Mindfulness Based Cognitive Therapy for Recurrent Depression
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Radboud University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Radboud University
Collaborator:
Fonds Psychische Gezondheid
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT01038765
First received: December 22, 2009
Last updated: December 23, 2009
Last verified: December 2009
| Tracking Information | |||||
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| First Received Date ICMJE | December 22, 2009 | ||||
| Last Updated Date | December 23, 2009 | ||||
| Start Date ICMJE | January 2005 | ||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Relapse/Recurrence of Major Depressive Episode [ Time Frame: 6, 9, 12, 15 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01038765 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Psychiatric symptoms and mindfulness skills measured by questionnaires [ Time Frame: 0, 3, 6, 9, 12, 15 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Mindfulness Based Cognitive Therapy for Recurrent Depression | ||||
| Official Title ICMJE | Mindfulness Based Cognitive Therapy for Patients With Recurrent Depression: a Clinical Trial | ||||
| Brief Summary | The purpose of this study is to investigate the effectiveness and possible mediating factors of Mindfulness Based Cognitive Therapy (MBCT) for recurrent depression. |
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| Detailed 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:
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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Depressive Disorder, Major | ||||
| Intervention ICMJE | Behavioral: Mindfulness Based Cognitive Therapy
8-weeks group based intervention of mindfulness and cognitive behavioural techniques
Other Name: MBCT |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 338 | ||||
| Estimated Completion Date | January 2011 | ||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01038765 | ||||
| Other Study ID Numbers ICMJE | MFN-2005-2010, 2005 6028 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Anne E.M. Speckens, Prof. dr., Radboud University Medical Centre | ||||
| Study Sponsor ICMJE | Radboud University | ||||
| Collaborators ICMJE | Fonds Psychische Gezondheid | ||||
| Investigators ICMJE |
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| Information Provided By | Radboud University | ||||
| Verification Date | December 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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