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Clinical Trials/NCT03771235
NCT03771235
Completed
Not Applicable

Online Mindfulness-based Tic Reduction: Development and Testing (Phase Two)

Bowdoin College2 sites in 1 country37 target enrollmentNovember 9, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tourette Syndrome
Sponsor
Bowdoin College
Enrollment
37
Locations
2
Primary Endpoint
Change in Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Tourette Syndrome (TS) and Persistent Tic Disorder (PTD) are chronic and potentially disabling neurobiological conditions. Although a range of pharmacological and psychosocial treatments exists, a significant number of individuals either do not respond to the current treatments or find them unacceptable. Thus, it is essential that researchers continue to develop and test novel treatment approaches.

In this randomized controlled trial the investigators will compare two different online group-based interventions for tics: a mindfulness-based program (Mindfulness-based Intervention for Tics (MBIT), and a psychoeducational and supportive therapy program (Tic Information and Coping Strategies (TICS)). The purpose of this study is to determine which intervention is more helpful for adults with a tic disorder.

Registry
clinicaltrials.gov
Start Date
November 9, 2018
End Date
December 2, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hannah Reese

Assistant Professor

Bowdoin College

Eligibility Criteria

Inclusion Criteria

  • be 18 years of age or older,
  • possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,
  • be fluent in English
  • reside in the United States,
  • either not be taking any tic suppressant medication or other psychotropic medication or be at a stable dose for 8 weeks prior to the baseline assessment and throughout the study

Exclusion Criteria

  • be receiving concurrent psychotherapy for the duration of the study
  • have prior extensive experience with mindfulness and/or meditation and
  • have another medical or psychological condition that would prevent the individual from fully engaging in the study or require a higher level of care (e.g., suicidality).

Outcomes

Primary Outcomes

Change in Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score

Time Frame: Screening, Week 0, Week 9, Week 13, Week 35

Clinician-rated measure of tic severity

Secondary Outcomes

  • Clinical Global Impressions Scale(Weeks 0, 9, 13, 35)
  • Yale-Brown Obsessive Compulsive Scale(Weeks 0, 9, 13, 35)
  • Attention-Deficit Hyperactivity Rating Scale(Weeks 0, 9, 13, 35)
  • Depression Anxiety Stress Scale(Weeks 0, 9, 13, 35)
  • Tic Rating Form(Weeks 1-8)
  • Problem Rating Form(Weeks 1-8)
  • Credibility and Expectancy Questionnaire(Week 3)
  • Adult Tic Questionnaire(Weeks 0, 9, 13, 35)
  • Premonitory Urge to Tic Scale(Weeks 0, 9, 13, 35)
  • Patient Health Questionnaire-9(Weeks 0, 9, 13, 35)
  • Patient Satisfaction Questionnaire(Week 9)
  • Self Compassion Scale(Weeks 0, 9, 13, 35)
  • Brief Irritability Test(Weeks 0, 9, 13, 35)
  • Work and Social Adjustment Survey(Weeks 0, 9, 13, 35)
  • Five Facet Mindfulness Questionnaire(Weeks 0, 4, 8, 9, 13, 35)
  • Affective Reactivity Index(Weeks 0, 9, 13, 35)

Study Sites (2)

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