Study protocol for a parallel-group randomized controlled trial of internet-delivered behavior therapy for adults with Tourette syndrome.
Max Sannemalm, Nathalie Lybert, Lisa Gunnarsson...
https://pubmed.ncbi.nlm.nih.gov/40949315Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06271083
A Parallel-group, Randomized Controlled Trial of Internet-based Behavior Therapy for Adults With Tourette Syndrome
Led by Karolinska Institutet · Updated on 2024-02-21
110
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an Internet-delivered behavior therapy based on exposure with response prevention (ERP) for adults diagnosed with Tourette syndrome (TS) or chronic tic disorder (CTD). This randomized controlled trial aims to compare the effects of ERP-based therapy on tic severity against a control group receiving general psychological support. The primary focus is on measuring tic severity using the Yale Global Tic Severity Scale (YGTSS-TTS) at week 11 after treatment begins, with additional assessments at 23 weeks and 14 months to examine long-term effects and cost-effectiveness. The study involves two groups: one receiving 10 weeks of ERP-based behavior therapy via an online platform with therapist guidance, and a control group receiving brief psychoeducational content along with general psychological support without active behavior therapy components. Participants in the therapy group will learn to expose themselves to tic triggers and practice tic suppression using tools such as the Ticstimer worksheet to record their progress. The control group receives therapist encouragement and can ask questions but will not receive active behavior therapy. Participants will be assessed through various scales and questionnaires measuring tic severity, impairment, depression, quality of life, and social adjustment at multiple points from baseline through 14 months after treatment start. Researchers will monitor adherence, adverse events, and safety throughout the trial. The study includes a health-economic evaluation to assess the cost-effectiveness of the intervention. The total participation time covers treatment and follow-up periods extending beyond one year.
CONDITIONS
Brief Title
Internet-based Behavior Therapy for Adults With Tourette Syndrome
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Primary diagnosis of Tourette syndrome or chronic tic disorder based on DSM-5 criteria
- Provided digital informed consent
- Total Tic Severity Score greater than 15, or greater than 10 for motor or vocal tics only, in the past week
- Willing and able to follow study procedures and participate in the 10-week treatment
- Fluent in Swedish
- Regular access to a computer with internet and a mobile phone
- Sufficient technical skills to use the online treatment platform
You will not qualify if you...
- Currently receiving or planned psychological treatment for Tourette syndrome or chronic tic disorder
- Received behavior therapy for tics of at least 8 sessions within 12 months prior to assessment
- Changed tic medication within 2 months prior to assessment
- Severe psychiatric conditions such as organic brain disorders, bipolar disorder, ongoing psychosis, anorexia nervosa, or substance use disorders interfering with treatment
- Severe acute psychiatric problems like severe depression or suicidal risk requiring immediate care
- Severe tics posing immediate risk to self or others requiring urgent medical attention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 10 weeks
Participants receive internet-based behavior therapy involving exposure with response prevention or psychoeducation with general psychological support over 10 weeks.
Weekly visits throughout treatment
Follow-up
Duration - Up to 14 months after treatment start
Participants are assessed at multiple time points after treatment to monitor tic severity, quality of life, and psychological status.
Visits at week 23 and 14 months after treatment start
Trial Site Locations
Total: 1 location
1
Karolinska Institutet
Stockholm, Sweden, 14157
Actively Recruiting
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Research Team
E
Ekaterina Ivanova, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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