- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00729547
The Therapeutic Efficacy of Neurofeedback in Depression (neurofeedback)
August 4, 2008 updated by: Korea University
The Therapeutic Efficacy of Frontal EEG Asymmetry Neurofeedback in Depression
The investigators examined the therapeutic efficacy of neurofeedback in depression subjects.
The investigators hypothesize that 5 weeks neurofeedback training will be able to alleviate depressive symptoms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Subject
- Fulfilled DSM-IV criteria for depressive disorders.
- Persons who had organic disorders were excluded.
- Who had been treated by psychoactive drugs for at least 2 months prior to the study were excluded.
Design
- Subjects were randomly assigned to two groups (EEG biofeedback /psychotherapy placebo) by block randomization.
- EEG biofeedback training was provided for 5 weeks(10 sessions, twice per week). Each training session was composed of 6 four minute trials followed by 5 thirty second rest periods
- Psychotherapy placebo session was provided for 5 weeks. These sessions consisted of additional assessment, interpretation of the test results and providing information on course and treatment of mood disorder.
- After subjects completed the training, they participated in a month-long (twice per week) self-training session to maintain a similar mental state during neurofeedback training sessions without feedback system's assistance.
- Subjects who had finished the psychotherapy placebo were referred to other therapists as necessary.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 130-702
- Department of Oriental Neuropsychiatry, Kyunghee Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- clinical diagnosis of mood disorder
- right handed
- current BDI-2 score exceed 10
Exclusion Criteria:
- with psychotic symptom
- with organic disorders
- treated by psychoactive drugs for at least 2 months prior to the study
- history of pathologic alcohol use
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Psychotherapy placebo session
|
These sessions consisted of additional assessment, interpretation of the test results and providing information on course and treatment of mood disorder.
|
Experimental: 1
Neurofeedback training which enhance left frontal alpha wave.
|
enhance relative activity level of left frontal activity
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
frontal EEG asymmetry indexes
Time Frame: 5 weeks
|
5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BDI-2
Time Frame: 5 weeks
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hyuntaek Kim, PHD, Department of Psychology, Korea university
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hammond DC. Neurofeedback with anxiety and affective disorders. Child Adolesc Psychiatr Clin N Am. 2005 Jan;14(1):105-23, vii. doi: 10.1016/j.chc.2004.07.008.
- Rosenfeld JP. An EEG biofeedback protocol for affective disorders. Clin Electroencephalogr. 2000 Jan;31(1):7-12. doi: 10.1177/155005940003100106. No abstract available.
- Kumano H, Horie H, Shidara T, Kuboki T, Suematsu H, Yasushi M. Treatment of a depressive disorder patient with EEG-driven photic stimulation. Biofeedback Self Regul. 1996 Dec;21(4):323-34. doi: 10.1007/BF02214432.
- Rosenfeld JP, Cha G, Blair T, Gotlib IH. Operant (biofeedback) control of left-right frontal alpha power differences: potential neurotherapy for affective disorders. Biofeedback Self Regul. 1995 Sep;20(3):241-58. doi: 10.1007/BF01474516.
- Saxby E, Peniston EG. Alpha-theta brainwave neurofeedback training: an effective treatment for male and female alcoholics with depressive symptoms. J Clin Psychol. 1995 Sep;51(5):685-93. doi: 10.1002/1097-4679(199509)51:53.0.co;2-k.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
August 4, 2008
First Submitted That Met QC Criteria
August 4, 2008
First Posted (Estimate)
August 7, 2008
Study Record Updates
Last Update Posted (Estimate)
August 7, 2008
Last Update Submitted That Met QC Criteria
August 4, 2008
Last Verified
September 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KRF-2005-079-HS0012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Lawson Health Research InstituteTerminated
Clinical Trials on Psychotherapy placebo
-
Chua Yi Rong ShawnNanyang Technological University; Therapeutic and Educational Riding in Singapore...CompletedAggression | Stress | Psychopathy | EmpathySingapore
-
Universidade Federal do Rio de JaneiroCompleted
-
University of WashingtonNational Institute of Mental Health (NIMH); University of Pennsylvania; University...CompletedChronic Posttraumatic Stress DisorderUnited States
-
Randi UlbergUniversity of OsloCompleted
-
Hopital MontfortThe Ottawa HospitalCompletedDepression | Parkinson's DiseaseCanada
-
Marianne Lau, MD, DSci.The Ministry of Science, Technology and Innovation, DenmarkUnknownBulimia Nervosa (BN) | Binge Eating Disorder (BED) | Eating Disorder Not Otherwise Specified (EDNOS)Denmark
-
University of Wisconsin, MadisonNational Institute of Mental Health (NIMH)Completed
-
University Hospital FreiburgCompletedChronic Major Depressive DisorderGermany
-
Oslo University HospitalSouth-Eastern Norway Regional Health AuthorityUnknown
-
Memorial Sloan Kettering Cancer CenterUniversity of Manitoba; National Cancer Institute (NCI); Visiting Nurse Service... and other collaboratorsCompleted