Group-based IMPROVE Therapy for Problematic Internet Use in University Students

NCT07434778 | Recruiting

• 2 other identifiers: 2026-01522022ZD0211200
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Problematic Internet Use

Keywords

problematic internet use; digital addiction; group psychotherapy; mindfulness; cognitive-behavioral therapy; exercise

Outcome Measures

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

  Baseline (T0) and Post-intervention (Week 8, T2)

Secondary Outcomes (25)

• Long-term Change in PIU Severity (IAT)

  Month 1 (T3), Month 3 (T4), Month 6 (T5), and Month 12 (T6) Follow-up

• Participant Satisfaction and Acceptability

  Post-intervention at Week 8 (T2)

• Smartphone Addiction Risk (SAS-SV)

  Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up

• Internet-use Disorder severity based on ICD-11 criteria (ACSID-11)

  Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up

• Internet Usage Duration

  Baseline (T0), Week 4 (T1), Week 8 (T2), Month 1 (T3), Month 3 (T4), Month 6 (T5), and Month 12 (T6) Follow-up.

Other Outcomes (2)

• Collection of neuroimaging data for exploratory analyses

  Baseline (T0) and Post-intervention at Week 8 (T2)

• Collection of peripheral blood samples for exploratory biomarker analyses

  Baseline (T0) and Post-intervention at Week 8 (T2)

Study Arms (2)

IMPROVE Intervention Group

EXPERIMENTAL

Participants receive IMPROVE therapy delivered in groups over 8 weeks, with 120 minutes per week (8 sessions total). The program integrates cognitive-behavioral strategies with motivational elements, mindfulness training, and socially interactive exercise. Sessions will be delivered by trained therapists using a standardized intervention manual, with regular weekly supervision to support consistency of intervention delivery.

Behavioral: IMPROVE Program

Enhanced Waitlist Control (EWC) Group

OTHER

Participants will receive one standardized digital newsletter per week via WeChat during the initial 8-week intervention period (T0-T2). They will then remain on the waitlist until completion of the 3-month follow-up assessment (T4), after which they will be offered the full 8-week IMPROVE intervention.

Behavioral: Digital Psychoeducation Newsletters

Interventions

IMPROVE Program BEHAVIORAL

A 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

IMPROVE Intervention Group

Digital Psychoeducation Newsletters BEHAVIORAL

Weekly newsletters pushed via WeChat containing psychoeducation on consequences of internet use and general advice for reducing screen time.

Enhanced Waitlist Control (EWC) Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (2)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 360000, China

RECRUITING

Zhejiang University

Hangzhou, Zhejiang, 360000, China

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Yanhui Liao, PhD

CONTACT

+86 18814898844; liaoyanhui@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and therapists cannot be blinded due to the nature of psychotherapy. Outcome assessors and data analysts will remain blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 27, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning immediately after publication of the primary trial results and ending 5 years thereafter.
• Access Criteria: Researchers seeking access should submit a methodologically sound research proposal and statistical analysis plan to the principal investigator. Requests will be evaluated on the basis of scientific merit, feasibility, consistency with participant consent, and compliance with applicable ethical and data-protection requirements. Approved requesters will be required to sign a data-use agreement, and the data may be used only for the analyses specified in the approved proposal.

Locations

CN (2)