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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Other: Compassion meditation; Behavioral: Applied relaxation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Bedford, Massachusetts, United States, 01730
      • VA Bedford Healthcare System
  • New York
    • Canandaigua, New York, United States, 14424-1159
      • VA Finger Lakes HCS
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Durham VA Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Compassion meditation; Compassion meditation is a contemplative meditation practice that fosters compassion through contemplation of common humanity.	Other: Compassion meditation; 10 week meditation course taught in 90-minute groups
Active Comparator: Applied relaxation; Veteran.calm is an applied relaxation program that exposes participants to a variety of relaxation strategies and their application.	Behavioral: Applied relaxation; 10 week applied relaxation course taught in 90-minute groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrolment rate	Proportion of consented subjects among all screened and eligible patients.	10 weeks
Initiation rate	Proportion of subjects who initiate the intervention among all consented subjects.	10 weeks
Per protocol completion rate	Proportion of subjects who complete 6 or more sessions (out of a total of 10 sessions) of intervention among those who start the intervention.	10 weeks
Intent-to-treat completion rate	Proportion of subjects who complete 6 or more sessions of intervention among all randomized subjects.	10 weeks
Credibility	An average of 3 items rated on a Likert scale.	10 weeks
Practice time	Number of minutes of practice divided the number of minutes assigned.	10 weeks
Participant satisfaction score	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.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapist fidelity to intervention	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.	10 weeks
Therapist adequacy addressing treatment elements	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.	10 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): January 31, 2026

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; Veterans; Meditation; Complementary and alternative medicine; Compassion meditation
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 0974700; U01AT010332 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be available after study completion
• IPD Sharing Time Frame: Data will be available for 5 years beginning 1 year after study completion
• IPD Sharing Access Criteria: Request to the Principal Investigator (PI) with an approved Institutional Review Board (IRB) or documentation of exemption
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No