Clinical trial NCT01473615: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Dysthymic Disorder
Depressive Disorder NOS
Chronic Pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.


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.

Primary outcomes:
measure: 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.
timeFrame: week 8
Secondary outcomes:
measure: Response according to the Beck Anxiety Inventory, 21 items (BAI).
timeFrame: Baseline, week 8, 6 months, 12 months
measure: Response according to Short Form Health Survey, 36 items (SF-36).
timeFrame: Baseline, week 8, 6 months, 12 months
measure: Response according to Brief Pain Inventory (BPI-sf).
timeFrame: Baseline, week 4, week 8, 6 months, 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH Depression Clinical and Research Program
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Heidi Ashih, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Masachusetts General Hospital
name: Marasha De Jong, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.