A Randomized Controlled Trial of a Web-Based Moral Elevation Intervention for Veterans With PTSD
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Adam P McGuire, PhD
- Phone Number: (254) 297-5173
- Email: Adam.McGuire@va.gov
Study Locations
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Texas
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Temple, Texas, United States, 76504-7451
- Recruiting
- Central Texas Veterans Health Care System, Temple, TX
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Contact:
- Adam P McGuire, PhD
- Phone Number: (254) 297-5173
- Email: Adam.McGuire@va.gov
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Principal Investigator:
- Adam P. McGuire, PhD
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Enrolled in a VISN 17 health care system
- English-speaking and able to provide written informed consent
- Willingness to complete study procedures and be randomized
- Internet access and an electronic device to complete the web-based sessions
- Current diagnosis of PTSD based on the CAPS-5
- History of PTSD diagnosis for at least 1 year
Exclusion Criteria:
- History of severe traumatic brain injury indicated by medical record review and the Ohio State Traumatic Brain Injury Identification Method (OSU TBI-ID)
- Current psychosis or mania as indicated by medical record review and the Mini International Neuropsychiatric Interview (MINI)
- Current suicide risk based on the Beck Depression Inventory-II (BDI-II)
Currently enrolled and actively participating in a trauma-focused treatment including:
- Cognitive Processing Therapy
- Prolonged Exposure
- Eye Movement Desensitization Reprocessing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: MOVED
Moral Elevation Online Intervention for Veterans Experiencing Distress.
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MOVED includes 8 self-guided, web-based sessions administered over 4 weeks.
Web-based sessions include 3 core components: (1) elicit moral elevation, (2) engage in reflection about moral elevation response, and (3) set a behavioral goal that is inspired by the moral elevation exercise.
Other Names:
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Active Comparator: Supportive Care Control
Present-centered, nondirective intervention
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A present-centered, nondirective intervention that aims to control for the nonspecific therapeutic effects of supportive care.
In this case, the effects of engaging in regular web-based sessions that convey information about PTSD symptoms.
Sessions will include psychoeducation materials about PTSD symptoms, functioning, and resources for dealing with related stressors.
Key components of MOVED will be strictly excluded.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time Frame: Follow-up assessments at posttreatment, 3-months, and 6-months.
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The CAPS-5 is a 30-item structured interview that will be used to assess clinician-rated PTSD symptom severity (range = 0-80).
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Follow-up assessments at posttreatment, 3-months, and 6-months.
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World Health Organization Quality of Life - Brief Version (WHOQOL-BREF)
Time Frame: Follow-up assessments at posttreatment, 3-months, and 6-months.
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The WHOQOL-BREF is a 26-item self-report measure that will be used to assess overall quality of life with 4 domains (physical health, psychological health, social relationships, and environment).
Subscales scores are computed by summing all items for each subscale, then all scores are transformed to a range of 0-100.
A higher score signifies higher or better quality of life.
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Follow-up assessments at posttreatment, 3-months, and 6-months.
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World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time Frame: Follow-up assessments at posttreatment, 3-months, and 6-months.
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The WHODAS 2.0 is a self-report measures of functioning.
Two socially-oriented subscales comprised of 13 items total will be used to assess social functioning across the Getting Along and Participation domains.
Higher scores indicate greater functioning.
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Follow-up assessments at posttreatment, 3-months, and 6-months.
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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PTSD Checklist for DSM-5 (PCL-5)
Time Frame: Follow-up assessments at posttreatment, 3-months, and 6-months.
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The PCL-5 is a 20-item self-report measure that will be used to assess PTSD symptom severity (range 0 = 80).
Higher scores indicate greater symptom severity.
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Follow-up assessments at posttreatment, 3-months, and 6-months.
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Moral Injury and Distress Scale (MIDS)
Time Frame: Follow-up assessments at posttreatment, 3-months, and 6-months.
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The MIDS is a 24-item self report measure that will be used to assess moral injury distress (range = 0-72).
Higher scores indicate greater distress.
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Follow-up assessments at posttreatment, 3-months, and 6-months.
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Engagement with Beauty Scale (EBS) - Moral Beauty Subscale
Time Frame: Follow-up assessments at posttreatment, 3-months, and 6-months.
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The EBS is a self-report measure that will be used to assess engagement with moral beauty or trait-level moral elevation.
The moral beauty subscale includes 7 items (range = 6-42).
Higher scores indicate greater engagement with moral beauty.
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Follow-up assessments at posttreatment, 3-months, and 6-months.
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Purpose in Life - Short Form (PIL-SF)
Time Frame: Follow-up assessments at posttreatment, 3-months, and 6-months.
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The PIL-SF is a 4-item self-report measure that will be used to assess perceived meaning and purpose in life (range = 4-28).
Higher scores indicate greater purpose in life.
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Follow-up assessments at posttreatment, 3-months, and 6-months.
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Posttraumatic Growth Inventory (PTGI)
Time Frame: Follow-up assessments at posttreatment, 3-months, and 6-months.
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The PTGI is a 21-item self-report measure that will be used to assess posttraumatic growth (range = 0-105).
Higher scores indicate greater posttraumatic growth.
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Follow-up assessments at posttreatment, 3-months, and 6-months.
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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State Moral Elevation Scale (SMES)
Time Frame: Administered during 8 sessions across 4 weeks
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The SMES is a 9-item self-report measure that will be used to assess state-level moral elevation experienced during each session for both conditions (range = 0-36).
Higher scores indicate greater moral elevation.
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Administered during 8 sessions across 4 weeks
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Adam P. McGuire, PhD, Central Texas Veterans Health Care System, Temple, TX
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- D5081-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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