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

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ClinicalTrials.gov Identifier: NCT00259506
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : June 3, 2009
Sponsor:
Collaborator:
Ministry of the Flemish Community
Information provided by:
University Hospital, Ghent

Tracking Information
First Submitted Date  ICMJE November 28, 2005
First Posted Date  ICMJE November 29, 2005
Last Update Posted Date June 3, 2009
Study Start Date  ICMJE March 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2006)
  • Feasibility to implement MBCT in a Flemish region
  • Relapse/recurrence of depression after approximately 12 months
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2005)
Recidives of depression after 12 months
Change History Complete list of historical versions of study NCT00259506 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2006)
  • Health status
  • Quality of life
  • Coping
  • Fear
  • Rumination
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2005)
  • Health status
  • Quality of life
  • Coping
  • Fear
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial
Official Title  ICMJE Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent Depression
Intervention  ICMJE Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 28, 2005)
405
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00259506
Other Study ID Numbers  ICMJE 2005/195
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE Ministry of the Flemish Community
Investigators  ICMJE
Principal Investigator: Kees van Heeringen, MD, PhD University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP