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Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01473615
Recruitment Status : Unknown
Verified May 2013 by Heidi Ashih, Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 17, 2011
Last Update Posted : May 7, 2013
Sponsor:
Information provided by (Responsible Party):
Heidi Ashih, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE November 9, 2011
First Posted Date  ICMJE November 17, 2011
Last Update Posted Date May 7, 2013
Study Start Date  ICMJE November 2011
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2011)
  • Response according to the Beck Anxiety Inventory, 21 items (BAI). [ Time Frame: 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 ]
  • Response according to Brief Pain Inventory (BPI-sf). [ Time Frame: Baseline, week 4, week 8, 6 months, 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression
Official Title  ICMJE Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression
Brief Summary

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Dysthymic Disorder
  • Depressive Disorder NOS
  • Chronic Pain
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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).
    Intervention: Behavioral: Mindfulness Based Cognitive Therapy
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 14, 2011)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2014
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01473615
Other Study ID Numbers  ICMJE 2011P001699
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heidi Ashih, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Heidi Ashih, MD, PhD Massachusetts General Hospital
Principal Investigator: Marasha De Jong, MD Masachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP