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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04793698
• Other study ID #: 0974700
• Secondary ID: U01AT010332
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Veterans Medical Research Foundation
• Contact: Ariel J Lang, PhD, MPH
• Phone: 858-552-8585
• Email: ariel.lang[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• Compassion meditation
10 week meditation course taught in 90-minute groups

Behavioral:
• Applied relaxation
10 week applied relaxation course taught in 90-minute groups

Locations

Country	Name	City	State
United States	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

Sponsors (6)

Lead Sponsor	Collaborator
Veterans Medical Research Foundation	Bedford Research Corporation, Inc., Emory University, Institute for Medical Research, Inc., National Center for Complementary and Integrative Health (NCCIH), Veterans Health Research Institute of CNY

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrolment rate	Proportion of consented subjects among all screened and eligible patients.	10 weeks
Primary	Initiation rate	Proportion of subjects who initiate the intervention among all consented subjects.	10 weeks
Primary	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
Primary	Intent-to-treat completion rate	Proportion of subjects who complete 6 or more sessions of intervention among all randomized subjects.	10 weeks
Primary	Credibility	An average of 3 items rated on a Likert scale.	10 weeks
Primary	Practice time	Number of minutes of practice divided the number of minutes assigned.	10 weeks
Primary	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	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
Secondary	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