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Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression

Primary Purpose

Major Depressive Disorder, Dysthymic Disorder, Depressive Disorder NOS

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness Based Cognitive Therapy

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

MGH Depression Clinical and Research Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment As Usual + Mindfulness Based Cognitive Therapy

Treatment As Usual

Arm Description

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).

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.

Outcomes

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.

Secondary Outcome Measures

Response according to the Beck Anxiety Inventory, 21 items (BAI).

Response according to Short Form Health Survey, 36 items (SF-36).

Response according to Brief Pain Inventory (BPI-sf).

Full Information

NCT ID

NCT01473615

First Posted

November 9, 2011

Last Updated

May 6, 2013

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01473615

Brief Title

Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression

Official Title

Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Unknown status

Study Start Date

November 2011 (undefined)

Primary Completion Date

June 2013 (Anticipated)

Study Completion Date

June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder, Dysthymic Disorder, Depressive Disorder NOS, Chronic Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment As Usual + Mindfulness Based Cognitive Therapy

Arm Type

Experimental

Arm Description

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).

Arm Title

Treatment As Usual

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness Based Cognitive Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Response according to the Beck Anxiety Inventory, 21 items (BAI).

Time Frame

Baseline, week 8, 6 months, 12 months

Title

Response according to Short Form Health Survey, 36 items (SF-36).

Time Frame

Baseline, week 8, 6 months, 12 months

Title

Response according to Brief Pain Inventory (BPI-sf).

Time Frame

Baseline, week 4, week 8, 6 months, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heidi Ashih, MD, PhD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marasha De Jong, MD

Organizational Affiliation

Masachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

MGH Depression Clinical and Research Program

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

10965637

Citation

Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23. doi: 10.1037//0022-006x.68.4.615.

Results Reference

background

PubMed Identifier

21251756

Citation

Veehof MM, Oskam MJ, Schreurs KMG, Bohlmeijer ET. Acceptance-based interventions for the treatment of chronic pain: a systematic review and meta-analysis. Pain. 2011 Mar;152(3):533-542. doi: 10.1016/j.pain.2010.11.002. Epub 2011 Jan 19.

Results Reference

background

PubMed Identifier

28252881

Citation

de Jong M, Peeters F, Gard T, Ashih H, Doorley J, Walker R, Rhoades L, Kulich RJ, Kueppenbender KD, Alpert JE, Hoge EA, Britton WB, Lazar SW, Fava M, Mischoulon D. A Randomized Controlled Pilot Study on Mindfulness-Based Cognitive Therapy for Unipolar Depression in Patients With Chronic Pain. J Clin Psychiatry. 2018 Jan/Feb;79(1):15m10160. doi: 10.4088/JCP.15m10160.

Results Reference

derived

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Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression

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