Investigating Distress Tolerance in Adults With Tourette Syndrome

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05047705
Collaborator
Tourette Association of America (Other)
35
1
1
41
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Distress Tolerance Skills Training
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigating Distress Tolerance in Adults With Tourette Syndrome
Actual Study Start Date :
Jun 2, 2022
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Distress Tolerance Scale (DTS) [Within 1 week after completion of Distress Tolerance Skills Training]

    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

  1. Yale Global Tic Severity Scale-Revised (YGTSS) [Within 1 week after completion of Distress Tolerance Skills Training]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins University School of Medicine Baltimore Maryland United States 21287

Sponsors and Collaborators

  • Johns Hopkins University
  • Tourette Association of America

Investigators

  • Principal Investigator: Joseph F. McGuire, Ph.D., Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT05047705
Other Study ID Numbers:
  • IRB00298541
First Posted:
Sep 17, 2021
Last Update Posted:
Jun 6, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johns Hopkins University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 6, 2022