Online Mindfulness-based Tic Reduction (Phase Two)

• ClinicalTrials.gov Identifier: NCT03771235
• Recruitment Status: Completed
• First Posted: December 11, 2018
• Last Update Posted: January 26, 2021
• Sponsor: Bowdoin College
• Collaborator: Massachusetts General Hospital
• Information provided by (Responsible Party): Hannah Reese, Bowdoin College

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.

Condition or disease	Intervention/treatment	Phase
Tourette Syndrome; Persistent Tic Disorder	Behavioral: Mindfulness-based Intervention for Tics; Behavioral: Tic Information and Coping Strategies	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Controlled Trial
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Online Mindfulness-based Tic Reduction: Development and Testing (Phase Two)
• Actual Study Start Date: November 9, 2018
• Actual Primary Completion Date: December 2, 2020
• Actual Study Completion Date: December 2, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score [ Time Frame: Screening, Week 0, Week 9, Week 13, Week 35 ]
   Clinician-rated measure of tic severity

Secondary Outcome Measures :

1. Clinical Global Impressions Scale [ Time Frame: Weeks 0, 9, 13, 35 ]
2. Adult Tic Questionnaire [ Time Frame: Weeks 0, 9, 13, 35 ]
3. Yale-Brown Obsessive Compulsive Scale [ Time Frame: Weeks 0, 9, 13, 35 ]
4. Attention-Deficit Hyperactivity Rating Scale [ Time Frame: Weeks 0, 9, 13, 35 ]
5. Depression Anxiety Stress Scale [ Time Frame: Weeks 0, 9, 13, 35 ]
6. Premonitory Urge to Tic Scale [ Time Frame: Weeks 0, 9, 13, 35 ]
7. Tic Rating Form [ Time Frame: Weeks 1-8 ]
8. Problem Rating Form [ Time Frame: Weeks 1-8 ]
9. Patient Health Questionnaire-9 [ Time Frame: Weeks 0, 9, 13, 35 ]
10. Work and Social Adjustment Survey [ Time Frame: Weeks 0, 9, 13, 35 ]
11. Five Facet Mindfulness Questionnaire [ Time Frame: Weeks 0, 4, 8, 9, 13, 35 ]
12. Credibility and Expectancy Questionnaire [ Time Frame: Week 3 ]
13. Patient Satisfaction Questionnaire [ Time Frame: Week 9 ]
14. Self Compassion Scale [ Time Frame: Weeks 0, 9, 13, 35 ]
15. Affective Reactivity Index [ Time Frame: Weeks 0, 9, 13, 35 ]
16. Brief Irritability Test [ Time Frame: Weeks 0, 9, 13, 35 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

Locations

United States, Maine

Bowdoin College

Brunswick, Maine, United States, 04011

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Bowdoin College

Massachusetts General Hospital

Investigators

• Principal Investigator: Hannah Reese, Ph.D.; Assistant Professor

More Information

• Responsible Party: Hannah Reese, Assistant Professor, Bowdoin College
• ClinicalTrials.gov Identifier: NCT03771235
• Other Study ID Numbers: 2018-30
• First Posted: December 11, 2018
• Last Update Posted: January 26, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hannah Reese, Bowdoin College:

Tourette Syndrome; Tic Disorder; Online; Adults; Mindfulness; Therapy

Additional relevant MeSH terms:

Tourette Syndrome; Tics; Tic Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations