Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the (cost)effectiveness of mindfulness based cognitive therapy (MBCT) compared to that of antidepressant medication, and its combination with regard to the prevention of relapse or recurrence in patients with recurrent depression.

Detailed Description
-----------------
In the Netherlands, treatment as usual for patients with (recurrent) Major Depressive Disorder consists of maintenance antidepressant medication. Mindfulness-based cognitive therapy (MBCT) is a recently developed psychological intervention that appears to be promising in terms of preventing relapse or recurrence in patients with recurrent depression. It consists of 8 weekly group sessions in which meditation exercises are combined with cognitive therapeutic elements such as identifying negative thoughts and monitoring and scheduling activities. In this study, the (cost)effectiveness of a) MBCT on its own, b) antidepressant medication on its own and c) the combination of MBCT and antidepressant medication will be investigated in 350 patients with recurrent depression who are currently in remission.

Official Title
-----------------
The Clinical and Cost-effectiveness of Mindfulness Based Cognitive Therapy, Maintenance Antidepressant Medication and Its Combination in the Prevention of Relapse in Patients With Recurrent Depression

Conditions
-----------------
Depressive Disorder, Major

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Based Cognitive Therapy
* Drug: Optimal Medical Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recurrent Major Depressive Episode (at least 3 previous episodes) Treatment with therapeutic dose of antidepressant medication during past six months Currently in full or partial remission Exclusion Criteria: Bipolar disorder (current and previous (hypo)manic episodes) Psychotic disorder (current and previous) Neurological or somatic illness affecting depression or outcome measures Current alcohol or drugs dependency Use of high dosage benzodiazepines (> 2 mg Lorazepam equivalents daily) Recent Electro Convulsive Therapy (< 3 months ago)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 and withdrawal of antidepressant medication between the 4th and 5th session, patients being off medication until the end of study period (15 months). | Behavioral: Mindfulness Based Cognitive Therapy<br>* Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.<br>|
| Experimental: Combination<br>Mindfulness Based Cognitive Therapy combined with the use of antidepressant medication during the study (15 months). | Behavioral: Mindfulness Based Cognitive Therapy<br>* Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.<br>Drug: Optimal Medical Care<br>* Therapeutic dose of antidepressant medication<br>|
| Active Comparator: Optimal Medical Care<br>Treatment with optimal medical care: therapeutic dose of antidepressant medication during at least 15 months, administered in accordance with current guidelines. | Drug: Optimal Medical Care<br>* Therapeutic dose of antidepressant medication<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse/recurrence of Major Depressive Episode | Relapse or recurrence of depression will be assessed trimonthly using the Structured Clinical Interview for DSM-V (SCID) depression module. | 3, 6, 9, 12, 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Costs made by consumption of medical care and production loss | Using prospective calendars and retrospective questionnaires about contacts with health care in the past 3 months (assessed trimonthly) we will estimate the costs of depression health care and the quality of life (selfreport). We will compare the cost-effectiveness ratios between the groups. | 3, 6, 9, 12, 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Recurrent Major Depressive Disorder, Mindfulness Based Cognitive Therapy, Cost-effectiveness, Antidepressant medication, Randomized Controlled Trial