Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression

November 12, 2020 updated by: Anne Speckens, Radboud University Medical Center

The Clinical and Cost-effectiveness of Mindfulness Based Cognitive Therapy, Maintenance Antidepressant Medication and Its Combination in the Prevention of Relapse in Patients With Recurrent Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

317

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Katwijk, Netherlands
        • GGZ Duin- en Bollenstreek
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6800
        • Pro Persona
      • Ede, Gelderland, Netherlands
        • Pro Persona
      • Nijmegen, Gelderland, Netherlands, 6525 GC
        • Radboud University Nijmegen Medical Center
      • Tiel, Gelderland, Netherlands
        • Pro Persona
    • Noord-Holland
      • Alkmaar, Noord-Holland, Netherlands
        • GGZ Noord-Holland-Noord
      • Amsterdam, Noord-Holland, Netherlands, 1000
        • Free University Medical Center and GGZ In Geest
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1100 DD
        • AMC Amsterdam
    • Utrecht
      • Amersfoort, Utrecht, Netherlands, 3800
        • GGz Centraal
    • Zuid Holland
      • Leiden, Zuid Holland, Netherlands, 2300 AT
        • GGZ Rivierduinen - Leiden
      • Leiden, Zuid Holland, Netherlands, 2300 RC
        • Leiden University Medical Center
    • Zuid-Holland
      • Den Haag, Zuid-Holland, Netherlands, 2500
        • PsyQ
      • Den Haag, Zuid-Holland, Netherlands
        • Parnassia ACO Zuid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness Based Cognitive Therapy
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).
Behavioral: Mindfulness Based Cognitive Therapy
Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.
Experimental: Combination
Mindfulness Based Cognitive Therapy combined with the use of antidepressant medication during the study (15 months).
Behavioral: Mindfulness Based Cognitive Therapy
Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.
Drug: Optimal Medical Care
Therapeutic dose of antidepressant medication
Active Comparator: Optimal Medical Care
Treatment with optimal medical care: therapeutic dose of antidepressant medication during at least 15 months, administered in accordance with current guidelines.
Drug: Optimal Medical Care
Therapeutic dose of antidepressant medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse/recurrence of Major Depressive Episode
Time Frame: 3, 6, 9, 12, 15 months
Relapse or recurrence of depression will be assessed trimonthly using the Structured Clinical Interview for DSM-V (SCID) depression module.
3, 6, 9, 12, 15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Costs made by consumption of medical care and production loss
Time Frame: 3, 6, 9, 12, 15 months
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.
3, 6, 9, 12, 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Anne EM Speckens, Prof. dr., Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 25, 2009

First Submitted That Met QC Criteria

June 25, 2009

First Posted (Estimate)

June 26, 2009

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFN-2009-2013
  • 80-82310-98-09018
  • 2008/242

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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