30 Participants Needed

Behavior Therapy for Tic Disorders

BW
Overseen ByBrianna Wellen, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Chronic tics are a disabling neuropsychiatric symptom associated with multiple child-onset mental disorders. Chronic tics affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, and peer victimization. Chronic tics are the primary symptom of Tourette Syndrome (TS) and Persistent Motor/Vocal Tic Disorders. CBIT is a manualized treatment focused on increasing tic controllability. Its core procedure is competing response training (CRT), in which patients learn to inhibit tics by learning and applying a competing motor action to one tic at a time. CBIT is recommended as a first-line treatment relative to medications and other therapies. However, only 52% of children and 38% of adults show clinically meaningful tic improvement. Large randomized trials have demonstrated the superiority of CBIT over supportive therapy in child and adult patients, and meta-analysis shows comparable effect sizes for CBIT and medication. Although increasing tic controllability is the primary goal of CBIT, tic controllability nor its correlates have been examined longitudinally during the intervention. The overall objective of this study is to use fine-grained data collection strategies to identify patterns in tic controllability and other relevant related variables that are associated with treatment response to CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded.

Will I have to stop taking my current medications?

The trial requires that participants not be on neuroleptic or antipsychotic medications. If you are taking other medications, they must be stable (same medication and dose) for at least 6 weeks with no planned changes during the study.

What data supports the effectiveness of the treatment CBIT for tic disorders?

Research shows that CBIT, a behavioral therapy, is effective in reducing tic symptoms in both children and adults with chronic tic disorders. Studies have demonstrated significant improvements in tic severity scores, and the treatment is well-received by patients and families, with effects that can last for months after treatment ends.12345

Is behavior therapy for tic disorders safe for humans?

Behavior therapy for tic disorders, including CBIT, is considered safe for humans. Studies have shown no safety concerns, and it is recommended as a first-line treatment for managing tics.45678

How is the treatment CBIT different from other treatments for tic disorders?

CBIT is unique because it is a behavioral therapy that focuses on teaching patients to manage their tics through techniques like habit reversal and relaxation, rather than relying on medication. It has been shown to be effective in reducing tic severity and improving daily functioning, and it can be considered a first-line treatment for tic disorders.268910

Research Team

CC

Christine Conelea, PhD, LP

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for young people aged 12-21 with chronic motor and/or vocal tics, which have lasted at least a year without a break of more than three months. Participants should have moderate tic severity as measured by the Yale scale, an IQ over 70, and must understand English well.

Inclusion Criteria

I am between 12 and 21 years old.
Full scale IQ greater than 70
English fluency to ensure comprehension of study measures and instructions
See 2 more

Exclusion Criteria

Previous diagnosis of psychosis or cognitive disability
Active suicidality
I am currently receiving therapy specifically for tics.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a manualized course of 10 outpatient, weekly CBIT sessions

10 weeks
10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 weeks
2 follow-up assessments (in-person)

Treatment Details

Interventions

  • CBIT
Trial Overview The study tests CBIT (Comprehensive Behavioral Intervention for Tics), focusing on increasing control over tics through competing response training. The treatment's effectiveness will be monitored across eight sessions using video recordings and assessments of behavior and overall functioning.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Study groupExperimental Treatment1 Intervention
Youth ages 12-21 years with chronic tics will complete a course of 10 outpatient, weekly CBIT sessions with pre-, post-, 1-month and 3-month follow up assessments.

CBIT is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as CBIT for:
  • Chronic tics associated with Tourette Syndrome (TS) and Persistent Motor/Vocal Tic Disorders
🇪🇺
Approved in European Union as CBIT for:
  • Chronic tics associated with Tourette Syndrome (TS) and Persistent Motor/Vocal Tic Disorders

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Findings from Research

A modified four-session Comprehensive Behavioral Intervention for Tics significantly reduced tic severity in children and adolescents with Tourette's syndrome compared to routine care, as shown by a randomized controlled study with 46 participants.
The positive effects of the intervention were maintained for at least 3 months after treatment, indicating its potential long-term benefits for managing tics.
Effectiveness of a modified comprehensive behavioral intervention for tics for children and adolescents with tourette's syndrome: A randomized controlled trial.Chen, CW., Wang, HS., Chang, HJ., et al.[2020]
A meta-analysis of 10 randomized controlled trials involving 586 patients found that habit reversal training (HRT) is effective in reducing tic symptoms, with a small to medium effect size (SMD of -0.43).
The efficacy of HRT was influenced by the type of behavioral therapy used in the control group, indicating that different comparison conditions can affect treatment outcomes.
The therapeutic effect of habit reversal training for Tourette syndrome: a meta-analysis of randomized control trials.Yu, L., Li, Y., Zhang, J., et al.[2021]
Current guidelines recommend behavioral interventions like habit reversal training and comprehensive behavioral intervention as first-line treatments for primary tic disorders, emphasizing the importance of patient selection based on age and comorbidities.
Emerging nonpharmacologic treatments, including Internet-based and telehealth approaches, show potential for improving accessibility and effectiveness in treating tics, while novel methods like autonomic modulation may offer new therapeutic options.
Behavioral therapy for Tourette syndrome and chronic tic disorders.Fründt, O., Woods, D., Ganos, C.[2022]

References

Effectiveness of a modified comprehensive behavioral intervention for tics for children and adolescents with tourette's syndrome: A randomized controlled trial. [2020]
The therapeutic effect of habit reversal training for Tourette syndrome: a meta-analysis of randomized control trials. [2021]
Behavioral therapy for Tourette syndrome and chronic tic disorders. [2022]
ONLINE-TICS: Internet-Delivered Behavioral Treatment for Patients with Chronic Tic Disorders. [2022]
Development and Open Trial of a Psychosocial Intervention for Young Children With Chronic Tics: The CBIT-JR Study. [2020]
Pilot Testing Behavior Therapy for Chronic Tic Disorders in Neurology and Developmental Pediatrics Clinics. [2016]
A preliminary study of comprehensive behavioral intervention for tics in Chinese children with chronic tic disorder or Tourette syndrome. [2022]
Current controversies on the role of behavior therapy in Tourette syndrome. [2021]
Effects of Group Comprehensive Behavioral Intervention for Tics in Children With Tourette's Disorder and Chronic Tic Disorder. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Comprehensive behavioral intervention to improve occupational performance in children with Tourette disorder. [2013]
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