Actively Recruiting
Internet-based Behavior Therapy for Adults With Tourette Syndrome
Led by Karolinska Institutet · Updated on 2024-02-21
110
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Internet-based Behavior Therapy for Adults With Tourette Syndrome
Who Can Participate
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
- Provided digital informed consent
- Yale Global Tic Severity Scale Total Tic Severity Score over 15, or over 10 for motor or vocal tics alone, in the past week
- Willing and able to follow study procedures and complete the 10-week treatment
- Fluent in Swedish
- Regular access to a computer with internet, sufficient technical skills for the platform, and a mobile phone for text messages
You will not qualify if you...
- Currently receiving or planning psychological treatment for TS/CTD
- Received at least 8 sessions of behavior therapy for tics with a qualified therapist within the last 12 months
- Changed tic medication within the last two months
- Severe psychiatric disorders like organic brain disorders, bipolar disorder, ongoing psychosis, anorexia nervosa, or substance use disorders interfering with TS/CTD treatment
- Acute severe psychiatric problems such as severe depression or suicidal risk needing immediate care
- Severe tics causing immediate risk to self or others requiring urgent medical attention
AI-Screening
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Trial Site Locations
Total: 1 location
1
Karolinska Institutet
Stockholm, Sweden, 14157
Actively Recruiting
Research Team
E
Ekaterina Ivanova, PhD
CONTACT
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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