Clinical trial NCT06271083: Internet-based Behavior Therapy for Adults With Tourette Syndrome
Official title: A Parallel-group, Randomized Controlled Trial of Internet-based Behavior Therapy for Adults With Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tourette Syndrome
Chronic Tic Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

≥ 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS)
timeFrame: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
Secondary outcomes:
measure: Yale Global Tic Severity Scale (YGTSS) - impairment scale
timeFrame: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
measure: Clinical Global Impression (CGI)
timeFrame: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
measure: Gilles de la Tourette Syndrome Quality of Life Scale (QTS-QoL)
timeFrame: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline, week 3, 7, 11 (primary end-point), 23 and 14 months after the treatment start.
measure: Adult Tic Questionnaire (ATQ)
timeFrame: Baseline, week 2-10, week 11 (primary end-point), week 23 and 14 months after the treatment start.
measure: Work and social adjustment scale (WSAS)
timeFrame: Baseline, week 2-10, week 11 (primary end-point), week 23 and 14 months after the treatment start.
measure: Treatment Inventory of Costs in Psychiatric Patients (TIC-P)
timeFrame: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
measure: Assessing Quality of Life 6 Dimensions (AQoL-6D)
timeFrame: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
Other outcomes:
measure: Internet Intervention Patient Adherence Scale for Guided Internet-Delivered Behavioural Interventions (iiPAS)
timeFrame: At week 6 and 11 after the treatment start
measure: Credibility/Expectancy Questionnaire (CEQ)
timeFrame: At treatment week 5
measure: Working Alliance Inventory-Short Form Revised (WAI-SR)
timeFrame: At treatment week 5
measure: Checklist for negative events
timeFrame: At week 11 (primary end-point) and 23.
measure: Events during treatment and adverse events
timeFrame: At week 3, 7, 11 (primary end-point) and 23.
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Ekaterina Ivanova, PhD
role: PRINCIPAL_INVESTIGATOR
References: