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

NCT ID: NCT04793698

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2026-09-30

Brief 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.

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Compassion meditation

Compassion meditation is a contemplative meditation practice that fosters compassion through contemplation of common humanity.

Group Type: EXPERIMENTAL

Compassion meditation

Intervention Type: OTHER

10 week meditation course taught in 90-minute groups

Applied relaxation

Veteran.calm is an applied relaxation program that exposes participants to a variety of relaxation strategies and their application.

Group Type: ACTIVE_COMPARATOR

Applied relaxation

Intervention Type: BEHAVIORAL

10 week applied relaxation course taught in 90-minute groups

Interventions

Compassion meditation

10 week meditation course taught in 90-minute groups

Intervention Type: OTHER

Applied relaxation

10 week applied relaxation course taught in 90-minute groups

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bedford Research Corporation, Inc.

OTHER

Sponsor Role: collaborator

Institute for Medical Research, Inc.

INDUSTRY

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

Veterans Health Research Institute of Central New York, Inc.

UNKNOWN

Sponsor Role: collaborator

Veterans Medical Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

VA Bedford Healthcare System

Bedford, Massachusetts, United States

VA Finger Lakes HCS

Canandaigua, New York, United States

Durham VA Health Care System

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

U01AT010332

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0974700

Identifier Type: -

Identifier Source: org_study_id