Clinical trial NCT06408662: Remote Delivery of a Mindfulness-based Intervention for Tics
Official title: Remote Delivery of a Mindfulness-based Intervention for Tics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Bowdoin College
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-05-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score
timeFrame: 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:
measure: Clinical Global Impressions Scales of Severity and Improvement (CGI-S & CGI-I)
timeFrame: 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)
measure: Adult Tic Questionnaire (ATQ)
timeFrame: 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)
measure: Yale-Brown Obsessive Compulsive Scale-II
timeFrame: 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)
measure: Attention-Deficit Hyperactivity Rating Scale (ADHD-RS)
timeFrame: 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)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 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)
measure: Premonitory Urge to Tic Scale (PUTS)
timeFrame: 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)
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: 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)
measure: Client Satisfaction Questionnaire
timeFrame: Post-treatment (Week 9)
measure: Self Compassion Scale
timeFrame: 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)
measure: Affective Reactivity Index
timeFrame: 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)
measure: Brief Irritability Test
timeFrame: 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:
measure: Individualized Premonitory Urge to Tic Scale (I-PUTS)
timeFrame: 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)
measure: Depression Anxiety and Stress Scale (DASS)
timeFrame: 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)
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Joseph F McGuire, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bowdoin College
name: Hannah Reese, PhD
role: PRINCIPAL_INVESTIGATOR
References: