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临床试验/NCT07410104
NCT07410104招募中不适用

Impact of Non-Invasive Neuromodulation on Social Media Addiction

Egas Moniz - Cooperativa de Ensino Superior, CRL1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Change in Internet Addiction Test (IAT) Total Score

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

Active vs sham conditions are double-blind using coded accounts ("real" and "sham") so participants and the research team do not know assignment until study completion; the control group receives no stimulation.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Active tDCS

Experimental

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).

干预措施: Transcranial Direct Current Stimulation (tDCS) (Device)

Sham tDCS

Sham Comparator

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.

干预措施: Sham Transcranial Direct Current Stimulation (Sham tDCS) (Device)

No Stimulation Control

No Intervention

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.

结局指标

主要结局

Change in Internet Addiction Test (IAT) Total Score

时间窗: 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.

次要结局

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

研究者

发起方
Egas Moniz - Cooperativa de Ensino Superior, CRL
申办方类型
Other
责任方
Sponsor

研究点 (1)

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