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A Randomized Controlled Trial of a Web-Based Moral Elevation Intervention for Veterans With PTSD

Not Applicable
Not yet recruiting
Conditions
Posttraumatic Stress Disorder
Registration Number
NCT06788678
Lead Sponsor
VA Office of Research and Development
Brief Summary

Despite the availability of evidence-based treatments for PTSD, there are many challenges to successful trauma recovery for Veterans including difficulties starting and completing these treatments and gaps in fully addressing additional important treatment targets including lower social functioning and quality of life. Alternative, stand-alone treatment options that address a range of outcomes and can be easily accessed are needed to expand the reach of PTSD treatment to Veterans. One way to address this need is with a positive psychology intervention called MOVED, which has shown promise in a prior pilot study. MOVED is a web-based, self-guided intervention (8 sessions, 4 weeks) that uses moral elevation-feeling inspired by others' virtuous actions. This clinical trial will test if MOVED leads to decreased PTSD symptoms and increased social functioning and quality of life compared to a generic supportive treatment that does not focus on moral elevation. Results will help determine if MOVED is a useful alternative approach to target trauma recovery among Veterans with PTSD.

Detailed Description

Poor treatment engagement and retention with evidence-based practices (EBPs) are significant problems for Veterans with posttraumatic stress disorder (PTSD). Additionally, Veterans with PTSD also face significant issues with impaired social functioning and diminished quality of life; however, research suggests EBPs may not full address these other important treatment targets despite their ability to reduce PTSD symptoms. These limitations showcase how difficult it is to successfully treat PTSD and highlight the need for novel, stand-alone approaches as alternatives to current treatments that can further facilitate trauma recovery. Accessible and easily disseminated treatments are needed to target ongoing concerns for Veterans including PTSD symptoms, lower QOL, and poor social functioning. One approach that is well-suited to target these issues is a positive psychology-based intervention that focuses on eliciting moral elevation and its benefits. Moral elevation is a positive, emotional state of feeling inspired or moved by witnessing others' virtuous actions, which leads to greater social engagement and self-improvement motives. Moral Elevation Online Intervention for Veterans Experiencing Distress (MOVED) was previously developed as a web-based, self-guided intervention (8 sessions; 4 weeks) and piloted with a sample of Veterans experiencing significant PTSD symptoms and moral injury-related distress. Results from the VA funded pilot trial suggested MOVED was highly feasible and acceptable by Veterans, it demonstrated high levels of treatment engagement, and Veterans reported positive treatment outcomes including large decreases in PTSD symptoms and medium increases in quality of life. Given the promising findings from the MOVED pilot trial, the goal of this proposed study is to proceed with the next phase of treatment development for MOVED by conducting a powered efficacy trial with a sample of Veterans diagnosed with PTSD for at least one year. Following recent adaptations to MOVED that were informed by Veteran feedback from the pilot trial and with input from key stakeholders (researchers, clinicians, and Veterans with PTSD), a refined version of MOVED will be examined with a randomized controlled trial (RCT). This RCT will test the efficacy of MOVED compared to a supportive care control treatment in decreasing PTSD symptom severity, increasing social functioning, and increasing quality of life. The targeted sample will include 250 Veterans who have a PTSD diagnosis for at least one year. Eligible participants will be randomized to the MOVED condition or a supportive care control condition. Both interventions will be self-guided, web-based, and will include 8 sessions lasting 4 weeks. The supportive care control treatment will be a present-centered, nondirective intervention that aims to control for the nonspecific therapeutic effects of supportive care, whereas MOVED will focus on eliciting experiences of moral elevation, guided reflection of those experiences, and facilitating the pursuit of weekly behavioral goals related to experiences of elevation. All participants in both conditions will complete clinician-administered interviews and self-report measures to assess outcomes at baseline, posttreatment, 3-month, and 6-month follow-up. Additionally, potential mechanisms of action on treatment outcomes will be assessed at each session including experiences of moral elevation and treatment adherence. Results from this study will indicate whether MOVED is a viable treatment that can reduce PTSD symptoms, boost quality of life, and enhance social functioning; thus, expanding the number of treatment options available for PTSD care.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
250
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)Follow-up assessments at posttreatment, 3-months, and 6-months.

The CAPS-5 is a 30-item structured interview that will be used to assess clinician-rated PTSD symptom severity (range = 0-80).

World Health Organization Quality of Life - Brief Version (WHOQOL-BREF)Follow-up assessments at posttreatment, 3-months, and 6-months.

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.

World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)Follow-up assessments at posttreatment, 3-months, and 6-months.

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.

Secondary Outcome Measures
NameTimeMethod
PTSD Checklist for DSM-5 (PCL-5)Follow-up assessments at posttreatment, 3-months, and 6-months.

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.

Moral Injury and Distress Scale (MIDS)Follow-up assessments at posttreatment, 3-months, and 6-months.

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.

Engagement with Beauty Scale (EBS) - Moral Beauty SubscaleFollow-up assessments at posttreatment, 3-months, and 6-months.

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.

Purpose in Life - Short Form (PIL-SF)Follow-up assessments at posttreatment, 3-months, and 6-months.

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.

Posttraumatic Growth Inventory (PTGI)Follow-up assessments at posttreatment, 3-months, and 6-months.

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.

Trial Locations

Locations (1)

Central Texas Veterans Health Care System, Temple, TX

🇺🇸

Temple, Texas, United States

Central Texas Veterans Health Care System, Temple, TX
🇺🇸Temple, Texas, United States
Adam P McGuire, PhD
Contact
254-297-5173
Adam.McGuire@va.gov
Adam P. McGuire, PhD
Principal Investigator
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