NCT00729547

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Sep 2006

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
Last Updated

August 7, 2008

Status Verified

September 1, 2006

Enrollment Period

3 months

First QC Date

August 4, 2008

Last Update Submit

August 4, 2008

Conditions

Depression

Keywords

DepressionBiofeedbackPsychophysiology

Outcome Measures

Primary Outcomes (1)

  • frontal EEG asymmetry indexes

    5 weeks

Secondary Outcomes (1)

  • BDI-2

    5 weeks

Study Arms (2)

2

PLACEBO COMPARATOR

Psychotherapy placebo session

Behavioral: Psychotherapy placebo

1

EXPERIMENTAL

Neurofeedback training which enhance left frontal alpha wave.

Behavioral: Neurofeedback

Interventions

NeurofeedbackBEHAVIORAL

enhance relative activity level of left frontal activity

Also known as: Asymmetry training
1
Psychotherapy placeboBEHAVIORAL

These sessions consisted of additional assessment, interpretation of the test results and providing information on course and treatment of mood disorder.

2

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • clinical diagnosis of mood disorder
  • right handed
  • current BDI-2 score exceed 10

You may not qualify if:

  • with psychotic symptom
  • with organic disorders
  • treated by psychoactive drugs for at least 2 months prior to the study
  • history of pathologic alcohol use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oriental Neuropsychiatry, Kyunghee Medical Center

Seoul, Seoul, 130-702, South Korea

Location

Related Publications (5)

  • 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.

    PMID: 15564054BACKGROUND

  • Rosenfeld JP. An EEG biofeedback protocol for affective disorders. Clin Electroencephalogr. 2000 Jan;31(1):7-12. doi: 10.1177/155005940003100106. No abstract available.

    PMID: 10638347BACKGROUND

  • 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.

    PMID: 9031711RESULT

  • 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.

    PMID: 7495918RESULT

  • 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.

    PMID: 8801245RESULT

Related Links

MeSH Terms

Conditions

Depression

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Hyuntaek Kim, PHD

    Department of Psychology, Korea university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2008

First Posted

August 7, 2008

Study Start

September 1, 2006

Primary Completion

December 1, 2006

Study Completion

January 1, 2007

Last Updated

August 7, 2008

Record last verified: 2006-09

Locations

KR(1)