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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
  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

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)
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014