Internet-based Behavior Therapy for Adults With Tourette Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Exposure with response prevention
BehavioralThe 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
BehavioralParticipants 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)
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Behavior therapy with exposure and response preventionExperimental treatment 1 intervention
Group B: Psychoeducation with general psychological supportActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.Secondary outcomes
1
Yale Global Tic Severity Scale (YGTSS) - impairment scale
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.
Time frame
Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.2
Clinical Global Impression (CGI)
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.
Time frame
Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.3
Gilles de la Tourette Syndrome Quality of Life Scale (QTS-QoL)
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.
Time frame
Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.4
Montgomery-Asberg Depression Rating Scale (MADRS)
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.
Time frame
Baseline, week 3, 7, 11 (primary end-point), 23 and 14 months after the treatment start.Other outcomes
1
Internet Intervention Patient Adherence Scale for Guided Internet-Delivered Behavioural Interventions (iiPAS)
The iiPAS is a 5-item, clinician-rated measure of patient adherence to internet-delivered behavioral interventions. The 5 items are rated by treating clinicians and cover 5 central aspects of adherence: the patient's work pace, engagement, communication with the clinician, motivation for change, and login frequency. The clinicians assess each domain on a 5-point likert scale (scored 0-4), with a total score ranging between 0-20 where higher score indicates higher treatment adherence.
Time frame
At week 6 and 11 after the treatment start2
Credibility/Expectancy Questionnaire (CEQ)
Measures treatment expectancy and rationale credibility. The CEQ is a 5-item measure of the treatment's credibility and the patients' expectations. The patients assess each domain on a 11-point likert scale (scored 0-10), with a total score ranging between 0-50 where higher score indicates higher credibility and higher expectations.
Time frame
At treatment week 53
Working Alliance Inventory-Short Form Revised (WAI-SR)
Measures the therapeutic alliance in therapy. The WAI-SR is a 12-item measure of the patient's experience of their working alliance with the therapist. The patients assess each item on a 7-point likert scale (scored 0-6), with a total score ranging between 0-72 where higher score indicates higher better working alliance according to the patient.
Time frame
At treatment week 54
Checklist for negative events
A checklist listing 16 different negative events asking about how often the participant experienced each of them and whether the participant thinks the event was due to the treatment they received.
Time frame
At week 11 (primary end-point) and 23.Sponsors and contacts
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Source ClinicalTrials.gov