Clinical Trial for Efficacy and Safety Evaluation of Neurostimulation using Electroacupuncture in Patients with Anxiety Disorder
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0008378
- Lead Sponsor
- Daejeon Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Participants who
1) aged 19-70 years old
2) diagnosed of anxiety disorder by Structured Clinical Interview for DSM-5 including social anxiety disorder, agoraphobia, panic disorder, generalized anxiety disorder, other specified anxiety disorders and unspecified anxiety disorder
3) voluntarily decide to participate in this clinical study and signed the written consent form
4) are able to complete electroacupuntrue-neural stimulation treatments for 8 weeks
1) risk of suicide with C-SSRS > 4
2) current or past history of schizophrenia or bipolar disorder
3) separation anxiety disorder, elective mutism, substance-induced anxiety disorder, anxiety disorder due to medication, or anxiety disorder due to other medical conditions
4) history of acupuncture treatment within 4 weeks
5) alcohol or other substance use disorders within 8 weeks
6) history of cerebrovascular diseases, brain tumor, or traumatic brain injury
7) history of neurological or systemic diseases that may affect central nervous system
8) unstable medical conditions requiring inpatient treatment
9) usage of a pacemaker
10) indications for acupuncture treatment being inappropriate or unsafe (e.g., acupuncture-associated vasovagal response or tissue damage due to acupuncture)
11) participation in medication or other intervention in other clinical trials within 1 month
12) pregnant or lactating women or not using medically acceptable contraception during the study period
13) inappropriate for enrollment due to other reasons as determined by the investigators
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hamilton Anxiety Rating Scale
- Secondary Outcome Measures
Name Time Method Beck Anxiety Inventory;Beck Depression Inventory;Patient Health Questionnaire-15;WHO QoL assessment instrument abbreviated version;Penn State Worry Questionnaire (only for Generalized anxiety disorder, Other specified anxiety disorders, Anxiety disorder, unspecified);The Panic Disorder Severity Scale (only for Panic disorder and Agoraphobia);Liebowitz Social Anxiety Scale (only for Social anxiety disorder)