Clinical trial NCT04793698: Multisite Feasibility of Compassion Meditation for Veterans With Posttraumatic Stress Disorder (PTSD)
Official title: Multisite Feasibility of Compassion Meditation for Veterans With Posttraumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Meditation
Compassion meditation
Veterans
Complementary and alternative medicine
PTSD
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: Bedford Research Corporation, Inc.
name: Institute for Medical Research, Inc.
name: National Center for Complementary and Integrative Health (NCCIH)
name: Emory University
name: Veterans Health Research Institute of CNY
First posted: 2021-03-11
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Enrolment rate
timeFrame: 10 weeks
measure: Initiation rate
timeFrame: 10 weeks
measure: Per protocol completion rate
timeFrame: 10 weeks
measure: Intent-to-treat completion rate
timeFrame: 10 weeks
measure: Credibility
timeFrame: 10 weeks
measure: Practice time
timeFrame: 10 weeks
measure: Participant satisfaction score
timeFrame: 10 weeks
Secondary outcomes:
measure: Therapist fidelity to intervention
timeFrame: 10 weeks
measure: Therapist adequacy addressing treatment elements
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Bedford
country: United States
facility: VA Bedford Healthcare System
state: Massachusetts
city: Canandaigua
country: United States
facility: VA Finger Lakes HCS
state: New York
city: Durham
country: United States
facility: Durham VA Health Care System
state: North Carolina
Study officials:
References: