Internet-based Behavior Therapy for Adults With Tourette Syndrome

NCT06271083 | Recruiting

• 1 other identifier: 2023-06541-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Tourette Syndrome; Chronic Tic Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (8)

• 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.

Other Outcomes (5)

• 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

Study Arms (2)

Behavior therapy with exposure and response prevention

EXPERIMENTAL

Behavioral: Exposure with response prevention

Psychoeducation with general psychological support

ACTIVE COMPARATOR

Behavioral: Brief psychoeducation with general psychological support

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.

Behavior therapy with exposure and response prevention

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)

Psychoeducation with general psychological support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age.
• Primary diagnosis of TS/CTD, according to criteria in Diagnostic and Statistical Manual of mental disorders 5th edition.
• Provided digital informed consent.
• Have a Total Tic Severity Score (TTS) of \>15, or \>10 for individuals with motor or vocal tics only, in the past week, as measured by the Yale Global Tic Severity Scale (YGTSS).
• Being willing and able to follow the study procedures and participate in the 10-week treatment program.
• Being fluent in Swedish.
• Have regular access to a computer connected to the Internet, sufficient technical skills to use the treatment platform, as well as a mobile phone to receive text messages.

You may not qualify if:

• Ongoing or planned psychological treatment for TS/CTD.
• Previous BT for tics of a minimum of 8 sessions with a qualified therapist within 12 months prior to assessment.
• Adjustment of medication for tics within the last two months prior to assessment.
• Severe psychiatric comorbidities such as organic brain disorders, bipolar disorder, ongoing psychosis, anorexia nervosa or substance use disorders that can interfere with the treatment for TS/CTD.
• Acute psychiatric problems such as severe depression or suicidal risk needing immediate psychiatric care.
• Severe tics causing immediate risk to the participants themselves or to others and requiring urgent medical attention.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, 14157, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 40949315 DERIVED

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ekaterina Ivanova, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ekaterina Ivanova, PhD

CONTACT

0046765807416; ekaterina.ivanova@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral researcher

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 21, 2024
• Study Start: February 2, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

SE (1)