Online Mindfulness-based Tic Reduction (Phase Two)

Tourette Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771235
• Other study ID #: 2018-30
• Status: Completed
• Phase: N/A
• Start date: November 9, 2018
• Est. completion date: December 2, 2020

Study information

• Verified date: April 2024
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2, 2020
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. be 18 years of age or older,

2. possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,

3. be fluent in English

4. reside 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. 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

• Persistent Tic Disorder
• Tic Disorders
• Tics
• Tourette Syndrome

Intervention

Behavioral:
• Mindfulness-based Intervention for Tics
Psychological intervention that focuses on cultivating awareness of urges to tic and developing a different relationship to those urges through meditation and other mindfulness practices.
• Tic Information and Coping Strategies
Psychological Intervention that focuses on learning more about tics, practicing a range of strategies for coping with tics (e.g., relaxation, effective communication), and discussing challenges commonly experienced by individuals with 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
Primary	Change in Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score	Clinician-rated measure of tic severity	Screening, Week 0, Week 9, Week 13, Week 35
Secondary	Clinical Global Impressions Scale		Weeks 0, 9, 13, 35
Secondary	Adult Tic Questionnaire		Weeks 0, 9, 13, 35
Secondary	Yale-Brown Obsessive Compulsive Scale		Weeks 0, 9, 13, 35
Secondary	Attention-Deficit Hyperactivity Rating Scale		Weeks 0, 9, 13, 35
Secondary	Depression Anxiety Stress Scale		Weeks 0, 9, 13, 35
Secondary	Premonitory Urge to Tic Scale		Weeks 0, 9, 13, 35
Secondary	Tic Rating Form		Weeks 1-8
Secondary	Problem Rating Form		Weeks 1-8
Secondary	Patient Health Questionnaire-9		Weeks 0, 9, 13, 35
Secondary	Work and Social Adjustment Survey		Weeks 0, 9, 13, 35
Secondary	Five Facet Mindfulness Questionnaire		Weeks 0, 4, 8, 9, 13, 35
Secondary	Credibility and Expectancy Questionnaire		Week 3
Secondary	Patient Satisfaction Questionnaire		Week 9
Secondary	Self Compassion Scale		Weeks 0, 9, 13, 35
Secondary	Affective Reactivity Index		Weeks 0, 9, 13, 35
Secondary	Brief Irritability Test		Weeks 0, 9, 13, 35