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Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Heidi Ashih, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01473615
First received: November 9, 2011
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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 Intervention
Major Depressive Disorder
Dysthymic Disorder
Depressive Disorder NOS
Chronic Pain
Behavioral: Mindfulness Based Cognitive Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response according to the Beck Anxiety Inventory, 21 items (BAI). [ Time Frame: Baseline, week 8, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Response according to Short Form Health Survey, 36 items (SF-36). [ Time Frame: Baseline, week 8, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Response according to Brief Pain Inventory (BPI-sf). [ Time Frame: Baseline, week 4, week 8, 6 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473615

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

Additional Information:
Publications:
Responsible Party: Heidi Ashih, Principal Investigator, Clinical Instructor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01473615     History of Changes
Other Study ID Numbers: 2011P001699
Study First Received: November 9, 2011
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014