search
Back to results

Investigating Distress Tolerance in Adults With Tourette Syndrome

Primary Purpose

Tourette Syndrome, Tic Disorders, Tics

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Distress Tolerance Skills Training
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring Tourette Syndrome, Distress Tolerance, Premonitory Urge, Tic Disorders, Distress tolerance skill training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Distress Tolerance Skills Training

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 13, 2021
Last Updated
June 8, 2023
Sponsor
Johns Hopkins University
Collaborators
Tourette Association of America
search

1. Study Identification

Unique Protocol Identification Number
NCT05047705
Brief Title
Investigating Distress Tolerance in Adults With Tourette Syndrome
Official Title
Investigating Distress Tolerance in Adults With Tourette Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Tourette Association of America

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome, Tic Disorders, Tics
Keywords
Tourette Syndrome, Distress Tolerance, Premonitory Urge, Tic Disorders, Distress tolerance skill training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Distress Tolerance Skills Training
Arm Type
Experimental
Arm Description
Distress tolerance skills training is a multicomponent intervention drawn from third-wave cognitive-behavioral therapy (CBT) protocols.
Intervention Type
Behavioral
Intervention Name(s)
Distress Tolerance Skills Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Distress Tolerance Scale (DTS)
Description
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.
Time Frame
Within 1 week after completion of Distress Tolerance Skills Training
Secondary Outcome Measure Information:
Title
Yale Global Tic Severity Scale-Revised (YGTSS)
Description
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.
Time Frame
Within 1 week after completion of Distress Tolerance Skills Training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kesley A Ramsey, Ph.D.
Phone
443-287-7157
Email
coach@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph F. McGuire, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph F. McGuire, Ph.D.
Phone
443-287-7157
Email
jfmcguire@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Joseph F. McGuire, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigating Distress Tolerance in Adults With Tourette Syndrome

We'll reach out to this number within 24 hrs