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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

Despite the availability of evidence-based treatments for post-traumatic stress disorder (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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Cognitive Processing Therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Supportive Care Control

    Other intervention

    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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: MOVEDExperimental treatment 1 intervention
Group B: Supportive Care ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Follow-up assessments at posttreatment, 3-months, and 6-months.
2

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.

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

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.

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

Secondary outcomes

1

PTSD Checklist for DSM-5 (PCL-5)

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.

Time frame
Follow-up assessments at posttreatment, 3-months, and 6-months.
2

Moral Injury and Distress Scale (MIDS)

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.

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

Engagement with Beauty Scale (EBS) - Moral Beauty Subscale

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.

Time frame
Follow-up assessments at posttreatment, 3-months, and 6-months.
4

Purpose in Life - Short Form (PIL-SF)

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.

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

Other outcomes

1

State Moral Elevation Scale (SMES)

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.

Time frame
Administered during 8 sessions across 4 weeks

Sponsors and contacts

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