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

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ClinicalTrials.gov Identifier: NCT03906240
Recruitment Status : Not yet recruiting
First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Moral Injury Behavioral: Moral Elevation intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Using Moral Elevation to Improve Functioning in Veterans With PTSD and Moral Injury: A Pilot Study of a Web-Based Intervention
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : August 31, 2021

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.




Primary Outcome Measures :
  1. Treatment Evaluation Inventory-Short Form (TEI-SF) [ Time Frame: Follow-up assessment within 1 week of study completion. ]
    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.

  2. Exercise-Specific Satisfaction Survey (ESSS) [ Time Frame: Follow-up assessment within 1 week of study completion. ]
    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 :
  1. Elevation Scale (ES) [ Time Frame: Repeated measure administered during online sessions 1-8 (approximately every Monday & Thursday for 4 weeks of study participation). ]
    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.


Other Outcome Measures:
  1. Posttraumatic Checklist for DSM-5 (PCL-5) [ Time Frame: Administered at baseline and follow-up assessment within 1 week of study completion. ]
    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.

  2. Expression of Moral Injury Scale-Military Version (EMIS-M) [ Time Frame: Administered at baseline and follow-up assessment within 1 week of study completion. ]
    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.

  3. World Health Organization Quality of Life (WHOQOL-BREF) [ Time Frame: Administered at baseline and follow-up assessment within 1 week of study completion. ]
    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.

  4. Prosocialness Scale (PS) - Self-report [ Time Frame: Administered at baseline and follow-up assessment within 1 week of study completion. ]
    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.

  5. Impact Message Inventory (IMI) [ Time Frame: Administered at baseline and follow-up assessment within 1 week of study completion. ]
    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.

  6. Positive and Negative Affect Schedule-Short Form (PANAS-SF) [ Time Frame: Repeated measure administered during online sessions 1-8 (approximately every Monday & Thursday for 4 weeks of study participation). ]
    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.

  7. Positive and Negative Social Exchange (PANSE) [ Time Frame: Repeated measure administered during online sessions 1-8 (approximately every Monday & Thursday for 4 weeks of study participation). ]
    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.

  8. Response to Positive Affect Scale (RPA) [ Time Frame: Repeated measure administered during online sessions 1-8 (approximately every Monday & Thursday for 4 weeks of study participation). ]
    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.

  9. Compassionate Goals (CG) [ Time Frame: Repeated measure administered during online sessions 1-8 (approximately every Monday & Thursday for 4 weeks of study participation). ]
    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.

  10. Prosocialness Scale (PS) - Observer rating [ Time Frame: Administered at baseline and follow-up assessment within 1 week of study completion. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906240


Contacts
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Contact: Adam P McGuire, PhD (254) 297-5173 Adam.McGuire@va.gov

Locations
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United States, Texas
Central Texas Veterans Health Care System, Temple, TX Not yet recruiting
Temple, Texas, United States, 76504
Contact: Adam P McGuire, PhD    254-297-5173    Adam.McGuire@va.gov   
Principal Investigator: Adam P. McGuire, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Adam P. McGuire, PhD Central Texas Veterans Health Care System, Temple, TX

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03906240     History of Changes
Other Study ID Numbers: D3035-P
First Posted: April 8, 2019    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD
Time Frame: 1 year after publication

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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
Keywords provided by VA Office of Research and Development:
Web-Based Intervention
Pilot Study
Moral Elevation
Veterans
PTSD
Moral Injury
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Wounds and Injuries
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders