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
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.
- 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.
- 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||Phase|
|Major Depressive Disorder Dysthymic Disorder Depressive Disorder NOS Chronic Pain||Behavioral: Mindfulness Based Cognitive Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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 ]
- 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 ]
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|
|Principal Investigator:||Heidi Ashih, MD, PhD||Massachusetts General Hospital|
|Principal Investigator:||Marasha De Jong, MD||Masachusetts General Hospital|