Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression

Radboud University Medical Center

Status: Completed

Conditions: Depressive Disorder, Major

Treatments: Behavioral: Mindfulness Based Cognitive Therapy; Drug: Optimal Medical Care

Study type: Interventional

Funder types: Other

Identifiers

NCT00928980

MFN-2009-2013

2008/242

80-82310-98-09018

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 317 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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317 participants in 3 patient groups

Mindfulness Based Cognitive Therapy

Experimental group

Description:

Mindfulness Based Cognitive Therapy and withdrawal of antidepressant medication between the 4th and 5th session, patients being off medication until the end of study period (15 months).

Treatment:

Behavioral: Mindfulness Based Cognitive Therapy

Combination

Experimental group

Description:

Mindfulness Based Cognitive Therapy combined with the use of antidepressant medication during the study (15 months).

Treatment:

Behavioral: Mindfulness Based Cognitive Therapy

Drug: Optimal Medical Care

Optimal Medical Care

Active Comparator group

Description:

Treatment with optimal medical care: therapeutic dose of antidepressant medication during at least 15 months, administered in accordance with current guidelines.

Treatment:

Drug: Optimal Medical Care