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Идёт набор NCT07434778

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

Без фазы С лечением Problematic Internet Use

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: IMPROVE Program, Digital Psychoeducation Newsletters.
Кому может быть актуально
Состояния в реестре: Problematic Internet Use. Базовые параметры: 18 лет — 30 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Change in Problematic Internet Use Severity (IAT Score) [Срок оценки: Baseline (T0) and Post-intervention (Week 8, T2)]
Вторичные конечные точки (12)
  • Long-term Change in PIU Severity (IAT) [Срок оценки: Month 1 (T3), Month 3 (T4), Month 6 (T5), and Month 12 (T6) Follow-up]
  • Participant Satisfaction and Acceptability [Срок оценки: Post-intervention at Week 8 (T2)]
  • Smartphone Addiction Risk (SAS-SV) [Срок оценки: 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) [Срок оценки: Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up]
  • Internet Usage Duration [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up]
  • Depressive Symptoms (PHQ-9 Score) [Срок оценки: Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up]
  • Anxiety Symptoms (GAD-7 Score) [Срок оценки: Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up]
  • Insomnia Severity (ISI Score) [Срок оценки: Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up]
  • ADHD Symptoms (ASRS-v1.1 Score) [Срок оценки: Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up]
  • Mental Well-being (WHO-5 Index) [Срок оценки: Baseline (T0), Post-intervention at Week 8 (T2), Month 3 (T4), and Month 12 (T6) Follow-up]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 2 центра
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Ханчжоу
  • Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT07434778 · 2026-0152 · 2022ZD0211200

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗