A Phase 2/3 interventional study of Comprehensive Behavioral Intervention for Tics in Tourette Syndrome and Tic Disorders, sponsored by Tourette Association of America. Completed at 3 sites in United States. Open to participants aged 9 Years to 17 Years. Per ClinicalTrials.gov, last updated 2015-12-14.
Sponsored by Tourette Association of America · Phase 2/3, Interventional, and Treatment
This study will determine the effectiveness of cognitive behavior therapy (CBT) with habit reversal training (HRT) in treating chronic tic disorders (CTDs) in children and adolescents.
CTDs and Tourette syndrome are neurobehavioral disorders that are characterized by a persistent pattern of motor and vocal tics. Tics are intermittent movements or sounds that occur repeatedly. They can be either brief, rapid, and darting movements or more purposeful movements, such as repetitively locking and unlocking a door. Vocal tics can be simple, as in sniffing or grunting, or more complex, such as complete words or phrases. Tic disorders can cause considerable distress in affected children, and can lead to social and academic impairment. If left untreated, CTDs can last into adulthood. The standard treatment for suppressing CTDs is medication; dopamine-blocking drugs are used most commonly. These medications, however, are associated with a range of adverse effects that can result in poor treatment compliance and premature treatment termination. Recent research suggests that HRT may be an effective, lower risk treatment for CTDs. HRT is a behavioral treatment based on increasing awareness of one's behaviors and replacing unwanted behaviors with less bothersome ones. This study will determine the effectiveness of CBT with HRT in treating CTDs in children and adolescents.
Participants in this double blind study will be randomly assigned to receive either CBT plus HRT or standard care, which will consist of psychoeducation and supportive therapy. All participants will partake in 8 sessions of their assigned therapy over the course of 10 weeks. After the initial 10 weeks, those who responded to treatment will report back to the study site for 3 monthly booster sessions. Changes in tic severity, effects of the therapies on overall functioning and quality of life, and possible predictors of treatment outcome will be assessed.
220 studies on the registry are indexed under Tourette Syndrome; 37 are open to participants now.
This study's planned enrollment of 120 is above the median of 34 across 166 interventional studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →This is the only study on the registry with Tourette Association of America as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Reduction in tic severity
Time frame: 10-22 weeks
Reduction in tic-related impairment and distress (measured at Week 10)
Time frame: measured at week 10
Tic severity and associated impairment and distress (measured at Week 36 follow-up)
Time frame: measured at week 36 follow-up
Changes in neurocognitive function (measured at Week 10)
Time frame: measured at week 10
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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