Mindfulness Based Cognitive Therapy for Recurrent Depression

Sponsor
Radboud University Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01038765
Collaborator
Fonds Psychische Gezondheid (Other)
338
1
2
72
4.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness Based Cognitive Therapy
N/A

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:
  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.

Study Design

Study Type:
Interventional
Actual Enrollment :
338 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Mindfulness Based Cognitive Therapy for Patients With Recurrent Depression: a Clinical Trial
Study Start Date :
Jan 1, 2005
Anticipated Primary Completion Date :
Mar 1, 2010
Anticipated Study Completion Date :
Jan 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mindfulness Based Cognitive Therapy

Mindfulness Based Cognitive Therapy

Behavioral: Mindfulness Based Cognitive Therapy
8-weeks group based intervention of mindfulness and cognitive behavioural techniques
Other Names:
  • MBCT
  • No Intervention: Waiting list control group

    3-month waiting list group

    Outcome Measures

    Primary Outcome Measures

    1. Relapse/Recurrence of Major Depressive Episode [6, 9, 12, 15 months]

    Secondary Outcome Measures

    1. Psychiatric symptoms and mindfulness skills measured by questionnaires [0, 3, 6, 9, 12, 15 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Radboud University Nijmegen Medical Center Nijmegen Gelderland Netherlands 6525 GC

    Sponsors and Collaborators

    • Radboud University Medical Center
    • Fonds Psychische Gezondheid

    Investigators

    • Principal Investigator: Anne EM Speckens, Prof. dr., Radboud University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01038765
    Other Study ID Numbers:
    • MFN-2005-2010
    • 2005 6028
    First Posted:
    Dec 24, 2009
    Last Update Posted:
    Dec 24, 2009
    Last Verified:
    Dec 1, 2009

    Study Results

    No Results Posted as of Dec 24, 2009