AddictionNCT02362698
Clinical Research of Electro-acupuncture Combined Psychological Intervention on Internet Addiction Disorder
A study testing electro-acupuncture and psychological intervention in people with Addiction, run by Chengdu University of Traditional Chinese Medicine.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Addiction
- What is being tested?
- electro-acupuncture and psychological intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the detailed 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.
- Conditions
- Addiction
- Being tested
- electro-acupuncture, psychological intervention
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electro-acupunctureOther
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 interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| electro-acupuncture | Experimental | 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. Receives: Other: electro-acupuncture |
| psychological intervention | Active comparator | 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. Receives: Other: psychological intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of the level of brain N-acetylaspartate on magnetic resonance spectroscopy from baseline at 40 days
analysis
Measured: 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
questionnaire
Measured: 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
analysis
Measured: day 1 and the day after treatment(treatment covered 40 days) had completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startJan 2010
- Primary completionOct 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tianmin Zhu, Doctor, Study chair, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362698
- Sponsor's protocol ID
- 06-07LQ04
- Status last verified
- Feb 2015
- First submitted
- 3 Jan 2015
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Peng W, Wang Y, Hao Q, Wang J, Chen Y, Qiu M, Tu Y, Li H, Zhu T. Effects of Electroacupuncture Combined With Psychological Intervention on Depressive Status and Contingent Negative Variation in Patients With Internet Addiction Disorder: A Randomized Controlled Trial. Front Psychiatry. 2021 Nov 15;12:722422. doi: 10.3389/fpsyt.2021.722422. eCollection 2021.
PubMed 34867514
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research of Electro-acupuncture Combined Psychological Intervention on Internet Addiction Disorder
- ClinicalTrials.gov ID
- NCT02362698
- Acronym / sponsor ID
- 06-07LQ04
- Conditions
- Addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electro-acupuncture | Experimental | Other: electro-acupunctureReceiving electro-acupuncture treatment once every other day, half an hour per treatment, 10 times as one treatment course, subjects received 2 courses of treatment. |
| psychological intervention | Active comparator | Other: psychological interventionReceiving cognitive behavioral therapy once every four days, each time two hours. Five times intervention as one treatment course, subjects received 2 courses of treatment. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electro-acupuncture13points 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. | Other | electro-acupuncture |
| psychological interventionCognitive 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. | Other | psychological intervention |
Primary outcome
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
- Derived from this study: PubMed 34867514Peng W, Wang Y, Hao Q, Wang J, Chen Y, Qiu M, Tu Y, Li H, Zhu T. Effects of Electroacupuncture Combined With Psychological Intervention on Depressive Status and Contingent Negative Variation in Patients With Internet Addiction Disorder: A Randomized Controlled Trial. Front Psychiatry. 2021 Nov 15;12:722422. doi: 10.3389/fpsyt.2021.722422. eCollection 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tianmin Zhu, Doctor study chair
Chengdu University of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A study testing electro-acupuncture and psychological intervention in people with Addiction, run by Chengdu University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02362698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2015.