Modeling Tic Change During Behavior Therapy for Tics
ConditionChronic Tic Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-21
SponsorUniversity of Minnesota
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 12-21 years at time of enrollment.
Current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance.
At least moderate tic severity, defined as a Yale Global Tic Severity Scale total score
Full scale IQ greater than 70
Disqualifiers
Active suicidality.
Previous diagnosis of psychosis or cognitive disability.
Substance abuse or dependence within the past year.
Concurrent psychotherapy focused on tics.
Trial design
Design model
Single group
Treatments tested in this trial
CBIT
Behavioral8sessions of CBIT following a published treatment manual delivered over 10 weeks (the last two sessions are biweekly) CBIT is a well-established behavioral treatment that is considered by the American Academy of Neurology to be the first-line intervention for tics.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Study groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tic Severity
Yale Global Tic Severity Scale (YGTSS) will be used, which is Gold-standard, clinician administered tic severity scale. It includes symptom checklist of specific tic types YGTSS ranges from 0-50, higher scores are more severe tic symptoms
Time frame
Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)2
Sheehan Disability scale
Self and parent measure of functional impairment
Time frame
Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)3
Behavior Rating Inventory of Executive Function
Self and parent-rated measure of impairment of executive function
Time frame
Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)4
Ask Suicide-Screening Questions (ASQ)
Clinician-administered screen of suicidality
Time frame
Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)Secondary outcomes
1
Premonitory Urge for Tics Scale
Self-report measure of intensity of urges to tic
Time frame
Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)2
Tic Suppression Task
Direct observation measure of tic suppression ability
Time frame
Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)3
Stop signal task
Computerized task measuring ability to inhibit prepotent motor responses. This task is optional.
Time frame
Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)Sponsors and contacts
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Source ClinicalTrials.gov