Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial
This study has been completed.
Sponsor:
University Hospital, Ghent
Collaborator:
Ministry of the Flemish Community
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00259506
First received: November 28, 2005
Last updated: June 2, 2009
Last verified: June 2009
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Purpose
Research project regarding the possibility to implement and the efficacy of a non-drug, psychotherapeutic intervention (MBCT), in preventing relapse/recurrence of depression.
| Condition | Intervention |
|---|---|
|
Recurrent Depression |
Behavioral: Mindfulness-Based Cognitive Therapy (MBCT) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial |
Resource links provided by NLM:
Further study details as provided by University Hospital, Ghent:
Primary Outcome Measures:
- Feasibility to implement MBCT in a Flemish region
- Relapse/recurrence of depression after approximately 12 months
Secondary Outcome Measures:
- Health status
- Quality of life
- Coping
- Fear
- Rumination
| Estimated Enrollment: | 405 |
| Study Start Date: | March 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259506
Locations
| Belgium | |
| University Hospital Ghent | |
| Ghent, Belgium, 9000 | |
Sponsors and Collaborators
University Hospital, Ghent
Ministry of the Flemish Community
Investigators
| Principal Investigator: | Kees van Heeringen, MD, PhD | University Hospital, Ghent |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00259506 History of Changes |
| Other Study ID Numbers: | 2005/195 |
| Study First Received: | November 28, 2005 |
| Last Updated: | June 2, 2009 |
| Health Authority: | Belgium: Institutional Review Board |
Keywords provided by University Hospital, Ghent:
|
Recurrent depression Mental Health |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013