Clinical trial NCT00729547: The Therapeutic Efficacy of Neurofeedback in Depression
Official title: The Therapeutic Efficacy of Frontal EEG Asymmetry Neurofeedback in Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Biofeedback
Psychophysiology
Lead sponsor: Korea University
Sponsor class: OTHER
Collaborators: name: Korea Research Foundation
name: Kyunghee University
First posted: 2008-08-07
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: frontal EEG asymmetry indexes
timeFrame: 5 weeks
Secondary outcomes:
measure: BDI-2
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Oriental Neuropsychiatry, Kyunghee Medical Center
Study officials:
affiliation: Department of Psychology, Korea university
name: Hyuntaek Kim, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Rosenfeld JP. An EEG biofeedback protocol for affective disorders. Clin Electroencephalogr. 2000 Jan;31(1):7-12. doi: 10.1177/155005940003100106. No abstract available.
citation: 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.
citation: 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.
citation: 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.