Investigating Distress Tolerance in Adults With Tourette Syndrome

NCT05047705 | Completed

• 1 other identifier: IRB00298541
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette Syndrome; Tic Disorders; Tics

Keywords

Tourette Syndrome; Distress Tolerance; Premonitory Urge; Tic Disorders; Distress tolerance skill training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Yale Global Tic Severity Scale-Revised (YGTSS)

  Within 1 week after completion of Distress Tolerance Skills Training

Study Arms (1)

Distress Tolerance Skills Training

EXPERIMENTAL

Distress tolerance skills training is a multicomponent intervention drawn from third-wave cognitive-behavioral therapy (CBT) protocols.

Behavioral: Distress Tolerance Skills Training

Interventions

Distress Tolerance Skills Training BEHAVIORAL

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.

Distress Tolerance Skills Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Tourette Association of America: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders; Tics

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph F. McGuire, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 17, 2021
• Study Start: June 2, 2022
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)