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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02362698
Other study ID # 06-07LQ04
Secondary ID
Status Completed
Phase N/A
First received January 3, 2015
Last updated February 12, 2015
Start date January 2010
Est. completion date October 2012

Study information

Verified date February 2015
Source Chengdu University of Traditional Chinese Medicine
Contact n/a
Is FDA regulated No
Health authority China: State Administration of Traditional Chinese Medicine
Study type Interventional

Clinical Trial Summary

this research adopted multicentered, randomly and parallel control methods to observe the clinical effects of electro-acupuncture combined psychological intervention on internet addiction disorder, aim to provide a convenient, affordable and effective clinical protocol.


Description:

This research was aimed to discuss the impact of acupuncture treatment on the impulsive behavior of Internet Addiction Disorder (IAD) sufferers, with the detection of magnetic resonance spectroscopy (MRS), the assessment of Young's Internet Addiction Test (IAT), Barratt Impulsivity Scale (BIS-11) and Go/No-go task, hopefully that this research could provide basis for the further study as well as the establishment of comprehensive assessment and treatment protocol of IAD.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date October 2012
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility 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: ?Satisfaction obtaining through markedly increasing time online ?Spending same period of time online but with dramatic declining satisfaction.

- (2) Any following symptoms appeared after quitting internet surfing: ?Obvious 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. ?Desperate 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
electro-acupuncture
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.
psychological intervention
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chengdu University of Traditional Chinese Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary the change of the level of brain N-acetylaspartate on magnetic resonance spectroscopy from baseline at 40 days analysis day 1 and the day after treatment(treatment covered 40 days) had completed Yes
Primary the change from baseline of the total scores on Internet Addiction Test(IAT) at 40 days questionnaire day 1 and the day after treatment(treatment covered 40 days) had completed Yes
Primary the change of the level of brain choline on magnetic resonance spectroscopy from baseline at 40 days analysis day 1 and the day after treatment(treatment covered 40 days) had completed Yes
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