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

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

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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder; Moral Injury
• Intervention / Treatment: Behavioral: Moral Elevation intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Temple, Texas, United States, 76504
      • Central Texas Veterans Health Care System, Temple, TX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)
EXPERIMENTAL: Moral Elevation Intervention; Moral Elevation Intervention (described in intervention section).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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).
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).
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).
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).
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.

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Adam P. McGuire, PhD, Central Texas Veterans Health Care System, Temple, TX

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2020
• Primary Completion (ACTUAL): November 30, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (ACTUAL): April 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: PTSD; Veterans; Pilot Study; Moral Injury; Web-Based Intervention; Moral Elevation
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Wounds and Injuries
• Other Study ID Numbers: D3035-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD
• IPD Sharing Time Frame: 1 year after publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No