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Behavioural Intervention

Mindfulness-Based Intervention for Tics (MBIT Trial)

N/A
Recruiting
Led By Joseph F McGuire, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be ≥18 years of age
Meet diagnostic criteria for a primary or co-primary diagnosis of Tourette Syndrome or a Persistent Motor or Vocal Tic Disorder on a structured clinical interview
Must not have
Severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0), mid-treatment (week 5), post-treatment (week 9), 1-month follow-up (week 13), 3-month follow-up (week 22), and 6-month follow-up (week 35)
Awards & highlights

Summary

This trial is comparing two different treatments for people with Tourette's syndrome or Persistent Tic Disorders. The goal is to see which treatment is more effective in managing tics and improving the overall well-being of

Who is the study for?
This trial is for individuals with Tourette's syndrome or Persistent Tic Disorders. Participants should be interested in trying mindfulness-based therapy or psychoeducation with relaxation and supportive therapy to manage their tics.
What is being tested?
The study compares two approaches: a Mindfulness-Based Intervention for Tics (MBIT) and Psychoeducation with Relaxation and Supportive Therapy (PRST). The goal is to see which method better helps people manage the symptoms of Tourette's syndrome or chronic tic disorders.
What are the potential side effects?
Since both interventions involve psychological therapies rather than medications, side effects may include emotional discomfort, increased awareness of tics, or stress during participation. Physical side effects are not commonly associated with these types of therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with Tourette Syndrome or a chronic tic disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe thoughts of harming myself or others that need medical help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0), mid-treatment (week 5), post-treatment (week 9), 1-month follow-up (week 13), 3-month follow-up (week 22), and 6-month follow-up (week 35)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), mid-treatment (week 5), post-treatment (week 9), 1-month follow-up (week 13), 3-month follow-up (week 22), and 6-month follow-up (week 35) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score
Secondary outcome measures
Adult Tic Questionnaire (ATQ)
Affective Reactivity Index
Attention-Deficit Hyperactivity Rating Scale (ADHD-RS)
+8 more
Other outcome measures
Depression Anxiety and Stress Scale (DASS)
Individualized Premonitory Urge to Tic Scale (I-PUTS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: mindfulness-based intervention for tics (MBIT)Experimental Treatment1 Intervention
This is an 8-week mindfulness-based group intervention delivered via telehealth. It consists of mindfulness and meditative practice, didactics, inquiry, discussion and weekly therapeutic exercises and assignments (i.e., homework).
Group II: psychoeducation with relaxation and supportive therapy (PRST)Active Control1 Intervention
This is an 8-week educational and supportive therapy group intervention delivered via telehealth. It consists of psychoeducation, relaxation, discussion, and weekly therapeutic exercises and assignments (i.e., homework).

Find a Location

Who is running the clinical trial?

Bowdoin CollegeOTHER
4 Previous Clinical Trials
7,394 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,307 Previous Clinical Trials
14,861,759 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
846 Previous Clinical Trials
672,775 Total Patients Enrolled
~100 spots leftby Jun 2028
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