No registrations found.
ID
Source
Brief title
Health condition
major depressive disorder, depression
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Hamilton depression rating scale (17-item);
2. Baseline frontal alpha-activity in resting EEG.
Secondary outcome
Quick Inventory Depression Scale- SelfRating (16 items).
Background summary
It is claimed that neurofeedback (NF) is efficacious in the treatment of MDD. So far, no studies have systematically examined such claims. However, basic neurophysiological studies appear to support the premise of NF that depression is associated with frontal alpha-asymmetry in the resting EEG. Reduction of this FA is thought to be related to a decrease in depressive symptomatology. The aim of this pilot-study is to investigate the effectiveness of NF (delivered as a frontal asymmetry protocol) in MDD by (1) decreasing FA, and (2) reducing severity of depressive symptomatology.
In case of positive results in this pilot-study a larger scale RCT will be conducted.
Study objective
Neurofeedback is effective in the treatment of major depressive disorder.
Study design
1. Premeasure; diagnosis and assessment of clinical variables (like severity of MDD);
2. Measurement of MDD severity before every NF session;
3. Assessment of clinical variables (like severity of MDD) upon completion of the intervention.
1. Premeasure: 6 days ESM;
2. Postmeasure: after 8 weeks of mindfulness training/time control: 6 days ESM;
3. Follow-ups are planned, but were not yet submitted to ethical committee;
4. Follow-up at 6 months;
5. Follow-up at 12 months.
Intervention
Neurofeedback will be administered based by means of frontal alpha-asymmetry (FA) feedback. Baseline resting-EEG signal will be analyzed and individual thresholds will be used to provide real-time visual feedback in order to diminish FA. A maximum of 30 NF sessions will be delivered with a frequency of 3 sessions each week.
University Hospital Maastricht
P.O. Box 5800
F.P.M.L. Peeters
Maastricht 6202 AZ
The Netherlands
043-3874130
f.peeters@maastrichtuniversity.nl
University Hospital Maastricht
P.O. Box 5800
F.P.M.L. Peeters
Maastricht 6202 AZ
The Netherlands
043-3874130
f.peeters@maastrichtuniversity.nl
Inclusion criteria
1. MMD as a primary axis-1 diagnosis according to criteria of the DSM-IV-TR;
2. Informed consent.
Exclusion criteria
1. History of braintrauma (commotio or contusio cerebri);
2. Current use of antipsychotics, moodstabilizers, benzodiazepines. the use of antidepressants is permitted if type and dosage are not changed during participation in the study;
3. Chronic MDD (>2 years duration of current episode);
4. Dysthymia;
5. Bipolar disorder;
6. Lefthandedness;
7. Severe (HDRS-17 > 25) episode of MDD which indicates prompt effective treatment;
8. Pregnancy;
9. Other psychiatric disorders other than co-morbid anxiety and personality disorders.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1551 |
| NTR-old | NTR1629 |
| CCMO | NL25291.068.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
| OMON | NL-OMON33576 |