Mindfulness Based Cognitive Therapy for Recurrent Depression
Primary Purpose
Depressive Disorder, Major
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Mindfulness Based Cognitive Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Recurrent Major Depressive Disorder, Mindfulness Based Cognitive Therapy, Randomized Controlled Trial
Eligibility Criteria
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
Sites / Locations
- Radboud University Nijmegen Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness Based Cognitive Therapy
Waiting list control group
Arm Description
Mindfulness Based Cognitive Therapy
3-month waiting list group
Outcomes
Primary Outcome Measures
Relapse/Recurrence of Major Depressive Episode
Secondary Outcome Measures
Psychiatric symptoms and mindfulness skills measured by questionnaires
Full Information
NCT ID
NCT01038765
First Posted
December 22, 2009
Last Updated
December 23, 2009
Sponsor
Radboud University Medical Center
Collaborators
Fonds Psychische Gezondheid
1. Study Identification
Unique Protocol Identification Number
NCT01038765
Brief Title
Mindfulness Based Cognitive Therapy for Recurrent Depression
Official Title
Mindfulness Based Cognitive Therapy for Patients With Recurrent Depression: a Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2005 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
January 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
Collaborators
Fonds Psychische Gezondheid
4. Oversight
Data Monitoring Committee
No
5. 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.
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:
to replicate previous findings in The Netherlands, by a research team which did not develop the intervention
to investigate if MBCT is applicable for patients with recurrent depression and current depressive symptoms
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Recurrent Major Depressive Disorder, Mindfulness Based Cognitive Therapy, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
338 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Based Cognitive Therapy
Arm Type
Experimental
Arm Description
Mindfulness Based Cognitive Therapy
Arm Title
Waiting list control group
Arm Type
No Intervention
Arm Description
3-month waiting list group
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Cognitive Therapy
Other Intervention Name(s)
MBCT
Intervention Description
8-weeks group based intervention of mindfulness and cognitive behavioural techniques
Primary Outcome Measure Information:
Title
Relapse/Recurrence of Major Depressive Episode
Time Frame
6, 9, 12, 15 months
Secondary Outcome Measure Information:
Title
Psychiatric symptoms and mindfulness skills measured by questionnaires
Time Frame
0, 3, 6, 9, 12, 15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne EM Speckens, Prof. dr.
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Nijmegen Medical Center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GC
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
10965637
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. doi: 10.1037//0022-006x.68.4.615.
Results Reference
background
PubMed Identifier
14756612
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. doi: 10.1037/0022-006X.72.1.31.
Results Reference
background
PubMed Identifier
19249017
Citation
Barnhofer T, Crane C, Hargus E, Amarasinghe M, Winder R, Williams JM. Mindfulness-based cognitive therapy as a treatment for chronic depression: A preliminary study. Behav Res Ther. 2009 May;47(5):366-73. doi: 10.1016/j.brat.2009.01.019. Epub 2009 Feb 5.
Results Reference
background
PubMed Identifier
16797486
Citation
Kenny MA, Williams JM. Treatment-resistant depressed patients show a good response to Mindfulness-based Cognitive Therapy. Behav Res Ther. 2007 Mar;45(3):617-25. doi: 10.1016/j.brat.2006.04.008. Epub 2006 Jun 23.
Results Reference
background
PubMed Identifier
17535594
Citation
Kingston T, Dooley B, Bates A, Lawlor E, Malone K. Mindfulness-based cognitive therapy for residual depressive symptoms. Psychol Psychother. 2007 Jun;80(Pt 2):193-203. doi: 10.1348/147608306X116016.
Results Reference
background
PubMed Identifier
22017808
Citation
van Aalderen JR, Donders AR, Giommi F, Spinhoven P, Barendregt HP, Speckens AE. The efficacy of mindfulness-based cognitive therapy in recurrent depressed patients with and without a current depressive episode: a randomized controlled trial. Psychol Med. 2012 May;42(5):989-1001. doi: 10.1017/S0033291711002054. Epub 2011 Oct 3.
Results Reference
derived
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Mindfulness Based Cognitive Therapy for Recurrent Depression
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