Online Mindfulness-based Tic Reduction
Primary Purpose
Tourette Syndrome, Tic Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online Mindfulness-based Tic Reduction
Sponsored by
About this trial
This is an interventional other trial for Tourette Syndrome focused on measuring Tic Disorders, Mindfulness, Meditation, Online, Internet-based, Treatment
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older,
- possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,
- fluent in English
- residing 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
- 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).
Sites / Locations
- Bowdoin College
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Online Mindfulness-based Tic Reduction
Arm Description
Outcomes
Primary Outcome Measures
Patient Satisfaction Questionnaire
Secondary Outcome Measures
Homework Compliance Questionnaire
Attrition Form
Adverse Events Monitoring Form
Yale Global Tic Severity Scale (YGTSS)
Adult Tic Questionnaire
Clinical Global Impressions Scale-Severity
Clinical Global Impressions Scale-Improvement
Full Information
NCT ID
NCT03525626
First Posted
April 24, 2018
Last Updated
July 8, 2019
Sponsor
Bowdoin College
Collaborators
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03525626
Brief Title
Online Mindfulness-based Tic Reduction
Official Title
Online Mindfulness-based Tic Reduction: Development and Testing (Phase One)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
August 7, 2018 (Actual)
Study Completion Date
August 7, 2018 (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
No
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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome, Tic Disorders
Keywords
Tic Disorders, Mindfulness, Meditation, Online, Internet-based, Treatment
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Online Mindfulness-based Tic Reduction
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Online Mindfulness-based Tic Reduction
Intervention Description
8-week online group mindfulness-based intervention for tics
Primary Outcome Measure Information:
Title
Patient Satisfaction Questionnaire
Time Frame
week 9
Secondary Outcome Measure Information:
Title
Homework Compliance Questionnaire
Time Frame
Weeks 1-8
Title
Attrition Form
Time Frame
Weeks 1-8
Title
Adverse Events Monitoring Form
Time Frame
Weeks 1-9
Title
Yale Global Tic Severity Scale (YGTSS)
Time Frame
Week 0, Week 9
Title
Adult Tic Questionnaire
Time Frame
Weeks 0-9
Title
Clinical Global Impressions Scale-Severity
Time Frame
Week 0, Week 9
Title
Clinical Global Impressions Scale-Improvement
Time Frame
Week 9
Other Pre-specified Outcome Measures:
Title
Yale-Brown Obsessive Compulsive Scale
Time Frame
Week 0, Week 9
Title
Attention Deficit Hyperactivity Disorder Rating Scale
Time Frame
Week 0, Week 9
Title
Patient Health Questionnaire-9
Time Frame
Week 0, Week 9
Title
Work and Social Adjustment Survey
Time Frame
Week 0, Week 9
Title
Five Facet Mindfulness Questionnaire
Time Frame
Weeks 0-9
Title
Credibility and Expectancy Questionnaire
Time Frame
Week 3
Title
Self Compassion Scale
Time Frame
Week 0, Week 9
Title
Affective Reactivity Index
Time Frame
Week 0, Week 9
Title
Brief Irritability Test
Time Frame
Week 0, Week 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older,
possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,
fluent in English
residing 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
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah Reese, Ph.D.
Organizational Affiliation
Bowdoin College
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
Citations:
PubMed Identifier
33757602
Citation
Reese HE, Brown WA, Summers BJ, Shin J, Wheeler G, Wilhelm S. Feasibility and acceptability of an online mindfulness-based group intervention for adults with tic disorders. Pilot Feasibility Stud. 2021 Mar 24;7(1):82. doi: 10.1186/s40814-021-00818-y.
Results Reference
derived
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Online Mindfulness-based Tic Reduction
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