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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

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

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
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:
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:

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
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013