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Completed

NCT Number: NCT04793698

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Bedford Healthcare System, Bedford, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Compassion meditation

Other

10 week meditation course taught in 90-minute groups

Applied Relaxation

Behavioral

10 week applied relaxation course taught in 90-minute groups

Primary outcomes

  1. Enrolment rate

    Time frame: 10 weeks

    Proportion of consented subjects among all screened and eligible patients.

  2. Initiation rate

    Time frame: 10 weeks

    Proportion of subjects who initiate the intervention among all consented subjects.

  3. Per protocol completion rate

    Time frame: 10 weeks

    Proportion of subjects who complete 6 or more sessions (out of a total of 10 sessions) of intervention among those who start the intervention.

  4. Intent-to-treat completion rate

    Time frame: 10 weeks

    Proportion of subjects who complete 6 or more sessions of intervention among all randomized subjects.

  5. Credibility

    Time frame: 10 weeks

    An average of 3 items rated on a Likert scale.

  6. Practice time

    Time frame: 10 weeks

    Number of minutes of practice divided the number of minutes assigned.

  7. Participant satisfaction score

    Time frame: 10 weeks

    Client Satisfaction Questionnaire (CSQ-8) score, an 8-item measure of satisfaction with services received. A total score will be calculated for comparison with normative data and with previous groups.

Secondary outcomes

  1. Therapist fidelity to intervention

    Time frame: 10 weeks

    Percent compliance ("yes" or "no") with whether they addressed items within 3 element types (whether they addressed the elements unique and essential, essential but not unique, proscribed) and overall.

  2. Therapist adequacy addressing treatment elements

    Time frame: 10 weeks

    Likert scale ratings on how well the therapist addressed themes/issues within 3 element types (unique and essential, essential but not unique, proscribed) and overall.

Sponsors and collaborators

Lead sponsor

Veterans Medical Research Foundation

Other

Collaborators

  • Bedford Research Corporation, Inc.
  • Emory University
  • Institute for Medical Research, Inc.
  • National Center for Complementary and Integrative Health (NCCIH)
  • Veterans Health Research Institute of Central New York, Inc.

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Mar 11, 2021
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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