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TICNET
A Parallel-group, Randomized Controlled Trial of Internet-based Behavior Therapy for Adults With Tourette Syndrome
Sponsor study identifier
Secondary identifiers
NIH
interventional
110
1 country
1
Study Start
February 2, 2024
Actual (reported)Primary Completion
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2, 2024
Actual (reported)February 6, 2024
Actual (reported)February 21, 2024
Actual (reported)May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS)
The YGTSS is made up of a semi-structured interview, followed by a questionnaire where individuals are asked to rate the severity of their tic symptoms (both motor and vocal) in domains such as: number, frequency, intensity, complexity, and interference. The Total Tic Severity subscale has a range of 0-50. A higher score suggests higher tic severity.
Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
Yale Global Tic Severity Scale (YGTSS) - impairment scale
Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
Clinical Global Impression (CGI)
Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
Gilles de la Tourette Syndrome Quality of Life Scale (QTS-QoL)
Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
Montgomery-Asberg Depression Rating Scale (MADRS)
Baseline, week 3, 7, 11 (primary end-point), 23 and 14 months after the treatment start.
Adult Tic Questionnaire (ATQ)
Baseline, week 2-10, week 11 (primary end-point), week 23 and 14 months after the treatment start.
Internet Intervention Patient Adherence Scale for Guided Internet-Delivered Behavioural Interventions (iiPAS)
At week 6 and 11 after the treatment start
Credibility/Expectancy Questionnaire (CEQ)
At treatment week 5
Working Alliance Inventory-Short Form Revised (WAI-SR)
At treatment week 5
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.
Karolinska Institutet
Stockholm, 14157, Sweden
Sannemalm M, Lybert N, Gunnarsson L, Andren P, Kraepelien M, Bragesjo M, Fondberg R, Ivanov VZ, Mataix-Cols D, Fernandez de la Cruz L, Andersson E, Ruck C, Ivanova E. Study protocol for a parallel-group randomized controlled trial of internet-delivered behavior therapy for adults with Tourette syndrome. Front Digit Health. 2025 Aug 29;7:1518666. doi: 10.3389/fdgth.2025.1518666. eCollection 2025.
Ekaterina Ivanova, PhD
Karolinska Institutet
First Submitted
February 6, 2024
First Posted
February 21, 2024
Study Start
February 2, 2024
Actual (reported)Primary Completion
May 2026
Estimated (date passed)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)
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 21, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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