跳至主要内容
临床试验/NCT06788678
NCT06788678招募中不适用

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

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年8月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
1
主要终点
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

研究概览

简要总结

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.

详细描述

Poor treatment engagement and retention with evidence-based practices (EBPs) are significant problems for Veterans with post-traumatic 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

MOVED

Experimental

Moral Elevation Online Intervention for Veterans Experiencing Distress.

干预措施: MOVED (Behavioral)

Supportive Care Control

Active Comparator

Present-centered, nondirective intervention

干预措施: Supportive Care Control (Other)

结局指标

主要结局

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

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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