The Therapeutic Efficacy of Neurofeedback in Depression (neurofeedback)

August 4, 2008 updated by: Korea University

The Therapeutic Efficacy of Frontal EEG Asymmetry Neurofeedback in Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Asymmetry training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
frontal EEG asymmetry indexes
Time Frame: 5 weeks
5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
BDI-2
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University

Collaborators

Kyunghee University
Korea Research Foundation

Investigators

  • Principal Investigator: Hyuntaek Kim, PHD, Department of Psychology, Korea university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

August 4, 2008

First Submitted That Met QC Criteria

August 4, 2008

First Posted (Estimate)

August 7, 2008

Study Record Updates

Last Update Posted (Estimate)

August 7, 2008

Last Update Submitted That Met QC Criteria

August 4, 2008

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRF-2005-079-HS0012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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