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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

No Placebo-Only Group

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 weeks3 visits

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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score

Secondary study objectives

Adult Tic Questionnaire (ATQ)

Affective Reactivity Index

Attention-Deficit Hyperactivity Rating Scale (ADHD-RS)

+8 more

Other study objectives

Depression Anxiety and Stress Scale (DASS)

Individualized Premonitory Urge to Tic Scale (I-PUTS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 3Eligibility criteria met