Internet-based Behavior Therapy for Adults With Tourette Syndrome

Sponsor
Karolinska Institutet
Study ID
NCT06271083
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exposure with response prevention — BEHAVIORAL
    The central component of the intervention will be ERP. During the treatment, participants will receive information about tics and how to work with ERP. Continuously throughout the treatment patients will work with exposing themselves to situations that trigger their premonitory urges and practice suppressing their tics. They will learn different strategies to provoke their premonitory urges to make suppression of their tics more challenging and gradually increase the time they can suppress the tics. A central tool in the treatment will be the Ticstimer, a worksheet where patients will continuously record their ERP practice, and the time they manage to suppress tics. The patients will be encouraged to work with the Ticstimer daily.
  • Brief psychoeducation with general psychological support — BEHAVIORAL
    Participants who are randomized to the control group will receive access to brief psychoeducational content in the platform in combination with general psychological support from a therapist. No active BT components (BT, Habit Reversal Training, applied relaxation) are provided to the participants in the control group. The therapists will welcome the patients to the treatment, encourage them to engage in the treatment content and reach out to the therapist if they have any questions. Thereafter, the therapists will only reply to the patients' messages without taking any contact initiative themselves (unless there is an indication of severe deterioration or severe depressive symptoms or suicidal ideation requiring medical attention)

Study Details

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.

Key Dates

Start date
Feb 2, 2024
Status verified
Feb 2024
Primary completion
May 31, 2026
Completion
May 31, 2028

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Behavior therapy with exposure and response prevention
  • Active Comparator: Psychoeducation with general psychological support

Primary Outcome Measure

Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS) [ Time Frame: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start. ]

Central Contacts

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