- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00974077
Psychophysiological Correlates of Mindfulness Based Cognitive Therapy (MBCT) in Recurrent Depression (MBCT & EEG)
December 19, 2014 updated by: Prof. Dr. Martin Hautzinger, University Hospital Tuebingen
Psychophysiological Correlates of Mindfulness and Attention in Recurrent Depression and Healthy Volunteers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tuebingen, Germany, D-72072
- Department of Psychology University of Tuebingen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Wait List Control
Patients do ot receive psychotherapy.
The wait list control group will be assessed according to study protocol and offered MBCT after 6 month
|
Patients receive MBCT with a delay of 6 months.
|
Experimental: Mindfulness Based Cognitive Therapy
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
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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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Relapse (MDE)
Time Frame: 12 month
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12 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Electroencephalography (EEG)
Time Frame: 6 month
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin Hautzinger, PhD, Eberhard Karls University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
September 9, 2009
First Submitted That Met QC Criteria
September 9, 2009
First Posted (Estimate)
September 10, 2009
Study Record Updates
Last Update Posted (Estimate)
December 23, 2014
Last Update Submitted That Met QC Criteria
December 19, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HA1399/16-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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