Online Mindfulness-based Tic Reduction

Tourette Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03525626
• Other study ID #: 2017-37
• Status: Completed
• Phase: N/A
• Start date: April 4, 2018
• Est. completion date: August 7, 2018

Study information

• Verified date: July 2019
• Source: Bowdoin College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 7, 2018
• Est. primary completion date: August 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Tic Disorders
• Tics
• Tourette Syndrome

Intervention

Behavioral:
• Online Mindfulness-based Tic Reduction
8-week online group mindfulness-based intervention for tics

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Bowdoin College	Brunswick	Maine

Sponsors (2)

Lead Sponsor	Collaborator
Bowdoin College	Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Yale-Brown Obsessive Compulsive Scale		Week 0, Week 9
Other	Attention Deficit Hyperactivity Disorder Rating Scale		Week 0, Week 9
Other	Patient Health Questionnaire-9		Week 0, Week 9
Other	Work and Social Adjustment Survey		Week 0, Week 9
Other	Five Facet Mindfulness Questionnaire		Weeks 0-9
Other	Credibility and Expectancy Questionnaire		Week 3
Other	Self Compassion Scale		Week 0, Week 9
Other	Affective Reactivity Index		Week 0, Week 9
Other	Brief Irritability Test		Week 0, Week 9
Primary	Patient Satisfaction Questionnaire		week 9
Secondary	Homework Compliance Questionnaire		Weeks 1-8
Secondary	Attrition Form		Weeks 1-8
Secondary	Adverse Events Monitoring Form		Weeks 1-9
Secondary	Yale Global Tic Severity Scale (YGTSS)		Week 0, Week 9
Secondary	Adult Tic Questionnaire		Weeks 0-9
Secondary	Clinical Global Impressions Scale-Severity		Week 0, Week 9
Secondary	Clinical Global Impressions Scale-Improvement		Week 9