protocolSection identificationModule nctId: NCT06271083, orgStudyIdInfo id: 2023-06541-01, briefTitle: Internet-based Behavior Therapy for Adults With Tourette Syndrome, acronym: TICNET, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-02, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, descriptionModule briefSummary: This study protocol outlines a parallel-group, randomized controlled trial (RCT) designed to evaluate the effectiveness of Internet-delivered behavior therapy (BT) based on exposure with response prevention (ERP) for adults with Tourette syndrome (TS) or chronic tic disorder (CTD). The primary aim is to evaluate the effects of Internet-delivered ERP-based BT on tic severity compared to a control condition offering general psychological support at week 11 counting from the treatment start. The primary outcome measure is the Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS). Secondary outcomes include measures of tics-related impairment, work and social adjustment, rates of responders, self-rated tic severity, symptoms of depression, and quality of life. Long-term maintenance of results will be assessed at week 23 and 14 months after the treatment start. Participants will be recruited nationwide. The intervention group will receive 10 weeks of ERP-based therapy delivered through an online platform, with therapist support. The control group will receive psychoeducational content and general psychological support. Adherence to treatment, adverse events, and patient safety will be closely monitored throughout the trial. The study population will be intent-to-treat and the between-group differences at the primary endpoint will be assessed using an analysis of covariance (ANCOVA) with pre-score of the measure as covariate. A health-economic evaluation will assess the cost-effectiveness of the intervention., conditionsModule conditions: Tourette Syndrome, conditions: Chronic Tic Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Exposure with response prevention, interventions name: Brief psychoeducation with general psychological support, outcomesModule primaryOutcomes measure: Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS), secondaryOutcomes measure: Yale Global Tic Severity Scale (YGTSS) - impairment scale, secondaryOutcomes measure: Clinical Global Impression (CGI), secondaryOutcomes measure: Gilles de la Tourette Syndrome Quality of Life Scale (QTS-QoL), secondaryOutcomes measure: Montgomery-Asberg Depression Rating Scale (MADRS), secondaryOutcomes measure: Adult Tic Questionnaire (ATQ), secondaryOutcomes measure: Work and social adjustment scale (WSAS), secondaryOutcomes measure: Treatment Inventory of Costs in Psychiatric Patients (TIC-P), secondaryOutcomes measure: Assessing Quality of Life 6 Dimensions (AQoL-6D), otherOutcomes measure: Internet Intervention Patient Adherence Scale for Guided Internet-Delivered Behavioural Interventions (iiPAS), otherOutcomes measure: Credibility/Expectancy Questionnaire (CEQ), otherOutcomes measure: Working Alliance Inventory-Short Form Revised (WAI-SR), otherOutcomes measure: Checklist for negative events, otherOutcomes measure: Events during treatment and adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska Institutet, status: RECRUITING, city: Stockholm, zip: 14157, country: Sweden, contacts name: Ekaterina Ivanova, PhD, role: CONTACT, phone: 0046765807416, email: ekaterina.ivanova@ki.se, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False