NCT00259506CompletedNot Applicable
Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial
University Hospital, Ghent1 site in 1 country405 target enrollmentStarted: March 1, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Ghent
- Enrollment
- 405
- Locations
- 1
- Primary Endpoint
- Feasibility to implement MBCT in a Flemish region
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Feasibility to implement MBCT in a Flemish region
Relapse/recurrence of depression after approximately 12 months
Secondary Outcomes
- Health status
- Quality of life
- Coping
- Fear
- Rumination
Investigators
Study Sites (1)
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