Online Mindfulness-based Tic Reduction (Phase Two)

Not Applicable

Completed

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

• Registration Number: NCT03771235
• Lead Sponsor: Bowdoin College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-09
• Study First Submitted: 2018-12-07
• Study First Submitted QC: 2018-12-07
• Study First Posted: 2018-12-11
• Primary Completion: 2020-12-02
• Study Completion: 2020-12-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-based Intervention for Tics	Mindfulness-based Intervention for Tics	8-week group-based mindfulness-based program
Tic Information and Coping Strategies	Tic Information and Coping Strategies	8-week group-based educational and supportive therapy program

Primary Outcome Measures

Name	Time	Method
Change in Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score	Screening, Week 0, Week 9, Week 13, Week 35	Clinician-rated measure of tic severity

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Bowdoin College; 🇺🇸 Brunswick, Maine, United States