ClinicalTrials.gg
CompletedNCT05047705Updated Jun 7, 2024

Investigating Distress Tolerance in Adults With Tourette Syndrome

An interventional study of Distress Tolerance Skills Training in Tourette Syndrome, Tic Disorders and Tics, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-07.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tourette Syndrome
  • Tic Disorders
  • Tics

Keywords

  • Tourette Syndrome
  • Distress Tolerance
  • Premonitory Urge
  • Tic Disorders
  • Distress tolerance skill training
03

In context

Tourette Syndrome

240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.

This study's enrollment of 9 is below the median of 36 across 183 interventional studies indexed under Tourette Syndrome.

Browse Tourette Syndrome studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.

Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralDistress 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.

06

What researchers measure

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.

    Time frame: Within 1 week after completion of Distress Tolerance Skills Training

Secondary outcomes

  1. 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.

    Time frame: Within 1 week after completion of Distress Tolerance Skills Training

07

Study locations

1 site
  • Johns Hopkins University School of Medicine
    Baltimore, Maryland 21287, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2022 to primary completion in May 2024, 23 months.

Of 65 non-industry interventional studies with no phase under Tourette Syndrome, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 50. This study's 23 months is below that.

Counting every sponsor, half of 65 studies reached it within 33 months; a quarter within 22 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 13, 2021
First posted
Sep 17, 2021
StartActual
Jun 2, 2022
Primary completionActual
May 28, 2024
CompletionActual
May 28, 2024
Last update
Jun 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05047705
Collaborators
Tourette Association of America
Responsible party
Sponsor
First posted
Sep 17, 2021
Start date
Jun 2, 2022
Primary completion
May 28, 2024
Completion
May 28, 2024
Last update
Jun 7, 2024

Study contacts

Joseph F. McGuire, Ph.D.
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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