Major Depressive Disorder Clinical Trial
Official title:
Mindfulness Based Cognitive Therapy for Chronic Pain and Comorbid Unipolar Depression
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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