Internet-based Behavior Therapy for Adults With Tourette Syndrome (NCT06271083) | Clinical Trial Compass
RecruitingNot Applicable
Internet-based Behavior Therapy for Adults With Tourette Syndrome
Sweden110 participantsStarted 2024-02-02
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
≥ 18 years of age.
Primary diagnosis of TS/CTD, according to criteria in Diagnostic and Statistical Manual of mental disorders 5th edition.
Provided digital informed consent.
Have a Total Tic Severity Score (TTS) of \>15, or \>10 for individuals with motor or vocal tics only, in the past week, as measured by the Yale Global Tic Severity Scale (YGTSS).
Being willing and able to follow the study procedures and participate in the 10-week treatment program.
Being fluent in Swedish.
Have regular access to a computer connected to the Internet, sufficient technical skills to use the treatment platform, as well as a mobile phone to receive text messages.
Exclusion Criteria:
Ongoing or planned psychological treatment for TS/CTD.
Previous BT for tics of a minimum of 8 sessions with a qualified therapist within 12 months prior to assessment.
Adjustment of medication for tics within the last two months prior to assessment.
Severe psychiatric comorbidities such as organic brain disorders, bipolar disorder, ongoing psychosis, anorexia nervosa or substance use disorders that can interfere with the treatment for TS/CTD.
Acute psychiatric problems such as severe depression or suicidal risk needing immediate psychiatric care.
Severe tics causing immediate risk to the participants themselves or to others and requiring urgent medical attention.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS)
Timeframe: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.