NCT02372396

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
3 months until next milestone

Results Posted

Study results publicly available

September 5, 2018

Completed
Last Updated

September 5, 2018

Status Verified

August 1, 2018

Enrollment Period

2.8 years

First QC Date

February 3, 2015

Results QC Date

June 5, 2018

Last Update Submit

August 5, 2018

Conditions

Posttraumatic Stress Disorder

Keywords

PTSDPsychotherapyOperation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF)Veterans

Outcome Measures

Primary Outcomes (1)

  • Clinician Administered PTSD Scale -5 (CAPS-5) PTSD Severity

    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

    Baseline and 10 weeks

Study Arms (2)

Compassion Meditation

EXPERIMENTAL

Compassion Meditation delivered in 10 2-hour group treatment sessions.

Behavioral: Compassion Meditation (CM)

Relaxation

ACTIVE COMPARATOR

Relaxation delivered in 10 2-hour group treatment sessions.

Behavioral: Relaxation

Interventions

Compassion Meditation (CM)BEHAVIORAL

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.

Also known as: CM
Compassion Meditation
RelaxationBEHAVIORAL

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).

Relaxation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Serious suicidality or homicidality that has required urgent or emergent evaluation or treatment within the past three months
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Results Point of Contact

Title
Dr. Ariel Lang
Organization
Veterans Medical Research Foundation
ajlang@ucsd.edu
858-552-8585

Study Officials

  • Ariel J Lang, PhD

    San Diego Veterans Healthcare System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Psychologist

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 26, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

September 5, 2018

Results First Posted

September 5, 2018

Record last verified: 2018-08

Locations

US(1)