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The Therapeutic Efficacy of Neurofeedback in Depression (neurofeedback)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Neurofeedback
Psychotherapy placebo
Sponsored by
Korea University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Biofeedback, Psychophysiology

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Oriental Neuropsychiatry, Kyunghee Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2

1

Arm Description

Psychotherapy placebo session

Neurofeedback training which enhance left frontal alpha wave.

Outcomes

Primary Outcome Measures

frontal EEG asymmetry indexes

Secondary Outcome Measures

BDI-2

Full Information

First Posted
August 4, 2008
Last Updated
August 4, 2008
Sponsor
Korea University
Collaborators
Korea Research Foundation, Kyunghee University
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1. Study Identification

Unique Protocol Identification Number
NCT00729547
Brief Title
The Therapeutic Efficacy of Neurofeedback in Depression
Acronym
neurofeedback
Official Title
The Therapeutic Efficacy of Frontal EEG Asymmetry Neurofeedback in Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Korea University
Collaborators
Korea Research Foundation, Kyunghee University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Biofeedback, Psychophysiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Psychotherapy placebo session
Arm Title
1
Arm Type
Experimental
Arm Description
Neurofeedback training which enhance left frontal alpha wave.
Intervention Type
Behavioral
Intervention Name(s)
Neurofeedback
Other Intervention Name(s)
Asymmetry training
Intervention Description
enhance relative activity level of left frontal activity
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy placebo
Intervention Description
These sessions consisted of additional assessment, interpretation of the test results and providing information on course and treatment of mood disorder.
Primary Outcome Measure Information:
Title
frontal EEG asymmetry indexes
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
BDI-2
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyuntaek Kim, PHD
Organizational Affiliation
Department of Psychology, Korea university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oriental Neuropsychiatry, Kyunghee Medical Center
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
15564054
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.
Results Reference
background
PubMed Identifier
10638347
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.
Results Reference
background
PubMed Identifier
9031711
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.
Results Reference
result
PubMed Identifier
7495918
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.
Results Reference
result
PubMed Identifier
8801245
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.
Results Reference
result
Links:
URL
http://www.psychonews.co.kr
Description
click here to review subject recruiting and information on this study
URL
http://psy.korea.ac.kr
Description
click here to see brief description of the department of psychology at Korea university
URL
http://www.khmc.or.kr
Description
click here to review the location of this study and the policy of IRB

Learn more about this trial

The Therapeutic Efficacy of Neurofeedback in Depression

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