Problematic Internet UseIMPROVE-PIUNCT07434778
Group-based IMPROVE Therapy for Problematic Internet Use in University Students
A study testing IMPROVE Program and Digital Psychoeducation Newsletters in people with Problematic Internet Use, run by Sir Run Run Shaw Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Problematic Internet Use
- What is being tested?
- IMPROVE Program and Digital Psychoeducation Newsletters
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesChina
- Study dates
- 17 Mar 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 360000
Yanhui Liao, PhD, +86 18814898844, liaoyanhui@zju.edu.cn
Yanhui Liao, PhD
- Recruiting
Zhejiang University
Hangzhou, Zhejiang, 360000
Yanhui Liao, PhD, +86 18814898844, liaoyanhui@zju.edu.cn
liaoyanhui@zju.edu.cn
About this study
Official title: 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).
Read the 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 the IMPROVE intervention group or the enhanced waitlist control group using a centralized computer-generated allocation sequence. 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, candidate psychological mediators will be assessed at baseline (T0), mid-intervention (T1), post-intervention (T2), and the 3-month follow-up (T4). Longitudinal mediation analyses will examine whether changes in maladaptive internet-related cognitions, emotion regulation difficulties, self-efficacy, anhedonia, perceived stress, mind wandering, and resilience statistically account for subsequent changes in PIU severity. Among participants reporting recent gaming, gaming-related maladaptive cognitions assessed using the C-RIGCS will also be examined.
A subset of participants of the IMPROVE intervention group 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.
- Conditions
- Problematic Internet Use
- Being tested
- IMPROVE Program, Digital Psychoeducation Newsletters
- Keywords
- problematic internet use, digital addiction, group psychotherapy, mindfulness, cognitive-behavioral therapy, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPROVE ProgramBehavioural
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 NewslettersBehavioural
Weekly newsletters pushed via WeChat containing psychoeducation on consequences of internet use and general advice for reducing screen time.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Digital Psychoeducation Newsletters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (T0) and Post-intervention (Week 8, T2)
Secondary outcomes (25)
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.
Measured: Month 1 (T3), Month 3 (T4), Month 6 (T5), and Month 12 (T6) Follow-up
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.
Measured: 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.
Measured: 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.
Measured: Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up
Internet Usage Duration
Self-reported daily usage hours. Prior to trial implementation, objective smartphone use time was removed from the secondary outcomes due to limited comparability across smartphone brands and operating systems.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 5 to 30, with higher scores indicating more frequent mind wandering.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T0), Mid-intervention at Week 4 (T1), Post-intervention at Week 8 (T2), and Month 3 Follow-up (T4)
Clinical Remission of Problematic Internet Use
Clinical remission is defined as an Internet Addiction Test total score below 50. Between-group comparisons will be conducted through the 3-month follow-up assessment (T4). Outcomes at T5 and T6 will be evaluated descriptively because participants in the enhanced waitlist control group will be offered the IMPROVE intervention after T4.
Measured: Postintervention at Week 8 (T2), Month 1 (T3), Month 3 (T4), Month 6 (T5), and Month 12 (T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start17 Mar 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Problematic Internet UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434778
- Sponsor's protocol ID
- 2026-0152
- Other IDs
- 2022ZD0211200
- Acronym
- IMPROVE-PIU
- Status last verified
- Dec 2025
- First submitted
- 12 Feb 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the results reported in the primary and secondary trial publications, together with a data dictionary, will be made available upon reasonable request. Data will be available beginning after publication of the primary trial results and for 5 years. Requests must include a scientifically sound research proposal and statistical analysis plan and will be reviewed by the principal investigator and study team. Access will be subject to participant consent, applicable ethical and data-protection requirements, and execution of a data-use agreement. Approved data will be provided only for the analyses specified in the accepted proposal.
Publications
Peng P, Lin S, Liao Y. Effectiveness and psychological mechanism of group-based IMPROVE therapy for treatment seeking college students with problematic internet use in China: study protocol for a prospective, single-blind, randomised clinical trial. BMJ Open. 2026 Sep 24;16(9):e119535. doi: 10.1136/bmjopen-2026-119535.
PubMed 42785939
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Psychological Mechanisms of Group-based IMPROVE Therapy for Problematic Internet Use in University Students: A Single-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07434778
- Acronym / sponsor ID
- IMPROVE-PIU / 2026-0152
- Conditions
- Problematic Internet Use
- Keywords
- problematic internet use, digital addiction, group psychotherapy, mindfulness, cognitive-behavioral therapy, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 the IMPROVE intervention group or the enhanced waitlist control group using a centralized computer-generated allocation sequence. 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, candidate psychological mediators will be assessed at baseline (T0), mid-intervention (T1), post-intervention (T2), and the 3-month follow-up (T4). Longitudinal mediation analyses will examine whether changes in maladaptive internet-related cognitions, emotion regulation difficulties, self-efficacy, anhedonia, perceived stress, mind wandering, and resilience statistically account for subsequent changes in PIU severity. Among participants reporting recent gaming, gaming-related maladaptive cognitions assessed using the C-RIGCS will also be examined.
A subset of participants of the IMPROVE intervention group 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMPROVE Intervention Group | Experimental | Behavioral: IMPROVE ProgramParticipants 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. |
| Enhanced Waitlist Control (EWC) Group | Other | Behavioral: Digital Psychoeducation NewslettersParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMPROVE ProgramA 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 | Behavioural | IMPROVE Intervention Group |
| Digital Psychoeducation NewslettersWeekly newsletters pushed via WeChat containing psychoeducation on consequences of internet use and general advice for reducing screen time. | Behavioural | Enhanced Waitlist Control (EWC) Group |
Primary outcome
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 20 to 100, with higher scores indicating greater severity. The primary endpoint is the change from baseline to post-intervention
25 secondary outcomes
Long-term Change in PIU Severity (IAT)
Time frame: Month 1 (T3), Month 3 (T4), Month 6 (T5), and Month 12 (T6) Follow-up
Participant Satisfaction and Acceptability
Time frame: Post-intervention at Week 8 (T2)
Smartphone Addiction Risk (SAS-SV)
Time frame: 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)
Time frame: Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up
Internet Usage Duration
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.
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
Functional Impairment (BNCS Score)
Time frame: Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up
Depressive Symptoms (PHQ-9 Score)
Time frame: Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up
Anxiety Symptoms (GAD-7 Score)
Time frame: Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up
Insomnia Severity (ISI Score)
Time frame: Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up
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
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
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
Physical Activity Level (IPAQ-SF)
Time frame: Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up
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)
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)
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)
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)
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)
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)
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)
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.
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
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)
Clinical Remission of Problematic Internet Use
Time frame: Postintervention at Week 8 (T2), Month 1 (T3), Month 3 (T4), Month 6 (T5), and Month 12 (T6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Derived from this study: PubMed 42785939Peng P, Lin S, Liao Y. Effectiveness and psychological mechanism of group-based IMPROVE therapy for treatment seeking college students with problematic internet use in China: study protocol for a prospective, single-blind, randomised clinical trial. BMJ Open. 2026 Sep 24;16(9):e119535. doi: 10.1136/bmjopen-2026-119535.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the results reported in the primary and secondary trial publications, together with a data dictionary, will be made available upon reasonable request. Data will be available beginning after publication of the primary trial results and for 5 years. Requests must include a scientifically sound research proposal and statistical analysis plan and will be reviewed by the principal investigator and study team. Access will be subject to participant consent, applicable ethical and data-protection requirements, and execution of a data-use agreement. Approved data will be provided only for the analyses specified in the accepted proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPROVE Program and Digital Psychoeducation Newsletters in people with Problematic Internet Use, run by Sir Run Run Shaw Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanhui Liao, PhD (+86 18814898844, liaoyanhui@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Problematic Internet Use Severity (IAT Score) (time frame: Baseline (T0) and Post-intervention (Week 8, T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07434778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.