Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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). |
Behavioral: Mindfulness Based Cognitive Therapy
Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.
|
| Experimental: Combination Mindfulness Based Cognitive Therapy combined with the use of antidepressant medication during the study (15 months). |
Behavioral: Mindfulness Based Cognitive Therapy
Mindfulness Based Cognitive Therapy is an 8-week during group intervention encompassing meditation practice and cognitive therapy techniques.
Drug: Optimal Medical Care
Therapeutic dose of antidepressant medication
|
| Active Comparator: Optimal Medical Care 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
Therapeutic dose of antidepressant medication
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
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:
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Bipolar disorder (current and previous (hypo)manic episodes)
-
Psychotic disorder (current and previous)
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Neurological or somatic illness affecting depression or outcome measures
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Current alcohol or drugs dependency
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Use of high dosage benzodiazepines (> 2 mg Lorazepam equivalents daily)
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Recent Electro Convulsive Therapy (< 3 months ago)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pro Persona | Arnhem | Gelderland | Netherlands | 6800 |
| 2 | Pro Persona | Ede | Gelderland | Netherlands | |
| 3 | Radboud University Nijmegen Medical Center | Nijmegen | Gelderland | Netherlands | 6525 GC |
| 4 | Pro Persona | Tiel | Gelderland | Netherlands | |
| 5 | GGZ Noord-Holland-Noord | Alkmaar | Noord-Holland | Netherlands | |
| 6 | Free University Medical Center and GGZ In Geest | Amsterdam | Noord-Holland | Netherlands | 1000 |
| 7 | AMC Amsterdam | Amsterdam | North Holland | Netherlands | 1100 DD |
| 8 | GGZ Centraal | Amersfoort | Utrecht | Netherlands | 3800 |
| 9 | GGZ Rivierduinen - Leiden | Leiden | Zuid Holland | Netherlands | 2300 AT |
| 10 | Leiden University Medical Center | Leiden | Zuid Holland | Netherlands | 2300 RC |
| 11 | PsyQ | Den Haag | Zuid-Holland | Netherlands | 2500 |
| 12 | Parnassia ACO Zuid | Den Haag | Zuid-Holland | Netherlands | |
| 13 | GGZ Duin- en Bollenstreek | Katwijk | Netherlands |
Sponsors and Collaborators
- Radboud University Medical Center
- ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
- Principal Investigator: Anne EM Speckens, Prof. dr., Radboud University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Kuyken W, Byford S, Taylor RS, Watkins E, Holden E, White K, Barrett B, Byng R, Evans A, Mullan E, Teasdale JD. Mindfulness-based cognitive therapy to prevent relapse in recurrent depression. J Consult Clin Psychol. 2008 Dec;76(6):966-78. doi: 10.1037/a0013786.
- Ma SH, Teasdale JD. Mindfulness-based cognitive therapy for depression: replication and exploration of differential relapse prevention effects. J Consult Clin Psychol. 2004 Feb;72(1):31-40.
- Teasdale JD, Segal ZV, Williams JM, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psychol. 2000 Aug;68(4):615-23.
- MFN-2009-2013
- 80-82310-98-09018
- 2008/242