Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression
- Conditions
- Depressive Disorder, Major
- Interventions
- Behavioral: Mindfulness Based Cognitive TherapyDrug: Optimal Medical Care
- Registration Number
- NCT00928980
- Lead Sponsor
- Radboud University Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 317
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mindfulness Based Cognitive Therapy Mindfulness Based Cognitive Therapy 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). Combination Mindfulness Based Cognitive Therapy Mindfulness Based Cognitive Therapy combined with the use of antidepressant medication during the study (15 months). Combination Optimal Medical Care Mindfulness Based Cognitive Therapy combined with the use of antidepressant medication during the study (15 months). Optimal Medical Care Optimal Medical Care Treatment with optimal medical care: therapeutic dose of antidepressant medication during at least 15 months, administered in accordance with current guidelines.
- Primary Outcome Measures
Name Time Method Relapse/recurrence of Major Depressive Episode 3, 6, 9, 12, 15 months Relapse or recurrence of depression will be assessed trimonthly using the Structured Clinical Interview for DSM-V (SCID) depression module.
- Secondary Outcome Measures
Name Time Method Costs made by consumption of medical care and production loss 3, 6, 9, 12, 15 months 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.
Trial Locations
- Locations (11)
Parnassia ACO Zuid
🇳🇱Den Haag, Zuid-Holland, Netherlands
GGZ Noord-Holland-Noord
🇳🇱Alkmaar, Noord-Holland, Netherlands
Radboud University Nijmegen Medical Center
🇳🇱Nijmegen, Gelderland, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Zuid Holland, Netherlands
GGZ Duin- en Bollenstreek
🇳🇱Katwijk, Netherlands
AMC Amsterdam
🇳🇱Amsterdam, North Holland, Netherlands
PsyQ
🇳🇱Den Haag, Zuid-Holland, Netherlands
Pro Persona
🇳🇱Tiel, Gelderland, Netherlands
Free University Medical Center and GGZ In Geest
🇳🇱Amsterdam, Noord-Holland, Netherlands
GGZ Rivierduinen - Leiden
🇳🇱Leiden, Zuid Holland, Netherlands
GGZ Centraal
🇳🇱Amersfoort, Utrecht, Netherlands