Mindfulness Based Cognitive Therapy and Antidepressant Medication in Recurrent Depression

Depressive Disorder, Major Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928980
• Other study ID #: MFN-2009-2013
• Secondary ID: 80-82310-98-0901
• Status: Completed
• Phase: N/A
• Start date: May 2009
• Est. completion date: June 2013

Study information

• Verified date: November 2020
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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

Locations

Country	Name	City	State
Netherlands	GGZ Noord-Holland-Noord	Alkmaar	Noord-Holland
Netherlands	GGZ Centraal	Amersfoort	Utrecht
Netherlands	AMC Amsterdam	Amsterdam	North Holland
Netherlands	Free University Medical Center and GGZ In Geest	Amsterdam	Noord-Holland
Netherlands	Pro Persona	Arnhem	Gelderland
Netherlands	Parnassia ACO Zuid	Den Haag	Zuid-Holland
Netherlands	PsyQ	Den Haag	Zuid-Holland
Netherlands	Pro Persona	Ede	Gelderland
Netherlands	GGZ Duin- en Bollenstreek	Katwijk
Netherlands	GGZ Rivierduinen - Leiden	Leiden	Zuid Holland
Netherlands	Leiden University Medical Center	Leiden	Zuid Holland
Netherlands	Radboud University Nijmegen Medical Center	Nijmegen	Gelderland
Netherlands	Pro Persona	Tiel	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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