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The Therapeutic Efficacy of Neurofeedback in Depression (neurofeedback)

This study has been completed.
Sponsor:
Collaborators:
Korea Research Foundation
Kyunghee University
Information provided by:
Korea University
ClinicalTrials.gov Identifier:
NCT00729547
First received: August 4, 2008
Last updated: NA
Last verified: September 2006
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Placebo Comparator: 2
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.
Experimental: 1
Neurofeedback training which enhance left frontal alpha wave.
Behavioral: Neurofeedback
enhance relative activity level of left frontal activity
Other Name: Asymmetry training

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
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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

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

Keywords provided by Korea University:
Depression
Biofeedback
Psychophysiology

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 25, 2014