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

Study Overview
=================
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.

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

Conditions
-----------------
Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Other: Compassion meditation
* Behavioral: Applied relaxation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compassion meditation<br>Compassion meditation is a contemplative meditation practice that fosters compassion through contemplation of common humanity. | Other: Compassion meditation<br>* 10 week meditation course taught in 90-minute groups<br>|
| Active Comparator: Applied relaxation<br>Veteran.calm is an applied relaxation program that exposes participants to a variety of relaxation strategies and their application. | Behavioral: Applied relaxation<br>* 10 week applied relaxation course taught in 90-minute groups<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Meditation, Compassion meditation, Veterans, Complementary and alternative medicine, PTSD