UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047480 |
|---|---|
| Receipt number | R000054148 |
| Scientific Title | Impact of Short-term Intensive-type Cognitive Behavioral Therapy Intervention on Internet Addiction among Chinese College Students: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2022/04/13 |
| Last modified on | 2022/04/13 18:50:33 |
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Basic information
Public title
Development and effectiveness of an intervention program for Internet Addiction among Chinese college students
Acronym
Intervention Study
Scientific Title
Impact of Short-term Intensive-type Cognitive Behavioral Therapy Intervention on Internet Addiction among Chinese College Students: A Randomized Controlled Trial
Scientific Title:Acronym
A Randomized Controlled Trial
Region
| Asia(except Japan) |
Condition
Condition
Internet Addiction Tendency
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effects of a short-term intensive-type CBT intervention with the purpose of preventing against IA among Chinese college students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Data were collected by three times for both groups: Pre-intervention, Post-intervention, and one month later.Primary outcome was Young's Internet Addiction Test.
Key secondary outcomes
The K6
Sense of Coherence (SOC-13)
The Multidimensional Scale of Perceived Social Support (MSPSS)
The General Procrastination Scale (GPS)
Internet Addiction Improvement Motivation Scale (IAIMS)
Subjective Evaluation of Self-status
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
6
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group received an intervention program in addition to a training course on IA, while the control group received only the training course on IA.The frequency and duration of the intervention program was 90 minutes per session for a total of 5 sessions (7.5 hours), delivered centrally over one weekend day.
Interventions/Control_2
The first session was titled "E-Net Sharing", and was designed to allow team members to get to know each other, sign team agreements, and share their histories, experiences, resources, and impressions about Internet use.
Interventions/Control_3
The second session was "Know Yourself", and the goals were to learn the characteristics of one's stress disposition and self-care behaviors, to recognize one's predominant resources, and to increase one's sense of self-esteem.
Interventions/Control_4
The third session was "Problem Solving", and the goals were to inspire the wisdom of group members to seek out each other's superior resources and confront practical concerns.
Interventions/Control_5
The fourth session was "Meaning of Life", and the goals were to get the team members to think deeply about the meaning and values of life through sharing with each other and to increase their sense of meaning.
Interventions/Control_6
The fifth session was "True Confessions", and the goals were to share their harvests with each other and process their feelings of separation among group members.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students who scored above the cut-off value of 50 on the Young's Internet Addiction Test; Students in their second year of college or above who have been taken the required course of college psycho-health education in their first-year; Students who understand the purpose of this study and can give informed consent to participate in this study; Students who are available to participate during the determined group intervention time frame.
Key exclusion criteria
Students undergoing treatment for mental disorders; Students receiving other counseling or group activities related to IA.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Morita |
Organization
Department of Social Psychiatry and Mental Health
Division name
Faculty of Medicine, University of Tsukuba
Zip code
305-8577
Address
Room D743, General Research Building, 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3099
nobu-mori@umin.ac.jp
Public contact
Name of contact person
| 1st name | Nobuaki |
| Middle name | |
| Last name | Morita |
Organization
Department of Social Psychiatry and Mental Health
Division name
Faculty of Medicine, University of Tsukuba
Zip code
305-8577
Address
Room D743, General Research Building, 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3099
Homepage URL
nobu-mori@umin.ac.jp
Sponsor or person
Institute
Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Zhejiang Gongshang University, China
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee, University of Tsukuba
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
029-853-3914
t-credo.adm@un.tsukuba.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
中国浙江工商大学心理健康教育センター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
43
Results
The results suggested that the intervention program may reduce Chinese college students' IA symptoms and improve their SOC, and have the potential to decrease their tendency to procrastinate. In addition, sustained effects were shown to have the potential to improve students' tendency toward IA and the perception of social support from significant others.
Results date posted
| 2022 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No significant differences were found between the two groups. Therefore, random assignment confirmed that participants in both groups were homogeneous in their characteristics at baseline.
Participant flow
50 college students were eligible to participate in this study, but 6 students were excluded due to personal reasons. As a result, 44 participants were eligible for random assignment, 22 in the intervention group and 22 in the control group. Of those who participated in the intervention program, 1 intervention group participant was excluded because he missed two sessions, and a total of 43 participants, 21 in the intervention group and 22 in the control group, were finally included in the analysis.
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 13 | Day |
Last modified on
| 2022 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054148
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