Online Mindfulness-based Tic Reduction

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

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.

Study Overview

• Status: Completed
• Conditions: Tourette Syndrome; Tic Disorders
• Intervention / Treatment: Behavioral: Online Mindfulness-based Tic Reduction

• Study Type: Interventional
• Enrollment (Actual): 6
• 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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Online Mindfulness-based Tic Reduction	Behavioral: Online Mindfulness-based Tic Reduction; 8-week online group mindfulness-based intervention for tics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient Satisfaction Questionnaire	week 9

Secondary Outcome Measures

Outcome Measure	Time Frame
Homework Compliance Questionnaire	Weeks 1-8
Attrition Form	Weeks 1-8
Adverse Events Monitoring Form	Weeks 1-9
Yale Global Tic Severity Scale (YGTSS)	Week 0, Week 9
Adult Tic Questionnaire	Weeks 0-9
Clinical Global Impressions Scale-Severity	Week 0, Week 9
Clinical Global Impressions Scale-Improvement	Week 9

Other Outcome Measures

Outcome Measure	Time Frame
Yale-Brown Obsessive Compulsive Scale	Week 0, Week 9
Attention Deficit Hyperactivity Disorder Rating Scale	Week 0, Week 9
Patient Health Questionnaire-9	Week 0, Week 9
Work and Social Adjustment Survey	Week 0, Week 9
Five Facet Mindfulness Questionnaire	Weeks 0-9
Credibility and Expectancy Questionnaire	Week 3
Self Compassion Scale	Week 0, Week 9
Affective Reactivity Index	Week 0, Week 9
Brief Irritability Test	Week 0, Week 9

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Actual): August 7, 2018
• Study Completion (Actual): August 7, 2018

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (Actual): May 15, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Treatment; Mindfulness; Meditation; Online; Tic Disorders; Internet-based
• 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: 2017-37

Drug and device information, study documents

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