Mindfulness-Based Cognitive Therapy (MBCT) in Recurrent Depression - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Recurrent Depression

Intervention / Treatment

Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

Detailed Description

This trial is based on the following publications:

Teasdale JD, Segal ZV, Williams JMG, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse / recurrence in major depression by Mindfulness-Based Cognitive Therapy. Journal of Consulting and Clinical Psychology 2000; 68(4): 615-623.

Ma SH, Teasdale JD. Mindfulness-Based Cognitive Therapy for depression: replication and exploration of differential relapse prevention effects. Journal of Consulting and Clinical Psychology 2004; 72(1): 31-40.

Study Type

Interventional

Enrollment (Anticipated)

405

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

Belgium
- - Ghent, Belgium, 9000
    - University Hospital Ghent

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:

Age: 18 years and above
place of residence in accordance with a well-defined region (pilot study)
given informed consent
diagnosis of recurrent depression (DSM-IV-TR)
at least 3 depressive episodes in the anamnesis (depression: either primary or secondary diagnosis)
last depressive episode at least 8 weeks ago (DSM-IV-TR)
absence of a present depressive episode
history of treatment by an antidepressant medication
HRSD-score <14 at baseline assessment (Hamilton Rating Scale for Depression, HRSD-17)
absence of exclusion criteria

Exclusion Criteria:

based on DSM-IV-TR: current diagnosis of any of the following psychiatric disorders: lifetime mood disorder, chronic depression, dysthymia, current substance abuse, obsessive-compulsive disorder, bipolar disorder, acute psychosis, cognitive disorder, organic mental disorder, pervasive developmental disorder, mental retardation, primary diagnosis of axis-II-disorder, at risk for suicide
Extended experience with zen- or vipassana meditation (or mindfulness) in the past or
more than 1 hour practice of zen- or vipassana meditation (or mindfulness) per week during the last 8 weeks
other meditation practices except for MBCT during the training
more than 1 psychiatric consultation per 3-4 weeks during the training and follow-up
intensive psychotherapy during the training and follow-up
schizophrenia or schizoaffective disorder in the anamnesis
physical problems which make it difficult to participate in the programme

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: Crossover Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Feasibility to implement MBCT in a Flemish region
Relapse/recurrence of depression after approximately 12 months

Secondary Outcome Measures

Outcome Measure
Quality of life
Health status
Coping
Fear
Rumination

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

Collaborators

Ministry of the Flemish Community

Investigators

Principal Investigator: Kees van Heeringen, MD, PhD, University Hospital, Ghent

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.

Helpful Links

website University Hospital Ghent

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

March 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)