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

NCT06788678 | Not Yet Recruiting

• 1 other identifier: D5081-R
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; Web-Based Intervention; Veterans; Randomized Controlled Trial; Moral Elevation

Outcome Measures

Primary Outcomes (3)

• Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

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

  Follow-up assessments at posttreatment, 3-months, and 6-months.

• World Health Organization Quality of Life - Brief Version (WHOQOL-BREF)

  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.

  Follow-up assessments at posttreatment, 3-months, and 6-months.

• World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

  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.

  Follow-up assessments at posttreatment, 3-months, and 6-months.

Secondary Outcomes (5)

• PTSD Checklist for DSM-5 (PCL-5)

  Follow-up assessments at posttreatment, 3-months, and 6-months.

• Moral Injury and Distress Scale (MIDS)

  Follow-up assessments at posttreatment, 3-months, and 6-months.

• Engagement with Beauty Scale (EBS) - Moral Beauty Subscale

  Follow-up assessments at posttreatment, 3-months, and 6-months.

• Purpose in Life - Short Form (PIL-SF)

  Follow-up assessments at posttreatment, 3-months, and 6-months.

• Posttraumatic Growth Inventory (PTGI)

  Follow-up assessments at posttreatment, 3-months, and 6-months.

Other Outcomes (1)

• State Moral Elevation Scale (SMES)

  Administered during 8 sessions across 4 weeks

Study Arms (2)

MOVED

EXPERIMENTAL

Moral Elevation Online Intervention for Veterans Experiencing Distress.

Behavioral: MOVED

Supportive Care Control

ACTIVE COMPARATOR

Present-centered, nondirective intervention

Other: Supportive Care Control

Interventions

MOVED BEHAVIORAL

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.

Also known as: Moral Elevation Online Intervention for Veterans Experiencing Distress

MOVED

Supportive Care Control OTHER

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.

Supportive Care Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Central Texas Veterans Health Care System, Temple, TX

Temple, Texas, 76504-7451, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Adam P. McGuire, PhD

  Central Texas Veterans Health Care System, Temple, TX

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam P McGuire, PhD

CONTACT

(254) 297-5173; Adam.McGuire@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All staff conducting baseline and follow-up assessments (i.e., posttreatment, 3-months, 6-months) will be blinded to the assigned condition for all participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: 1 year after publication

Locations

US (1)