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Clinical Trials/NCT03525626
NCT03525626
Completed
Not Applicable

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

Bowdoin College2 sites in 1 country6 target enrollmentApril 4, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tourette Syndrome
Sponsor
Bowdoin College
Enrollment
6
Locations
2
Primary Endpoint
Patient Satisfaction Questionnaire
Status
Completed
Last Updated
6 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, find them unacceptable, or cannot access them. Thus, it is essential that researchers continue to pursue novel treatment approaches that can also be easily disseminated to those in need.

Initial pilot data suggest that a mindfulness-based intervention may be beneficial for adults with tic disorders. In the present study, the researchers aim to further develop this mindfulness-based intervention, adapt it to be delivered online and pilot test the intervention with a small group of participants. The data from this pilot test will inform a subsequent randomized controlled trial comparing online mindfulness-based tic reduction to online psychoeducation, relaxation, and supportive therapy.

The specific aim is to determine the feasibility and acceptability of Online Mindfulness-based Tic Reduction in 6 adults with TS or PTD.

The researchers hypothesize that Online Mindfulness-based Tic Reduction will be feasible and acceptable to adults with tic disorders as measured by participant satisfaction, qualitative participant feedback, home practice compliance, dropout, and adverse events.

Registry
clinicaltrials.gov
Start Date
April 4, 2018
End Date
August 7, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hannah Reese

Assistant Professor

Bowdoin College

Eligibility Criteria

Inclusion Criteria

  • 18 years of age or older,
  • possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,
  • fluent in English
  • residing 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
  • cannot 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

Patient Satisfaction Questionnaire

Time Frame: week 9

Secondary Outcomes

  • Adverse Events Monitoring Form(Weeks 1-9)
  • Homework Compliance Questionnaire(Weeks 1-8)
  • Attrition Form(Weeks 1-8)
  • Yale Global Tic Severity Scale (YGTSS)(Week 0, Week 9)
  • Adult Tic Questionnaire(Weeks 0-9)
  • Clinical Global Impressions Scale-Severity(Week 0, Week 9)
  • Clinical Global Impressions Scale-Improvement(Week 9)

Study Sites (2)

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