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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04793698
Enrollment
113
Registered
2021-03-11
Start date
2021-05-06
Completion date
2026-01-31
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Keywords

Meditation, Compassion meditation, Veterans, Complementary and alternative medicine, PTSD

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.

Interventions

10 week meditation course taught in 90-minute groups

10 week applied relaxation course taught in 90-minute groups

Sponsors

Veterans Medical Research Foundation
Lead SponsorOTHER
Bedford Research Corporation, Inc.
CollaboratorOTHER
Institute for Medical Research, Inc.
CollaboratorOTHER
National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Emory University
CollaboratorOTHER
Veterans Health Research Institute of Central New York, Inc.
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Blinded to intervention arm

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Enrolment rate10 weeksProportion of consented subjects among all screened and eligible patients.
Initiation rate10 weeksProportion of subjects who initiate the intervention among all consented subjects.
Per protocol completion rate10 weeksProportion of subjects who complete 6 or more sessions (out of a total of 10 sessions) of intervention among those who start the intervention.
Intent-to-treat completion rate10 weeksProportion of subjects who complete 6 or more sessions of intervention among all randomized subjects.
Credibility10 weeksAn average of 3 items rated on a Likert scale.
Practice time10 weeksNumber of minutes of practice divided the number of minutes assigned.
Participant satisfaction score10 weeksClient 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

MeasureTime frameDescription
Therapist fidelity to intervention10 weeksPercent 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.
Therapist adequacy addressing treatment elements10 weeksLikert scale ratings on how well the therapist addressed themes/issues within 3 element types (unique and essential, essential but not unique, proscribed) and overall.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026