Multisite Feasibility of Compassion Meditation for Veterans With Posttraumatic Stress Disorder (PTSD)

Last updated: March 4, 2024
Sponsor: Veterans Medical Research Foundation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-traumatic Stress Disorders

Treatment

Applied relaxation

Compassion meditation

Clinical Study ID

NCT04793698
0974700
U01AT010332
  • Ages > 18
  • All Genders

Study Summary

Compassion meditation (CM) is a contemplative practice that builds compassion for and connectedness with others. CM has shown promise as a way of enhancing recovery for Veterans with Posttraumatic Stress Disorder (PTSD). The proposed project will examine the feasibility of a clinical trial by assessing our ability to deliver CM and a control intervention consistently with a diverse groups of Veterans from different parts of the country and optimizing the way in which outcomes are determined.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Veteran status
  • Able/willing to consent
  • Primary complaint of Posttraumatic Stress Disorder (PTSD) or subsyndromal PTSD withaccompanying distress and impairment

Exclusion

Exclusion Criteria:

  • Serious suicidality or homicidality
  • Known, untreated substance use or dependence problem
  • Untreated/unstable serious mental illness
  • Cognitive impairment that would interfere with study activities
  • Concurrent enrollment in other treatment for PTSD or other meditation-based practice

Study Design

Total Participants: 144
Treatment Group(s): 2
Primary Treatment: Applied relaxation
Phase:
Study Start date:
May 06, 2021
Estimated Completion Date:
June 30, 2026

Study Description

Posttraumatic stress disorder (PTSD) is a common health concern among Veterans. Although empirically-supported approaches are widely available, engagement rates are low and partial/non response is common. There has been considerable interest in the role of complementary and alternative interventions for PTSD, but little research is available to guide decisions about care. Compassion meditation (CM), a contemplative practice that is intended to foster connectedness with others, shows promise for the treatment of PTSD in Veterans. In healthy populations, CM fosters positive emotion and social connectedness, both of which are known to enhance coping and resilience in the face of extreme stress. Based on this theoretical rationale, the investigators' recently completed a two-phase proof of concept trial of CM for Veterans with PTSD. The first phase employed qualitative and quantitative procedures to iteratively refine an existing CM protocol for Veterans with PTSD. The second phase utilized a pilot randomized controlled trial to establish the feasibility and acceptability of a randomized trial of CM for Veterans with PTSD and to examine potential clinical impact. On the basis of promising results, this project will evaluate the feasibility of a future multi-site efficacy trial of CM for PTSD.

Although the investigators' prior work is an encouraging first step, key questions remain. First, the investigators' data come from a single site in Southern California. It is possible that there are regional differences in the acceptability of CM, so the investigators plan to examine the feasibility of recruiting and retaining a diverse group of Veterans residing in other areas as well as confirming the acceptability of the approach to this broader group of Veterans. Second, the investigators' previous trial relied on a single therapist, who was actively engaged in the development process. It is important to demonstrate that others can be trained to deliver the approach with fidelity and to have some confidence that results are attributable to the protocol rather than to an individual. Finally, in the interest of ultimately understanding the way in which these interventions lead to symptom change, the investigators' will continue to refine their assessment strategy. If successful, this project will lay the necessary groundwork for an efficacy trial of CM, which ultimately could provide an additional evidence-based treatment option for Veterans with PTSD.

Connect with a study center

  • VA Bedford Healthcare System

    Bedford, Massachusetts 01730
    United States

    Terminated

  • VA Finger Lakes HCS

    Canandaigua, New York 14424-1159
    United States

    Active - Recruiting

  • Durham VA Health Care System

    Durham, North Carolina 27705
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.