The Therapeutic Efficacy of Neurofeedback in Depression

Depression Clinical Trial

— neurofeedback  

Official title:

The Therapeutic Efficacy of Frontal EEG Asymmetry Neurofeedback in Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729547
• Other study ID #: KRF-2005-079-HS0012
• Status: Completed
• Phase: N/A
• First received: August 4, 2008
• Last updated: August 4, 2008
• Start date: September 2006
• Est. completion date: January 2007

Study information

• Verified date: September 2006
• Source: Korea University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Neurofeedback
enhance relative activity level of left frontal activity
• Psychotherapy placebo
These sessions consisted of additional assessment, interpretation of the test results and providing information on course and treatment of mood disorder.

Locations

Country	Name	City	State
Korea, Republic of	Department of Oriental Neuropsychiatry, Kyunghee Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Korea University	Korea Research Foundation, Kyunghee University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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

Rosenfeld JP. An EEG biofeedback protocol for affective disorders. Clin Electroencephalogr. 2000 Jan;31(1):7-12. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frontal EEG asymmetry indexes		5 weeks	No
Secondary	BDI-2		5 weeks	No

External Links

•   click here to review the location of this study and the policy of IRB
•   click here to see brief description of the department of psychology at Korea university