Pilot Study Testing a Web-Based Moral Elevation Intervention for Veterans With PTSD and Moral Injury
Primary Purpose
Posttraumatic Stress Disorder, Moral Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moral Elevation intervention
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Web-Based Intervention, Pilot Study, Moral Elevation, Veterans, PTSD, Moral Injury
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
Sites / Locations
- Central Texas Veterans Health Care System, Temple, TX
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No intervention
Moral Elevation Intervention
Arm Description
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 (described in intervention section).
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03906240
First Posted
March 27, 2019
Last Updated
December 15, 2021
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03906240
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Moral Injury
Keywords
Web-Based Intervention, Pilot Study, Moral Elevation, Veterans, PTSD, Moral Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
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)
Arm Title
Moral Elevation Intervention
Arm Type
Experimental
Arm Description
Moral Elevation Intervention (described in intervention section).
Intervention Type
Behavioral
Intervention Name(s)
Moral Elevation intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Evaluation Inventory-Short Form (TEI-SF)
Description
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.
Time Frame
Follow-up assessment within 1 week of study completion.
Title
Exercise-Specific Satisfaction Survey (ESSS)
Description
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.
Time Frame
Follow-up assessment within 1 week of study completion.
Secondary Outcome Measure Information:
Title
Elevation Scale (ES)
Description
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.
Time Frame
Repeated measure administered during online sessions 1-8 (approximately every Monday & Thursday for 4 weeks of study participation).
Other Pre-specified Outcome Measures:
Title
Posttraumatic Checklist for DSM-5 (PCL-5)
Description
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.
Time Frame
Administered at baseline and follow-up assessment within 1 week of study completion.
Title
Expression of Moral Injury Scale-Military Version (EMIS-M)
Description
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.
Time Frame
Administered at baseline and follow-up assessment within 1 week of study completion.
Title
World Health Organization Quality of Life (WHOQOL-BREF)
Description
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.
Time Frame
Administered at baseline and follow-up assessment within 1 week of study completion.
Title
Prosocialness Scale (PS) - Self-report
Description
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.
Time Frame
Administered at baseline and follow-up assessment within 1 week of study completion.
Title
Impact Message Inventory (IMI)
Description
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.
Time Frame
Administered at baseline and follow-up assessment within 1 week of study completion.
Title
Positive and Negative Affect Schedule-Short Form (PANAS-SF)
Description
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.
Time Frame
Repeated measure administered during online sessions 1-8 (approximately every Monday & Thursday for 4 weeks of study participation).
Title
Positive and Negative Social Exchange (PANSE)
Description
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.
Time Frame
Repeated measure administered during online sessions 1-8 (approximately every Monday & Thursday for 4 weeks of study participation).
Title
Response to Positive Affect Scale (RPA)
Description
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.
Time Frame
Repeated measure administered during online sessions 1-8 (approximately every Monday & Thursday for 4 weeks of study participation).
Title
Compassionate Goals (CG)
Description
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.
Time Frame
Repeated measure administered during online sessions 1-8 (approximately every Monday & Thursday for 4 weeks of study participation).
Title
Prosocialness Scale (PS) - Observer rating
Description
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.
Time Frame
Administered at baseline and follow-up assessment within 1 week of study completion.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam P. McGuire, PhD
Organizational Affiliation
Central Texas Veterans Health Care System, Temple, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Texas Veterans Health Care System, Temple, TX
City
Temple
State/Province
Texas
ZIP/Postal Code
76504
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD
IPD Sharing Time Frame
1 year after publication
Learn more about this trial
Pilot Study Testing a Web-Based Moral Elevation Intervention for Veterans With PTSD and Moral Injury
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