Trials / Unknown
UnknownNCT01473615
Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Massachusetts General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2011-11-01
- Primary completion
- 2013-06-01
- Completion
- 2014-06-01
- First posted
- 2011-11-17
- Last updated
- 2013-05-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01473615. Inclusion in this directory is not an endorsement.