Online Mindfulness-based Tic Reduction (Phase Two)

Sponsor

Bowdoin College (Other)

Overall Status

Completed

CT.gov ID

NCT03771235

Collaborator

Massachusetts General Hospital (Other)

Enrollment

Locations

Arms

24.8

Actual Duration (Months)

18.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Controlled TrialRandomized 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 :

Nov 9, 2018

Actual Primary Completion Date :

Dec 2, 2020

Actual Study Completion Date :

Dec 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.

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).