Online Mindfulness-based Tic Reduction (Phase Two)

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

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.

Study Overview

• Status: Completed
• Conditions: Tourette Syndrome; Persistent Tic Disorder
• Intervention / Treatment: Behavioral: Mindfulness-based Intervention for Tics; Behavioral: Tic Information and Coping Strategies

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maine
    • Brunswick, Maine, United States, 04011
      • Bowdoin College
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-based Intervention for Tics; 8-week group-based mindfulness-based program	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.
Active Comparator: Tic Information and Coping Strategies; 8-week group-based educational and supportive therapy program	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Credibility and Expectancy Questionnaire	Week 3
Clinical Global Impressions Scale	Weeks 0, 9, 13, 35
Adult Tic Questionnaire	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
Premonitory Urge to Tic Scale	Weeks 0, 9, 13, 35
Tic Rating Form	Weeks 1-8
Problem Rating Form	Weeks 1-8
Patient Health Questionnaire-9	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
Patient Satisfaction Questionnaire	Week 9
Self Compassion Scale	Weeks 0, 9, 13, 35
Affective Reactivity Index	Weeks 0, 9, 13, 35
Brief Irritability Test	Weeks 0, 9, 13, 35

Collaborators and Investigators

• Sponsor: Bowdoin College
• Collaborators: Massachusetts General Hospital
• Investigators: Principal Investigator: Hannah Reese, Ph.D., Assistant professor

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Actual): December 2, 2020
• Study Completion (Actual): December 2, 2020

Study Registration Dates

• First Submitted: December 7, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Adults; Mindfulness; Therapy; Tourette Syndrome; Tic Disorder; Online
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Dyskinesias; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Tourette Syndrome; Tic Disorders; Tics
• Other Study ID Numbers: 2018-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No