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

Sponsor
Veterans Medical Research Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT04793698
Collaborator
Bedford Research Corporation, Inc. (Other), Institute for Medical Research, Inc. (Industry), National Center for Complementary and Integrative Health (NCCIH) (NIH), Emory University (Other)
144
2
2
37.8
72
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Compassion meditation
  • Behavioral: Applied relaxation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Blinded to intervention arm
Primary Purpose:
Treatment
Official Title:
Multisite Feasibility of Compassion Meditation for Veterans With Posttraumatic Stress Disorder (PTSD)
Actual Study Start Date :
May 6, 2021
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Enrolment rate [10 weeks]

    Proportion of consented subjects among all screened and eligible patients.

  2. Initiation rate [10 weeks]

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

  3. Per protocol completion rate [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 [10 weeks]

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

  5. Credibility [10 weeks]

    An average of 3 items rated on a Likert scale.

  6. Practice time [10 weeks]

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

  7. Participant satisfaction score [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 Outcome Measures

  1. Therapist fidelity to intervention [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA Bedford Healthcare System Bedford Massachusetts United States 01730
2 Durham VA Health Care System Durham North Carolina United States 27705

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT04793698
Other Study ID Numbers:
  • 0974700
  • U01AT010332
First Posted:
Mar 11, 2021
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Veterans Medical Research Foundation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2022