The Use of Nursing-students-led bCBTMI

May 31, 2023 updated by: Dr Katherine Lam, The Hong Kong Polytechnic University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Hong Kong
    • Hong Kong,China
      • Hong Kong, Hong Kong,China, Hong Kong, 0000
        • Recruiting
        • Katherine Lam
        • Contact:
          • Katherine Lam, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • With physical or cognitive impairment and learning problems as identified from the medical records

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: bCBTMI
bCBTMI care for IA.
Behavioral: bCBTMI
This experimental group involves 4 weekly 30-45 minute sessions using the brief CBT and the brief MI models by trained nursing students.
Placebo Comparator: Control
Routine care for IA.
Behavioral: Control
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at day 1
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.
at day 1
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.
at the 6-month follow-up
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.
at day 1
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.
Immediately after the bCBTMI intervention
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.
at the 6-month 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.
at the 1-month follow-up
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.
at the 6-month 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.
at the 6-month follow-up
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.
at the 6-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported abstinence at the 1-week follow-up
Time Frame: at the 1-week follow-up
Measured by the number of IA symptoms via a self-reported questionnaire.
at the 1-week follow-up
Self-reported abstinence at the 1-month follow-up
Time Frame: at the 1-month follow-up
Measured by the number of IA symptoms via a self-reported questionnaire.
at the 1-month follow-up
Self-reported abstinence at the 3-month follow-up
Time Frame: at the 3-month follow-up
Measured by the number of IA symptoms via a self-reported questionnaire.
at the 3-month follow-up
Self-reported abstinence at the 6-month follow-up
Time Frame: at the 6-month follow-up
Measured by the number of IA symptoms via a self-reported questionnaire.
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
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.
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
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.
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
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.
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
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.
at the 6-month follow-up
Anxiety level
Time Frame: at the 1-week follow-up
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.
at the 1-week follow-up
Anxiety level
Time Frame: at the 1-month follow-up
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.
at the 1-month follow-up
Anxiety level
Time Frame: at the 3-month follow-up
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.
at the 3-month follow-up
Anxiety level
Time Frame: at the 6-month follow-up
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.
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
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.
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
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.
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
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.
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
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.
at the 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ka Wai Katherine Lam, School of Nursing, Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • bCBTMI-Adolescents

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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