Investigating Distress Tolerance in Adults With Tourette Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Tourette Syndrome; Tic Disorders; Tics
• Intervention / Treatment: Behavioral: Distress Tolerance Skills Training

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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kesley A Ramsey, Ph.D.; Phone Number: 443-287-7157; Email: coach@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University School of Medicine
      • Contact: Joseph F. McGuire, Ph.D.; Phone Number: 443-287-7157; Email: jfmcguire@jhmi.edu
      • Principal Investigator: Joseph F. McGuire, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Distress Tolerance Skills Training; Distress tolerance skills training is a multicomponent intervention drawn from third-wave cognitive-behavioral therapy (CBT) protocols.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Tourette Association of America
• Investigators: Principal Investigator: Joseph F. McGuire, Ph.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 13, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Tourette Syndrome; Tic Disorders; Distress Tolerance; Premonitory Urge; Distress tolerance skill training
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Disease; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Dyskinesias; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Syndrome; Tourette Syndrome; Tic Disorders; Tics
• Other Study ID Numbers: IRB00298541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No