About this trial
Problematic internet use (PIU) is a growing behavioral health concern among university students. This study aims to evaluate the effectiveness and psychological mechanisms of "IMPROVE," a manualized, multimodal group-based psychotherapy. The IMPROVE program integrates cognitive-behavioral strategies with motivational elements, mindfulness training, and socially interactive exercise. In this randomized controlled trial, 600 university students with moderate to severe PIU will be randomized to either the 8-week IMPROVE intervention or an enhanced waitlist control group. The primary outcome is the change in PIU severity, assessed by the Internet Addiction Test (IAT) score, from baseline to the post-intervention endpoint (8 weeks).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
University students aged between 18 and 30 years.
Score 50 or above on the Internet Addiction Test (IAT), indicating moderate to severe PIU.
Report subjective suffering regarding internet use.
Own a personal smartphone or other electronic communication device.
Disqualifiers
Self-reported history of substance use (excluding tobacco and alcohol) within the past 12 months.
Current or previous participation in any form of psychotherapy for PIU.
Presence of severe physical or neurological conditions (e.g., organic brain diseases, TBI).
Self-reported history of diagnosed psychiatric disorders (e.g., schizophrenia, bipolar disorder).
Trial design
Parallel
Treatments tested in this trial
IMPROVE Program
BehavioralA manualized, group-based, multimodal integrative psychotherapy. It integrates CBT-informed strategies, Mindfulness-Based Interventions, and Socially Interactive Exercise. Delivered over 8 weekly sessions (120 minutes each). Groups consist of 10-15 participants
Digital Psychoeducation Newsletters
BehavioralWeekly newsletters pushed via WeChat containing psychoeducation on consequences of internet use and general advice for reducing screen time.
Treatment groups
Trial outcomes
Primary outcomes
Change in Problematic Internet Use Severity (IAT Score)
Assessed using the Internet Addiction Test (IAT). Scores range from 0 to 100, with higher scores indicating greater severity. The primary endpoint is the change from baseline to post-intervention
Secondary outcomes
Long-term Change in PIU Severity (IAT)
Assessing the maintenance of intervention effects using the Internet Addiction Test (IAT) scores during the follow-up phase.
Participant Satisfaction ( CSQ-8)
Assessed using the modified version of the Client Satisfaction Questionnaire (CSQ-8) to evaluate the acceptability of the intervention. The total scores range from 8 to 40, with higher scores indicating higher satisfaction.
Smartphone Addiction Risk (SAS-SV)
Assessed using the Smartphone Addiction Scale-Short Version (SAS-SV). Scores range from 10 to 60, with higher scores indicating higher risk of smartphone addiction.
Internet-use Disorder severity based on ICD-11 criteria (ACSID-11)
Assessed using the Assessment of Criteria for Specific Internet-use Disorders (ACSID-11). Frequency scores of four core ICD-11 diagnostic features (impaired control, increasing priority, continuation despite negative consequences, and functional impairment) will be evaluated. Scores range from 0 to 33, with higher scores indicating more severe addiction.
Other outcomes
Collection of neuroimaging data for exploratory analyses
Structural and functional MRI data will be acquired in a voluntary substudy for exploratory, hypothesis-generating analyses. Imaging-derived metrics (e.g., regional brain measures, task-related activation, or connectivity indices) will be determined based on prespecified analytic plans developed prior to data analysis.
Collection of peripheral blood samples for exploratory biomarker analyses
Peripheral blood samples will be collected for future exploratory analyses of stress-related and inflammatory biomarkers.
Sponsors and contacts
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