Remote Delivery of a Mindfulness-based Intervention for Tics (NCT06408662) | Clinical Trial Compass
RecruitingNot Applicable
Remote Delivery of a Mindfulness-based Intervention for Tics
United States150 participantsStarted 2024-05-23
Plain-language summary
This research study is being done to compare a mindfulness-based intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) for individuals with Tourette's syndrome or Persistent Tic Disorders (collectively TS). It is the investigator's hope that this information cam be used to improve current treatments for individuals with TS.
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
. be ≥18 years of age;
. meet diagnostic criteria for a primary or co-primary diagnosis of Tourette Syndrome or a Persistent Motor or Vocal Tic Disorder on a structured clinical interview;
. have moderate or greater tic severity as evidenced by a YGTSS Total Tic Score of \>14 (when motor and vocal tics are present) or \>10 (when only motor or vocal tics are present);
. be medication free and/or on a stable dose of psychiatric medication 8 weeks prior to study participation;
. be not engaged in psychotherapy for non-TS conditions and/or be on a stable course of therapy for 6 months prior to study participation
. be fluent in English;
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 (YGTSS) Total Tic Severity Score