Evaluation of an Online Comprehensive Behavioral Intervention for Tics (CBIT) Therapist Training Program

NCT05547854 | Unknown

• 1 other identifier: 00158298
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 2

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

Keywords

Comprehensive Behavioral Intervention for Tics

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  10-12 weeks from the start of treatment (post-treatment)

Other Outcomes (11)

• Therapist change scores on the Evidence-Based Practice and Attitudes Scale (EBPAS)

  Immediately pre- and 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

• Therapist scores on the Acceptability of Intervention Measure (AIM) at post-training

  Immediately post-training

• Therapist scores on the Acceptability of Intervention Measure (AIM) at post-treatment

  10-12 weeks from the start of treatment delivery with a patient

Study Arms (2)

In-Person Therapist Training

ACTIVE COMPARATOR

Behavioral: Behavior Therapy Training Institute

Online Therapist Training

EXPERIMENTAL

Behavioral: CBIT-Trainer

Interventions

Behavior Therapy Training Institute BEHAVIORAL

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.

In-Person Therapist Training

CBIT-Trainer BEHAVIORAL

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.

Online Therapist Training

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• (1) Therapist is a first, second, or third degree biological relative, stepparent, or legal guardian of the study-matched patient.
• 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 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.

Sponsors & Collaborators

• University of Utah: lead
• Marquette University: collaborator
• PsycTech, LLC: collaborator

Study Sites (2)

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Marquette University

Milwaukee, Wisconsin, 53201, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 18940377 BACKGROUND

• Evans 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.

  PMID: 26880181 BACKGROUND

• Conelea 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.

  PMID: 22052430 BACKGROUND

• Piacentini 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.

  PMID: 20483969 BACKGROUND

• Wilhelm 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.

  PMID: 22868933 BACKGROUND

• Roessner 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.

  PMID: 21445724 BACKGROUND

• Pringsheim 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.

  PMID: 22397999 BACKGROUND

• Pringsheim 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.

  PMID: 31061209 BACKGROUND

MeSH Terms

Conditions

Tics; Tic Disorders; Tourette Syndrome

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Movement Disorders; Central Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders; Basal Ganglia Diseases; Brain Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Suzanne Mouton-Odum, PhD

  PsycTech, LLC

  PRINCIPAL INVESTIGATOR

• Michael Himle, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Doug Woods, PhD

  Marquette University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Himle, PhD

CONTACT

801-581-7529; michael.himle@utah.edu

Doug Woods, PhD

CONTACT

414-288-3769; douglas.woods@marquette.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators will be masked to treatment condition
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Effectiveness-implementation hybrid non-inferiority trial

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 21, 2022
• Study Start: June 27, 2023
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

US (2)