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

V

Veterans Medical Research Foundation

Status

Active, not recruiting

Conditions

Posttraumatic Stress Disorder

Treatments

Other: Compassion meditation
Behavioral: Applied relaxation

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT04793698
0974700
U01AT010332 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

144 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

144 participants in 2 patient groups

Compassion meditation
Experimental group
Description:
Compassion meditation is a contemplative meditation practice that fosters compassion through contemplation of common humanity.
Treatment:
Other: Compassion meditation
Applied relaxation
Active Comparator group
Description:
Veteran.calm is an applied relaxation program that exposes participants to a variety of relaxation strategies and their application.
Treatment:
Behavioral: Applied relaxation

Trial documents
1

Trial contacts and locations

3

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Central trial contact

Ariel J Lang, PhD, MPH; Haley Suit, MA

Data sourced from clinicaltrials.gov

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