Remote Delivery of a Mindfulness-based Intervention for Tics

NCT06408662 | Recruiting DMC

• 2 other identifiers: IRB00413599R01AT012455
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

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

  The YGTSS is a clinician-administered measure of tic symptom severity (0-50) and impairment (0-50). Greater scores are reflective of greater severity and/or impairment.

  Screen, 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)

Secondary Outcomes (11)

• Clinical Global Impressions Scales of Severity and Improvement (CGI-S & CGI-I)

  Screen, 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)

• Adult Tic Questionnaire (ATQ)

  Screen, 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)

• Yale-Brown Obsessive Compulsive Scale-II

  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)

• Attention-Deficit Hyperactivity Rating Scale (ADHD-RS)

  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)

• Patient Health Questionnaire-9 (PHQ-9)

  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)

Other Outcomes (2)

• Individualized Premonitory Urge to Tic Scale (I-PUTS)

  Screen, 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)

• Depression Anxiety and Stress Scale (DASS)

  Screen, 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)

Study Arms (2)

mindfulness-based intervention for tics (MBIT)

EXPERIMENTAL

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).

Other: mindfulness-based intervention for tics (MBIT)

psychoeducation with relaxation and supportive therapy (PRST)

ACTIVE COMPARATOR

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).

Other: psychoeducation with relaxation and supportive therapy (PRST)

Interventions

mindfulness-based intervention for tics (MBIT) 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

mindfulness-based intervention for tics (MBIT)

psychoeducation with relaxation and supportive therapy (PRST) 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.

psychoeducation with relaxation and supportive therapy (PRST)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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);
• be medication free and/or on a stable dose of psychiatric medication 8 weeks prior to study participation;
• 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
• be fluent in English;
• have access to a smart phone and/or tablet.

You may not qualify if:

• a current diagnosis of substance use disorder, psychosis, mania or another condition that requires another form of care;
• severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention;
• concurrent psychotherapy for TS;
• prior extensive experience with mindfulness and/or meditation.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Bowdoin College: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Joseph F McGuire, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Hannah Reese, PhD

  Bowdoin College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Browning

CONTACT

443-300-8836; mbit@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The independent evaluator (IE) will conduct study related assessments during the treatment and follow-up periods, and will be masked to treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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. The study interventions will be delivered in a group format and provided remotely using a secure telehealth services platform. The study assessments will be completed using a secure telehealth services platform 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.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 10, 2024
• Study Start: May 23, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)