Mindfulness Based Cognitive Therapy for Recurrent Depression

January 29, 2024 updated by: Anne Speckens, Radboud University Medical Center

Mindfulness Based Cognitive Therapy for Patients With Recurrent Depression: a Clinical Trial

The purpose of this study is to investigate the effectiveness and possible mediating factors of Mindfulness Based Cognitive Therapy (MBCT) for recurrent depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Mindfulness Based Cognitive Therapy (MBCT) is a 8 session group intervention and is well described by several authors.

Previous studies showed Mindfulness Based Cognitive Therapy (MBCT) to be effective to prevent relapse in patients with recurrent depression and 3 or more previous depressive episodes.

Study aims are:

  1. to replicate previous findings in The Netherlands, by a research team which did not develop the intervention
  2. to investigate if MBCT is applicable for patients with recurrent depression and current depressive symptoms
  3. to examine possible mediators of treatment effect and predictors of relapse in the year following the treatment

In this study, patients are randomly assigned to a MBCT intervention group or a waiting list control group. Patients allocated to the waiting list control condition will receive the MBCT course three months later. All patients who participated in a MBCT training will be assessed during the year following the completion of the MBCT course. We aim to include about 220 patients.

Study Type

Interventional

Enrollment (Actual)

220

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
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GC
        • Radboud University Nijmegen Medical Center

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

Description

Inclusion Criteria:

  • 3 or more previous depressive episodes
  • if treated with medication: constant dose of at least 6 weeks

Exclusion Criteria:

  • Bipolar Disorder
  • Psychotic disorder
  • Neurological or somatic illness affecting depression or outcome measures
  • Current alcohol or drugs dependency
  • Acute need of psychiatric treatment

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
Behavioral: Mindfulness Based Cognitive Therapy
8-weeks group based intervention of mindfulness and cognitive behavioural techniques
Other Names:
  • MBCT
No Intervention: Waiting list control group
3-month waiting list group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive Symptoms
Time Frame: Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis.

Hamilton Depression Rating Scale. The HAMD is a standardized 17-item interview to measure number and severity of depressive symptoms on a 0-52 score.

Higher values indicate a worse outcome. Specifical, HAMD scores can be interpreted as "no depression" (0-7), "mild depression" (8-16), "moderate depression" (17-23) and "severe depression" (24-52).
Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-report Depressive Symptoms
Time Frame: Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis

Beck Depression Inventory (BDI), a 21-item self-report questionnaire to measure depressive symptoms, score range 0-63.

Higher scores indicate a worse outcome. Specifically, BDI scores can be interpreted as "minimal depression" (0-13), "mild depression" (14-19), "moderate depression" (20-28) and "severe depression" (29-63).
Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis

Collaborators and Investigators

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

Sponsor

Radboud University Medical Center

Collaborators

Fonds Psychische Gezondheid

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

January 1, 2005

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

December 22, 2009

First Submitted That Met QC Criteria

December 23, 2009

First Posted (Estimated)

December 24, 2009

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFN-2005-2010
  • 2005 6028 (Other Identifier: Fonds Psychische Gezondheid, Netherlands (previously: NFGV))

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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