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:
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

November 28, 2005
June 2, 2009
March 2006
July 2008   (final data collection date for primary outcome measure)
  • Feasibility to implement MBCT in a Flemish region
  • Relapse/recurrence of depression after approximately 12 months
Recidives of depression after 12 months
Complete list of historical versions of study NCT00259506 on ClinicalTrials.gov Archive Site
  • Health status
  • Quality of life
  • Coping
  • Fear
  • Rumination
  • Health status
  • Quality of life
  • Coping
  • Fear
Not Provided
Not Provided
 
Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial
Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Recurrent Depression
Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
405
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00259506
2005/195
No
Not Provided
University Hospital, Ghent
Ministry of the Flemish Community
Principal Investigator: Kees van Heeringen, MD, PhD University Hospital, Ghent
University Hospital, Ghent
June 2009

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