Investigating Distress Tolerance in Adults With Tourette Syndrome

Tourette Syndrome Clinical Trial

Official title:

Investigating Distress Tolerance in Adults With Tourette Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05047705
• Other study ID #: IRB00298541
• Status: Completed
• Phase: N/A
• Start date: June 2, 2022
• Est. completion date: May 28, 2024

Study information

• Verified date: June 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 28, 2024
• Est. primary completion date: May 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Tic Disorders
• Tics
• Tourette Syndrome

Intervention

Behavioral:
• Distress Tolerance Skills Training
Individuals with TS will receive distress tolerance skill training. Therapeutic skill training will consist of 4 weekly 1-hour sessions. Skill training will occur either in-person or remotely via videoconferencing software. Sessions will focus on building participants' distress tolerance skills with strategies drawn from third-wave CBT.

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Tourette Association of America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distress Tolerance Scale (DTS)	The Distress Tolerance Scale is a 15-item self-report measure that measures the perceived capacity to tolerate distress from a multidimensional framework, including tolerance, appraisal, absorption, and regulation. Items are rated on a 1-5 Likert scale, and then summed. Score ranges from 15-75. Higher total scores indicate greater difficulty with tolerating distress.	Within 1 week after completion of Distress Tolerance Skills Training
Secondary	Yale Global Tic Severity Scale-Revised (YGTSS)	The YGTSS is a clinician-rated semi-structured interview that measures tic symptom severity over the previous week. It consists of 10-items that assess different dimensions of tic severity for motor and vocal tics, which are rated on a 0-5 scale. The YGTSS produces a Total Tic Score (range: 0-50), with higher ratings indicating greater tic severity.	Within 1 week after completion of Distress Tolerance Skills Training