Clinical trial NCT06788678: A Randomized Controlled Trial of a Web-Based Moral Elevation Intervention for Veterans With PTSD
Official title: A Randomized Controlled Trial of a Web-Based Moral Elevation Intervention for Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
Web-Based Intervention
Veterans
Randomized Controlled Trial
Moral Elevation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2025-01-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to either the MOVED condition (target intervention) or a Supportive Care Control (SCC) condition. Both conditions are accessed through an online portal. The MOVED condition includes the moral elevation treatment with intervention content and goal setting activities. The SCC condition is a present-centered, nondirective interaction that aims to control for the nonspecific therapeutic effects of engaging in regular web-based session. Specifically, it includes psychoeducation materials about PTSD symptoms, functioning, and resources for related stressors. Key intervention components of MOVED (e.g., moral elevation exercises and goal-setting) will be excluded from SCC.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Follow-up assessments at posttreatment, 3-months, and 6-months.
measure: World Health Organization Quality of Life - Brief Version (WHOQOL-BREF)
timeFrame: Follow-up assessments at posttreatment, 3-months, and 6-months.
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Follow-up assessments at posttreatment, 3-months, and 6-months.
Secondary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Follow-up assessments at posttreatment, 3-months, and 6-months.
measure: Moral Injury and Distress Scale (MIDS)
timeFrame: Follow-up assessments at posttreatment, 3-months, and 6-months.
measure: Engagement with Beauty Scale (EBS) - Moral Beauty Subscale
timeFrame: Follow-up assessments at posttreatment, 3-months, and 6-months.
measure: Purpose in Life - Short Form (PIL-SF)
timeFrame: Follow-up assessments at posttreatment, 3-months, and 6-months.
measure: Posttraumatic Growth Inventory (PTGI)
timeFrame: Follow-up assessments at posttreatment, 3-months, and 6-months.
Other outcomes:
measure: State Moral Elevation Scale (SMES)
timeFrame: Administered during 8 sessions across 4 weeks
Locations:
city: Temple
country: United States
facility: Central Texas Veterans Health Care System, Temple, TX
state: Texas
Study officials:
affiliation: Central Texas Veterans Health Care System, Temple, TX
name: Adam P. McGuire, PhD
role: PRINCIPAL_INVESTIGATOR
References: