Status Approved
First Submitted Date
2019/06/11
Registered Date
2019/06/14
Last Updated Date
2019/06/14
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0004065 |
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Unique Protocol ID | 2016-66 |
Public/Brief Title | Clinical trials evaluating the effect of cranial electrotherapy stimulation (CES) for anxiety and stress reduction |
Scientific Title | Randomized Controlled, Double-blinded, Active-controlled designed clinical trial evaluating The effects of cranial electrotherapy stimulation(CES) in treatment anxiety and stress. |
Acronym | cranial electrotherapy stimulation (CES) |
MFDS Regulated Study | No |
IND/IDE Protocol | |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 2016-66 |
Approval Date | 2016-08-17 |
Institutional Review Board Name | Chuncheon Sacred Heart Hospital Institusional Review Board/Ethics Committee |
Institutional Review Board Address | 77, Sakju-ro, Chuncheon-si, Gangwon-do |
Institutional Review Board Telephone | 033-240-5128 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Daeyoung Roh |
Title | Clin. Assist. Prof. |
Telephone | +82-33-240-5739 |
Affiliation | Hallym University Medical Center- Chuncheon |
Address | Department of Psychiatry, Chuncheon Sacred Heart Hospital, 77 Sakju-ro, Chuncheon, Gangwon-Do, 24253, Republic of Korea |
Contact Person for Public Queries | |
Name | Jiheon Kim |
Title | Researcher |
Telephone | +82-33-240-5739 |
Affiliation | Hallym University Medical Center- Chuncheon |
Address | Department of Psychiatry, Chuncheon Sacred Heart Hospital, 77 Sakju-ro, Chuncheon, Gangwon-Do, 24253, Republic of Korea |
Contact Person for Updating Information | |
Name | Daeyoung Roh |
Title | Clin. Assist. Prof. |
Telephone | +82-33-240-5739 |
Affiliation | Hallym University Medical Center- Chuncheon |
Address | Department of Psychiatry, Chuncheon Sacred Heart Hospital, 77 Sakju-ro, Chuncheon, Gangwon-Do, 24253, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2017-02-15 Actual | |
Target Number of Participant | 60 | |
Primary Completion Date | 2018-10-01 , Actual | |
Study Completion Date | 2019-12-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Hallym University Medical Center- Chuncheon | |
Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2017-02-15 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Hallym University Medical Center- Chuncheon |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Hallym University Medical Center- Chuncheon |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Anxiety and stress-related disorders could be improved and return to normal life if they are treated at appropriate time. But most of patients with anxiety and stress-related disorders do not consider visiting hospital or cannot obtain help from mental health professional because they consider their disorders as an emotional status and have a reluctance to visit psychiatry department. If therapeutic apparatus which improve their symptoms in daily life easily are developed, it is possible to improve their symptom and resolve social issue related psychiatric disorder. With high effectiveness and safety, the CES is appropriate technology to develop as therapeutic apparatus that can treat anxiety, depression, sleep disorder, stress-related disorder and cognitive dysfunction. The purpose of this study is to evaluate of effectiveness of the equipment that is developed to miniaturize than other CES equipment and used as therapeutic apparatus that improves the people with anxiety, depression, sleep disorder and stress-related disorder in daily life through connects with other IT equipment. The device provides alternating current with a frequency of 10 Hz and an intensity of 500μA, linked with smartphone recording treatment logs. Stimulation electrodes were placed resembling the in-ear headphone locations so that it can play music in addition to electrical stimulation. At baseline, participants were randomly assigned to active and sham groups, and then at one time, half of each group told music and half did not. Therefore, In this study, we test the effectiveness of the newly developed CES equipment on anxiety and stress-related symptom in people with anxiety and stress. Also, we compare sleep quality, quality of life, depression, suicidality, cognitive function, fatigue and brain waves between treat group and control group. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Supportive Care |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Double |
Blinded Subject | Subject, Investigator |
Allocation | RCT |
Intervention Type | Medical Device |
Intervention Description | Experimental group: 50 minutes of Active CES, once everyday, for 3 weeks. Apply bi-phase pulse below 1mA. For the first application, apply music to half of the group and not the other half Active Comarator group: 50 minutes of Sham control CES, once everyday, for 3 weeks. Maintain current-free state. For the first application, apply music to half of the group and not the other half |
Number of Arms | 2 |
Arm 1 |
Arm Label Active CES(Cranial electrotherapy stimulation) Group |
Target Number of Participant 30 |
|
Arm Type Experimental |
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Arm Description 50 minutes of once everyday, for 3 weeks, applies Active CES which is micro-electricity device. participants are educated by the study presenter Before apply Active CES. To prevent dropout of patients due to injury and exhaustion, at least, participants are visited hospital once a week. For the first application, half of the group will listen to classical music and not the other half. |
|
Arm 2 |
Arm Label Sham control CES Group |
Target Number of Participant 30 |
|
Arm Type Active comparator |
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Arm Description 50 minutes of once everyday, for 3 weeks, applies Sham control CES. This device looks same with Active CES But not micro-electricity device. For the first application, half of the group will listen to classical music and not the other half. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (F00-F99)Mental and behavioural disorders (F41.2)Mixed anxiety and depressive disorder Anxiety Disorder: Persistent and disabling ANXIETY. Stress, Pshychological: Stress wherein emotional factors predominate. |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~65Year |
|
Description 1) Participants with Anxiety, Stress-relate disorder self-report score higher then four. 2) Men and women aged 19 to 65. 3) Those who are able to read and understand subject explanations and agreements, and who have the language ability to respond to the questionnaire. 4) Those who have voluntarily participated in the clinical trial and have agreed to the written consent of the subject and are able to participate in the entire period of the clinical trial. |
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Exclusion Criteria |
1) Except Anxiety disorder, according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) dignosed Axis I. 2) Primary diagnosis of alcohol or substance abuse 3) diagnosed with bipolar or psychotic major depressive disorder 4) attempted suicide before 6 months of screening 5) A person who is rated at 6 or more in suicidal tendency 6) A person judged to have problems with electroencephalography (EEG) or Alternating Current (AC) stimulation electrodes due to deformity of the scalp, inflammation reaction or other dermatological problems. 7) Have a contraindication about CES equipment(ex, A metal board is Inserted in the head). 8) A history of epilepsy and family history 9) Those with serious clinical impairment of cardiovascular, digestive, respiratory, endocrine, and central nervous system 10) Those who participated in other clinical trials within 30 days from the screening date 11) Female subjects likely to become pregnant 12) Pregnant or lactating women 13) In addition to the above, persons with clinical symptoms who are judged medically by the person in charge of testing or who are considered inappropriate for this test |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | SRI(Stress Response Instrument) |
|
Timepoint | Baseline and follow-up measurements (after 3 weeks of intervention) +- 1 week |
|
Primary Outcome(s) 2 | ||
Outcome | HAM-A(Hamilton Anxiety Rating Scale), STAI(State-Trait Anxiety Inventory) |
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Timepoint | Baseline and follow-up measurements (after 3 weeks of intervention) +- 1 week |
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Secondary Outcome(s) 1 | ||
Outcome | HAM-D(Hamilton Depression Rating Scale), BDI(Beck Depression Inventory) |
|
Timepoint | Baseline and follow-up measurements (after 3 weeks of intervention) +- 1 week |
|
Secondary Outcome(s) 2 | ||
Outcome | Wisconsin Card Sorting Test |
|
Timepoint | Baseline and follow-up measurements (after 3 weeks of intervention) +- 1 week |
|
Secondary Outcome(s) 3 | ||
Outcome | (PQSI)Pittsburgh Sleep Quality Index |
|
Timepoint | Baseline and follow-up measurements (after 3 weeks of intervention) +- 1 week |
|
Secondary Outcome(s) 4 | ||
Outcome | Suicidality Scale |
|
Timepoint | Baseline and follow-up measurements (after 3 weeks of intervention)+- 1 week |
|
Secondary Outcome(s) 5 | ||
Outcome | WHOQOL-BREF(Korean Version of WHO Quality of Life Scale Abbreviated Version) |
|
Timepoint | Baseline and follow-up measurements (after 3 weeks of intervention)+- 1 week |
|
Secondary Outcome(s) 6 | ||
Outcome | CGISI(clinician-rated Clinical Global Impression-Severity of Illness scale) |
|
Timepoint | Baseline and follow-up measurements (after 3 weeks of intervention)+- 1 week |
|
Secondary Outcome(s) 7 | ||
Outcome | qEEG (quantitative electroencephalography) |
|
Timepoint | Baseline and follow-up measurements (after 3 weeks of intervention)+- 1 week |
|
Secondary Outcome(s) 8 | ||
Outcome | EEG Coherence |
|
Timepoint | Baseline and follow-up measurements (after 3 weeks of intervention)+- 1 week |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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