Clinical trial NCT05897359: The Use of Nursing-students-led bCBTMI
Official title: The Use of Nursing-students-led bCBTMI for Internet Addiction Among Adolescents: a Feasibility Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Internet Addiction
Keywords: Adolescents
Nursing-students-led
Cognitive Behavioural therapy
Motivational Interviewing
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility criteria: 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

Primary outcomes:
measure: Screening rate
timeFrame: at day 1
measure: Eligibility rate
timeFrame: at day 1
measure: Consent rate
timeFrame: at the 6-month follow-up
measure: Randomization rate
timeFrame: at day 1
measure: Attendance rate
timeFrame: Immediately after the bCBTMI intervention
measure: Retention rate
timeFrame: at the 6-month follow-up
measure: Adherence to intervention protocol
timeFrame: at the 1-month follow-up
measure: Complete rate
timeFrame: at the 6-month follow-up
measure: Missing data
timeFrame: at the 6-month follow-up
measure: Adverse events
timeFrame: at the 6-month follow-up
Secondary outcomes:
measure: Self-reported abstinence at the 1-week follow-up
timeFrame: at the 1-week follow-up
measure: Self-reported abstinence at the 1-month follow-up
timeFrame: at the 1-month follow-up
measure: Self-reported abstinence at the 3-month follow-up
timeFrame: at the 3-month follow-up
measure: Self-reported abstinence at the 6-month follow-up
timeFrame: at the 6-month follow-up
measure: The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
timeFrame: at the 1-week follow-up
measure: The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
timeFrame: at the 1-month follow-up
measure: The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
timeFrame: at the 3-month follow-up
measure: The Chinese version of Center for Epidemiologic Studies Depression Scale for Children (CES-DC)
timeFrame: at the 6-month follow-up
measure: Anxiety level
timeFrame: at the 1-week follow-up
measure: Anxiety level
timeFrame: at the 1-month follow-up
measure: Anxiety level
timeFrame: at the 3-month follow-up
measure: Anxiety level
timeFrame: at the 6-month follow-up
measure: Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: at the 1-week follow-up
measure: Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: at the 1-month follow-up
measure: Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: at the 3-month follow-up
measure: Sleep quality of secondary schools students with IA will be assessed using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: at the 6-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Katherine Lam
state: Hong Kong,China
Study officials:
affiliation: School of Nursing, Hong Kong Polytechnic University
name: Ka Wai Katherine Lam
role: PRINCIPAL_INVESTIGATOR
References: