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

Sponsor
University Hospital, Ghent (Other)
Overall Status
Completed
CT.gov ID
NCT00259506
Collaborator
Ministry of the Flemish Community (Other)
405
Enrollment
1
Location
28
Duration (Months)
14.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
405 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (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
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Jul 1, 2008

Outcome Measures

Primary Outcome Measures

  1. Feasibility to implement MBCT in a Flemish region []

  2. Relapse/recurrence of depression after approximately 12 months []

Secondary Outcome Measures

  1. Health status []

  2. Quality of life []

  3. Coping []

  4. Fear []

  5. Rumination []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00259506
Other Study ID Numbers:
  • 2005/195
First Posted:
Nov 29, 2005
Last Update Posted:
Jun 3, 2009
Last Verified:
Jun 1, 2009
Keywords provided by , ,
Recurrent depression
Mental Health
Additional relevant MeSH terms:
Depression

Study Results

No Results Posted as of Jun 3, 2009