Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01473615

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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:

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2011

Anticipated Primary Completion Date :

Jun 1, 2013

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

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. [week 8]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.