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

Primary Purpose

Recurrent Depression

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Mindfulness-Based Cognitive Therapy (MBCT)
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Depression focused on measuring Recurrent depression, Mental Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Outcomes

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

Full Information

First Posted
November 28, 2005
Last Updated
June 2, 2009
Sponsor
University Hospital, Ghent
Collaborators
Ministry of the Flemish Community
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1. Study Identification

Unique Protocol Identification Number
NCT00259506
Brief Title
Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial
Official Title
Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Ghent
Collaborators
Ministry of the Flemish Community

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Depression
Keywords
Recurrent depression, Mental Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
405 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Cognitive Therapy (MBCT)
Primary Outcome Measure Information:
Title
Feasibility to implement MBCT in a Flemish region
Title
Relapse/recurrence of depression after approximately 12 months
Secondary Outcome Measure Information:
Title
Health status
Title
Quality of life
Title
Coping
Title
Fear
Title
Rumination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kees van Heeringen, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent

Learn more about this trial

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

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