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NCT Number: NCT07434778

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

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).

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Key information

Conditions

Problematic Internet Use Behavior Motor Activity

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 360000, China

Location contact

Yanhui Liao, PhD

CONTACT

[email protected]

+86 18814898844

Yanhui Liao, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Digital Psychoeducation Newsletters

Behavioral

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

Primary outcomes

  1. Change in Problematic Internet Use Severity (IAT Score)

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

    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

  1. Long-term Change in PIU Severity (IAT)

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

    Assessing the maintenance of intervention effects using the Internet Addiction Test (IAT) scores during the follow-up phase.

  2. Participant Satisfaction ( CSQ-8)

    Time frame: Post-intervention at Week 8 (T2)

    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.

  3. Smartphone Addiction Risk (SAS-SV)

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

    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.

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

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

    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.

  5. Internet Usage Duration (Objective and Subjective)

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

    Objective screen time (screenshots) and self-reported daily usage hours.

  6. Craving Intensity (QSU-Brief)

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

    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.

  7. Functional Impairment (BNCS Score)

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

    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.

  8. Depressive Symptoms (PHQ-9 Score)

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

    Assessed using the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27, with higher scores indicating more severe depression.

  9. Anxiety Symptoms (GAD-7 Score)

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

    Assessed using the Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0 to 21, with higher scores indicating more severe anxiety.

  10. Insomnia Severity (ISI Score)

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

    Assessed using the Insomnia Severity Index (ISI). Scores range from 0 to 28, with higher scores indicating more severe insomnia.

  11. ADHD Symptoms (ASRS-v1.1 Score)

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

    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.

  12. Mental Well-being (WHO-5 Index)

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

    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.

  13. Subjective Quality of Life (QOL-VAS)

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

    Assessed using a single-item Quality of Life Visual Analog Scale (0-100), where 100 represents the best imaginable quality of life.

  14. Physical Activity Level (IPAQ-SF)

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

    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.

  15. Maladaptive Cognitions related to internet use (CAMCS)

    Time frame: Baseline (T0), Mid-intervention at Week 4 (T1), Post-intervention at Week 8 (T2), and Month 3 Follow-up (T4)

    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.

  16. Emotion Regulation Difficulties (DERS Score)

    Time frame: Baseline (T0), Mid-intervention at Week 4 (T1), Post-intervention at Week 8 (T2), and Month 3 Follow-up (T4)

    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.

  17. General Self-Efficacy (GSES Score)

    Time frame: Baseline (T0), Mid-intervention at Week 4 (T1), Post-intervention at Week 8 (T2), and Month 3 Follow-up (T4)

    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.

  18. Anhedonia (ASA-C Score)

    Time frame: Baseline (T0), Mid-intervention at Week 4 (T1), Post-intervention at Week 8 (T2), and Month 3 Follow-up (T4)

    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.

  19. Perceived Stress (PSS-10 Score)

    Time frame: Baseline (T0), Mid-intervention at Week 4 (T1), Post-intervention at Week 8 (T2), and Month 3 Follow-up (T4)

    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.

  20. Mind Wandering (MWQ Score)

    Time frame: Baseline (T0), Mid-intervention at Week 4 (T1), Post-intervention at Week 8 (T2), and Month 3 Follow-up (T4)

    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.

  21. Resilience (CD-RISC-10 Score)

    Time frame: Baseline (T0), Mid-intervention at Week 4 (T1), Post-intervention at Week 8 (T2), and Month 3 Follow-up (T4)

    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.

  22. Internet gaming disorder severity (IGDS9-SF)

    Time frame: 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.

    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.

  23. Current craving intensity (VAS)

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

    Assessed by a single-item Visual Analogue Scale (VAS, 0-100) for current craving intensity. Higher scores indicate more severe craving.

  24. Maladaptive Cognitions related to gaming (C-RIGCS)

    Time frame: Baseline (T0), Mid-intervention at Week 4 (T1), Post-intervention at Week 8 (T2), and Month 3 Follow-up (T4)

    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.

Other outcomes

  1. Collection of neuroimaging data for exploratory analyses

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

    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.

  2. Collection of peripheral blood samples for exploratory biomarker analyses

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

    Peripheral blood samples will be collected for future exploratory analyses of stress-related and inflammatory biomarkers.

Study contacts

Contact information is provided by the study sponsor or research team.

Yanhui Liao, PhD

CONTACT

[email protected]

+86 18814898844

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Official study title

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

Acronym: IMPROVE-PIU

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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