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CBIT Therapist Training for Tourette Syndrome (CBIT-Trainer Trial)
N/A
Recruiting
Led By Doug Woods, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Professionally licensed or certified to practice in their area of speciality
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
CBIT-Trainer Trial Summary
This trial will test an online training program to train therapists to help reduce tic symptoms in children and adults.
Who is the study for?
This trial is for licensed therapists with a Master's degree or higher in mental/behavioral health, medical, or related fields. They must be able to travel for training and find at least one patient with tic disorders to participate. Patients should have a diagnosed tic disorder, be 7 years old or older, speak English fluently, and have internet access.Check my eligibility
What is being tested?
The study compares traditional in-person CBIT therapist training to an online self-paced program called CBIT-Trainer. It evaluates the effectiveness of each method by assessing therapists' ability to administer CBIT and the resulting change in patients' tic severity.See study design
What are the potential side effects?
Since this trial involves educational training programs rather than medications, there are no direct side effects like those associated with drugs. However, participants may experience typical discomforts related to learning new therapeutic techniques.
CBIT-Trainer Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am licensed or certified in my professional field.
Select...
I can travel and attend in-person training if needed.
CBIT-Trainer Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient changes in overall symptom severity on the Clinical Global Impression Severity Scale (CGI-S)
Proportion of treatment responders at follow-up on the Clinical Global Impression Improvement Scale (CGI-I)
Proportion of treatment responders at post-treatment on the Clinical Global Impression Improvement Scale (CGI-I)
+3 moreSecondary outcome measures
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)
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)
Patient changes in tic severity as measured by the Yale Global Tic Severity Scale (YGTSS) Total Tic Score
+5 moreOther outcome measures
Number of patients reporting adverse events
Therapist change scores on the Evidence-Based Practice and Attitudes Scale (EBPAS)
Therapist scores on the Acceptability of Intervention Measure (AIM) at follow-up
+8 moreCBIT-Trainer Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Online Therapist TrainingExperimental Treatment1 Intervention
Group II: In-Person Therapist TrainingActive Control1 Intervention
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Who is running the clinical trial?
PsycTech, LLCUNKNOWN
University of UtahLead Sponsor
1,100 Previous Clinical Trials
1,778,667 Total Patients Enrolled
6 Trials studying Tourette Syndrome
258 Patients Enrolled for Tourette Syndrome
Marquette UniversityOTHER
62 Previous Clinical Trials
200,089 Total Patients Enrolled
2 Trials studying Tourette Syndrome
85 Patients Enrolled for Tourette Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at least 7 years old. If under 18, I have a consenting adult.I am licensed or certified in my professional field.You have frequent tics, like sudden movements or sounds, throughout the day.I can travel and attend in-person training if needed.I cannot participate if a suitable therapist for me is not found.I can or am willing to find a patient with a tic disorder for the study, whom I'm licensed to treat.I am open to being randomly placed in a study group.I have been diagnosed with a tic disorder by a healthcare professional.You have a serious mental or neurological condition that needs urgent treatment or would make it hard for you to take part in the study, according to your doctor or the study team.
Research Study Groups:
This trial has the following groups:- Group 1: In-Person Therapist Training
- Group 2: Online Therapist Training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being examined as part of this medical study?
"Affirmative. As per the clinicaltrials.gov website, this medical research is actively recruiting individuals for participation. This trial was initially posted on June 27th 2023 and its most recent update came on August 4th of the same year. The study requires 234 participants to be recruited from two separate sites."
Answered by AI
Are there still open enrollments for participants in this research trial?
"Affirmative, clinicaltrials.gov has information demonstrating that this research is recruiting volunteers at the time of writing. This medical study was posted on June 27th 2023 and latest revised 8/4/2023, aiming to enrol 234 patients from two sites."
Answered by AI
What goals are researchers striving to achieve through this clinical experiment?
"This trial will measure efficacy over a 14-day period post-training. The primary indicator of success is the CBIT Fidelity Checklist & Rating Scale, which observes therapist performance at 6 months out. Secondary outcomes include changes in tic severity and related impairment (as measured by the Yale Global Tic Severity Scale), as well as psychological/behavioral alterations and adaptive functioning through Patient Reported Outcome Measurement Information System scores (for adult patients only)."
Answered by AI
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