Modeling Tic Change During Behavior Therapy for Tics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Minnesota
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Clinical Global Impressions (CGI)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •≥14 (≥9 for those with motor or vocal tics only).
- •Full scale IQ greater than 70
- •English fluency to ensure comprehension of study measures and instructions.
Exclusion Criteria
- •Active suicidality.
- •Previous diagnosis of psychosis or cognitive disability.
- •Substance abuse or dependence within the past year.
- •Concurrent psychotherapy focused on tics.
- •Neuroleptic/antipsychotic medications.
- •Taking a medication that has not reached stability criterion (same medication and dose for 6 weeks with no planned changes over the intervention period)
Outcomes
Primary Outcomes
Clinical Global Impressions (CGI)
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)
Clinician, patient, parent-rated global measure of illness severity and improvement
Sheehan Disability scale
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)
Self and parent measure of functional impairment
Parent/Adult Tic Questionnaire
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)
Adult-self or parent-report measure of tic symptoms and severity
Tic Severity
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)
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
Caregiver Strain Questionnaire
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)
Measure of strain experienced by caregivers and family of youth with health/emotional challenges
Behavior Rating Inventory 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)
Self and parent-rated measure of impairment of executive function
Ask Suicide-Screening Questions (ASQ)
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)
Clinician-administered screen of suicidality
Child Attitudes Toward Illness Scale (CATIS)
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)
Self-report measure of favorably or unfavorably adolescent feels about having a chronic illness
Rosenberg Self-Esteem Scale
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)
Self-report measure of adolescent feelings of self-esteem and self-worth
Secondary Outcomes
- Tic Suppression Task(Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment))
- Stop signal task(Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment))
- Premonitory Urge for Tics Scale(Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment))