Effects of Mindfulness on PTSD

June 29, 2018 updated by: Autumn Gallegos, University of Rochester

Effects of Mindfulness on PTSD: A Community-Based Clinical Trial Among Trauma Survivors

The purpose of this randomized control trial is to examine the effects of a Mindfulness-Based Stress Reduction (MBSR) program on women with posttraumatic stress disorder related to intimate partner violence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Posttraumatic stress disorder is a prevalent, chronic, and debilitating disorder characterized by a reduced capacity to adapt to stressors, marked by poor regulation in the following domains: emotion, attentional function, and physiological stress. Mindfulness-based stress reduction (MBSR) holds promise for treating symptoms of trauma and PTSD as evidence suggests it targets these domains. The central hypothesis is that MBSR, which teaches non-judgmental awareness, can improve emotion regulation and attentional function, and diminish physiological stress dysregulation, which in turn will improve PTSD symptoms. We will examine changes in stress capacity and PTSD symptom severity among women survivors of intimate partner violence with PTSD after participation in an MBSR program.

Study Type

Interventional

Enrollment (Actual)

35

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
    • New York
      • Rochester, New York, United States, 14614
        • Monroe County Family Court

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

14 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • English-speaking
  • Women
  • 18-64 years of age
  • Victim of IPV
  • Meet diagnostic criteria for PTSD
  • No or stable use of medications (including, for example, beta blockers).

Exclusion Criteria:

  • There is suspicion or evidence of dementia or cognitive impairment (Mini-Mental State Examination score < 24) or inability to provide informed consent
  • They have ever been a perpetrator of IPV
  • History of schizophrenia or bipolar I disorder; current suicidality with either plan, intent, or a suicide attempt in the past 6 months
  • Active substance dependence or in remission < 3 months
  • Cardiovascular conditions (e.g., congestive heart failure, pacemaker, prior myocardial infarction)
  • The age range was chosen to reduce heterogeneity in this pilot study, as aging is associated with changes in emotion regulation, attention, and PNS tone.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-based stress reduction
The MBSR program is a manualized course that includes meditation, relaxing movement, and breathing. A certified MBSR instructor will teach the courses in a group-based format for 120 minute sessions, once per week for eight weeks.
Behavioral: Mindfulness-based stress reduction
Active Comparator: Wellness Group
The Wellness control group uses a health education manual that provides information on various aspects of health, including diet, physical activity, sleep, stress management, and communication. The manual is used during weekly check-in phone calls for an 8-week period.
Behavioral: Wellness Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Symptoms Checklist (PCL-5)
Time Frame: 12 weeks
The PTSD Symptoms Checklist (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 asks respondents to rate how much they have been bothered by particular PTSD symptoms in the past month on a 0-4 scale.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: 12 weeks
The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure that assesses emotion dysregulation in six domains: nonacceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity.
12 weeks
Heart rate variability
Time Frame: 12 weeks
To assess cardiovascular measures, ECG, basal thoracic impedance (Z0), the first derivative of the impedance signal (dZ/dt), and continuous strain gauge signal, will be obtained (BioNex Mainframe, Mindware Technologies, Gahanna, OH). Three disposable ECG electrodes will be placed in a lead II configuration to record the ECG signal. Four additional disposable patient ECG spot electrodes (2 current and 2 recording electrodes) will be used to obtain the Z0 and dZ/dt signals. A strain gauge will be secured around the lower chest to record respiration rate. The BioNex will be connected to a laptop: signals will be conditioned and collected (1000 Hz sampling; 5 Hz for strain gauge) through an integrated A/D board, and written to disk and later scored (with Mindware software).
12 weeks
Useful Field of View Test (UFOV)
Time Frame: 12 weeks
The Useful Field of View Test (UFOV) is a computerized test with 3 assessments: speed of processing; selective attention; divided attention. The test determines the minimum display duration at which participants can process information for increasingly difficult subtests and is the primary outcome for prior studies of speed of processing training.
12 weeks
Five-Facet Mindfulness Questionnaire (FFMQ)
Time Frame: 12 weeks
The Five-Facet Mindfulness Questionnaire assesses five factors that represent mindfulness as it is currently conceptualized: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
12 weeks

Collaborators and Investigators

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

Sponsor

University of Rochester

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)

August 15, 2016

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

March 22, 2018

First Submitted That Met QC Criteria

March 29, 2018

First Posted (Actual)

March 30, 2018

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 29, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 64139

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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