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

Effectiveness and Psychological Mechanisms of Group-based IMPROVE Therapy for Problematic Internet Use in University Students: A Single-blind Randomized Controlled 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).

Study Overview

• Status: Not yet recruiting
• Conditions: Problematic Internet Use
• Intervention / Treatment: Behavioral: IMPROVE Program; Behavioral: Digital Psychoeducation Newsletters

Detailed Description

Problematic internet use (PIU) has emerged as a prevalent and clinically significant behavioral health problem among university students, characterized by impaired control over online behaviors and associated psychological distress, functional impairment, and academic difficulties. It is increasingly conceptualized as a spectrum of heterogeneous behaviors (e.g., gaming, social media use, short-form video consumption) rather than a single homogeneous entity.

Although a growing body of research has examined interventions for PIU, the current evidence base remains limited by several methodological shortcomings, including small sample sizes , short intervention durations, insufficient follow-up, insufficient consideration of the heterogeneity of PIU, and a lack of theory-driven investigation into psychological mechanisms of change. Moreover, many existing interventions focus on single components (e.g., cognitive-behavioral techniques alone), while neglecting the multidimensional nature of PIU, which involves complex interactions between cognitive biases, emotion dysregulation, and anhedonia.

To address these gaps, this prospective, single-blind, parallel-group randomized controlled trial evaluates the efficacy, durability, and potential mechanisms of action of a manualized, group-based intervention-IMPROVE therapy-for treatment-seeking university students with PIU. IMPROVE therapy is designed as an integrative program that combines cognitive-behavioral strategies with motivational elements, mindfulness training, and socially interactive exercise, targeting core psychological processes implicated in the development and maintenance of PIU.

Eligible participants will be randomized in a 1:1 ratio to receive immediate IMPROVE therapy or an enhanced waitlist control. Crucially, randomization will be stratified by the sex, age, severity of PIU and primary PIU subtype (e.g., gaming, social media, short-form video) to ensure balanced allocation and facilitate potential subgroup analyses. Participants in the IMPROVE group receive an 8-week structured group therapy consisting of one 120-minute session per week . Outcome assessments are conducted at baseline (T0), mid-intervention (Week 4, T1), post-intervention (Week 8, T2), and at follow-up time points of 1 month (T3), 3 months (T4), 6 months (T5), and 12 months (T6) after completion of the intervention.

The primary objective of the trial is to determine whether IMPROVE therapy leads to a greater reduction in PIU severity compared with the enhanced waitlist control at the end of the intervention. Accordingly, the primary outcome is PIU severity measured by the Internet Addiction Test (IAT), operationalized as the between-group difference in change in IAT total score from baseline (T0) to the post-intervention endpoint (T2).

The secondary objectives are to evaluate (1) the maintenance and durability of treatment effects across short-, medium-, and long-term follow-up periods, and (2) additional clinically relevant outcomes related to PIU. Secondary outcomes therefore include IAT scores at follow-up time points (T3-T6), rates of clinical remission defined by a prespecified IAT threshold, changes in associated psychological symptoms and functional impairment, and indicators of feasibility, adherence, and acceptability of the group-based intervention.

A core objective of this trial is to elucidate how the intervention exerts its effects. Guided by the I-PACE model, the study assesses potential mediators at Baseline (T0), Mid-intervention (T1), and Post-intervention (T2). Longitudinal mediation analyses will test whether improvements in Maladaptive Cognitions, Emotion Regulation, Self-Efficacy, Anhedonia, Perceived Stress, Mind Wandering, Resilience precede and mediate reductions in PIU severity.

A subset of participants will voluntarily undergo neuroimaging (fMRI) and blood sampling at T0 and T2 to explore the neurobiological correlates of therapeutic change.

Outcome assessors and data analysts will be blinded to treatment allocation to minimize assessment and analytic bias.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanhui Liao, PhD; Phone Number: +86 18814898844; Email: liaoyanhui@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 360000
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Contact: Yanhui Liao, PhD; Phone Number: +86 18814898844; Email: liaoyanhui@zju.edu.cn
      • Principal Investigator: Yanhui Liao, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMPROVE Intervention Group; 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; 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
Other: Enhanced Waitlist Control (EWC) Group; 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; Weekly newsletters pushed via WeChat containing psychoeducation on consequences of internet use and general advice for reducing screen time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 1 (T3), Month 3 (T4), Month 6 (T5), and Month 12 (T6) Follow-up
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.	Post-intervention at Week 8 (T2)
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.	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)	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.	Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up
Internet Usage Duration (Objective and Subjective)	Objective screen time (screenshots) and self-reported daily usage hours.	Baseline (T0), Week 4 (T1), Week 8 (T2), Month 1 (T3), Month 3 (T4), Month 6 (T5), and Month 12 (T6) Follow-up
Craving Intensity (QSU-Brief)	Assessed using a modified Questionnaire on Smoking Urges-Brief (QSU-Brief) adapted for internet use. Scores range from 10 to 70, with higher scores indicating more severe craving.	Baseline (T0), Week 4 (T1), Week 8 (T2), Month 1 (T3), Month 3 (T4), Month 6 (T5), and Month 12 (T6) Follow-up
Functional Impairment (BNCS Score)	Assessed using the adapted Brief Negative Consequence Scale (BNCS). Evaluates negative consequences across six domains (occupational, academic, interpersonal, etc.) on a 4-point scale. Scores range from 0 to 18, with higher scores suggesting more functional impairment.	Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up
Depressive Symptoms (PHQ-9 Score)	Assessed using the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27, with higher scores indicating more severe depression.	Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up
Anxiety Symptoms (GAD-7 Score)	Assessed using the Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0 to 21, with higher scores indicating more severe anxiety.	Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up
Insomnia Severity (ISI Score)	Assessed using the Insomnia Severity Index (ISI). Scores range from 0 to 28, with higher scores indicating more severe insomnia.	Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up
ADHD Symptoms (ASRS-v1.1 Score)	Assessed using the Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist to screen for attention-deficit/hyperactivity disorder symptoms.The total score ranges from 0 to 72. Higher scores indicate greater ADHD symptom severity.	Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up
Mental Well-being (WHO-5 Index)	Assessed using the WHO-Five Well-Being Index. A 5-item measure of current mental well-being. Each item is scored from 0 to 5. The raw total score ranges from 0 to 25. Higher scores indicate better mental well-being.	Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up
Subjective Quality of Life (QOL-VAS)	Assessed using a single-item Quality of Life Visual Analog Scale (0-100), where 100 represents the best imaginable quality of life.	Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up
Physical Activity Level (IPAQ-SF)	Assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). Measures frequency and duration of physical activity. Physical activity is expressed as metabolic equivalent task minutes per week (MET-minutes/week), derived from walking, moderate-intensity, and vigorous-intensity activities. Higher values indicate greater levels of physical activity. There is no fixed upper limit.	Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up
Maladaptive Cognitions related to internet use (CAMCS)	Assessed using the Chinese Adolescents Maladaptive Cognitions Scale (CAMCS). Measures dimensions such as social comfort, distraction, and self-realization. The total score ranges from 0 to 48. Higher scores indicate greater levels of maladaptive cognitions.	Baseline (T0), Mid-intervention at Week 4 (T1), Post-intervention at Week 8 (T2), and Month 3 Follow-up (T4)
Emotion Regulation Difficulties (DERS Score)	Assessed using the Difficulties in Emotion Regulation Scale (DERS-16).The total score ranges from 16 to 80. Higher scores indicate greater problems with emotion regulation.	Baseline (T0), Mid-intervention at Week 4 (T1), Post-intervention at Week 8 (T2), and Month 3 Follow-up (T4)
General Self-Efficacy (GSES Score)	Assessed using the General Self-Efficacy Scale (GSES). Measures perceived ability to cope with challenges. Items are rated on a 4-point Likert scale (1-4). The total score ranges from 10 to 40. Higher scores indicate greater perceived self-efficacy.	Baseline (T0), Mid-intervention at Week 4 (T1), Post-intervention at Week 8 (T2), and Month 3 Follow-up (T4)
Anhedonia (ASA-C Score)	Assessed using the Anhedonia Scale for Adolescents-Chinese version (ASA-C) to evaluate reward processing and motivation. The total score ranges from 0 to 42. Higher scores indicate worse anhedonia.	Baseline (T0), Mid-intervention at Week 4 (T1), Post-intervention at Week 8 (T2), and Month 3 Follow-up (T4)
Perceived Stress (PSS-10 Score)	Assessed using the Perceived Stress Scale (PSS-10). Measures the degree to which life situations are appraised as stressful. Total scores range from 0 to 40, with higher scores suggesting higher perceived stress.	Baseline (T0), Mid-intervention at Week 4 (T1), Post-intervention at Week 8 (T2), and Month 3 Follow-up (T4)
Mind Wandering (MWQ Score)	Assessed using the Mind Wandering Questionnaire (MWQ). Measures the frequency of task-unrelated thoughts. Scores range from 6 to 30, with higher scores indicating more frequent mind wandering.	Baseline (T0), Mid-intervention at Week 4 (T1), Post-intervention at Week 8 (T2), and Month 3 Follow-up (T4)
Resilience (CD-RISC-10 Score)	Assessed using the 10-item Connor-Davidson Resilience Scale (CD-RISC). Measures stress coping ability. Scores range from 0 to 40, with higher scores suggesting better resilience.	Baseline (T0), Mid-intervention at Week 4 (T1), Post-intervention at Week 8 (T2), and Month 3 Follow-up (T4)
Internet gaming disorder severity (IGDS9-SF)	Gamers were additionally assessed with IGDS9-SF. Measure the severity of IGD, the only internet-related behavioral addictions that get recognized in DSM-5 and ICD-11. Scores range from 9 to 45, with higher scores suggesting more severe internet gaming disorder.	Baseline (T0), Week 4 (T1), Week 8 (T2), Month 1 (T3), Month 3 (T4), Month 6 (T5), and Month 12 (T6) Follow-up for gamers only.
Current craving intensity (VAS)	Assessed by a single-item Visual Analogue Scale (VAS, 0-100) for current craving intensity. Higher scores indicate more severe craving.	Baseline (T0), Week 4 (T1), Week 8 (T2), Month 1 (T3), Month 3 (T4), Month 6 (T5), and Month 12 (T6) Follow-up
Maladaptive Cognitions related to gaming (C-RIGCS)	For gamers, The Chinese version of Revised Internet Gaming Cognition Scale (C-RIGCS) were also assessed. Scores range from 0 to 60, with higher scores suggesting more severe maladaptive cognitions related to gaming.	Baseline (T0), Mid-intervention at Week 4 (T1), Post-intervention at Week 8 (T2), and Month 3 Follow-up (T4)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (T0) and Post-intervention at Week 8 (T2)
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.	Baseline (T0) and Post-intervention at Week 8 (T2)

Collaborators and Investigators

• Sponsor: Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: exercise; mindfulness; cognitive-behavioral therapy; group psychotherapy; problematic internet use; digital addiction
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: 2026-0152; 2022ZD0211200 (Other Grant/Funding Number: STI 2030-Major Projects of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No