TicsCBIT-TrainerNCT05547854
Evaluation of an Online Comprehensive Behavioral Intervention for Tics (CBIT) Therapist Training Program
A study testing Behavior Therapy Training Institute and CBIT-Trainer in people with Tics and Tic Disorders, run by University of Utah at 2 sites in United States.
Trial summary
Tic disorders are a class of childhood-onset neuropsychiatric disorders that occur in 1-3% of the population. Studies have shown that a non-drug treatment known as Comprehensive Behavioral Intervention for Tics (CBIT) is more effective than supportive therapy for reducing tics in children and adults. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Tics, Tic Disorders, Tourette Syndrome
- What is being tested?
- Behavior Therapy Training Institute and CBIT-Trainer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jun 2023to 30 Aug 2025
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
This study will recruit therapist-patient dyads who meet the criteria below:
Therapist Inclusion Criteria:
- Have the equivalent of a Master's degree (or higher) in a mental/behavioral health, medical, or related discipline.
- Professionally licensed or certified to practice in their area of speciality.
- Attest that providing comprehensive behavioral intervention for tics (CBIT) to treat children and/or adults with tic disorders falls within their scope of practice according to state licensing laws and regulations in the therapist's jurisdiction.
- Have never attended the Tourette Association of America's Behavior Therapy Training Institute or an equivalent focused on CBIT.
- Have access to a secure personal computer with high-speed internet access.
- Speaks fluent English.
- Has identified, or is willing to try to identify, at least 1 child or adult patient with a tic disorder who meets the patient inclusion criteria and who might be willing to participate in the study as a member of the therapist-patient dyad, and for whom the therapist is licensed or certified to treat with CBIT according to state licensing laws and regulations in the therapist's jurisdiction.
- Is willing to be randomly assigned to training condition.
- Is willing, able, and has the necessary resources to travel to, and attend, one of several in-person training sites if assigned to the in-person training condition.
Therapist Exclusion Criteria:
(1) Therapist is a first, second, or third degree biological relative, stepparent, or legal guardian of the study-matched patient.
Patient Inclusion Criteria:
- 7 years of age or older (with consenting adult for minors).
- Self- or parent-reported diagnosis of a tic disorder (e.g., provisional tic disorder, persistent motor/vocal tic disorder, or Tourette's disorder) issued by a qualified professional.
- Currently engages in at least one motor and/or vocal tic multiple times per day.
- Patient (and consenting adult for minors) speaks fluent English.
- Access to a private computer with high-speed internet access.
Patient Exclusion Criteria:
- Patients will be excluded if the study team is unable to identify and enroll a patient-matched therapist who meets the therapist inclusion criteria.
- Patient is a first, second, or third degree biological relative of the study-matched therapist or if the study-matched therapist is the patient's legal guardian.
- Any serious psychiatric or neurological condition that requires more immediate intervention or would interfere with study participation, based on the assessment of the treating therapist or the study investigators.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Marquette University
Milwaukee, Wisconsin, 53201
University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Finalizing and Testing an Online Therapist Training and Assistance Program to Facilitate Implementation of Comprehensive Behavioral Intervention for Tic Disorders
Tic disorders are a class of childhood-onset neuropsychiatric disorders that occur in 1-3% of the population. Studies have shown that a non-drug treatment known as Comprehensive Behavioral Intervention for Tics (CBIT) is more effective than supportive therapy for reducing tics in children and adults. Although CBIT is now recommended as a first-line intervention for tic disorders, many patients do not have access to CBIT, in part due to a lack of trained therapists. Currently, the only option available for training therapists in CBIT is an intensive, two day, in-person behavior therapy training institute (BTTI). This study will compare the traditional in-person training approach to a recently developed online, self-paced CBIT therapist training program called CBIT-Trainer with regard to (1) therapists' ability to accurately administer CBIT and (2) change in the severity of patients' tic symptoms after being treated by a CBIT-trained therapist.
Read the detailed description
Tic disorders are a class of childhood-onset neuropsychiatric disorders that occur in 1-3% of the population and often cause significant impairment in physical, social, academic, and interpersonal functioning and reduced quality of life. There is currently no cure for tic disorders, however large-scale randomized controlled trials have shown that a non-drug treatment known as Comprehensive Behavioral Intervention for Tics (CBIT) is more effective than supportive psychotherapy for reducing tics in both children and adults. Although CBIT is now recommended as a first-line intervention for tic disorders, many patients do not have access to CBIT, in part due to a lack of trained therapists. Given the need and desire for CBIT among individuals with tic disorders, high demand for therapist trainings, and the lack of therapists adequately trained in CBIT, there is a clear need for innovative ways to train more providers in this evidence-based treatment. To address this gap, the investigators recently developed an innovative online program for training therapists to deliver CBIT (called CBIT-Trainer). This study will test CBIT-Trainer against an intensive in-person therapist training program in a randomized controlled trial. This study will accomplish four aims: (1) to compare CBIT-Trainer to traditional in-person training on therapists' ability to administer CBIT with fidelity, (2) to compare CBIT-Trainer to in-person training on patient outcomes when patients are treated by a CBIT-trained therapist, (3) to identify therapist factors that might improve (or limit) adoption and use of CBIT-Trainer, and (4) to identify therapist factors likely to influence continued use of CBIT after training. These aims will be tested using an effectiveness-implementation hybrid randomized controlled trial comparing CBIT-Trainer (online therapist training) to the Tourette Association of America's Behavior Therapy Training Institute (in-person therapist training), which is the current gold-standard for training CBIT therapists. Therapist-patient dyads will be recruited to participate. The primary therapist outcome will be therapists' skill in delivering CBIT in a standardized role-play, which will be assessed at post-training (Week 0), after administering CBIT with a patient (Week 10), and at 6-month follow-up (Week 24). The primary patient outcome will be overall clinical improvement, which will be assessed at pre-treatment (Week 0), post-treatment (Week 10), and 6-month follow up (Week 24). Secondary therapist outcomes that will be assessed include changes in knowledge of tic disorders and CBIT; changes in comfort and self-efficacy in delivering CBIT; adherence to the CBIT protocol when treating a patient with tics; attitudes toward evidence-based practice and CBIT; and therapists' ratings of the acceptability, appropriateness, and feasibility of the training. Secondary patient outcomes that will be assessed include changes in motor and/or vocal tic severity; changes in overall psychological/behavioral, physical, and social functioning; and satisfaction with the treatment received.
- Conditions
- Tics, Tic Disorders, Tourette Syndrome
- Being tested
- Behavior Therapy Training Institute, CBIT-Trainer
- Keywords
- Comprehensive Behavioral Intervention for Tics
- Medical subject headings
- Tics, Tic Disorders, Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior Therapy Training InstituteBehavioural
In-person therapist training will follow the Tourette Association of America's established Behavior Therapy Training Institute procedures and will consist of 12 hours of in-person training conducted over the course of 2 days. Day 1 will involve standardized didactic lectures on tic disorders and video demonstrations of therapeutic techniques. Day 2 will involve break-out groups and role-play practice of CBIT techniques. Participants (therapists) will receive up to three, 30-minute follow-up consultations with a training instructor while providing CBIT to a study-enrolled patient.
CBIT-TrainerBehavioural
In the online therapist training condition participants will be provided with access to the CBIT-Trainer program and asked to complete the training over the course of 4 weeks. CBIT-Trainer is designed for the average user to complete in approximately 12 hours. Participants (therapists) will receive up to three, 30-minute follow-up consultations with a CBIT expert while providing CBIT to a study-enrolled patient.
| Study group | Role | What they receive |
|---|---|---|
| In-Person Therapist Training | Active comparator | Not described Receives: Behavioral: Behavior Therapy Training Institute |
| Online Therapist Training | Experimental | Not described Receives: Behavioral: CBIT-Trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapist scores on the CBIT Fidelity Checklist and Rating Scale at post-training
The CBIT Fidelity Checklist and Rating Scale measures therapists' accuracy in administering 12 core components of CBIT during a standardized role-play. Items are rated using a series of 5-point Likert-type ratings ranging from "poor" to "excellent." Item ratings are aggregated to provide an overall fidelity rating ranging from 0-48. Higher ratings indicate better performance.
Measured: up to 2 weeks post-training
Therapist scores on the CBIT Fidelity Checklist and Rating Scale at post-treatment
The CBIT Fidelity Checklist and Rating Scale measures therapists' accuracy in administering 12 core components of CBIT during a standardized role-play. Items are rated using a series of 5-point Likert-type ratings ranging from "poor" to "excellent." Item ratings are aggregated to provide an overall fidelity rating ranging from 0-48. Higher ratings indicate better performance.
Measured: 10-12 weeks post-training
Therapist scores on the CBIT Fidelity Checklist & Rating Scale at 6-month follow-up
The CBIT Fidelity Checklist and Rating Scale measures therapists' accuracy in administering 12 core components of CBIT during a standardized role-play. Items are rated using a series of 5-point Likert-type ratings ranging from "poor" to "excellent." Item ratings are aggregated to provide an overall fidelity rating ranging from 0-48. Higher ratings indicate better performance.
Measured: 24-26 weeks post-training
Proportion of treatment responders at post-treatment on the Clinical Global Impression Improvement Scale (CGI-I)
The CGI-I is a single-item clinical rating of symptom improvement relative to baseline. Ratings on the CGI-I range from 1 (very much improved) to 7 (very much worse). CGI-I ratings of 1 (very much improved) or 2 (much improved) indicate positive treatment response. Higher scores are related to worse treatment response.
Measured: 10-12 weeks from the start of treatment (post-treatment)
Proportion of treatment responders at follow-up on the Clinical Global Impression Improvement Scale (CGI-I)
The CGI-I is a single-item clinical rating of symptom improvement relative to baseline. Ratings on the CGI-I range from 1 (very much improved) to 7 (very much worse). CGI-I ratings of 1 (very much improved) or 2 (much improved) indicate positive treatment response. Higher scores are related to worse treatment response.
Measured: 24-26 weeks from the start of treatment (6-month follow-up)
Patient changes in overall symptom severity on the Clinical Global Impression Severity Scale (CGI-S)
The CGI-S is a single-item clinical rating of the participant's illness at the time of the assessment. Ratings on the CGI-S range from 1 (slight psychiatric illness) to 7 (extremely severe psychiatric illness). Higher scores indicate greater symptom severity.
Measured: Up to 2 weeks prior to starting treatment (baseline), 10-12 weeks from the start of treatment (post-treatment), 24-26 weeks from the start of treatment (6-month follow-up)
Secondary outcomes (8)
Therapist change scores on the Tic Disorder & CBIT Knowledge Test
The Tic Disorder \& CBIT Knowledge Test is a 20-item pre-post multiple choice test that assesses therapists' knowledge of several essential concepts taught during the psychoeducation component of CBIT. Scores are based on the percentage of items answered correctly. Higher scores indicate greater understanding and mastery of the material.
Measured: Up to 2 weeks pre-training and up to 2 weeks post training
Therapist changes in self-efficacy to treat tic disorders as measured by the Therapist Self-Assessment & Rating Form
The Therapist Self-Assessment \& Rating Form is a therapist self-rating form developed for this study. It is a face-valid measure designed to assess therapists' self-efficacy regarding to their ability to competently and effectively treat tic disorders using CBIT and intent to use CBIT to treat tic disorders in the future. Ten self-statements are each rated on a 5-point Likert-type scale ranging from "Strongly Disagree" to "Strongly Agree." Higher scores indicate higher self-efficacy on each item.
Measured: Up to 2 weeks pre-training, up to 2 weeks post-training, 10-12 weeks from the start of treatment delivery with a patient, 24-26 weeks from the start of treatment delivery with a patient
Patient changes in tic severity as measured by the Yale Global Tic Severity Scale (YGTSS) Total Tic Score
The YGTSS is a clinician-rated interview assessing motor and vocal tics symptom severity during the past week. Motor and vocal tics are rated separately across 5 domains: number (0-5), frequency (0-5), intensity (0-5), complexity (0-5), and interference (0-5). The ratings for each motor and vocal tic domain are then summed to produce an overall total tic score ranging from 0-50 with higher scores indicating greater severity.
Measured: Up to 2 weeks prior to starting treatment (baseline), 10-12 weeks from the start of treatment (post-treatment), 24-26 weeks from the start of treatment (6-month follow-up)
Patient changes in tic-related impairment as measured by the Yale Global Tic Severity Scale (YGTSS) Overall Tic Related Impairment Scores
The YGTSS Overall Tic Related Impairment Score is a single-item clinician rating of overall impairment caused by tics. Impairment is rated on a 0-50 scale with higher scores indicating greater impairment.
Measured: Up to 2 weeks prior to starting treatment (baseline), 10-12 weeks from the start of treatment (post-treatment), 24-26 weeks from the start of treatment (6-month follow-up)
Patient treatment satisfaction scores on the Treatment Satisfaction Questionnaire (TSQ) at post-treatment
The TSQ is a brief 10-item self-report measure that assesses patients' satisfaction with their therapist and the treatment that they received. Each item is rated on a 4-point Likert-type scale. Scores range from 0-40 with higher scores indicating greater overall treatment satisfaction.
Measured: 10-12 weeks from the start of treatment (post-treatment)
Patient treatment satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at follow-up
The TSQ is a brief 10-item self-report measure that assesses patients' satisfaction with their therapist and the treatment that they received. Each item is rated on a 4-point Likert-type scale. Scores range from 0-40 with higher scores indicating greater overall treatment satisfaction.
Measured: 24-26 weeks from the start of treatment (6-month follow-up)
Changes in psychological/behavioral symptoms and adaptive functioning as indicated by change scores on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric/Parent Proxy Profile 25 (for child patients & caregivers only)
The PROMIS Pediatric/Parent Proxy Profile 25 contains a collection of 25 caregiver and child-report items assessing psychological/behavioral symptoms in children in the following domains: anxiety, depressive symptoms, fatigue, pain interference, physical function-mobility, and peer relationships. Each item is rated on a 1-5 scale with higher scores indicate more severe symptoms or poorer adaptive functioning.
Measured: Up to 2 weeks prior to starting treatment (baseline), 10-12 weeks from the start of treatment (post-treatment), 24-26 weeks from the start of treatment (6-month follow-up)
Changes in psychological/behavioral symptoms and adaptive functioning as indicated by change scores on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Profile (for adult patients only)
The PROMIS-29 Profile contains a collection of 29 patient-report items assessing psychological/behavioral symptoms in adults in the following domains: anxiety, depression, fatigue, pain interference, physical function, and ability to participate in social roles and activities. Each item is rated on a 1-5 scale with higher scores indicate more severe symptoms or poorer adaptive functioning. Higher scores indicate more severe symptoms or poorer adaptive functioning.
Measured: Up to 2 weeks prior to starting treatment (baseline), 10-12 weeks from the start of treatment (post-treatment), 24-26 weeks from the start of treatment (6-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start27 Jun 2023
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for TicsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Effectiveness-implementation hybrid non-inferiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Marquette University, PsycTech, LLC
- Responsible party
- Principal investigator, Mike Himle, University of Utah
- Investigators
- Suzanne Mouton-Odum, PhD, Principal investigator, PsycTech, LLCMichael Himle, PhD, Principal investigator, University of UtahDoug Woods, PhD, Principal investigator, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547854
- Sponsor's protocol ID
- 00158298
- Acronym
- CBIT-Trainer
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2022
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in any publication(s) may be provided to qualified researchers with academic interests in tic disorders and related conditions and expertise in the scoring and interpretation of the outcome measures administered. All data shared will be coded with no identifying information included. Approval of the request by the study primary investigators and execution of all applicable data sharing agreements are prerequisites to the sharing of data with the requesting party.
Publications
Robertson MM. The prevalence and epidemiology of Gilles de la Tourette syndrome. Part 1: the epidemiological and prevalence studies. J Psychosom Res. 2008 Nov;65(5):461-72. doi: 10.1016/j.jpsychores.2008.03.006. Epub 2008 Oct 2.
PubMed 18940377Evans J, Seri S, Cavanna AE. The effects of Gilles de la Tourette syndrome and other chronic tic disorders on quality of life across the lifespan: a systematic review. Eur Child Adolesc Psychiatry. 2016 Sep;25(9):939-48. doi: 10.1007/s00787-016-0823-8. Epub 2016 Feb 15.
PubMed 26880181Conelea CA, Woods DW, Zinner SH, Budman CL, Murphy TK, Scahill LD, Compton SN, Walkup JT. The impact of Tourette Syndrome in adults: results from the Tourette Syndrome impact survey. Community Ment Health J. 2013 Feb;49(1):110-20. doi: 10.1007/s10597-011-9465-y. Epub 2011 Nov 4.
PubMed 22052430Piacentini J, Woods DW, Scahill L, Wilhelm S, Peterson AL, Chang S, Ginsburg GS, Deckersbach T, Dziura J, Levi-Pearl S, Walkup JT. Behavior therapy for children with Tourette disorder: a randomized controlled trial. JAMA. 2010 May 19;303(19):1929-37. doi: 10.1001/jama.2010.607.
PubMed 20483969Wilhelm S, Peterson AL, Piacentini J, Woods DW, Deckersbach T, Sukhodolsky DG, Chang S, Liu H, Dziura J, Walkup JT, Scahill L. Randomized trial of behavior therapy for adults with Tourette syndrome. Arch Gen Psychiatry. 2012 Aug;69(8):795-803. doi: 10.1001/archgenpsychiatry.2011.1528.
PubMed 22868933Roessner V, Plessen KJ, Rothenberger A, Ludolph AG, Rizzo R, Skov L, Strand G, Stern JS, Termine C, Hoekstra PJ; ESSTS Guidelines Group. European clinical guidelines for Tourette syndrome and other tic disorders. Part II: pharmacological treatment. Eur Child Adolesc Psychiatry. 2011 Apr;20(4):173-96. doi: 10.1007/s00787-011-0163-7.
PubMed 21445724Pringsheim T, Doja A, Gorman D, McKinlay D, Day L, Billinghurst L, Carroll A, Dion Y, Luscombe S, Steeves T, Sandor P. Canadian guidelines for the evidence-based treatment of tic disorders: pharmacotherapy. Can J Psychiatry. 2012 Mar;57(3):133-43. doi: 10.1177/070674371205700302.
PubMed 22397999Pringsheim T, Holler-Managan Y, Okun MS, Jankovic J, Piacentini J, Cavanna AE, Martino D, Muller-Vahl K, Woods DW, Robinson M, Jarvie E, Roessner V, Oskoui M. Comprehensive systematic review summary: Treatment of tics in people with Tourette syndrome and chronic tic disorders. Neurology. 2019 May 7;92(19):907-915. doi: 10.1212/WNL.0000000000007467.
PubMed 31061209
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finalizing and Testing an Online Therapist Training and Assistance Program to Facilitate Implementation of Comprehensive Behavioral Intervention for Tic Disorders
- ClinicalTrials.gov ID
- NCT05547854
- Acronym / sponsor ID
- CBIT-Trainer / 00158298
- Conditions
- Tics, Tic Disorders, Tourette Syndrome
- Keywords
- Comprehensive Behavioral Intervention for Tics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Marquette University, PsycTech, LLC
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 21 Sep 2022 (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.
Tic disorders are a class of childhood-onset neuropsychiatric disorders that occur in 1-3% of the population. Studies have shown that a non-drug treatment known as Comprehensive Behavioral Intervention for Tics (CBIT) is more effective than supportive therapy for reducing tics in children and adults. Although CBIT is now recommended as a first-line intervention for tic disorders, many patients do not have access to CBIT, in part due to a lack of trained therapists. Currently, the only option available for training therapists in CBIT is an intensive, two day, in-person behavior therapy training institute (BTTI). This study will compare the traditional in-person training approach to a recently developed online, self-paced CBIT therapist training program called CBIT-Trainer with regard to (1) therapists' ability to accurately administer CBIT and (2) change in the severity of patients' tic symptoms after being treated by a CBIT-trained therapist.
Detailed description
Tic disorders are a class of childhood-onset neuropsychiatric disorders that occur in 1-3% of the population and often cause significant impairment in physical, social, academic, and interpersonal functioning and reduced quality of life. There is currently no cure for tic disorders, however large-scale randomized controlled trials have shown that a non-drug treatment known as Comprehensive Behavioral Intervention for Tics (CBIT) is more effective than supportive psychotherapy for reducing tics in both children and adults. Although CBIT is now recommended as a first-line intervention for tic disorders, many patients do not have access to CBIT, in part due to a lack of trained therapists. Given the need and desire for CBIT among individuals with tic disorders, high demand for therapist trainings, and the lack of therapists adequately trained in CBIT, there is a clear need for innovative ways to train more providers in this evidence-based treatment. To address this gap, the investigators recently developed an innovative online program for training therapists to deliver CBIT (called CBIT-Trainer). This study will test CBIT-Trainer against an intensive in-person therapist training program in a randomized controlled trial. This study will accomplish four aims: (1) to compare CBIT-Trainer to traditional in-person training on therapists' ability to administer CBIT with fidelity, (2) to compare CBIT-Trainer to in-person training on patient outcomes when patients are treated by a CBIT-trained therapist, (3) to identify therapist factors that might improve (or limit) adoption and use of CBIT-Trainer, and (4) to identify therapist factors likely to influence continued use of CBIT after training. These aims will be tested using an effectiveness-implementation hybrid randomized controlled trial comparing CBIT-Trainer (online therapist training) to the Tourette Association of America's Behavior Therapy Training Institute (in-person therapist training), which is the current gold-standard for training CBIT therapists. Therapist-patient dyads will be recruited to participate. The primary therapist outcome will be therapists' skill in delivering CBIT in a standardized role-play, which will be assessed at post-training (Week 0), after administering CBIT with a patient (Week 10), and at 6-month follow-up (Week 24). The primary patient outcome will be overall clinical improvement, which will be assessed at pre-treatment (Week 0), post-treatment (Week 10), and 6-month follow up (Week 24). Secondary therapist outcomes that will be assessed include changes in knowledge of tic disorders and CBIT; changes in comfort and self-efficacy in delivering CBIT; adherence to the CBIT protocol when treating a patient with tics; attitudes toward evidence-based practice and CBIT; and therapists' ratings of the acceptability, appropriateness, and feasibility of the training. Secondary patient outcomes that will be assessed include changes in motor and/or vocal tic severity; changes in overall psychological/behavioral, physical, and social functioning; and satisfaction with the treatment received.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Effectiveness-implementation hybrid non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| In-Person Therapist Training | Active comparator | Behavioral: Behavior Therapy Training Institute |
| Online Therapist Training | Experimental | Behavioral: CBIT-Trainer |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Behavior Therapy Training InstituteIn-person therapist training will follow the Tourette Association of America's established Behavior Therapy Training Institute procedures and will consist of 12 hours of in-person training conducted over the course of 2 days. Day 1 will involve standardized didactic lectures on tic disorders and video demonstrations of therapeutic techniques. Day 2 will involve break-out groups and role-play practice of CBIT techniques. Participants (therapists) will receive up to three, 30-minute follow-up consultations with a training instructor while providing CBIT to a study-enrolled patient. | Behavioural | In-Person Therapist Training |
| CBIT-TrainerIn the online therapist training condition participants will be provided with access to the CBIT-Trainer program and asked to complete the training over the course of 4 weeks. CBIT-Trainer is designed for the average user to complete in approximately 12 hours. Participants (therapists) will receive up to three, 30-minute follow-up consultations with a CBIT expert while providing CBIT to a study-enrolled patient. | Behavioural | Online Therapist Training |
Primary outcome
Therapist scores on the CBIT Fidelity Checklist and Rating Scale at post-training
Time frame: up to 2 weeks post-training
The CBIT Fidelity Checklist and Rating Scale measures therapists' accuracy in administering 12 core components of CBIT during a standardized role-play. Items are rated using a series of 5-point Likert-type ratings ranging from "poor" to "excellent." Item ratings are aggregated to provide an overall fidelity rating ranging from 0-48. Higher ratings indicate better performance.
Therapist scores on the CBIT Fidelity Checklist and Rating Scale at post-treatment
Time frame: 10-12 weeks post-training
The CBIT Fidelity Checklist and Rating Scale measures therapists' accuracy in administering 12 core components of CBIT during a standardized role-play. Items are rated using a series of 5-point Likert-type ratings ranging from "poor" to "excellent." Item ratings are aggregated to provide an overall fidelity rating ranging from 0-48. Higher ratings indicate better performance.
Therapist scores on the CBIT Fidelity Checklist & Rating Scale at 6-month follow-up
Time frame: 24-26 weeks post-training
The CBIT Fidelity Checklist and Rating Scale measures therapists' accuracy in administering 12 core components of CBIT during a standardized role-play. Items are rated using a series of 5-point Likert-type ratings ranging from "poor" to "excellent." Item ratings are aggregated to provide an overall fidelity rating ranging from 0-48. Higher ratings indicate better performance.
Proportion of treatment responders at post-treatment on the Clinical Global Impression Improvement Scale (CGI-I)
Time frame: 10-12 weeks from the start of treatment (post-treatment)
The CGI-I is a single-item clinical rating of symptom improvement relative to baseline. Ratings on the CGI-I range from 1 (very much improved) to 7 (very much worse). CGI-I ratings of 1 (very much improved) or 2 (much improved) indicate positive treatment response. Higher scores are related to worse treatment response.
Proportion of treatment responders at follow-up on the Clinical Global Impression Improvement Scale (CGI-I)
Time frame: 24-26 weeks from the start of treatment (6-month follow-up)
The CGI-I is a single-item clinical rating of symptom improvement relative to baseline. Ratings on the CGI-I range from 1 (very much improved) to 7 (very much worse). CGI-I ratings of 1 (very much improved) or 2 (much improved) indicate positive treatment response. Higher scores are related to worse treatment response.
Patient changes in overall symptom severity on the Clinical Global Impression Severity Scale (CGI-S)
Time frame: Up to 2 weeks prior to starting treatment (baseline), 10-12 weeks from the start of treatment (post-treatment), 24-26 weeks from the start of treatment (6-month follow-up)
The CGI-S is a single-item clinical rating of the participant's illness at the time of the assessment. Ratings on the CGI-S range from 1 (slight psychiatric illness) to 7 (extremely severe psychiatric illness). Higher scores indicate greater symptom severity.
8 secondary outcomes
Therapist change scores on the Tic Disorder & CBIT Knowledge Test
Time frame: Up to 2 weeks pre-training and up to 2 weeks post training
Therapist changes in self-efficacy to treat tic disorders as measured by the Therapist Self-Assessment & Rating Form
Time frame: Up to 2 weeks pre-training, up to 2 weeks post-training, 10-12 weeks from the start of treatment delivery with a patient, 24-26 weeks from the start of treatment delivery with a patient
Patient changes in tic severity as measured by the Yale Global Tic Severity Scale (YGTSS) Total Tic Score
Time frame: Up to 2 weeks prior to starting treatment (baseline), 10-12 weeks from the start of treatment (post-treatment), 24-26 weeks from the start of treatment (6-month follow-up)
Patient changes in tic-related impairment as measured by the Yale Global Tic Severity Scale (YGTSS) Overall Tic Related Impairment Scores
Time frame: Up to 2 weeks prior to starting treatment (baseline), 10-12 weeks from the start of treatment (post-treatment), 24-26 weeks from the start of treatment (6-month follow-up)
Patient treatment satisfaction scores on the Treatment Satisfaction Questionnaire (TSQ) at post-treatment
Time frame: 10-12 weeks from the start of treatment (post-treatment)
Patient treatment satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at follow-up
Time frame: 24-26 weeks from the start of treatment (6-month follow-up)
Changes in psychological/behavioral symptoms and adaptive functioning as indicated by change scores on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric/Parent Proxy Profile 25 (for child patients & caregivers only)
Time frame: Up to 2 weeks prior to starting treatment (baseline), 10-12 weeks from the start of treatment (post-treatment), 24-26 weeks from the start of treatment (6-month follow-up)
Changes in psychological/behavioral symptoms and adaptive functioning as indicated by change scores on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Profile (for adult patients only)
Time frame: Up to 2 weeks prior to starting treatment (baseline), 10-12 weeks from the start of treatment (post-treatment), 24-26 weeks from the start of treatment (6-month follow-up)
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 Oct 2026.
- Background: PubMed 18940377Robertson MM. The prevalence and epidemiology of Gilles de la Tourette syndrome. Part 1: the epidemiological and prevalence studies. J Psychosom Res. 2008 Nov;65(5):461-72. doi: 10.1016/j.jpsychores.2008.03.006. Epub 2008 Oct 2.
- Background: PubMed 26880181Evans J, Seri S, Cavanna AE. The effects of Gilles de la Tourette syndrome and other chronic tic disorders on quality of life across the lifespan: a systematic review. Eur Child Adolesc Psychiatry. 2016 Sep;25(9):939-48. doi: 10.1007/s00787-016-0823-8. Epub 2016 Feb 15.
- Background: PubMed 22052430Conelea CA, Woods DW, Zinner SH, Budman CL, Murphy TK, Scahill LD, Compton SN, Walkup JT. The impact of Tourette Syndrome in adults: results from the Tourette Syndrome impact survey. Community Ment Health J. 2013 Feb;49(1):110-20. doi: 10.1007/s10597-011-9465-y. Epub 2011 Nov 4.
- Background: PubMed 20483969Piacentini J, Woods DW, Scahill L, Wilhelm S, Peterson AL, Chang S, Ginsburg GS, Deckersbach T, Dziura J, Levi-Pearl S, Walkup JT. Behavior therapy for children with Tourette disorder: a randomized controlled trial. JAMA. 2010 May 19;303(19):1929-37. doi: 10.1001/jama.2010.607.
- Background: PubMed 22868933Wilhelm S, Peterson AL, Piacentini J, Woods DW, Deckersbach T, Sukhodolsky DG, Chang S, Liu H, Dziura J, Walkup JT, Scahill L. Randomized trial of behavior therapy for adults with Tourette syndrome. Arch Gen Psychiatry. 2012 Aug;69(8):795-803. doi: 10.1001/archgenpsychiatry.2011.1528.
- Background: PubMed 21445724Roessner V, Plessen KJ, Rothenberger A, Ludolph AG, Rizzo R, Skov L, Strand G, Stern JS, Termine C, Hoekstra PJ; ESSTS Guidelines Group. European clinical guidelines for Tourette syndrome and other tic disorders. Part II: pharmacological treatment. Eur Child Adolesc Psychiatry. 2011 Apr;20(4):173-96. doi: 10.1007/s00787-011-0163-7.
- Background: PubMed 22397999Pringsheim T, Doja A, Gorman D, McKinlay D, Day L, Billinghurst L, Carroll A, Dion Y, Luscombe S, Steeves T, Sandor P. Canadian guidelines for the evidence-based treatment of tic disorders: pharmacotherapy. Can J Psychiatry. 2012 Mar;57(3):133-43. doi: 10.1177/070674371205700302.
- Background: PubMed 31061209Pringsheim T, Holler-Managan Y, Okun MS, Jankovic J, Piacentini J, Cavanna AE, Martino D, Muller-Vahl K, Woods DW, Robinson M, Jarvie E, Roessner V, Oskoui M. Comprehensive systematic review summary: Treatment of tics in people with Tourette syndrome and chronic tic disorders. Neurology. 2019 May 7;92(19):907-915. doi: 10.1212/WNL.0000000000007467.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in any publication(s) may be provided to qualified researchers with academic interests in tic disorders and related conditions and expertise in the scoring and interpretation of the outcome measures administered. All data shared will be coded with no identifying information included. Approval of the request by the study primary investigators and execution of all applicable data sharing agreements are prerequisites to the sharing of data with the requesting party.
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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.
Suzanne Mouton-Odum, PhD principal investigator
PsycTech, LLC
Michael Himle, PhD principal investigator
University of Utah
Doug Woods, PhD principal investigator
Marquette University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavior Therapy Training Institute and CBIT-Trainer in people with Tics and Tic Disorders, run by University of Utah 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?
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 Oct 2026. 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?
Therapist scores on the CBIT Fidelity Checklist and Rating Scale at post-training (time frame: up to 2 weeks post-training). The study lists 6 primary outcomes in all. 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 NCT05547854, which also lists 8 linked publications.
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 Oct 2026.