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tDCS治疗社交媒体成瘾 (tDCS4SMA)

非侵入性神经调节对社交媒体成瘾的影响

The goal of this clinical trial is to learn whether transcranial direct current stimulation (tDCS), a non-invasive brain stimulation, can reduce "craving" and problematic levels of social media/internet use in university students.

The main questions it aims to answer are:

  • Does active tDCS reduce craving to use social media during the intervention period compared with sham stimulation and no stimulation?
  • Does active tDCS reduce internet/social media addiction severity (measured with the Internet Addiction Test, IAT) compared with sham stimulation and no stimulation, and are any effects still present at follow-up? Researchers will compare three groups-active tDCS, sham tDCS (a simulation where stimulation is stopped after the first seconds), and a control group (no stimulation)-to see whether changes are due to tDCS rather than placebo effects or time.

Participants will:

  • Complete an initial screening and baseline questionnaires (a sociodemographic questionnaire and the IAT).
  • Be randomly assigned to one of three groups: active tDCS, sham tDCS, or control (no stimulation).
  • Complete the IAT again after the intervention and again about 5 weeks later (follow-up), along with questions about social media use habits.

During intervention, participants in active tDCS and sham tDCS will:

  • Attend 10 sessions over 2 consecutive weeks (Monday-Friday), with each session lasting about 30 minutes; mobile phone use is not allowed during sessions.
  • Rate craving on a Visual Analogue Scale (VAS) at the start and end of each session.

This study will be conducted with university students in the Greater Lisbon area and will follow double-blind procedures for the active vs sham conditions (participants and researchers will not know the assigned condition until the end of the study).

研究概览

详细说明

This study investigates whether non-invasive neuromodulation using transcranial direct current stimulation (tDCS) can reduce craving and problematic social media/internet use in university students. The rationale for the study is that excessive and compulsive social media use has been associated with negative mental health outcomes, and behavioral addictions may share neurobiological features with substance addictions, including reward-circuit involvement and reduced inhibitory control. Because tDCS can modulate cortical excitability, often targeting prefrontal areas involved in executive control, this project evaluates whether repeated tDCS sessions can help reduce craving and improve digital self-regulation in individuals with moderate-to-severe problematic use.

Study design and setting The study uses an experimental, double-blind design to strengthen internal validity by reducing expectation and observer bias. Recruitment and data collection will be carried out with university students from the Greater Lisbon area, and study activities will take place in a controlled setting with supervision by the research team. The study is planned as a quantitative, applied primary research project.

Participants and eligibility criteria The sample will be non-probabilistic and recruited by convenience among university students in the Greater Lisbon area. Eligible participants must be 18 years of age or older, available for all study phases, and score 31 or higher on the Internet Addiction Test (IAT), indicating moderate-to-severe dependence.

Participants will be excluded if they have had recent psychopharmacological changes (use or dose change within the last 3 months), a history of dizziness or seizures, a current need for hospitalization or psychotherapy, or diagnoses such as depressive, anxiety, or bipolar disorders with recent symptoms, schizophrenia, other psychotic disorders, or autism spectrum disorder. Additional exclusions include contraindications to tDCS, such as pregnancy, metallic implants, tumors, prior brain surgery, or significant anatomical brain changes.

Recruitment and informed consent Recruitment will occur through in-person informational sessions, where study objectives will be presented and a QR code will be provided for enrollment. Outreach will also be supported through social media and flyers in institutions in the Greater Lisbon area. Interested individuals will provide informed consent and complete an initial sociodemographic questionnaire and the IAT as part of screening/baseline assessment.

Group allocation and masking After recruitment, participants will be randomly allocated to one of three groups: (1) active tDCS, (2) sham stimulation, or (3) control without stimulation, and then contacted via email. The sham condition is designed to mimic the sensation of stimulation to help control for placebo effects. Double-blinding will be implemented for the active vs sham conditions, with coded accounts ("real" and "sham") created to ensure the research team does not know condition assignments until the study ends. The control group does not receive stimulation.

Intervention (tDCS) and device The intervention consists of 10 consecutive sessions delivered over two weeks (Monday to Friday), with each session lasting approximately 30 minutes and following recommended safety parameters. Sessions will be supervised by the research team in a controlled environment, and mobile phone use will be prohibited during sessions.

Stimulation will be delivered using the PlatoWork tDCS Headset, a certified non-invasive neuromodulation device, controlled through the PlatoApp, which guides positioning and helps prevent configuration errors. Electrode positioning will follow the International 10/20 system, with the anode placed at F4 (right dorsolateral prefrontal cortex) and the cathode at F3 (left dorsolateral prefrontal cortex).

Measures and outcomes Data will be collected using a sociodemographic questionnaire, the Internet Addiction Test (IAT), and a Visual Analogue Scale (VAS) for craving. The sociodemographic questionnaire will be used to characterize the sample and verify inclusion/exclusion criteria, including variables such as age, sex, psychotropic medication use, pregnancy status, recent therapies, psychological diagnoses, and presence of metallic implants; it also includes questions on social media habits (daily time, frequency, and typical moments of use).

The IAT is a 20-item self-report Likert-scale measure (0-5), with a total score ranging from 0 to 100; higher scores indicate greater dependence/problematic use. Craving will be measured with a VAS consisting of a 10 cm line anchored from 0 (no desire) to 10 (extremely strong desire).

Craving (VAS) will be assessed twice per stimulation session: at the beginning of each session (baseline craving for that session) and at the end of each session (post-stimulation craving). The IAT and social media habit questions will be administered again after the intervention period and again at follow-up approximately five weeks later to evaluate potential cumulative and sustained effects.

Study procedure and timeline After baseline screening and enrollment, participants will attend the intervention period (10 sessions across two weeks) according to their assigned group (active tDCS, sham, or control). Participants in the stimulation arms will complete craving ratings at the start and end of each session. After the two-week intervention, participants will repeat the IAT and usage-habit questions. Five weeks after the intervention, participants will complete follow-up measures (IAT and usage-habit questions). After completion of the study, a debriefing will be conducted, and participants in the sham and control groups may be offered the real tDCS protocol.

Data management and statistical analysis Data will be extracted from the instruments, organized in digital databases, and analyzed using IBM SPSS Statistics (version 30), with procedures to ensure anonymization and confidentiality. Each participant will be identified only by a numeric code. Analyses will compare changes in craving and dependence across three time points (pre, post, and follow-up) and across groups (active, sham, control).

A repeated-measures MANOVA is planned to test group effects, time effects, and group × time interactions across dependent variables, followed by univariate repeated-measures ANOVAs and post-hoc tests with correction for multiple comparisons when appropriate. The significance level will be set at p < .05.

Ethical considerations and participant safety Participation will be voluntary, and all participants will receive clear information about study objectives, procedures, risks, benefits, and data handling before providing written informed consent. Participants may refuse or withdraw at any time without consequences and may request deletion of their data at any stage.

All data will be pseudonymized using numeric codes, and the code-key linking identities to study codes will be stored separately in an encrypted, password-protected file accessible only to the research team. Data will be stored in a secure institutional digital environment (OneDrive). The PlatoApp associated with the PlatoWork headset does not collect personal information; it records only technical session data (e.g., date, time, duration, intensity) without individual identification.

tDCS is described as a safe and non-invasive technique with typically mild, temporary side effects such as tingling, mild skin discomfort, or mild headache; any adverse effects will be recorded and evaluated, and medical referral may be arranged if needed. Equipment will be sanitized between uses, and conductive sponges will be dedicated to each participant. Participants showing signs of emotional or psychological fragility may be advised to discontinue and may be referred for psychological support at the university psychology clinic.

研究类型

介入性

注册 (实际的)

61

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Almada、葡萄牙
        • Egas Moniz School of Health and Science

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age ≥18 years.
  • Availability to participate in all study phases/sessions.
  • IAT score ≥31 (moderate to severe level).

Exclusion Criteria:

  • Diagnosis of depressive, anxiety, or bipolar disorders with recent symptoms; schizophrenia; psychotic disorders; or autism spectrum disorder.
  • Recent psychotropic medication use or dose change within the last 3 months.
  • Current need for inpatient care or ongoing psychotherapy.
  • History of dizziness or seizures/convulsions.
  • Contraindications to tDCS, including pregnancy, metallic implants, tumors, prior brain surgery, or significant anatomical brain alterations.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Active tDCS

Participants receive active transcranial direct current stimulation (tDCS) delivered in 10 consecutive sessions (Monday-Friday for 2 weeks), 30 minutes per session, under supervision in a controlled setting. Electrode placement follows the International 10/20 system with the anode at F4 (right DLPFC) and the cathode at F3 (left DLPFC). Craving is rated before and after each session using a Visual Analogue Scale (VAS).

Active tDCS delivered in 10 consecutive sessions (Monday-Friday over 2 weeks), 30 minutes per session, in a supervised controlled environment. Electrode montage follows the International 10/20 system with the anode at F4 (right dorsolateral prefrontal cortex) and the cathode at F3 (left dorsolateral prefrontal cortex).

其他名称:
  • (tDCS)
假比较器:Sham tDCS

Participants undergo the same schedule and procedures as the experimental arm (10 sessions over 2 weeks; 30 minutes/session; supervised; same electrode placement), but stimulation is discontinued after the first seconds to simulate stimulation while minimizing neuromodulatory effects.

Sham stimulation using the same device setup and schedule as active tDCS, but the stimulation is turned off after the first seconds to mimic the sensation while minimizing neuromodulatory effects. Sessions are supervised, with the same electrode positioning (anode F4; cathode F3).

其他名称:
  • (假tDCS)
  • 模拟经颅直流电刺激
无干预:No Stimulation Control

Participants do not receive tDCS sessions (no stimulation intervention). They complete the study assessments, including the Internet Addiction Test (IAT) and questions about social media use habits at baseline and post-intervention, with follow-up reassessment approximately 5 weeks later.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Internet Addiction Test (IAT) Total Score
大体时间:Baseline (pre-intervention); immediately post-intervention (after the 10-session/2-week period); follow-up ~5 weeks after the intervention.

Severity of problematic internet/social media use measured by the Internet Addiction Test (IAT; 20 items; total score 0-100, higher scores mean worse outcome). The IAT is administered at baseline (pre-intervention), after completion of the intervention period, and again at follow-up to evaluate sustained effects. Group comparisons will be made between active tDCS, sham, and control arms.

Baseline (pre-intervention); immediately post-intervention (after the 10-session/2-week period); follow-up ~5 weeks after the intervention.

次要结果测量

结果测量
措施说明
大体时间
Change in Social Media Craving (VAS)
大体时间:Each of 10 sessions over 2 consecutive weeks: assessed immediately pre-session and immediately post-session.

A Visual Analogue Scale (VAS) to assess Craving to social media . The VAS is administered twice per tDCS session: at the start of the session (pre) and at the end of the session (post). Participants are asked to rate their desire to use social media from 0 to 10, higher scores mean worse outcome.

Each of 10 sessions over 2 consecutive weeks: assessed immediately pre-session and immediately post-session.
Change in Social Media Use Habits (Self-Report)
大体时间:Baseline (pre-intervention); immediately post-intervention; follow-up ~5 weeks after the intervention.

Self-reported social media use habits collected via the study's questionnaire items (e.g., daily time, frequency, and typical moments of access). These items are used to characterize patterns of use and to assess changes over time following the intervention.

Baseline (pre-intervention); immediately post-intervention; follow-up ~5 weeks after the intervention.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月1日

初级完成 (实际的)

2026年7月31日

研究完成 (实际的)

2026年11月2日

研究注册日期

首次提交

2026年2月7日

首先提交符合 QC 标准的

2026年2月7日

首次发布 (实际的)

2026年2月13日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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