Clinical trial NCT06270251: Modeling Tic Change During Behavior Therapy for Tics
Official title: Modeling Tic Change During Behavior Therapy for Tics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Tic Disorder
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Tic Severity
timeFrame: Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
measure: Sheehan Disability scale
timeFrame: Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
measure: Behavior Rating Inventory of Executive Function
timeFrame: Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
measure: Ask Suicide-Screening Questions (ASQ)
timeFrame: Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
measure: Child Attitudes Toward Illness Scale (CATIS)
timeFrame: Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
measure: Rosenberg Self-Esteem Scale
timeFrame: Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
measure: Caregiver Strain Questionnaire
timeFrame: Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
measure: Clinical Global Impressions (CGI)
timeFrame: Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
measure: Parent/Adult Tic Questionnaire
timeFrame: 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:
measure: Premonitory Urge for Tics Scale
timeFrame: Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
measure: Tic Suppression Task
timeFrame: Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
measure: Stop signal task
timeFrame: Baseline, post-treatment (week 8-10), follow up 1 (week 4-6 post-treatment) and follow up 2 (week 12-14) post-treatment)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Christine Conelea, PhD
role: PRINCIPAL_INVESTIGATOR
References: