Tic DisordersNCT04007913
Incorporating teleCBIT Into a Hospital-Based Tic Program
A study testing teleCBIT in people with Tic Disorders and Tourette Syndrome, run by San Jose State University at 2 sites in United States.
Trial summary
This is a single-arm open trial of Comprehensive Behavioral Intervention for Tics (CBIT) delivered to pediatric and adult patients with persistent tic disorders in their homes via videoconferencing (i.e., teleCBIT). All participants who enroll will receive teleCBIT. Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Tic Disorders, Tourette Syndrome
- What is being tested?
- teleCBIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Sep 2016to 15 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age 5-65, diagnosis of Tourette Syndrome or other persistent tic disorder (per diagnostic interview and self-report of prior physician diagnosis)
- Clinical Global Impressions - Severity Score > 3 (i.e., "moderately ill" or worse),
- unmedicated or on stable medication treatment for tics and psychiatric problems,
- fluency in English
- a functional accessible home computer and high speed (i.e., cable/DSL) internet connection
- willingness to sign a release of information to contact a local, licensed medical or mental health provider, of whom they are currently a patient (in case of emergent safety concerns).
- Minor participants must have a parent or guardian who is fluent in English available to attend treatment and assessment sessions.
Who cannot join
- significant suicidality, (i.e., a score of > 12 on the MINI or MINI-Kid suicidality module);
- prior diagnoses of intellectual disability; pervasive developmental disorder, mania, schizophrenia, psychotic disorder, substance abuse, substance dependence, or conduct disorder; currently experiencing a psychosocial, psychiatric, or neurological problem that requires immediate care
- lack of a functional home computer with high speed (i.e., cable or DSL) internet connection;
- or, prior receipt of >3 previous sessions of behavior therapy for tics within the past year (per self/parent report)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Florida Health
Gainesville, Florida, 32606
San Jose State University
San Jose, California, 95192
About this study
This is a single-arm open trial of Comprehensive Behavioral Intervention for Tics (CBIT) delivered to pediatric and adult patients with persistent tic disorders in their homes via videoconferencing (i.e., teleCBIT). All participants who enroll will receive teleCBIT.
Read the detailed description
Comprehensive Behavioral Intervention for Tics (CBIT) is a behavioral therapy with proven efficacy for treating persistent tic disorders (e.g., Tourette Syndrome) in youth and adults. Lack of access to a local CBIT provider prevents treatment access for many patients who could benefit from CBIT. Providing CBIT to patients in their homes via videoconferencing technology (i.e., teleCBIT) is a promising approach to increasing CBIT access. This study investigates treatment uptake, acceptability, feasibility, and clinical effectiveness of teleCBIT among pediatric and adult patients enrolled as patients in a state-of-the-art medical tic program.
- Conditions
- Tic Disorders, Tourette Syndrome
- Being tested
- teleCBIT
- Medical subject headings
- Tic Disorders, Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teleCBITBehavioural
Eight sessions of individual behavior therapy
| Study group | Role | What they receive |
|---|---|---|
| teleCBIT | Experimental | Patient receive eight sessions of individual teleCBIT, in accordance with Woods et al's (2008) protocol, from a licensed psychologist. Receives: Behavioral: teleCBIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Yale Global Tic Severity Scale Tic Severity Score (YGTSS)
YGTSS Tic Severity Score (0-50) as rated by independent evaluator. Higher scores indicate more severe tics.
Measured: Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)
Secondary outcomes (4)
Clinical Global Impression: Improvement (CGI:I) Score
CGI:I scores (range: 1-7) describe the global level of change in clinical severity of a disorder. Lower scores indicate more favorable change over time. Following common practice, we will also dichotomize CGI:I scores to evaluate Clinical Responder Status according to CGI:I score (i.e., responder: CGI:I=1 or 2; non-responder=CGI:I>2)
Measured: CGI:I score at post-treatment (Week 10), which assesses change from pre-treatment (i.e., week 0)
Parent Tic Questionnaire (PTQ) Total Tic Severity Score
Child Tic Severity as measured by parent-report on the PTQ (range: 0-224). Higher scores indicate more severe tics.
Measured: Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)
Adult Tic Questionnaire (ATQ) Total Tic Severity Score
Adult Tic Severity as measured by self-report on the ATQ (range: 0-224). Higher scores indicate more severe tics.
Measured: Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)
Yale Global Tic Severity Scale (YGTSS) Impairment Score
YGTSS Impairment Score (0-50) as rated by independent evaluator. Higher scores indicate greater tic-related impairment
Measured: Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start21 Sep 2016
- Primary completion15 Jun 2019
- Study completion15 Jun 2019
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 Tic DisordersStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Jose State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Neurology, Tourette Association of America
- Responsible party
- Principal investigator, Matthew Capriotti, San Jose State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007913
- Sponsor's protocol ID
- TSCTRF2016
- Status last verified
- Jul 2019
- First submitted
- 27 Jun 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Capriotti MR, Wellen BC, Young BN, Himle MB, Conelea CA, Espil FM, Simpson H, Mathews CA. Evaluating the feasibility, acceptability, and preliminary effectiveness of tele-comprehensive behavior therapy for tics (teleCBIT) for Tourette syndrome in youth and adults. J Telemed Telecare. 2025 Apr;31(3):328-337. doi: 10.1177/1357633X231189305. Epub 2023 Aug 7.
PubMed 37545359
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating teleCBIT Into a Hospital-Based Tic Program
- ClinicalTrials.gov ID
- NCT04007913
- Acronym / sponsor ID
- TSCTRF2016
- Conditions
- Tic Disorders, Tourette Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- San Jose State UniversityUniversity, hospital or other
- Collaborators
- American Academy of Neurology, Tourette Association of America
- Study start
- 21 Sep 2016 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 5 Jul 2019 (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 is a single-arm open trial of Comprehensive Behavioral Intervention for Tics (CBIT) delivered to pediatric and adult patients with persistent tic disorders in their homes via videoconferencing (i.e., teleCBIT). All participants who enroll will receive teleCBIT.
Detailed description
Comprehensive Behavioral Intervention for Tics (CBIT) is a behavioral therapy with proven efficacy for treating persistent tic disorders (e.g., Tourette Syndrome) in youth and adults. Lack of access to a local CBIT provider prevents treatment access for many patients who could benefit from CBIT. Providing CBIT to patients in their homes via videoconferencing technology (i.e., teleCBIT) is a promising approach to increasing CBIT access. This study investigates treatment uptake, acceptability, feasibility, and clinical effectiveness of teleCBIT among pediatric and adult patients enrolled as patients in a state-of-the-art medical tic program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| teleCBIT | Experimental | Behavioral: teleCBITPatient receive eight sessions of individual teleCBIT, in accordance with Woods et al's (2008) protocol, from a licensed psychologist. |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- age 5-65, diagnosis of Tourette Syndrome or other persistent tic disorder (per diagnostic interview and self-report of prior physician diagnosis)
- Clinical Global Impressions - Severity Score > 3 (i.e., "moderately ill" or worse),
- unmedicated or on stable medication treatment for tics and psychiatric problems,
- fluency in English
- a functional accessible home computer and high speed (i.e., cable/DSL) internet connection
Key exclusion criteria (4 listed)
- significant suicidality, (i.e., a score of > 12 on the MINI or MINI-Kid suicidality module);
- prior diagnoses of intellectual disability; pervasive developmental disorder, mania, schizophrenia, psychotic disorder, substance abuse, substance dependence, or conduct disorder; currently experiencing a psychosocial, psychiatric, or neurological problem that requires immediate care
- lack of a functional home computer with high speed (i.e., cable or DSL) internet connection;
- or, prior receipt of >3 previous sessions of behavior therapy for tics within the past year (per self/parent report)
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 |
|---|---|---|
| teleCBITEight sessions of individual behavior therapy | Behavioural | teleCBIT |
Primary outcome
Change in Yale Global Tic Severity Scale Tic Severity Score (YGTSS)
Time frame: Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)
YGTSS Tic Severity Score (0-50) as rated by independent evaluator. Higher scores indicate more severe tics.
4 secondary outcomes
Clinical Global Impression: Improvement (CGI:I) Score
Time frame: CGI:I score at post-treatment (Week 10), which assesses change from pre-treatment (i.e., week 0)
Parent Tic Questionnaire (PTQ) Total Tic Severity Score
Time frame: Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)
Adult Tic Questionnaire (ATQ) Total Tic Severity Score
Time frame: Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)
Yale Global Tic Severity Scale (YGTSS) Impairment Score
Time frame: Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 37545359Capriotti MR, Wellen BC, Young BN, Himle MB, Conelea CA, Espil FM, Simpson H, Mathews CA. Evaluating the feasibility, acceptability, and preliminary effectiveness of tele-comprehensive behavior therapy for tics (teleCBIT) for Tourette syndrome in youth and adults. J Telemed Telecare. 2025 Apr;31(3):328-337. doi: 10.1177/1357633X231189305. Epub 2023 Aug 7.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing teleCBIT in people with Tic Disorders and Tourette Syndrome, run by San Jose State University at 2 sites in United States.
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 4 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: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Yale Global Tic Severity Scale Tic Severity Score (YGTSS) (time frame: Change from pre-treatment (i.e., week 0) to post-treatment (i.e., 10-week)). 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 NCT04007913, 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 5 Jul 2019.