Psychophysiological Correlates of Mindfulness Based Cognitive Therapy (MBCT) in Recurrent Depression (MBCT & EEG)
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mindfulness Based Cognitive Therapy
Waiting List Control
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring recurrent depression,, mindfulness training, attention, Evoked EEG potentials, Relapse prevention in recurrent depression
Eligibility Criteria
Inclusion Criteria:
- recurrent depression with at least 3 previous MD-episodes, currently remitted (no symptoms)
Exclusion Criteria:
- current depression
- lifetime schizophrenia
- bipolar or schizoaffective disorder
- any neurological disorders
- other psychopathology during last 3 years
Sites / Locations
- Department of Psychology University of Tuebingen
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Wait List Control
Mindfulness Based Cognitive Therapy
Arm Description
Patients do ot receive psychotherapy. The wait list control group will be assessed according to study protocol and offered MBCT after 6 month
The published protocol of MBCT will be used. This is an eight week group program. Participants learn mindfulness techniques but also cognitive techniques to prevent new depressive episodes
Outcomes
Primary Outcome Measures
Relapse (MDE)
Secondary Outcome Measures
Electroencephalography (EEG)
Full Information
NCT ID
NCT00974077
First Posted
September 9, 2009
Last Updated
December 19, 2014
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT00974077
Brief Title
Psychophysiological Correlates of Mindfulness Based Cognitive Therapy (MBCT) in Recurrent Depression
Acronym
MBCT & EEG
Official Title
Psychophysiological Correlates of Mindfulness and Attention in Recurrent Depression and Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study investigates cognitive attention, rumination and psychophysiological (EEG) processes in healthy subjects and remitted patients with at least three previous depressive episodes. The investigators expect that Mindfulness Based Cognitive Therapy prevents future depressive episodes and has influence on cognitive and psychophysiological measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
recurrent depression,, mindfulness training, attention, Evoked EEG potentials, Relapse prevention in recurrent depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wait List Control
Arm Type
Other
Arm Description
Patients do ot receive psychotherapy. The wait list control group will be assessed according to study protocol and offered MBCT after 6 month
Arm Title
Mindfulness Based Cognitive Therapy
Arm Type
Experimental
Arm Description
The published protocol of MBCT will be used. This is an eight week group program. Participants learn mindfulness techniques but also cognitive techniques to prevent new depressive episodes
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Cognitive Therapy
Intervention Description
Group treatment over 8 weeks with training in meditation, stress regulation, shift attention, stay present, in addition with cognitive and behavioral strategies (following Williams et al. Manual 2002)
Intervention Type
Other
Intervention Name(s)
Waiting List Control
Intervention Description
Patients receive MBCT with a delay of 6 months.
Primary Outcome Measure Information:
Title
Relapse (MDE)
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Electroencephalography (EEG)
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
recurrent depression with at least 3 previous MD-episodes, currently remitted (no symptoms)
Exclusion Criteria:
current depression
lifetime schizophrenia
bipolar or schizoaffective disorder
any neurological disorders
other psychopathology during last 3 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Hautzinger, PhD
Organizational Affiliation
Eberhard Karls University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology University of Tuebingen
City
Tuebingen
ZIP/Postal Code
D-72072
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
22771173
Citation
Bostanov V, Keune PM, Kotchoubey B, Hautzinger M. Event-related brain potentials reflect increased concentration ability after mindfulness-based cognitive therapy for depression: a randomized clinical trial. Psychiatry Res. 2012 Oct 30;199(3):174-80. doi: 10.1016/j.psychres.2012.05.031. Epub 2012 Jul 6.
Results Reference
result
PubMed Identifier
23410762
Citation
Keune PM, Bostanov V, Hautzinger M, Kotchoubey B. Approaching dysphoric mood: state-effects of mindfulness meditation on frontal brain asymmetry. Biol Psychol. 2013 Apr;93(1):105-13. doi: 10.1016/j.biopsycho.2013.01.016. Epub 2013 Feb 11.
Results Reference
result
Learn more about this trial
Psychophysiological Correlates of Mindfulness Based Cognitive Therapy (MBCT) in Recurrent Depression
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