Psychophysiological Correlates of Mindfulness Based Cognitive Therapy (MBCT) in Recurrent Depression

This study has been completed.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00974077
First received: September 9, 2009
Last updated: August 3, 2011
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Depression
Behavioral: Mindfulness Based Cognitive Therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Psychophysiological Correlates of Mindfulness and Attention in Recurrent Depression and Healthy Volunteers

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Relapse (MDE) [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Electroencephalography (EEG) [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: September 2008
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Wait List
Eligible patients were randomized into MBCT or wait. The wait list control group will be assessed according to study protocol and offered MBCT after 6 month
Behavioral: Mindfulness Based Cognitive Therapy
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974077

Locations
Germany
Department of Psychology University of Tuebingen
Tuebingen, Germany, D-72072
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Martin Hautzinger, PhD Eberhard Karls University
  More Information

No publications provided

Responsible Party: Professor Dr. Martin Hautzinger, University of Tuebingen
ClinicalTrials.gov Identifier: NCT00974077     History of Changes
Other Study ID Numbers: MBCT & EEG, DFG HA 1399/16-1
Study First Received: September 9, 2009
Last Updated: August 3, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Tuebingen:
recurrent depression,
mindfulness training
attention
Evoked EEG potentials
Relapse prevention in recurrent depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014