Internet AddictionNCT05897359
The Use of Nursing-students-led bCBTMI
A study testing bCBTMI in people with Internet Addiction, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The use of the internet is very popular in adolescence. Notwithstanding the benefits from the internet, many users are addicted to the internet and develop problematic behaviours which are regarded as "Internet addiction" (IA). Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Internet Addiction
- What is being tested?
- bCBTMI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2022to 1 May 2024
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 13 to 17
- Studying Forms 2 to 4
- Classified as IA by the Chinese version of Young's 10-item Internet Addiction Test (IAT)
- Can communicate in Cantonese and read Chinese.
Who cannot join
- With physical or cognitive impairment and learning problems as identified from the medical records
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Katherine Lam
Hong Kong, Hong Kong,China, 0000
Katherine Lam, Phd
About this study
Official title: The Use of Nursing-students-led bCBTMI for Internet Addiction Among Adolescents: a Feasibility Cluster Randomised Controlled Trial
The use of the internet is very popular in adolescence. Notwithstanding the benefits from the internet, many users are addicted to the internet and develop problematic behaviours which are regarded as "Internet addiction" (IA). Trained nursing students, who are the future nurses and well-equipped with basic health knowledge, as the interventionists to deliver a bCBTMI intervention to the eligible subjects. The result of this study is expected to provide evidence of the feasibility and effectiveness of training nursing students to conduct bCBTMI in Hong Kong Chinese adolescents with IA for a definitive RCT.
Read the detailed description
A two-arm, parallel-group, feasibility cluster randomized controlled trial will be conducted. 60 adolescents with IA will be recruited from secondary schools in Hong Kong. Participants in the intervention group will receive 4 weekly 30-45 minute sessions using the brief CBT and the brief MI models by nursing students. Control group participants will receive routine care for IA.
- Conditions
- Internet Addiction
- Being tested
- bCBTMI, Control
- Keywords
- Adolescents, Nursing-students-led, Cognitive Behavioural therapy, Motivational Interviewing
- Medical subject headings
- Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bCBTMIBehavioural
This experimental group involves 4 weekly 30-45 minute sessions using the brief CBT and the brief MI models by trained nursing students.
ControlBehavioural
The control group will receive health talks about internet addiction consequences and impacts on young people by nursing students who are not involved in the intervention group to mimic the time and attention spent on the intervention group. These health talks are considered routine care for IA health promotion.
| Study group | Role | What they receive |
|---|---|---|
| bCBTMI | Experimental | bCBTMI care for IA. Receives: Behavioral: bCBTMI |
| Control | Placebo comparator | Routine care for IA. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening rate
Calculated as the number of students screened at participated secondary schools divided by number of students at participated schools during the recruitment period.
Measured: at day 1
Eligibility rate
Calculated by dividing the number of secondary school students who are eligible by the number who are screened.
Measured: at day 1
Consent rate
Calculated by dividing the number of secondary school students who consent to join the study by the number who are eligible.
Measured: at the 6-month follow-up
Randomization rate
Calculated by dividing the number of secondary school students who are randomized into intervention and control groups by those who provide consent.
Measured: at day 1
Attendance rate
Calculated by dividing the number of secondary school students who complete the intervention by those who are randomized.
Measured: Immediately after the bCBTMI intervention
Retention rate
Calculated by dividing the number of secondary school students who remain in the study by those who are randomized. Retention rates for the intervention and control groups will be calculated at each follow-up.
Measured: at the 6-month follow-up
Adherence to intervention protocol
Calculated by dividing the number of secondary school students who follow the intervention protocol by those who are randomized.
Measured: at the 1-month follow-up
Complete rate
Calculated by dividing the number of secondary school students who returned questionnaires by the number of questionnaires distributed. This will be calculated by groups at baseline and each follow-up.
Measured: at the 6-month follow-up
Missing data
Calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values.
Measured: at the 6-month follow-up
Adverse events
Are defined as unfavorable and unintended events that are not present at baseline, or appear to have worsened during the study. The relation to the intervention will be assessed in accordance with the protocol for adverse events management (It can be provided upon request). The number and event severity will be recorded. Numbers and reasons for exclusions will be noted.
Measured: at the 6-month follow-up
Secondary outcomes (16)
Self-reported abstinence at the 1-week follow-up
Measured by the number of IA symptoms via a self-reported questionnaire.
Measured: at the 1-week follow-up
Self-reported abstinence at the 1-month follow-up
Measured by the number of IA symptoms via a self-reported questionnaire.
Measured: at the 1-month follow-up
Self-reported abstinence at the 3-month follow-up
Measured by the number of IA symptoms via a self-reported questionnaire.
Measured: at the 3-month follow-up
Self-reported abstinence at the 6-month follow-up
Measured by the number of IA symptoms via a self-reported questionnaire.
Measured: at the 6-month follow-up
The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
CES-DC will be used to record the number of depression symptoms in secondary schools students with IA at each follow-up. It includes 20 items asking on a 4-point Likert scale in relation to the incidence of the stated symptoms during the previous week, and are scored from 0 to 3 (0 = not at all, 3 = a lot). Total scores range from 0 to 60, with higher scores indicating greater number of depressive symptoms. This questionnaire has been empirically tested and validated in Hong Kong children and are currently using in Youth Quitline.
Measured: at the 1-week follow-up
The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
CES-DC will be used to record the number of depression symptoms in secondary schools students with IA at each follow-up. It includes 20 items asking on a 4-point Likert scale in relation to the incidence of the stated symptoms during the previous week, and are scored from 0 to 3 (0 = not at all, 3 = a lot). Total scores range from 0 to 60, with higher scores indicating greater number of depressive symptoms. This questionnaire has been empirically tested and validated in Hong Kong children and are currently using in Youth Quitline.
Measured: at the 1-month follow-up
The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
CES-DC will be used to record the number of depression symptoms in secondary schools students with IA at each follow-up. It includes 20 items asking on a 4-point Likert scale in relation to the incidence of the stated symptoms during the previous week, and are scored from 0 to 3 (0 = not at all, 3 = a lot). Total scores range from 0 to 60, with higher scores indicating greater number of depressive symptoms. This questionnaire has been empirically tested and validated in Hong Kong children and are currently using in Youth Quitline.
Measured: at the 3-month follow-up
The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
CES-DC will be used to record the number of depression symptoms in secondary schools students with IA at each follow-up. It includes 20 items asking on a 4-point Likert scale in relation to the incidence of the stated symptoms during the previous week, and are scored from 0 to 3 (0 = not at all, 3 = a lot). Total scores range from 0 to 60, with higher scores indicating greater number of depressive symptoms. This questionnaire has been empirically tested and validated in Hong Kong children and are currently using in Youth Quitline.
Measured: at the 6-month follow-up
Anxiety level
The anxiety level of secondary school students with IA will be measured by the short form of the Chinese Version of the State Anxiety Scale for Children (CSAS-C) at each follow-up. It has 10 itmes with scores from 1 to 3. Total scores range from 10 to 30, with higher scores indicating a higher level of anxiety. This questionnaire has been empirically tested and validated in Hong Kong children.
Measured: at the 1-week follow-up
Anxiety level
The anxiety level of secondary school students with IA will be measured by the short form of the Chinese Version of the State Anxiety Scale for Children (CSAS-C) at each follow-up. It has 10 itmes with scores from 1 to 3. Total scores range from 10 to 30, with higher scores indicating a higher level of anxiety. This questionnaire has been empirically tested and validated in Hong Kong children.
Measured: at the 1-month follow-up
Anxiety level
The anxiety level of secondary school students with IA will be measured by the short form of the Chinese Version of the State Anxiety Scale for Children (CSAS-C) at each follow-up. It has 10 itmes with scores from 1 to 3. Total scores range from 10 to 30, with higher scores indicating a higher level of anxiety. This questionnaire has been empirically tested and validated in Hong Kong children.
Measured: at the 3-month follow-up
Anxiety level
The anxiety level of secondary school students with IA will be measured by the short form of the Chinese Version of the State Anxiety Scale for Children (CSAS-C) at each follow-up. It has 10 itmes with scores from 1 to 3. Total scores range from 10 to 30, with higher scores indicating a higher level of anxiety. This questionnaire has been empirically tested and validated in Hong Kong children.
Measured: at the 6-month follow-up
Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)
It contains 19 items measuring 7 domains: subjective sleep quality, latency, duration, habitual efficiency, disturbances, use of medication, and daytime dysfunction on a 3-point scale (0: no difficulty to 3: severe difficulty) except for the items reporting bedtime and time awake. The sum of the seven component scores produces a global score with higher scores represent poorer subjective sleep quality. It has been validated in Hong Kong children and adolescents previously.
Measured: at the 1-week follow-up
Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)
It contains 19 items measuring 7 domains: subjective sleep quality, latency, duration, habitual efficiency, disturbances, use of medication, and daytime dysfunction on a 3-point scale (0: no difficulty to 3: severe difficulty) except for the items reporting bedtime and time awake. The sum of the seven component scores produces a global score with higher scores represent poorer subjective sleep quality. It has been validated in Hong Kong children and adolescents previously.
Measured: at the 1-month follow-up
Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)
It contains 19 items measuring 7 domains: subjective sleep quality, latency, duration, habitual efficiency, disturbances, use of medication, and daytime dysfunction on a 3-point scale (0: no difficulty to 3: severe difficulty) except for the items reporting bedtime and time awake. The sum of the seven component scores produces a global score with higher scores represent poorer subjective sleep quality. It has been validated in Hong Kong children and adolescents previously.
Measured: at the 3-month follow-up
Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)
It contains 19 items measuring 7 domains: subjective sleep quality, latency, duration, habitual efficiency, disturbances, use of medication, and daytime dysfunction on a 3-point scale (0: no difficulty to 3: severe difficulty) except for the items reporting bedtime and time awake. The sum of the seven component scores produces a global score with higher scores represent poorer subjective sleep quality. It has been validated in Hong Kong children and adolescents previously.
Measured: at the 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Sep 2022
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internet AddictionStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Katherine Lam, The Hong Kong Polytechnic University
- Investigators
- Ka Wai Katherine Lam, Principal investigator, School of Nursing, Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897359
- Sponsor's protocol ID
- bCBTMI-Adolescents
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Nursing-students-led bCBTMI for Internet Addiction Among Adolescents: a Feasibility Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05897359
- Acronym / sponsor ID
- bCBTMI-Adolescents
- Conditions
- Internet Addiction
- Keywords
- Adolescents, Nursing-students-led, Cognitive Behavioural therapy, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 9 Jun 2023 (actual)
- 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.
The use of the internet is very popular in adolescence. Notwithstanding the benefits from the internet, many users are addicted to the internet and develop problematic behaviours which are regarded as "Internet addiction" (IA). Trained nursing students, who are the future nurses and well-equipped with basic health knowledge, as the interventionists to deliver a bCBTMI intervention to the eligible subjects. The result of this study is expected to provide evidence of the feasibility and effectiveness of training nursing students to conduct bCBTMI in Hong Kong Chinese adolescents with IA for a definitive RCT.
Detailed description
A two-arm, parallel-group, feasibility cluster randomized controlled trial will be conducted. 60 adolescents with IA will be recruited from secondary schools in Hong Kong. Participants in the intervention group will receive 4 weekly 30-45 minute sessions using the brief CBT and the brief MI models by nursing students. Control group participants will receive routine care for IA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bCBTMI | Experimental | Behavioral: bCBTMIbCBTMI care for IA. |
| Control | Placebo comparator | Behavioral: ControlRoutine care for IA. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 13 to 17
- Studying Forms 2 to 4
- Classified as IA by the Chinese version of Young's 10-item Internet Addiction Test (IAT)
- Can communicate in Cantonese and read Chinese.
Key exclusion criteria (1 listed)
- With physical or cognitive impairment and learning problems as identified from the medical records
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 |
|---|---|---|
| bCBTMIThis experimental group involves 4 weekly 30-45 minute sessions using the brief CBT and the brief MI models by trained nursing students. | Behavioural | bCBTMI |
| ControlThe control group will receive health talks about internet addiction consequences and impacts on young people by nursing students who are not involved in the intervention group to mimic the time and attention spent on the intervention group. These health talks are considered routine care for IA health promotion. | Behavioural | Control |
Primary outcome
Screening rate
Time frame: at day 1
Calculated as the number of students screened at participated secondary schools divided by number of students at participated schools during the recruitment period.
Eligibility rate
Time frame: at day 1
Calculated by dividing the number of secondary school students who are eligible by the number who are screened.
Consent rate
Time frame: at the 6-month follow-up
Calculated by dividing the number of secondary school students who consent to join the study by the number who are eligible.
Randomization rate
Time frame: at day 1
Calculated by dividing the number of secondary school students who are randomized into intervention and control groups by those who provide consent.
Attendance rate
Time frame: Immediately after the bCBTMI intervention
Calculated by dividing the number of secondary school students who complete the intervention by those who are randomized.
Retention rate
Time frame: at the 6-month follow-up
Calculated by dividing the number of secondary school students who remain in the study by those who are randomized. Retention rates for the intervention and control groups will be calculated at each follow-up.
Adherence to intervention protocol
Time frame: at the 1-month follow-up
Calculated by dividing the number of secondary school students who follow the intervention protocol by those who are randomized.
Complete rate
Time frame: at the 6-month follow-up
Calculated by dividing the number of secondary school students who returned questionnaires by the number of questionnaires distributed. This will be calculated by groups at baseline and each follow-up.
Missing data
Time frame: at the 6-month follow-up
Calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values.
Adverse events
Time frame: at the 6-month follow-up
Are defined as unfavorable and unintended events that are not present at baseline, or appear to have worsened during the study. The relation to the intervention will be assessed in accordance with the protocol for adverse events management (It can be provided upon request). The number and event severity will be recorded. Numbers and reasons for exclusions will be noted.
16 secondary outcomes
Self-reported abstinence at the 1-week follow-up
Time frame: at the 1-week follow-up
Self-reported abstinence at the 1-month follow-up
Time frame: at the 1-month follow-up
Self-reported abstinence at the 3-month follow-up
Time frame: at the 3-month follow-up
Self-reported abstinence at the 6-month follow-up
Time frame: at the 6-month follow-up
The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
Time frame: at the 1-week follow-up
The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
Time frame: at the 1-month follow-up
The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
Time frame: at the 3-month follow-up
The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
Time frame: at the 6-month follow-up
Anxiety level
Time frame: at the 1-week follow-up
Anxiety level
Time frame: at the 1-month follow-up
Anxiety level
Time frame: at the 3-month follow-up
Anxiety level
Time frame: at the 6-month follow-up
Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: at the 1-week follow-up
Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: at the 1-month follow-up
Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: at the 3-month follow-up
Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: at the 6-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
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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.
Ka Wai Katherine Lam principal investigator
School of Nursing, Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bCBTMI in people with Internet Addiction, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ka Wai Katherine Lam (27666420, kw-katherine.lam@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening rate (time frame: at day 1). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2023.