Care System, Temple, TX	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Posttraumatic Checklist for DSM-5 (PCL-5)	The PCL-5 is a 20-item self-report measure that will assess PTSD symptom severity in the past month. Items are scored from 0 to 4 and summed to create a total score ranging from 0 to 80. Higher scores indicate greater symptom severity.	Administered at baseline and follow-up assessment within 1 week of study completion.
Other	Expression of Moral Injury Scale-Military Version (EMIS-M)	The EMIS-M is a 17-item self-report measure of expressions of distress related to a moral injury directed at both self and others. Items are scored from 1 to 5 and summed to create a total score ranging from 17 to 85. Higher scores indicate greater moral injury-related distress.	Administered at baseline and follow-up assessment within 1 week of study completion.
Other	World Health Organization Quality of Life (WHOQOL-BREF)	The WHOQOL-BREF is a 26-item self-report measure of overall quality of life with 4 domains (physical health, psychological health, social relationships, and environment) and will be used to assess perceptions of psychological health and quality of social relationships. Items are scored from 1 to 5 and summed to create sum scores for each domain, with higher scores indicating greater functioning. The psychological health domain score ranges from 6 to 30 and the social relationships domain score ranges from 3 to 15.	Administered at baseline and follow-up assessment within 1 week of study completion.
Other	Prosocialness Scale (PS) - Self-report	The PS is a 16-item measure that will be completed by Veterans (self-report) to assess their prosocial behaviors and tendencies to help others. Items are scored from 1 to 5 and summed to create a total score ranging from 16 to 80. Higher scores indicate greater prosocial behavior.	Administered at baseline and follow-up assessment within 1 week of study completion.
Other	Impact Message Inventory (IMI)	The IMI is a 59-item measure that will assess the Veterans' interpersonal behaviors, as rated by a Significant Other of the Veteran (observational). Items are scored from 1 to 4 and summed to create eight subscale scores that represent different types of interpersonal behavior or impact on the Significant Other (e.g., hostile, friendly, dominant). Each subscale score ranges from 7 to 28. Higher subscale scores indicate a greater level of interpersonal impact within that domain.	Administered at baseline and follow-up assessment within 1 week of study completion.
Other	Positive and Negative Affect Schedule-Short Form (PANAS-SF)	The PANAS-SF is a 10-item self-report measure of positive and negative affect, which will assess general affect experienced since the prior session. Items are scored from 1 to 5 and summed to create two subscale scores for positive and negative affect, each ranging from 5 to 25. Higher scores indicate higher levels of affect experienced.	Repeated measure administered during online sessions 1-8 (approximately every Monday & Thursday for 4 weeks of study participation).
Other	Positive and Negative Social Exchange (PANSE)	The PANSE is a 24-item self-report measure of the frequency and impact of positive and negative social interactions, which will assess interactions experienced since the prior session. Items are scored from 0 to 4 and summed to create four domains for positive interactions (e.g., emotional support) and four domains for negative interactions (e.g., rejection or neglect). Total scores for each domain range from 0 to 12. Higher scores on a given domain indicates higher frequency of that interaction type.	Repeated measure administered during online sessions 1-8 (approximately every Monday & Thursday for 4 weeks of study participation).
Other	Response to Positive Affect Scale (RPA)	The RPA is a 17-item self-report measure of rumination on positive affective states and will assess responses to positive affect in daily life since the prior session. Items are scored from 1 to 4 and summed to create three subscale scores: dampening (range: 8-32), self-focused positive rumination (range: 4-16), and emotion-focused positive rumination (range: 5-20). Higher scores on a given subscale indicate greater frequency of that rumination response.	Repeated measure administered during online sessions 1-8 (approximately every Monday & Thursday for 4 weeks of study participation).
Other	Compassionate Goals (CG)	The CG is a 7-item self-report questionnaire will measure Veterans' rating of their compassion-based motivations in their interactions with others since the prior session. Items are scored from 1 to 5 and summed to create a total score ranging from 7 to 35. Higher scores indicate greater compassion-based motivations.	Repeated measure administered during online sessions 1-8 (approximately every Monday & Thursday for 4 weeks of study participation).
Other	Prosocialness Scale (PS) - Observer rating	The PS is a 16-item measure that will be completed by a Significant Other of the Veteran (observational) to assess their perspective of a Veteran's prosocial behaviors and tendencies to help others. Items are scored from 1 to 5 and summed to create a total score ranging from 16 to 80. Higher scores indicate greater prosocial behavior.	Administered at baseline and follow-up assessment within 1 week of study completion.
Primary	Treatment Evaluation Inventory-Short Form (TEI-SF)	The TEI-SF is a 9-item self-report measure that will assess acceptability of the moral elevation intervention and its procedure. Items are scored from 1 to 5 and summed to create a total score ranging from 9 to 45. Higher scores indicate greater acceptability.	Follow-up assessment within 1 week of study completion.
Primary	Exercise-Specific Satisfaction Survey (ESSS)	The ESSS is a 4-item self-report measure that will assess acceptability of and satisfaction with the moral elevation exercises within the intervention condition. Items are scored from 1 to 9 and summed to create a total score ranging from 4 to 36. Higher scores indicate greater perceived helpfulness and satisfaction with moral elevation exercises.	Follow-up assessment within 1 week of study completion.
Secondary	Elevation Scale (ES)	The ES is a 13-item self-report measure of the degree to which state-level moral elevation is experienced. Items are scored from 1 to 4. Ten items are summed to create a total score ranging from 10 to 40. Higher total scores indicate higher levels of state moral elevation. The remaining 3 items not included in the total score are not characteristic of elevation and are used to screen for individuals that may endorse all items.	Repeated measure administered during online sessions 1-8 (approximately every Monday & Thursday for 4 weeks of study participation).