Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression

Major Depressive Disorder Clinical Trial

Official title:

Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01473615
• Other study ID #: 2011P001699
• Status: Active, not recruiting
• Phase: N/A
• First received: November 9, 2011
• Last updated: May 6, 2013
• Start date: November 2011
• Est. completion date: June 2014

Study information

• Verified date: May 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Depression
• Depressive Disorder
• Depressive Disorder NOS
• Depressive Disorder, Major
• Disease
• Dysthymic Disorder
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	MGH Depression Clinical and Research Program	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Veehof MM, Oskam MJ, Schreurs KM, Bohlmeijer ET. Acceptance-based interventions for the treatment of chronic pain: a systematic review and meta-analysis. Pain. 2011 Mar;152(3):533-42. doi: 10.1016/j.pain.2010.11.002. Epub 2011 Jan 19. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Response according to the Beck Anxiety Inventory, 21 items (BAI).		Baseline, week 8, 6 months, 12 months	No
Secondary	Response according to Short Form Health Survey, 36 items (SF-36).		Baseline, week 8, 6 months, 12 months	No
Secondary	Response according to Brief Pain Inventory (BPI-sf).		Baseline, week 4, week 8, 6 months, 12 months	No

External Links

•   Depression Clinical and Research Program