DepressionMBCT & EEGNCT00974077
Psychophysiological Correlates of Mindfulness Based Cognitive Therapy (MBCT) in Recurrent Depression
A study testing Mindfulness Based Cognitive Therapy in people with Depression, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Mindfulness Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- recurrent depression with at least 3 previous MD-episodes, currently remitted (no symptoms)
Who cannot join
- current depression
- lifetime schizophrenia
- bipolar or schizoaffective disorder
- any neurological disorders
- other psychopathology during last 3 years
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychology University of Tuebingen
Tübingen, D-72072
About this study
Official title: 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.
- Conditions
- Depression
- Being tested
- Mindfulness Based Cognitive Therapy, Waiting List Control
- Keywords
- recurrent depression,, mindfulness training, attention, Evoked EEG potentials, Relapse prevention in recurrent depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive TherapyBehavioural
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)
Waiting List ControlOther
Patients receive MBCT with a delay of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Mindfulness Based Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse (MDE)
Measured: 12 month
Secondary outcomes (1)
Electroencephalography (EEG)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startSep 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Martin Hautzinger, University Hospital Tuebingen
- Investigators
- Martin Hautzinger, PhD, Principal investigator, Eberhard Karls University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974077
- Sponsor's protocol ID
- HA1399/16-1
- Acronym
- MBCT & EEG
- Status last verified
- Dec 2014
- First submitted
- 9 Sep 2009
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 22771173Keune 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.
PubMed 23410762
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychophysiological Correlates of Mindfulness and Attention in Recurrent Depression and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00974077
- Acronym / sponsor ID
- MBCT & EEG / HA1399/16-1
- Conditions
- Depression
- Keywords
- recurrent depression,, mindfulness training, attention, Evoked EEG potentials, Relapse prevention in recurrent depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait List Control | Other | Other: Waiting List ControlPatients do ot receive psychotherapy. The wait list control group will be assessed according to study protocol and offered MBCT after 6 month |
| Mindfulness Based Cognitive Therapy | Experimental | Behavioral: Mindfulness Based Cognitive TherapyThe 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- recurrent depression with at least 3 previous MD-episodes, currently remitted (no symptoms)
Key exclusion criteria (5 listed)
- current depression
- lifetime schizophrenia
- bipolar or schizoaffective disorder
- any neurological disorders
- other psychopathology during last 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Cognitive TherapyGroup 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) | Behavioural | Mindfulness Based Cognitive Therapy |
| Waiting List ControlPatients receive MBCT with a delay of 6 months. | Other | Wait List Control |
Primary outcome
Relapse (MDE)
Time frame: 12 month
1 secondary outcome
Electroencephalography (EEG)
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
- Results publication: PubMed 22771173Bostanov 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 publication: PubMed 23410762Keune 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Hautzinger, PhD principal investigator
Eberhard Karls University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Cognitive Therapy in people with Depression, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse (MDE) (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00974077, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.