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Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression

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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
Information provided by (Responsible Party):
Heidi Ashih, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment
Major Depressive Disorder Dysthymic Disorder Depressive Disorder NOS Chronic Pain Behavioral: Mindfulness Based Cognitive Therapy

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression
Study Start Date : November 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473615

United States, Massachusetts
MGH Depression Clinical and Research Program
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Heidi Ashih, MD, PhD Massachusetts General Hospital
Principal Investigator: Marasha De Jong, MD Masachusetts General Hospital

Additional Information:
Responsible Party: Heidi Ashih, Principal Investigator, Clinical Instructor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01473615     History of Changes
Other Study ID Numbers: 2011P001699
First Posted: November 17, 2011    Key Record Dates
Last Update Posted: May 7, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Chronic Pain
Dysthymic Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms