Mindfulness Based Cognitive Therapy for Recurrent Depression

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effectiveness and possible mediating factors of Mindfulness Based Cognitive Therapy (MBCT) for recurrent depression.

Detailed Description
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Mindfulness Based Cognitive Therapy (MBCT) is a 8 session group intervention and is well described by several authors. Previous studies showed Mindfulness Based Cognitive Therapy (MBCT) to be effective to prevent relapse in patients with recurrent depression and 3 or more previous depressive episodes. Study aims are: to replicate previous findings in The Netherlands, by a research team which did not develop the intervention to investigate if MBCT is applicable for patients with recurrent depression and current depressive symptoms to examine possible mediators of treatment effect and predictors of relapse in the year following the treatment In this study, patients are randomly assigned to a MBCT intervention group or a waiting list control group. Patients allocated to the waiting list control condition will receive the MBCT course three months later. All patients who participated in a MBCT training will be assessed during the year following the completion of the MBCT course. We aim to include about 220 patients.

Official Title
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Mindfulness Based Cognitive Therapy for Patients With Recurrent Depression: a Clinical Trial

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Behavioral: Mindfulness Based Cognitive Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3 or more previous depressive episodes if treated with medication: constant dose of at least 6 weeks Exclusion Criteria: Bipolar Disorder Psychotic disorder Neurological or somatic illness affecting depression or outcome measures Current alcohol or drugs dependency Acute need of psychiatric treatment

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Based Cognitive Therapy<br>Mindfulness Based Cognitive Therapy | Behavioral: Mindfulness Based Cognitive Therapy<br>* 8-weeks group based intervention of mindfulness and cognitive behavioural techniques<br>* Other names: MBCT;|
| No Intervention: Waiting list control group<br>3-month waiting list group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse/Recurrence of Major Depressive Episode |  | 6, 9, 12, 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychiatric symptoms and mindfulness skills measured by questionnaires |  | 0, 3, 6, 9, 12, 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent Major Depressive Disorder, Mindfulness Based Cognitive Therapy, Randomized Controlled Trial