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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Recurrent Depression

Intervention / Treatment
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* Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility to implement MBCT in a Flemish region |  |  | 
| Relapse/recurrence of depression after approximately 12 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health status |  |  | 
| Quality of life |  |  | 
| Coping |  |  | 
| Fear |  |  | 
| Rumination |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent depression, Mental Health