DepressionneurofeedbackNCT00729547
The Therapeutic Efficacy of Neurofeedback in Depression
A study testing Neurofeedback in people with Depression, run by Korea University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- Neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2006to Jan 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- clinical diagnosis of mood disorder
- right handed
- current BDI-2 score exceed 10
Who cannot join
- with psychotic symptom
- with organic disorders
- treated by psychoactive drugs for at least 2 months prior to the study
- history of pathologic alcohol use
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Oriental Neuropsychiatry, Kyunghee Medical Center
Seoul, Seoul, 130-702
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression
- Being tested
- Neurofeedback, Psychotherapy placebo
- Keywords
- Depression, Biofeedback, Psychophysiology
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackBehavioural
Also called Asymmetry training
enhance relative activity level of left frontal activity
Psychotherapy placeboBehavioural
These sessions consisted of additional assessment, interpretation of the test results and providing information on course and treatment of mood disorder.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Psychotherapy placebo session Receives: Behavioral: Psychotherapy placebo |
| 1 | Experimental | Neurofeedback training which enhance left frontal alpha wave. Receives: Behavioral: Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
frontal EEG asymmetry indexes
Measured: 5 weeks
Secondary outcomes (1)
BDI-2
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startSep 2006
- Primary completionDec 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Research Foundation, Kyunghee University
- Investigators
- Hyuntaek Kim, PHD, Principal investigator, Department of Psychology, Korea university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729547
- Sponsor's protocol ID
- KRF-2005-079-HS0012
- Acronym
- neurofeedback
- Status last verified
- Sep 2006
- First submitted
- 4 Aug 2008
- Last updated
- 7 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15564054Rosenfeld JP. An EEG biofeedback protocol for affective disorders. Clin Electroencephalogr. 2000 Jan;31(1):7-12. doi: 10.1177/155005940003100106. No abstract available.
PubMed 10638347Kumano 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.
PubMed 9031711Rosenfeld 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.
PubMed 7495918Saxby 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.
PubMed 8801245
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Efficacy of Frontal EEG Asymmetry Neurofeedback in Depression
- ClinicalTrials.gov ID
- NCT00729547
- Acronym / sponsor ID
- neurofeedback / KRF-2005-079-HS0012
- Conditions
- Depression
- Keywords
- Depression, Biofeedback, Psychophysiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Collaborators
- Korea Research Foundation, Kyunghee University
- Study start
- Sep 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 7 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Behavioral: Psychotherapy placeboPsychotherapy placebo session |
| 1 | Experimental | Behavioral: NeurofeedbackNeurofeedback training which enhance left frontal alpha wave. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- clinical diagnosis of mood disorder
- right handed
- current BDI-2 score exceed 10
Key exclusion criteria (4 listed)
- with psychotic symptom
- with organic disorders
- treated by psychoactive drugs for at least 2 months prior to the study
- history of pathologic alcohol use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurofeedbackAlso: Asymmetry trainingenhance relative activity level of left frontal activity | Behavioural | 1 |
| Psychotherapy placeboThese sessions consisted of additional assessment, interpretation of the test results and providing information on course and treatment of mood disorder. | Behavioural | 2 |
Primary outcome
frontal EEG asymmetry indexes
Time frame: 5 weeks
1 secondary outcome
BDI-2
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2008.
- Background: PubMed 15564054Hammond 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.
- Background: PubMed 10638347Rosenfeld JP. An EEG biofeedback protocol for affective disorders. Clin Electroencephalogr. 2000 Jan;31(1):7-12. doi: 10.1177/155005940003100106. No abstract available.
- Results publication: PubMed 9031711Kumano 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 publication: PubMed 7495918Rosenfeld 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 publication: PubMed 8801245Saxby 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.
- click here to review subject recruiting and information on this studyLink provided by the sponsor.
- click here to see brief description of the department of psychology at Korea universityLink provided by the sponsor.
- click here to review the location of this study and the policy of IRBLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyuntaek Kim, PHD principal investigator
Department of Psychology, Korea university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback in people with Depression, run by Korea University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frontal EEG asymmetry indexes (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00729547, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2008.