Back to resultsOnline Mindfulness-based Tic Reduction (Phase Two)
Primary Purpose
Tourette Syndrome, Persistent Tic Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-based Intervention for Tics
Tic Information and Coping Strategies
Sponsored by
About this trial
This is an interventional treatment trial for Tourette Syndrome focused on measuring Tourette Syndrome, Tic Disorder, Online, Adults, Mindfulness, Therapy
Eligibility Criteria
Inclusion Criteria:
- be 18 years of age or older,
- possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,
- be fluent in English
- reside 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
- 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).
Sites / Locations
- Bowdoin College
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness-based Intervention for Tics
Tic Information and Coping Strategies
Arm Description
8-week group-based mindfulness-based program
8-week group-based educational and supportive therapy program
Outcomes
Primary Outcome Measures
Change in Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score
Clinician-rated measure of tic severity
Secondary Outcome Measures
Clinical Global Impressions Scale
Adult Tic Questionnaire
Yale-Brown Obsessive Compulsive Scale
Attention-Deficit Hyperactivity Rating Scale
Depression Anxiety Stress Scale
Premonitory Urge to Tic Scale
Tic Rating Form
Problem Rating Form
Patient Health Questionnaire-9
Work and Social Adjustment Survey
Five Facet Mindfulness Questionnaire
Credibility and Expectancy Questionnaire
Patient Satisfaction Questionnaire
Self Compassion Scale
Affective Reactivity Index
Brief Irritability Test
Full Information
NCT ID
NCT03771235
First Posted
December 7, 2018
Last Updated
January 25, 2021
Sponsor
Bowdoin College
Collaborators
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03771235
Brief Title
Online Mindfulness-based Tic Reduction (Phase Two)
Official Title
Online Mindfulness-based Tic Reduction: Development and Testing (Phase Two)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
December 2, 2020 (Actual)
Study Completion Date
December 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bowdoin College
Collaborators
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome, Persistent Tic Disorder
Keywords
Tourette Syndrome, Tic Disorder, Online, Adults, Mindfulness, Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-based Intervention for Tics
Arm Type
Experimental
Arm Description
8-week group-based mindfulness-based program
Arm Title
Tic Information and Coping Strategies
Arm Type
Active Comparator
Arm Description
8-week group-based educational and supportive therapy program
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based Intervention for Tics
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tic Information and Coping Strategies
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score
Description
Clinician-rated measure of tic severity
Time Frame
Screening, Week 0, Week 9, Week 13, Week 35
Secondary Outcome Measure Information:
Title
Clinical Global Impressions Scale
Time Frame
Weeks 0, 9, 13, 35
Title
Adult Tic Questionnaire
Time Frame
Weeks 0, 9, 13, 35
Title
Yale-Brown Obsessive Compulsive Scale
Time Frame
Weeks 0, 9, 13, 35
Title
Attention-Deficit Hyperactivity Rating Scale
Time Frame
Weeks 0, 9, 13, 35
Title
Depression Anxiety Stress Scale
Time Frame
Weeks 0, 9, 13, 35
Title
Premonitory Urge to Tic Scale
Time Frame
Weeks 0, 9, 13, 35
Title
Tic Rating Form
Time Frame
Weeks 1-8
Title
Problem Rating Form
Time Frame
Weeks 1-8
Title
Patient Health Questionnaire-9
Time Frame
Weeks 0, 9, 13, 35
Title
Work and Social Adjustment Survey
Time Frame
Weeks 0, 9, 13, 35
Title
Five Facet Mindfulness Questionnaire
Time Frame
Weeks 0, 4, 8, 9, 13, 35
Title
Credibility and Expectancy Questionnaire
Time Frame
Week 3
Title
Patient Satisfaction Questionnaire
Time Frame
Week 9
Title
Self Compassion Scale
Time Frame
Weeks 0, 9, 13, 35
Title
Affective Reactivity Index
Time Frame
Weeks 0, 9, 13, 35
Title
Brief Irritability Test
Time Frame
Weeks 0, 9, 13, 35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
be 18 years of age or older,
possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,
be fluent in English
reside 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
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah Reese, Ph.D.
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bowdoin College
City
Brunswick
State/Province
Maine
ZIP/Postal Code
04011
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Online Mindfulness-based Tic Reduction (Phase Two)
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