Online Mindfulness-based Tic Reduction

Not Applicable

Completed

• Conditions: Tourette Syndrome; Tic Disorders
• Interventions: Behavioral: Online Mindfulness-based Tic Reduction

• Registration Number: NCT03525626
• Lead Sponsor: Bowdoin College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-04
• Study First Submitted: 2018-04-24
• Study First Submitted QC: 2018-05-03
• Study First Posted: 2018-05-15
• Primary Completion: 2018-08-07
• Study Completion: 2018-08-07
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. 18 years of age or older,
2. possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,
3. fluent in English
4. residing in the United States,
5. 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

1. be receiving concurrent psychotherapy for the duration of the study
2. have prior extensive experience with mindfulness and/or meditation and
3. 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Online Mindfulness-based Tic Reduction	Online Mindfulness-based Tic Reduction	-

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction Questionnaire	week 9

Secondary Outcome Measures

Name	Time	Method
Adult Tic Questionnaire	Weeks 0-9
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
Clinical Global Impressions Scale-Severity	Week 0, Week 9
Clinical Global Impressions Scale-Improvement	Week 9

Trial Locations

Locations (2)

Bowdoin College; 🇺🇸 Brunswick, Maine, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States