NCT00974077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

2.8 years

First QC Date

September 9, 2009

Last Update Submit

December 19, 2014

Conditions

Depression

Keywords

recurrent depression,mindfulness trainingattentionEvoked EEG potentialsRelapse prevention in recurrent depression

Outcome Measures

Primary Outcomes (1)

  • Relapse (MDE)

    12 month

Secondary Outcomes (1)

  • Electroencephalography (EEG)

    6 month

Study Arms (2)

Wait List Control

OTHER

Patients do ot receive psychotherapy. The wait list control group will be assessed according to study protocol and offered MBCT after 6 month

Other: Waiting List Control

Mindfulness Based Cognitive Therapy

EXPERIMENTAL

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

Behavioral: Mindfulness Based Cognitive Therapy

Interventions

Mindfulness Based Cognitive TherapyBEHAVIORAL

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)

Mindfulness Based Cognitive Therapy
Waiting List ControlOTHER

Patients receive MBCT with a delay of 6 months.

Wait List Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • recurrent depression with at least 3 previous MD-episodes, currently remitted (no symptoms)

You may not qualify if:

  • current depression
  • lifetime schizophrenia
  • bipolar or schizoaffective disorder
  • any neurological disorders
  • other psychopathology during last 3 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology University of Tuebingen

Tübingen, D-72072, Germany

Location

Related 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: 10.1016/j.psychres.2012.05.031. Epub 2012 Jul 6.

    PMID: 22771173RESULT

  • 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.

    PMID: 23410762RESULT

MeSH Terms

Conditions

Depression

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Martin Hautzinger, PhD

    Eberhard Karls University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Professor of Clinical Psychology and Psychotherapy

Study Record Dates

First Submitted

September 9, 2009

First Posted

September 10, 2009

Study Start

September 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

DE(1)