Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial

NCT ID: NCT00259506

Last Updated: 2009-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 405 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2008-07-31

Brief Summary

Research project regarding the possibility to implement and the efficacy of a non-drug, psychotherapeutic intervention (MBCT), in preventing relapse/recurrence of depression.

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.

Conditions

Recurrent Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Mindfulness-Based Cognitive Therapy (MBCT)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of the Flemish Community

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Principal Investigators

Kees van Heeringen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

University Hospital Ghent

Ghent, , Belgium

Countries

Belgium

Related Links

http://www.uzgent.be

Website University Hospital Ghent

Other Identifiers

2005/195

Identifier Type: -

Identifier Source: org_study_id