- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02362698
Clinical Research of Electro-acupuncture Combined Psychological Intervention on Internet Addiction Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects manifested three or more among the seven following conditions within one year could be defined as internet addiction:
- (1) Tolerance, complied with either one: ①Satisfaction obtaining through markedly increasing time online ②Spending same period of time online but with dramatic declining satisfaction.
- (2) Any following symptoms appeared after quitting internet surfing: ①Obvious withdrawal syndrome: A-- Quitted or decreased long time internet surfing. B--Within one month after A, two or more following symptoms appeared: (a) Depressed. (b) Psychomotor fidgety. (c) Compulsively thought things happened online. (d) Hallucinated or dreamed about internet related stuff. (e) Consciously or unconsciously carried out tapping the keyboard movement. C--The symptoms in B led to unexpected damage to one's social life, work and other important aspects of life, even depression. ②Desperate to surf the internet or seek similar online service in a bid to relieve or avoid withdrawal syndrome.
- (3) More frequent online behaviors or longer online time than planned.
- (4) Had been trying hard to reduce or control internet use but never succeeded.
- (5) Spent large amount of time on internet related things, such as purchasing online books, trying out new browsers, organizing downloaded files, etc.
- (6) Giving up or reducing important social, work or entertainment activities.
- (7) Despite unfavorable physical, mental, social or work consequences, continued to use internet.
Exclusion Criteria:
- Other psychiatric disease history.
- Drug addiction history
- Severe cardiovascular disease, blood diseases, malignant tumors or any other contraindication of electro-acupuncture.
- Allergic to acupuncture treatment.
- Participants with intracranial diseases or abnormal scalp structure.
- Participants with metal implant.
- Color blindness, left handedness.
- Women in gestation or lactation period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: electro-acupuncture
Receiving electro-acupuncture treatment once every other day, half an hour per treatment, 10 times as one treatment course, subjects received 2 courses of treatment.
|
13points were selected including he-gu(LI4), nei-guan(PC6), tai-chong(LR3) and san-yin-jiao(SP6) from both sides, bai-hui(GV20) and si-shen-cong(EX-HN1) from head. HANS-200A acupoints stimulator, which had two output channels, was connected to some selected points. Dilatational wave was adopted in this research, the frequency of rarefaction wave was 2 hertz and condensation wave was 100 hertz, with a waviness width of 0.3ms. Switched the stimulator on after connected the poles to the needles, adjusted the intensity of output gradually from 0 milliampere to the extent of subject's maximum tolerance. Then needles would be remained on the body for half an hour. |
Active Comparator: psychological intervention
Receiving cognitive behavioral therapy once every four days, each time two hours.
Five times intervention as one treatment course, subjects received 2 courses of treatment.
|
Cognitive behavioral therapy was adopted by national accredited professional psychologist, in the form of team work and individual counseling, aim to help IA participants to understand their deviant behaviors, correct unhealthy cognitive states and eventually retrieve normal life style.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the change of the level of brain N-acetylaspartate on magnetic resonance spectroscopy from baseline at 40 days
Time Frame: day 1 and the day after treatment(treatment covered 40 days) had completed
|
analysis
|
day 1 and the day after treatment(treatment covered 40 days) had completed
|
the change from baseline of the total scores on Internet Addiction Test(IAT) at 40 days
Time Frame: day 1 and the day after treatment(treatment covered 40 days) had completed
|
questionnaire
|
day 1 and the day after treatment(treatment covered 40 days) had completed
|
the change of the level of brain choline on magnetic resonance spectroscopy from baseline at 40 days
Time Frame: day 1 and the day after treatment(treatment covered 40 days) had completed
|
analysis
|
day 1 and the day after treatment(treatment covered 40 days) had completed
|
Collaborators and Investigators
Investigators
- Study Chair: Tianmin Zhu, Doctor, Chengdu University of Traditional Chinese Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-07LQ04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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