Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression

May 6, 2013 updated by: Heidi Ashih, Massachusetts General Hospital

The primary aim of this study is to test the feasibility and efficacy of Mindfulness Based Cognitive Therapy (MBCT) training for the treatment of depressive symptoms in patients with chronic pain. The study also aims to elucidate the mechanisms underlying MBCT on a psychological and neurobiological level. For this purpose the study subjects will fill out several psychological questionnaires related to mindfulness, depression and chronic pain. Moreover this study involves optional fMRI scans of the brain and blood measures before and after the intervention.

Main hypotheses:

  1. The MBCT training will be a feasible intervention in patients with chronic pain and co-morbid depression as defined by no occurrence of serious adverse events related to the intervention and a retention rate of more than 70% in the subjects assigned to the MBCT arm.
  2. Patients who have completed the MBCT training will demonstrate a significant decrease in depressive symptoms as measured on the Quick Inventory of Depressive Symptomatology - Clinician rated (QIDS-C16), and the Hamilton Rating Scale for Depression (HRSD17) (QIDS-C/HRDS) severity scale for depressive symptoms (the primary outcome measure), compared to the control group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • MGH Depression Clinical and Research Program

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:

  • The presence of Chronic Pain, which has persisted for at least 3 months.
  • Meets criteria of Major Depressive Disorder, Dysthymic Disorder or Depressive disorder NOS as defined by DSM-IV criteria.
  • Have a minimum score of depressive symptoms of > 10 as rated on the QIDS-C, administered during the screen.
  • Able to provide written informed consent.
  • Adults 18 years or older
  • English-language literacy.

Exclusion Criteria:

  • Serious suicide or homicide risk, as assessed by evaluating clinician.
  • Severe and unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological or hematological disease for which hospitalization is likely to be required within the next half year.
  • The following DSM-IV disorders: any bipolar disorder (current or past), current psychotic symptoms, or a primary psychotic disorder (current or past). Entry of patients with anxiety disorder will be permitted if the depressive disorder is judged to be the predominant disorder, in order to increase accrual of a clinically relevant sample.
  • Active diagnosis of substance abuse or dependence disorders within the last 3 months.

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment As Usual + Mindfulness Based Cognitive Therapy
Subjects randomized into the intervention group will receive, a manualized 8-week MBCT group skills program with sessions that each last 2 hours, in addition to their treatment as usual (TAU).
Behavioral: Mindfulness Based Cognitive Therapy
A manualized 8-week MBCT group skills program with weekly sessions that each last 2 hours. The MBCT sessions combine elements of cognitive therapy with a mindful approach to thoughts and feelings, including a significant meditation component. The program is specifically tailored to a population that suffers from active depressive symptoms and chronic pain. The program also includes daily homework exercises.
NO_INTERVENTION: Treatment As Usual
Patients randomized into the TAU group will continue to receive their care as usual and be put on a waitlist. They will be offered the MBCT treatment after the completion of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline on the combined Quick Inventory of Depressive Symptomatology-clinician rated and the Hamilton Rating Scale for Depression (QIDS-C16/HRDS17), at week 8.
Time Frame: week 8
week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Response according to the Beck Anxiety Inventory, 21 items (BAI).
Time Frame: Baseline, week 8, 6 months, 12 months
Baseline, week 8, 6 months, 12 months
Response according to Short Form Health Survey, 36 items (SF-36).
Time Frame: Baseline, week 8, 6 months, 12 months
Baseline, week 8, 6 months, 12 months
Response according to Brief Pain Inventory (BPI-sf).
Time Frame: Baseline, week 4, week 8, 6 months, 12 months
Baseline, week 4, week 8, 6 months, 12 months

Collaborators and Investigators

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

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Heidi Ashih, MD, PhD, Massachusetts General Hospital
  • Principal Investigator: Marasha De Jong, MD, Masachusetts General Hospital

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

November 1, 2011

Primary Completion (ANTICIPATED)

June 1, 2013

Study Completion (ANTICIPATED)

June 1, 2014

Study Registration Dates

First Submitted

November 9, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (ESTIMATE)

November 17, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 7, 2013

Last Update Submitted That Met QC Criteria

May 6, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011P001699

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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