Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:19 AM
Study NCT ID:
NCT07410104
Status:
RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
tDCS for Social Media Addiction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082424', 'term': 'Internet Addiction Disorder'}], 'ancestors': [{'id': 'D000088942', 'term': 'Technology Addiction'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, controlled, three-arm parallel design with repeated assessments across three time points (pre-intervention, post-intervention, and \\~5-week follow-up).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-07', 'studyFirstSubmitQcDate': '2026-02-07', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Internet Addiction Test (IAT) Total Score', 'timeFrame': 'Baseline (pre-intervention); immediately post-intervention (after the 10-session/2-week period); follow-up ~5 weeks after the intervention.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Social Media Craving (VAS)', 'timeFrame': 'Each of 10 sessions over 2 consecutive weeks: assessed immediately pre-session and immediately post-session.', 'description': '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.'}, {'measure': 'Change in Social Media Use Habits (Self-Report)', 'timeFrame': 'Baseline (pre-intervention); immediately post-intervention; follow-up ~5 weeks after the intervention.', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Social media addiction', 'Internet addiction', 'Digital addiction', 'Craving', 'Transcranial direct current stimulation', 'tDCS', 'Non-invasive neuromodulation'], 'conditions': ['Social Media Addiction', 'Craving to Use Social Media', 'Craving', 'Internet Addiction']}, 'referencesModule': {'references': [{'pmid': '20545603', 'type': 'BACKGROUND', 'citation': 'Weinstein A, Lejoyeux M. Internet addiction or excessive internet use. Am J Drug Alcohol Abuse. 2010 Sep;36(5):277-83. doi: 10.3109/00952990.2010.491880.'}, {'pmid': '33302798', 'type': 'BACKGROUND', 'citation': 'Uram P, Skalski S. Still Logged in? The Link Between Facebook Addiction, FoMO, Self-Esteem, Life Satisfaction and Loneliness in Social Media Users. Psychol Rep. 2022 Feb;125(1):218-231. doi: 10.1177/0033294120980970. Epub 2020 Dec 10.'}, {'pmid': '32903205', 'type': 'BACKGROUND', 'citation': 'Li Y, Li G, Liu L, Wu H. Correlations between mobile phone addiction and anxiety, depression, impulsivity, and poor sleep quality among college students: A systematic review and meta-analysis. J Behav Addict. 2020 Sep 8;9(3):551-571. doi: 10.1556/2006.2020.00057. Print 2020 Oct 12.'}, {'pmid': '34106366', 'type': 'BACKGROUND', 'citation': 'Correa Rangel T, Falcao Raposo MC, Sampaio Rocha-Filho PA. Internet addiction, headache, and insomnia in university students: a cross-sectional study. Neurol Sci. 2022 Feb;43(2):1035-1041. doi: 10.1007/s10072-021-05377-x. Epub 2021 Jun 9.'}, {'pmid': '20729009', 'type': 'BACKGROUND', 'citation': 'Boggio PS, Zaghi S, Villani AB, Fecteau S, Pascual-Leone A, Fregni F. Modulation of risk-taking in marijuana users by transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC). Drug Alcohol Depend. 2010 Dec 1;112(3):220-5. doi: 10.1016/j.drugalcdep.2010.06.019. Epub 2010 Aug 21.'}, {'pmid': '19619607', 'type': 'BACKGROUND', 'citation': 'Boggio PS, Liguori P, Sultani N, Rezende L, Fecteau S, Fregni F. Cumulative priming effects of cortical stimulation on smoking cue-induced craving. Neurosci Lett. 2009 Sep 29;463(1):82-6. doi: 10.1016/j.neulet.2009.07.041. Epub 2009 Jul 18.'}, {'pmid': '28210202', 'type': 'BACKGROUND', 'citation': 'Giordano J, Bikson M, Kappenman ES, Clark VP, Coslett HB, Hamblin MR, Hamilton R, Jankord R, Kozumbo WJ, McKinley RA, Nitsche MA, Reilly JP, Richardson J, Wurzman R, Calabrese E. Mechanisms and Effects of Transcranial Direct Current Stimulation. Dose Response. 2017 Feb 9;15(1):1559325816685467. doi: 10.1177/1559325816685467. eCollection 2017 Jan-Mar.'}, {'pmid': '26652115', 'type': 'BACKGROUND', 'citation': 'Woods AJ, Antal A, Bikson M, Boggio PS, Brunoni AR, Celnik P, Cohen LG, Fregni F, Herrmann CS, Kappenman ES, Knotkova H, Liebetanz D, Miniussi C, Miranda PC, Paulus W, Priori A, Reato D, Stagg C, Wenderoth N, Nitsche MA. A technical guide to tDCS, and related non-invasive brain stimulation tools. Clin Neurophysiol. 2016 Feb;127(2):1031-1048. doi: 10.1016/j.clinph.2015.11.012. Epub 2015 Nov 22.'}, {'pmid': '21352881', 'type': 'BACKGROUND', 'citation': "Goldman RL, Borckardt JJ, Frohman HA, O'Neil PM, Madan A, Campbell LK, Budak A, George MS. Prefrontal cortex transcranial direct current stimulation (tDCS) temporarily reduces food cravings and increases the self-reported ability to resist food in adults with frequent food craving. Appetite. 2011 Jun;56(3):741-6. doi: 10.1016/j.appet.2011.02.013. Epub 2011 Feb 23."}, {'pmid': '17640830', 'type': 'BACKGROUND', 'citation': 'Boggio PS, Sultani N, Fecteau S, Merabet L, Mecca T, Pascual-Leone A, Basaglia A, Fregni F. Prefrontal cortex modulation using transcranial DC stimulation reduces alcohol craving: a double-blind, sham-controlled study. Drug Alcohol Depend. 2008 Jan 1;92(1-3):55-60. doi: 10.1016/j.drugalcdep.2007.06.011. Epub 2007 Jul 19.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\n* Does active tDCS reduce craving to use social media during the intervention period compared with sham stimulation and no stimulation?\n* 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.\n\nParticipants will:\n\n* Complete an initial screening and baseline questionnaires (a sociodemographic questionnaire and the IAT).\n* Be randomly assigned to one of three groups: active tDCS, sham tDCS, or control (no stimulation).\n* Complete the IAT again after the intervention and again about 5 weeks later (follow-up), along with questions about social media use habits.\n\nDuring intervention, participants in active tDCS and sham tDCS will:\n\n* Attend 10 sessions over 2 consecutive weeks (Monday-Friday), with each session lasting about 30 minutes; mobile phone use is not allowed during sessions.\n* Rate craving on a Visual Analogue Scale (VAS) at the start and end of each session.\n\nThis 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).', 'detailedDescription': '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.\n\nStudy 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.\n\nParticipants 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.\n\nParticipants 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.\n\nRecruitment 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.\n\nGroup 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.\n\nIntervention (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.\n\nStimulation 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).\n\nMeasures 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).\n\nThe 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).\n\nCraving (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.\n\nStudy 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.\n\nData 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).\n\nA 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.\n\nEthical 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.\n\nAll 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.\n\ntDCS 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* Availability to participate in all study phases/sessions.\n* IAT score ≥31 (moderate to severe level).\n\nExclusion Criteria:\n\n* Diagnosis of depressive, anxiety, or bipolar disorders with recent symptoms; schizophrenia; psychotic disorders; or autism spectrum disorder.\n* Recent psychotropic medication use or dose change within the last 3 months.\n* Current need for inpatient care or ongoing psychotherapy.\n* History of dizziness or seizures/convulsions.\n* Contraindications to tDCS, including pregnancy, metallic implants, tumors, prior brain surgery, or significant anatomical brain alterations.'}, 'identificationModule': {'nctId': 'NCT07410104', 'acronym': 'tDCS4SMA', 'briefTitle': 'tDCS for Social Media Addiction', 'organization': {'class': 'OTHER', 'fullName': 'Egas Moniz - Cooperativa de Ensino Superior, CRL'}, 'officialTitle': 'Impact of Non-Invasive Neuromodulation on Social Media Addiction', 'orgStudyIdInfo': {'id': 'PT-213/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active tDCS', 'description': '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).', 'interventionNames': ['Device: Transcranial Direct Current Stimulation (tDCS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS', 'description': '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.', 'interventionNames': ['Device: Sham Transcranial Direct Current Stimulation (Sham tDCS)']}, {'type': 'NO_INTERVENTION', 'label': 'No Stimulation Control', 'description': '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.'}], 'interventions': [{'name': 'Transcranial Direct Current Stimulation (tDCS)', 'type': 'DEVICE', 'otherNames': ['(tDCS)'], 'description': '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).', 'armGroupLabels': ['Active tDCS']}, {'name': 'Sham Transcranial Direct Current Stimulation (Sham tDCS)', 'type': 'DEVICE', 'otherNames': ['(Sham tDCS)', 'Simulated tDCS'], 'description': '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).', 'armGroupLabels': ['Sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Almada', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Paulo Chaló, PhD', 'role': 'CONTACT', 'email': 'pchalo@egasmoniz.edu.pt', 'phone': '+351 212 946 700'}], 'facility': 'Egas Moniz School of Health and Science', 'geoPoint': {'lat': 38.67902, 'lon': -9.1569}}], 'centralContacts': [{'name': 'Paulo Chaló, PhD', 'role': 'CONTACT', 'email': 'pchalo@egasmoniz.edu.pt', 'phone': '(+351) 212 946 700'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Egas Moniz - Cooperativa de Ensino Superior, CRL', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}