Clinical trial NCT05047705: Investigating Distress Tolerance in Adults With Tourette Syndrome
Official title: Investigating Distress Tolerance in Adults With Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tourette Syndrome
Tic Disorders
Tics
Keywords: Tourette Syndrome
Distress Tolerance
Premonitory Urge
Tic Disorders
Distress tolerance skill training
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Tourette Association of America
First posted: 2021-09-17
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Although behavior therapy is recognized as a first-line intervention for Tourette's Disorder (TD), less than 40% of adults with TD respond to this evidence-based treatment. Limited tolerance for aversive premonitory urges and affective states that accompany tics may be one likely factor that impedes behavior therapy outcomes. This study examines the relationship between distress tolerance and tic inhibition among adults with TD, and investigates the mechanism and effect of therapeutic skills training to enhance distress tolerance abilities. Findings will determine the optimal approach to enhance distress tolerance among adults with TD and ultimately lead to better behavior therapy outcomes.

Detailed description: Tourette's Disorder and other persistent tic disorders collectively affect about about 1% of the population, cause significant distress, and functional impairment. Although behavior therapy is recognized as a first-line intervention for Tourette's Disorder (TD), less than 40% of adults with TD respond to this evidence-based treatment. Limited tolerance for aversive premonitory urges and affective states that accompany tics may be one likely factor that impedes behavior therapy outcomes. This study examines the relationship between distress tolerance and tic inhibition among adults with TD, and investigates the mechanism and effect of therapeutic skills training to enhance distress tolerance abilities.

Eligibility criteria: Participants will be eligible for participation if the following inclusion criteria are met:

* at least 18 years of age
* have moderate tic severity or greater as evidenced by a YGTSS Total Tic Score greater than 14 (\>9 for adults with motor or vocal tics only)
* exhibit a tic frequency of at least one visible tic per minute
* be fluent in English
* have a total premonitory urge for tics scale (PUTS) total score greater than 17 at Visit 2
* have a total DTS score greater than 30 at Visit 2

Exclusion criteria for participants include:

* history of cardiovascular disorder
* history of fainting or seizures
* history of frostbite
* open cut or sore on hand to be immersed
* fracture to the limb to be immersed
* history of Reynaud's phenomenon
* inability to complete rating scales
* inability to attend study visits

Primary outcomes:
measure: Distress Tolerance Scale (DTS)
timeFrame: Within 1 week after completion of Distress Tolerance Skills Training
Secondary outcomes:
measure: Yale Global Tic Severity Scale-Revised (YGTSS)
timeFrame: Within 1 week after completion of Distress Tolerance Skills Training
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Joseph F. McGuire, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: