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A randomized controlled trial of Mindfulness-Based Cognitive Therapy (MBCT) versus treatment-as-usual (TAU) for chronic, treatment-resistant depression: study protocol

Mira B. Cladder-Micus, J. Vrijsen, E. Becker, Rogier Donders, Jan Spijker, Anne E. M. Speckens

BMC Psychiatry November 9, 2015 DOI: 10.1186/s12888-015-0647-y (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Peer reviewed
Population Patients with chronic, treatment-resistant depression who have received antidepressant medication and cognitive behavioral therapy or interpersonal therapy
Interventions Mindfulness-Based Cognitive Therapy treatment-as-usual
Topics Depression Meditation
Key findings The trial will examine the effectiveness of MBCT in reducing depressive symptoms in chronic, treatment-resistant depression.

Abstract

BackgroundMajor depression is a common psychiatric disorder, frequently taking a chronic course. Despite provision of evidence-based treatments, including antidepressant medication and psychological treatments like cognitive behavioral therapy or interpersonal therapy, a substantial amount of patients do not recover. Mindfulness-Based Cognitive Therapy (MBCT) has been found to be effective in reducing relapse in recurrent depression, as well as lowering symptom levels in acute depression. The effectiveness of MBCT for chronic, treatment-resistant depression has only be studied in a few pilot trials. A large randomized controlled trial is necessary to examine the effectiveness of MBCT in reducing depressive symptoms in chronic, treatment-resistant depression.Methods/DesignA randomized-controlled trial is conducted to compare MBCT with treatment-as-usual (TAU). Patients with chronic, treatment-resistant depression who have received antidepressant medication and cognitive behavioral therapy or interpersonal therapy are included. Assessments take place at baseline and post intervention/TAU-period. The primary outcome are depressive symptoms. Secondary outcomes are: remission rates, quality of life, rumination, mindfulness skills and self-compassion. Patients in the TAU condition are offered to participate in the MBCT after the post TAU-period assessment. From all completers of the MBCT (MBCT condition and patients participating after the TAU-period), follow-up assessments are taken at three and six months after the completion of the MBCT.DiscussionThis trial will result in valuable information about the effectiveness of MBCT in chronic, treatment-resistant depressed patients who previously received antidepressant medication and psychological treatment.Trial registrationtrialregister.nl NTR4843, registered 14th October 2014.

Comparable studies

Other randomized controlled trials on depression, most cited first.

Study Year Design Participants
A Randomized Trial of an N-methyl-D-aspartate Antagonist in Treatment-Resistant Major Depression Subjects with DSM-IV major depression (treatment resistant) 2006 Randomized, placebo-controlled, double-blind crossover study n = 18
Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients 2000 Randomized controlled trial n = 145
Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Cancer patients with life-threatening diagnoses and symptoms of depression and/or anxiety 2016 Randomized controlled trial n = 51
Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Patients with cancer-related anxiety and depression 2016 Double-blind, placebo-controlled, crossover trial n = 29
Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients 2004 Randomized controlled trial n = 73

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