Internet-based Behavior Therapy for Adults With Tourette Syndrome
- Conditions
- Tourette SyndromeChronic Tic Disorder
- Interventions
- Behavioral: Brief psychoeducation with general psychological supportBehavioral: Exposure with response prevention
- Registration Number
- NCT06271083
- Lead Sponsor
- Karolinska Institutet
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
≥ 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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psychoeducation with general psychological support Brief psychoeducation with general psychological support - Behavior therapy with exposure and response prevention Exposure with response prevention -
- Primary Outcome Measures
Name Time Method Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS) Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start. 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.
- Secondary Outcome Measures
Name Time Method Yale Global Tic Severity Scale (YGTSS) - impairment scale Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start. 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. There is also an impairment scale, where the individual rates how the tic impacts on their daily life and activities. The impairment score has a range of 0-50 (steps of 0,10,20,30,40,50). A higher score suggests or a greater impact the tics have on the person's life.
Adult Tic Questionnaire (ATQ) Baseline, week 2-10, week 11 (primary end-point), week 23 and 14 months after the treatment start. The Adult Tic Questionnaire (ATQ) is a self-report measure used to assess the frequency, severity, and impact of tic symptoms in adults with Tourette syndrome or chronic tic disorder. It includes questions on 28 different types of tics, each type being scored regarding both intensity and frequency using 4-step likert-scale. The total score ranges between 0 and 224 with higher scores indicating higher tic severity.
Montgomery-Asberg Depression Rating Scale (MADRS) Baseline, week 3, 7, 11 (primary end-point), 23 and 14 months after the treatment start. MADRS is a 9-item depressive symptoms scale where the symptoms are assessed on a 7-point likert scale from no symptoms to very high severity. The total score ranges from 0 to 54 with higher score indicating more severe problems.
Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start. Self-rated questionnaire on healthcare utilization and productivity losses in patients with a psychiatric disorder. The TIC-P questionnaire measures costs in two dimensions: use of health resources and loss of productivity. Lower cost is better.
Work and social adjustment scale (WSAS) Baseline, week 2-10, week 11 (primary end-point), week 23 and 14 months after the treatment start. Work and social adjustment scale (WSAS) includes five questions on the person's functioning at home, school/work, leisure, relationships and social activities, each scored on a 9-step likert scale. The total score ranges between 0 and 40 with higher scores indicating lower functioning.
Assessing Quality of Life 6 Dimensions (AQoL-6D) Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start. Used to assess cost-effectiveness. 20 questions that assess different aspects of quality of life. The AQoL provides a utility score that ranges from 1.00 (full health) to 0.00 (death-equivalent health states) to -0.04 (health states worse than death).
Clinical Global Impression (CGI) Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start. The Clinical Global Impression - Severity (CGI-S) and Clinical Global Impression - Improvement (CGI-I) Scales will be used to assess overall clinical severity and consequent treatment response (scores of "very much improved" (1) or "much improved" (2) will define treatment response according to previous trials in tic disorders.
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. QTS-QoL is a syndrome-specific quality of life scale with 27 items scored on a 5-point likert scale from no problems to very severe problems.The total score ranges from 0 to 108 with higher score indicating more severe problems.
Trial Locations
- Locations (1)
Karolinska Institutet
🇸🇪Stockholm, Sweden