Multisite Feasibility of Compassion Meditation for Veterans With Posttraumatic Stress Disorder (PTSD)
- Conditions
- Posttraumatic Stress Disorder
- Interventions
- Behavioral: Applied relaxationOther: Compassion meditation
- Registration Number
- NCT04793698
- Lead Sponsor
- Veterans Medical Research Foundation
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 144
- Veteran status
- Able/willing to consent
- Primary complaint of Posttraumatic Stress Disorder (PTSD) or subsyndromal PTSD with accompanying distress and impairment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Applied relaxation Applied relaxation Veteran.calm is an applied relaxation program that exposes participants to a variety of relaxation strategies and their application. Compassion meditation Compassion meditation Compassion meditation is a contemplative meditation practice that fosters compassion through contemplation of common humanity.
- Primary Outcome Measures
Name Time Method Initiation rate 10 weeks Proportion of subjects who initiate the intervention among all consented subjects.
Credibility 10 weeks An average of 3 items rated on a Likert scale.
Intent-to-treat completion rate 10 weeks Proportion of subjects who complete 6 or more sessions of intervention among all randomized subjects.
Practice time 10 weeks Number of minutes of practice divided the number of minutes assigned.
Enrolment rate 10 weeks Proportion of consented subjects among all screened and eligible patients.
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.
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
Name Time Method 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.
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.
Trial Locations
- Locations (3)
VA Finger Lakes HCS
🇺🇸Canandaigua, New York, United States
Durham VA Health Care System
🇺🇸Durham, North Carolina, United States
VA Bedford Healthcare System
🇺🇸Bedford, Massachusetts, United States