This trial is active, not recruiting.

Condition depressive disorder, major
Treatment mindfulness based cognitive therapy
Sponsor Radboud University
Collaborator Fonds Psychische Gezondheid
Start date January 2005
End date March 2010
Trial size 338 participants
Trial identifier NCT01038765, 2005 6028, MFN-2005-2010


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Mindfulness Based Cognitive Therapy
mindfulness based cognitive therapy MBCT
8-weeks group based intervention of mindfulness and cognitive behavioural techniques
(No Intervention)
3-month waiting list group

Primary Outcomes

Relapse/Recurrence of Major Depressive Episode
time frame: 6, 9, 12, 15 months

Secondary Outcomes

Psychiatric symptoms and mindfulness skills measured by questionnaires
time frame: 0, 3, 6, 9, 12, 15 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Mindfulness Based Cognitive Therapy for Patients With Recurrent Depression: a Clinical Trial
Principal investigator Anne EM Speckens, Prof. dr.
Description 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: 1. to replicate previous findings in The Netherlands, by a research team which did not develop the intervention 2. to investigate if MBCT is applicable for patients with recurrent depression and current depressive symptoms 3. 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2009.
Information provided to ClinicalTrials.gov by Radboud University.