Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression

Radboud University Medical Center317 enrolled

Overview

The purpose of this study is to investigate the (cost)effectiveness of mindfulness based cognitive therapy (MBCT) compared to that of antidepressant medication, and its combination with regard to the prevention of relapse or recurrence in patients with recurrent depression.

In the Netherlands, treatment as usual for patients with (recurrent) Major Depressive Disorder consists of maintenance antidepressant medication. Mindfulness-based cognitive therapy (MBCT) is a recently developed psychological intervention that appears to be promising in terms of preventing relapse or recurrence in patients with recurrent depression. It consists of 8 weekly group sessions in which meditation exercises are combined with cognitive therapeutic elements such as identifying negative thoughts and monitoring and scheduling activities. In this study, the (cost)effectiveness of a) MBCT on its own, b) antidepressant medication on its own and c) the combination of MBCT and antidepressant medication will be investigated in 350 patients with recurrent depression who are currently in remission.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

317

Conditions

Depressive Disorder, Major

Interventions

Mindfulness Based Cognitive TherapyBEHAVIORAL

Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.

Optimal Medical CareDRUG

Therapeutic dose of antidepressant medication

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Recurrent Major Depressive Episode (at least 3 previous episodes) * Treatment with therapeutic dose of antidepressant medication during past six months * Currently in full or partial remission Exclusion Criteria: * Bipolar disorder (current and previous (hypo)manic episodes) * Psychotic disorder (current and previous) * Neurological or somatic illness affecting depression or outcome measures * Current alcohol or drugs dependency * Use of high dosage benzodiazepines (\> 2 mg Lorazepam equivalents daily) * Recent Electro Convulsive Therapy (\< 3 months ago)

Locations (13)

Pro Persona

Arnhem, Gelderland, Netherlands

Pro Persona

Ede, Gelderland, Netherlands

Radboud University Nijmegen Medical Center

Nijmegen, Gelderland, Netherlands

Outcomes

Primary Outcomes

Relapse/recurrence of Major Depressive Episode

Relapse or recurrence of depression will be assessed trimonthly using the Structured Clinical Interview for DSM-V (SCID) depression module.

Time frame: 3, 6, 9, 12, 15 months

Secondary Outcomes

Costs made by consumption of medical care and production loss

Using prospective calendars and retrospective questionnaires about contacts with health care in the past 3 months (assessed trimonthly) we will estimate the costs of depression health care and the quality of life (selfreport). We will compare the cost-effectiveness ratios between the groups.

Time frame: 3, 6, 9, 12, 15 months

Data from ClinicalTrials.gov

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