Modeling Tic Change During Behavior Therapy for Tics

Chronic Tic Disorder Clinical Trial

Official title:

Modeling Tic Change During Behavior Therapy for Tics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06270251
• Other study ID #: PSYCH-2023-32292
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: September 1, 2028

Study information

• Verified date: March 2024
• Source: University of Minnesota
• Contact: Brianna Wellen, PhD
• Phone: 6126265472
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2028
• Est. primary completion date: March 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Tic Disorder
• Tic Disorders

Intervention

Behavioral:
• CBIT
8sessions 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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
Primary	Sheehan Disability scale	Self and parent measure of functional impairment	Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
Primary	Behavior Rating Inventory of Executive Function	Self and parent-rated measure of impairment of executive function	Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
Primary	Ask Suicide-Screening Questions (ASQ)	Clinician-administered screen of suicidality	Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
Primary	Child Attitudes Toward Illness Scale (CATIS)	Self-report measure of favorably or unfavorably adolescent feels about having a chronic illness	Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
Primary	Rosenberg Self-Esteem Scale	Self-report measure of adolescent feelings of self-esteem and self-worth	Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
Primary	Caregiver Strain Questionnaire	Measure of strain experienced by caregivers and family of youth with health/emotional challenges	Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
Primary	Clinical Global Impressions (CGI)	Clinician, patient, parent-rated global measure of illness severity and improvement	Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
Primary	Parent/Adult Tic Questionnaire	Adult-self or parent-report measure of tic symptoms and severity	Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
Secondary	Premonitory Urge for Tics Scale	Self-report measure of intensity of urges to tic	Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
Secondary	Tic Suppression Task	Direct observation measure of tic suppression ability	Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
Secondary	Stop signal task	Computerized task measuring ability to inhibit prepotent motor responses. This task is optional.	Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)