Tourette SyndromeTICNETNCT06271083
Internet-based Behavior Therapy for Adults With Tourette Syndrome
A study testing Exposure with response prevention and Brief psychoeducation with general psychological support in people with Tourette Syndrome and Chronic Tic Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tourette Syndrome, Chronic Tic Disorder
- What is being tested?
- Exposure with response prevention and Brief psychoeducation with general psychological support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSweden
- Study dates
- 2 Feb 2024to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Stockholm, 14157
Ekaterina Ivanova, PhD, 0046765807416, ekaterina.ivanova@ki.se
About this study
Official title: A Parallel-group, Randomized Controlled Trial of Internet-based Behavior Therapy for Adults With Tourette Syndrome
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
- Being tested
- Exposure with response prevention, Brief psychoeducation with general psychological support
- Medical subject headings
- Tourette Syndrome, Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure with response preventionBehavioural
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.
Brief psychoeducation with general psychological supportBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Behavior therapy with exposure and response prevention | Experimental | Not described Receives: Behavioral: Exposure with response prevention |
| Psychoeducation with general psychological support | Active comparator | Not described Receives: Behavioral: Brief psychoeducation with general psychological support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
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.
Measured: 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)
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.
Measured: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
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.
Measured: Baseline, week 3, 7, 11 (primary end-point), 23 and 14 months after the treatment start.
Adult Tic Questionnaire (ATQ)
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.
Measured: Baseline, week 2-10, week 11 (primary end-point), week 23 and 14 months after the treatment start.
Work and social adjustment scale (WSAS)
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.
Measured: Baseline, week 2-10, week 11 (primary end-point), week 23 and 14 months after the treatment start.
Treatment Inventory of Costs in Psychiatric Patients (TIC-P)
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.
Measured: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
Assessing Quality of Life 6 Dimensions (AQoL-6D)
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).
Measured: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start2 Feb 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekaterina Ivanova, Karolinska Institutet
- Investigators
- Ekaterina Ivanova, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271083
- Sponsor's protocol ID
- 2023-06541-01
- Other IDs
- 2023
- Acronym
- TICNET
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40949315
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel-group, Randomized Controlled Trial of Internet-based Behavior Therapy for Adults With Tourette Syndrome
- ClinicalTrials.gov ID
- NCT06271083
- Acronym / sponsor ID
- TICNET / 2023-06541-01
- Conditions
- Tourette Syndrome, Chronic Tic Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure with response preventionThe 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. | Behavioural | Behavior therapy with exposure and response prevention |
| Brief psychoeducation with general psychological supportParticipants 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) | Behavioural | Psychoeducation with general psychological support |
Primary outcome
Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS)
Time frame: 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.
8 secondary outcomes
Yale Global Tic Severity Scale (YGTSS) - impairment scale
Time frame: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
Clinical Global Impression (CGI)
Time frame: 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)
Time frame: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Baseline, week 3, 7, 11 (primary end-point), 23 and 14 months after the treatment start.
Adult Tic Questionnaire (ATQ)
Time frame: Baseline, week 2-10, week 11 (primary end-point), week 23 and 14 months after the treatment start.
Work and social adjustment scale (WSAS)
Time frame: Baseline, week 2-10, week 11 (primary end-point), week 23 and 14 months after the treatment start.
Treatment Inventory of Costs in Psychiatric Patients (TIC-P)
Time frame: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
Assessing Quality of Life 6 Dimensions (AQoL-6D)
Time frame: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Derived from this study: PubMed 40949315Sannemalm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ekaterina Ivanova, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure with response prevention and Brief psychoeducation with general psychological support in people with Tourette Syndrome and Chronic Tic Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ekaterina Ivanova, PhD (0046765807416, ekaterina.ivanova@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS) (time frame: Baseline, week 11 (primary end-point), 23 and 14 months after the treatment start.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06271083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.