Clinical trials evaluating the effect of cranial electrotherapy stimulation (CES) for anxiety and stress reductio
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0004065
- Lead Sponsor
- Hallym University Medical Center- Chuncheon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 60
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SRI(Stress Response Instrument);HAM-A(Hamilton Anxiety Rating Scale), STAI(State-Trait Anxiety Inventory)
- Secondary Outcome Measures
Name Time Method HAM-D(Hamilton Depression Rating Scale), BDI(Beck Depression Inventory);Wisconsin Card Sorting Test;(PQSI)Pittsburgh Sleep Quality Index;Suicidality Scale;WHOQOL-BREF(Korean Version of WHO Quality of Life Scale Abbreviated Version);CGISI(clinician-rated Clinical Global Impression-Severity of Illness scale);qEEG (quantitative electroencephalography);EEG Coherence