Remote Delivery of a Mindfulness-based Intervention for Tics

NCT ID: NCT06408662

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-23
• Study Completion Date: 2028-12-31

Brief Summary

This research study is being done to compare a mindfulness-based intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) for individuals with Tourette's syndrome or Persistent Tic Disorders (collectively TS). It is the investigator's hope that this information cam be used to improve current treatments for individuals with TS.

Detailed Description

Tourette's syndrome and other persistent tic disorders (collectively, TS) is a condition that onsets in childhood and affects ~1% of the population. Alongside motor and vocal tics, patients with TS experience distressing somatosensory sensations (i.e., premonitory urges) and co-occurring mental health conditions such as anxiety disorders, depressive disorders, obsessive-compulsive disorder (OCD), and ADHD. Tics and comorbid symptoms cause individuals with TS significant distress and impairment across life domains (e.g., physical, social, academic, occupational, emotional, and familial). Two evidence-based treatments exist for TS: behavior therapy and pharmacotherapy. Behavior therapy [often referred to as habit reversal training (HRT) or the comprehensive behavioral intervention for tics (CBIT)] is an evidence-based treatment that has been shown to reduce the severity of tic symptoms, and has a low risk for adverse effects. Although behavior therapy is recognized as a first-line intervention for TS, less than 40% of adults with TS respond to this evidence-based treatment. Additionally, current behavioral interventions are often inaccessible for adults with TS. While pharmacotherapy for tic management (e.g., antipsychotic medications) has been shown to be effective, these treatments can have adverse side effects with detrimental health consequences. Thus, there is a critical need for new treatments for adults with TS that are efficacious for reducing tic severity, beneficial for co-occurring conditions, and have few adverse health effects. Mindfulness-based interventions have proven beneficial for adults with a wide range of neuropsychiatric conditions. Based on the investigator's prior work, the investigators believe that a mindfulness-based intervention for tics (MBIT) is beneficial for adults with TS.

This project is a randomized controlled trial (RCT) that will compare the efficacy of a mindfulness-based intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) in 150 adults with TS. All interventions and assessments will be delivered remotely using secure telehealth services platforms and online electronic data capture systems. An independent evaluator (IE) masked to treatment condition will administer all assessments during the treatment and follow-up periods. The investigators will test the mechanisms by which MBIT reduces tic severity, and examine the efficacy of MBIT relative to PRST for common co-occurring psychiatric symptoms and quality of life impairments-towards "treating the whole person". Finally, the investigators will explore the sustained therapeutic improvement from MBIT over a 6-month follow-up period focusing on tic severity, tic-related impairment, co-occurring psychiatric symptoms, and quality of life.

Conditions

Tourette Syndrome; Tourette's Disorder; Chronic Motor Tic Disorder; Chronic Vocal Tic Disorder; Persistent Motor Tic Disorder; Persistent Vocal Tic Disorder; Persistent Tic Disorder; Tic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

mindfulness-based intervention for tics (MBIT)

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 Type: EXPERIMENTAL

mindfulness-based intervention for tics (MBIT)

Intervention Type: OTHER

Psychological intervention that focuses on cultivating awareness of urges to tic and developing a different relationship to those urges through meditation and other mindfulness practice

psychoeducation with relaxation and supportive therapy (PRST)

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).

Group Type: ACTIVE_COMPARATOR

psychoeducation with relaxation and supportive therapy (PRST)

Intervention Type: OTHER

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.

Interventions

mindfulness-based intervention for tics (MBIT)

Psychological intervention that focuses on cultivating awareness of urges to tic and developing a different relationship to those urges through meditation and other mindfulness practice

Intervention Type: OTHER

psychoeducation with relaxation and supportive therapy (PRST)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. be ≥18 years of age;

2. 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;

3. have moderate or greater tic severity as evidenced by a YGTSS Total Tic Score of >14 (when motor and vocal tics are present) or >10 (when only motor or vocal tics are present);

4. be medication free and/or on a stable dose of psychiatric medication 8 weeks prior to study participation;

5. be not engaged in psychotherapy for non-TS conditions and/or be on a stable course of therapy for 6 months prior to study participation

6. be fluent in English;

7. have access to a smart phone and/or tablet.

Exclusion Criteria

1. a current diagnosis of substance use disorder, psychosis, mania or another condition that requires another form of care;

2. severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention;

3. concurrent psychotherapy for TS;

4. prior extensive experience with mindfulness and/or meditation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bowdoin College

OTHER

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph F McGuire, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Hannah Reese, PhD

Role: PRINCIPAL_INVESTIGATOR

Bowdoin College

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lauren Browning

Role: CONTACT

mbit@jh.edu

443-300-8836

Facility Contacts

Joseph F McGuire, PhD

Role: primary

mbit@jh.edu

443-300-8836

Other Identifiers

R01AT012455

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00413599

Identifier Type: -

Identifier Source: org_study_id