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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00974077
Other study ID # HA1399/16-1
Secondary ID
Status Completed
Phase N/A
First received September 9, 2009
Last updated December 19, 2014
Start date September 2008
Est. completion date July 2011

Study information

Verified date December 2014
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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)
Other:
Waiting List Control
Patients receive MBCT with a delay of 6 months.

Locations

Country Name City State
Germany Department of Psychology University of Tuebingen Tuebingen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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: — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Relapse (MDE) 12 month No
Secondary Electroencephalography (EEG) 6 month No
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