Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial
1 other identifier
interventional
405
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2005
CompletedFirst Posted
Study publicly available on registry
November 29, 2005
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedJune 3, 2009
June 1, 2009
2.3 years
November 28, 2005
June 2, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility to implement MBCT in a Flemish region
Relapse/recurrence of depression after approximately 12 months
Secondary Outcomes (5)
Health status
Quality of life
Coping
Fear
Rumination
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Ghentlead
- Ministry of the Flemish Communitycollaborator
Study Sites (1)
University Hospital Ghent
Ghent, 9000, Belgium
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kees van Heeringen, MD, PhD
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 28, 2005
First Posted
November 29, 2005
Study Start
March 1, 2006
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
June 3, 2009
Record last verified: 2009-06