Multisite Feasibility of Compassion Meditation for Veterans With Posttraumatic Stress Disorder (PTSD)
Primary Purpose
Posttraumatic Stress Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compassion meditation
Applied relaxation
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Meditation, Compassion meditation, Veterans, Complementary and alternative medicine, 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
Sites / Locations
- VA Bedford Healthcare SystemRecruiting
- Durham VA Health Care SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Compassion meditation
Applied relaxation
Arm Description
Compassion meditation is a contemplative meditation practice that fosters compassion through contemplation of common humanity.
Veteran.calm is an applied relaxation program that exposes participants to a variety of relaxation strategies and their application.
Outcomes
Primary Outcome Measures
Enrolment rate
Proportion of consented subjects among all screened and eligible patients.
Initiation rate
Proportion of subjects who initiate the intervention among all consented subjects.
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.
Intent-to-treat completion rate
Proportion of subjects who complete 6 or more sessions of intervention among all randomized subjects.
Credibility
An average of 3 items rated on a Likert scale.
Practice time
Number of minutes of practice divided the number of minutes assigned.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04793698
First Posted
February 11, 2021
Last Updated
August 3, 2022
Sponsor
Veterans Medical Research Foundation
Collaborators
Bedford Research Corporation, Inc., Institute for Medical Research, Inc., National Center for Complementary and Integrative Health (NCCIH), Emory University
1. Study Identification
Unique Protocol Identification Number
NCT04793698
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Veterans Medical Research Foundation
Collaborators
Bedford Research Corporation, Inc., Institute for Medical Research, Inc., National Center for Complementary and Integrative Health (NCCIH), Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Meditation, Compassion meditation, Veterans, Complementary and alternative medicine, PTSD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Blinded to intervention arm
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Compassion meditation
Arm Type
Experimental
Arm Description
Compassion meditation is a contemplative meditation practice that fosters compassion through contemplation of common humanity.
Arm Title
Applied relaxation
Arm Type
Active Comparator
Arm Description
Veteran.calm is an applied relaxation program that exposes participants to a variety of relaxation strategies and their application.
Intervention Type
Other
Intervention Name(s)
Compassion meditation
Intervention Description
10 week meditation course taught in 90-minute groups
Intervention Type
Behavioral
Intervention Name(s)
Applied relaxation
Intervention Description
10 week applied relaxation course taught in 90-minute groups
Primary Outcome Measure Information:
Title
Enrolment rate
Description
Proportion of consented subjects among all screened and eligible patients.
Time Frame
10 weeks
Title
Initiation rate
Description
Proportion of subjects who initiate the intervention among all consented subjects.
Time Frame
10 weeks
Title
Per protocol completion rate
Description
Proportion of subjects who complete 6 or more sessions (out of a total of 10 sessions) of intervention among those who start the intervention.
Time Frame
10 weeks
Title
Intent-to-treat completion rate
Description
Proportion of subjects who complete 6 or more sessions of intervention among all randomized subjects.
Time Frame
10 weeks
Title
Credibility
Description
An average of 3 items rated on a Likert scale.
Time Frame
10 weeks
Title
Practice time
Description
Number of minutes of practice divided the number of minutes assigned.
Time Frame
10 weeks
Title
Participant satisfaction score
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Therapist fidelity to intervention
Description
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.
Time Frame
10 weeks
Title
Therapist adequacy addressing treatment elements
Description
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.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ariel J Lang, PhD, MPH
Phone
858-552-8585
Ext
5359
Email
ariel.lang@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Haley Suit, MA
Phone
858-552-8585
Ext
6297
Email
haley.suit@va.gov
Facility Information:
Facility Name
VA Bedford Healthcare System
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Harris, PhD
Email
Jeanette.Harris2@va.gov
First Name & Middle Initial & Last Name & Degree
Amanda Ayre
Email
Amanda.Ayre@va.gov
First Name & Middle Initial & Last Name & Degree
Irene Harris, PhD
Facility Name
Durham VA Health Care System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Y. Wells, PhD
Email
stephanie.wells2@va.gov
First Name & Middle Initial & Last Name & Degree
Stephanie Y. Wells, PHD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be available after study completion
IPD Sharing Time Frame
Data will be available for 5 years beginning 1 year after study completion
IPD Sharing Access Criteria
Request to the Principal Investigator (PI) with an approved Institutional Review Board (IRB) or documentation of exemption
Learn more about this trial
Multisite Feasibility of Compassion Meditation for Veterans With Posttraumatic Stress Disorder (PTSD)
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