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

NCT07434778 | Not Yet Recruiting

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

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 0 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 (24)

• Long-term Change in PIU Severity (IAT)

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

• Participant Satisfaction ( CSQ-8)

  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 (Objective and Subjective)

  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 are delivered by trained therapists using a standardized manual with fidelity monitoring.

Behavioral: IMPROVE Program

Enhanced Waitlist Control (EWC) Group

OTHER

Participants receive a minimal intervention (weekly digital newsletters) during the first phase (0-6 months). After the 3-month follow-up assessment (T4), they are 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:

• 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.
• Provide written informed consent

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 360000, China

Location

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 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2025-12

Locations

CN (1)