Group-based IMPROVE Therapy for Problematic Internet Use in University Students
ConditionProblematic Internet Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorSir Run Run Shaw Hospital
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
be university students aged between 18 and 30 years;
report subjective suffering regarding their own internet use and score 50 or above on the Internet Addiction Test (IAT), indicating at least a moderate level of PIU;
own a personal smartphone or other electronic communication device to ensure accessibility to digital intervention components;
provide written informed consent prior to enrollment.
Disqualifiers
a 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;
the presence of severe physical or neurological conditions (e.g., organic brain diseases, history of traumatic brain injury, or coma);
a self-reported history of diagnosed psychiatric disorders (e.g., schizophrenia, bipolar disorder).
Trial design
Design model
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
600 Participants
are divided into 2 treatment groupsGroup A: IMPROVE Intervention GroupExperimental treatment 1 intervention
Group B: Enhanced Waitlist Control (EWC) GroupOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in Problematic Internet Use Severity (IAT Score)
Assessed using the Internet Addiction Test (IAT). Scores range from 20 to 100, with higher scores indicating greater severity. The primary endpoint is the change from baseline to post-intervention
Time frame
Baseline (T0) and Post-intervention (Week 8, T2)Secondary outcomes
1
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.
Time frame
Month 1 (T3), Month 3 (T4), Month 6 (T5), and Month 12 (T6) Follow-up2
Participant Satisfaction and Acceptability
Participant satisfaction and acceptability will be assessed at postintervention using an adapted eight-item questionnaire based on the Client Satisfaction Questionnaire, supplemented by study-specific closed-ended items assessing overall programme quality, perceived helpfulness, needs fulfilment, willingness to recommend or participate again, satisfaction with therapist guidance, the helpfulness of individual sessions and intervention components, session length, programme duration, between-session practice burden, and group atmosphere. Item-level response distributions will be summarized descriptively.
Time frame
Post-intervention at Week 8 (T2)3
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.
Time frame
Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up4
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.
Time frame
Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-upOther outcomes
1
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. Analyses will be restricted to consenting participants assigned to the IMPROVE intervention group and will examine within-participant changes in neuroimaging measures from T0 to T2 and their associations with clinical improvement.
Time frame
Baseline (T0) and Post-intervention at Week 8 (T2)2
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. Analyses will be restricted to consenting participants assigned to the IMPROVE intervention group and will examine within-participant changes in peripheral biological measures from T0 to T2 and their associations with clinical improvement.
Time frame
Baseline (T0) and Post-intervention at Week 8 (T2)Sponsors and contacts
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Source ClinicalTrials.gov