Recruiting

CBIT vs. BTTI

Sponsor:

University of Utah

Code:

NCT05547854

Conditions

Tics

Tic Disorders

Tourette Syndrome

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

Interventions

Behavior Therapy Training Institute

CBIT-Trainer

Study Details

Brief 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. 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.

Conditions

Tics

Tic Disorders

Tourette Syndrome

Study ID

NCT05547854

Start date

Jun 27, 2023

Status verified date

Aug, 2023

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Not accepted

This study will recruit therapist-patient dyads who meet the criteria below:

Therapist Inclusion Criteria:

1. Have the equivalent of a Master's degree (or higher) in a mental/behavioral health, medical, or related discipline.
2. Professionally licensed or certified to practice in their area of speciality.
3. 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.
4. Have never attended the Tourette Association of America's Behavior Therapy Training Institute or an equivalent focused on CBIT.
5. Have access to a secure personal computer with high-speed internet access.
6. Speaks fluent English.
7. 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.
8. Is willing to be randomly assigned to training condition.
9. 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:

1. 7 years of age or older (with consenting adult for minors).
2. 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.
3. Currently engages in at least one motor and/or vocal tic multiple times per day.
4. Patient (and consenting adult for minors) speaks fluent English.
5. Access to a private computer with high-speed internet access.

Patient Exclusion Criteria:

1. Patients will be excluded if the study team is unable to identify and enroll a patient-matched therapist who meets the therapist inclusion criteria.
2. 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.
3. 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.

Study Design

Enrollment

234 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: In-Person Therapist Training

experimental: Online Therapist Training

Interventions

Behavior Therapy Training Institute

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-Trainer

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.

Primary outcome measure

  • Therapist scores on the CBIT Fidelity Checklist and Rating Scale at post-training [ Time Frame: up to 2 weeks post-training ]
  • Therapist scores on the CBIT Fidelity Checklist and Rating Scale at post-treatment [ Time Frame: 10-12 weeks post-training ]
  • Therapist scores on the CBIT Fidelity Checklist & Rating Scale at 6-month follow-up [ Time Frame: 24-26 weeks post-training ]
  • 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) ]
  • 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) ]
  • 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) ]

Central Contacts and Locations

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Marquette University

Recruiting

Milwaukee, Wisconsin, United States, 53201

Contacts

More Information

Sponsor

University of Utah

Last update posted

Aug 18, 2023

Last verified

Aug, 2023

Keywords

  • Comprehensive Behavioral Intervention for Tics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Utah on 2023-08-18.