Expired Study
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San Diego, California 92161


Purpose:

The goal of this project is to refine an existing compassion meditation protocol for individuals with posttraumatic stress disorder (PTSD), to examine the safety and feasibility of this approach and to collect data to make initial estimates of efficacy.


Study summary:

There is considerable public and professional interest in complementary and alternative approaches, including meditation, for managing posttraumatic stress disorder (PTSD), but there is little empirical support to guide their use. Multiple meditative techniques can be applied to the amelioration of this disorder, and the literature suggests that they operate by different mechanisms. Compassion meditation is a meditative practice focused on the wish that others and the self may be free of suffering. Because this particular form of meditation has been shown to elicit positive emotion and feelings of connection with other people, it is uniquely well suited to addressing PTSD, which is characterized by strong negative affect, deficits in positive emotion and social connectedness. Compassion meditation has not been evaluated for use with PTSD patients; therefore, the goal of this project is to refine an existing compassion meditation protocol for individuals with PTSD, to examine the safety and feasibility of this approach and to collect data to make initial estimates of efficacy. The proposed project will be completed in two phases. In phase one, the compassion meditation protocol will be executed with individuals with PTSD and iteratively refined based on therapist and participant feedback. In addition, a relaxation protocol that was used in a previous PTSD trial will be modified to match the length and format of the meditative practice. In phase two, the investigators will complete a pilot study to examine the feasibility of conducting a randomized trial comparing these interventions and to provide information that will allow us to better design future projects. Ultimately, the research informed by this project may provide an additional option for treatment of PTSD, which would be an important contribution because existing treatment approaches are not universally acceptable or effective.


Criteria:

Inclusion Criteria: - Veteran of at least 18 years of age - PTSD as defined by the Diagnostic and Statistical Manual Version 5 (DSM-5) - Capacity to consent - Willing to commit to 8 consecutive weekly sessions lasting 2 hours in duration and to complete assessment materials. Exclusion Criteria: - Serious suicidality or homicidality that has required urgent or emergent evaluation or treatment within the past three months - A known, untreated substance use disorder (inclusion is possible if there is evidence that the individual has been afforded and is complying with treatment for the substance problem) - Serious Axis I mental disorders, such as psychotic disorders or bipolar type I, or serious dissociative symptoms - Cognitive impairment that would interfere with consent or treatment - Circumstances that lead to recurrent traumatization (e.g., engaged in a violent relationship) - Concurrent enrollment in any other treatment specifically targeting PTSD symptoms or social functioning (e.g., couples therapy)


Study is Available At:


Original ID:

H130565


NCT ID:

NCT02372396


Secondary ID:

1R34AT007936-01A1


Study Acronym:


Brief Title:

Compassion Meditation for PTSD


Official Title:

A Proof of Concept and Feasibility Trial of Compassion Meditation for PTSD


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Veterans Medical Research Foundation


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

37


Enrollment Type:

Actual


Overall Contact Information

Official Name:Ariel J Lang, PhD
Principal Investigator
San Diego Veterans Healthcare System

Study Dates

Start Date:February 2015
Completion Date:June 2018
Completion Type:Actual
Primary Completion Date:December 2017
Primary Completion Type:Actual
Verification Date:August 2018
Last Changed Date:August 5, 2018
First Received Date:February 3, 2015
First Results Date:June 5, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Clinician Administered PTSD Scale -5 (CAPS-5) PTSD Severity
Time Frame:Baseline and 10 weeks
Safety Issues:False
Description:Clinical interview that quantifies PTSD symptomatology according to DSM-5, generating a continuous measure of severity (range 0-80) where higher scores indicate more symptomatology

Study Interventions

Intervention Type:Behavioral
Name:Compassion Meditation (CM)
Description:Compassion meditation is a meditative practice focused on the wish that others and the self may be free of suffering. Because this particular form of meditation has been shown to elicit positive emotion and feelings of connection with other people, it is uniquely well suited to addressing PTSD, which is characterized by strong negative affect, deficits in positive emotion and social connectedness.
Arm Name:Compassion Meditation
Other Name:CM
Intervention Type:Behavioral
Name:Relaxation
Description:Relaxation Training is selected as the control condition because it is a good match for nonspecific aspects of the meditative practice (e.g., attention, support, contact with a mental health provider) and it is structurally similar to meditation (e.g., restful, in session and at home exercises).
Arm Name:Relaxation

Study Arms

Study Arm Type:Active Comparator
Arm Name:Relaxation
Description:Relaxation delivered in 10 2-hour group treatment sessions.
Study Arm Type:Experimental
Arm Name:Compassion Meditation
Description:Compassion Meditation delivered in 10 2-hour group treatment sessions.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Veterans Medical Research Foundation
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Center for Complementary and Integrative Health (NCCIH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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