Loving-Kindness Meditation for PTSD

March 9, 2020 updated by: VA Office of Research and Development

A Trial of Loving-Kindness Meditation and Cognitive Processing Therapy for PTSD

This randomized controlled trial will assess whether a novel complementary and alternative medicines (CAM) intervention, Loving-kindness Meditation (LKM), is not meaningfully inferior to another group-based PTSD treatment , Cognitive Processing Therapy (Cognitive Only version; CPT-C) for reductions in PTSD and depressive symptoms. 170 male and female Veterans with current PTSD will be randomized to LKM or CPT-C. The investigators hypothesize that Veterans randomized to LKM will report mean reductions in PTSD and depressive symptom severity that are not meaningfully worse than CPT-C. The investigators further hypothesize that reductions in posttraumatic maladaptive beliefs will more strongly mediate PTSD and depressive symptom improvement for those assigned to CPT-C than those assigned to LKM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim 1: Evaluate if LKM is non-inferior to CPT-C in producing reductions in PTSD symptoms among Veterans with current PTSD. Aim 2: Evaluate the non-inferiority of LKM and CPT-C in producing reductions in depressive symptoms among Veterans with current PTSD. Exploratory Aim: Evaluate potential mediators of response to LKM and to CPT to provide preliminary information regarding whether they are consistent with the mechanisms of change conceptualized by each intervention to be associated with improvement in PTSD and depression.

Methods: A randomized controlled non-inferiority trial comparing LKM to CPT-C. In the proposed project 170 Veterans with PTSD will be randomized to LKM or CPT-C. Comprehensive assessments will be performed at baseline as well as at the end of the 12-week interventions and 3 and 6 months later. PTSD symptoms, depression, posttraumatic maladaptive cognitions and self-compassion will be assessed weekly during the treatment phase to assess temporality of change and to assess mediators of outcomes.

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current Diagnostic and Statistical Manual of Mental Disorder (DSM)-5 diagnosis of PTSD,
  • 18 or over,
  • English fluency,
  • Willingness to not participate in Mindfulness-Based Stress Reduction or other meditation programs, as well as Prolonged Exposure (PE) or CPT during the study period.

Exclusion Criteria:

  • Any of the following substance use criteria: 1) Use in the past 90 days of illicit substance (do not include cannabis)/ street drug (non-prescribed); 2) Use in the past 90 days of prescription drug of abuse, use is not as prescribed AND poses safety concern
  • Alcohol involvement that poses a safety concern or is associated with inability to follow through on assessments and class attendance as evinced by current drinking AND dt's or seizure in past year
  • Suicidal or homicidal ideation with intent or plan
  • Attempted harm to Self or others in the past month
  • A lifetime psychotic disorder or current psychotic symptoms
  • Uncontrolled bipolar disorder (ie current mania, current hypomania is not an exclusion)
  • Chart diagnoses of borderline personality disorder or antisocial personality disorder
  • In-patient admission for psychiatric reasons within the past month
  • Prior participation in LKM or CPT
  • Dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Loving-Kindness Meditation
A 12-week duration, 90-minute per session Loving-Kindness Meditation (LKM) course, taught in groups of 10 participants.
Behavioral: Loving-Kindness Meditation
12-week loving-kindness meditation course
Active Comparator: Cognitive Processing Therapy - Cognitive Only
A 12-week duration, 90-minute per session Cognitive Processing Therapy (CPT) course, taught in groups of 10 participants.
Behavioral: Cognitive Processing Therapy
12-week CPT course

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician Administered PTSD Scale (CAPS-5) Score
Time Frame: 6 months post-intervention
PTSD diagnostic severity was measured using the 30-item CAPS-5 structured interview (range 0-80; higher scores indicate worse PTSD). Linear mixed effects models (LMM) were used to analyze continuous outcomes, with time and time by treatment interaction included as fixed effects to determine if differences exist between conditions by time. Non-inferiority of LKM to CPT-C was claimed if the lower limit of the 95% confidence interval for difference in change rate from baseline to 6-month follow-up in mean CAPS or depression score was greater than (i.e., did not extend beyond) negative delta (defined as 5 points on the CAPS-5 measure). A 2-sided 95% confidence interval of the difference in change rate from baseline to 6-month follow-up between groups (CPT-C minus LKM) was calculated, with a positive value indicating a greater reduction in scores from baseline for LKM compared to CPT-C.
6 months post-intervention
NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score
Time Frame: 6 months post-intervention
Depression was assessed using the National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) depression measure. This scale utilizes item-response theory and is scored using a T-score metric with a mean of 50 and SD=10 in the US general population. Higher scores indicate more severe depression.
6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

November 29, 2018

Study Completion (Actual)

November 29, 2018

Study Registration Dates

First Submitted

October 10, 2013

First Submitted That Met QC Criteria

October 10, 2013

First Posted (Estimate)

October 14, 2013

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHBA-006-13S
  • 5I01CX000857-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A de-identified, anonymized dataset will be created and shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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