The Therapeutic Efficacy of Neurofeedback in Depression - Full Text View

Sponsors and Collaborators:	Korea University Korea research foundation Kyunghee University
Information provided by:	Korea University
ClinicalTrials.gov Identifier:	NCT00729547

Purpose

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.

Condition	Intervention
Depression	Behavioral: Neurofeedback Behavioral: Psychotherapy placebo

MedlinePlus related topics: Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	The Therapeutic Efficacy of Frontal EEG Asymmetry Neurofeedback in Depression

Further study details as provided by Korea University:

Primary Outcome Measures:

frontal EEG asymmetry indexes [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

BDI-2 [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	September 2006
Study Completion Date:	January 2007
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator Psychotherapy placebo session	Behavioral: Psychotherapy placebo These sessions consisted of additional assessment, interpretation of the test results and providing information on course and treatment of mood disorder.
1: Experimental Neurofeedback training which enhance left frontal alpha wave.	Behavioral: Neurofeedback enhance relative activity level of left frontal activity

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.

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729547

Locations

Korea, Republic of
Department of Oriental Neuropsychiatry, Kyunghee Medical Center
Seoul, Korea, Republic of, 130-702

Sponsors and Collaborators

Korea University

Korea research foundation

Kyunghee University

Investigators

Principal Investigator:

Hyuntaek Kim, PHD

Department of Psychology, Korea university

More Information

click here to review subject recruiting and information on this study This link exits the ClinicalTrials.gov site

click here to see brief description of the department of psychology at Korea university This link exits the ClinicalTrials.gov site

click here to review the location of this study and the policy of IRB This link exits the ClinicalTrials.gov site

Publications of Results:

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.

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.

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.

Other Publications:

Hammond DC. Neurofeedback with anxiety and affective disorders. Child Adolesc Psychiatr Clin N Am. 2005 Jan;14(1):105-23, vii. Review.

Rosenfeld JP. An EEG biofeedback protocol for affective disorders. Clin Electroencephalogr. 2000 Jan;31(1):7-12. Review. No abstract available.

Responsible Party:	Department of Psychology, Korea University ( Hyun Taek Kim/Professor )
Study ID Numbers:	KRF-2005-079-HS0012
Study First Received:	August 4, 2008
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00729547
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Korea University:

Depression
Biofeedback
Psychophysiology

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 13, 2009