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Идёт набор NCT06408662

Remote Delivery of a Mindfulness-based Intervention for Tics

Без фазы С лечением Tourette Syndrome Tourette's Disorder Chronic Motor Tic Disorder Chronic Vocal Tic Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: mindfulness-based intervention for tics (MBIT), psychoeducation with relaxation and supportive therapy (PRST).
Кому может быть актуально
Состояния в реестре: Tourette Syndrome, Tourette's Disorder, Chronic Motor Tic Disorder, Chronic Vocal Tic Disorder. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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
  • Другое 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.

Первичные конечные точки

  • Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score [Срок оценки: 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)]
Вторичные конечные точки (11)
  • Clinical Global Impressions Scales of Severity and Improvement (CGI-S & CGI-I) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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)]
  • Premonitory Urge to Tic Scale (PUTS) [Срок оценки: 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)]
  • Five Facet Mindfulness Questionnaire (FFMQ) [Срок оценки: 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)]
  • Client Satisfaction Questionnaire [Срок оценки: Post-treatment (Week 9)]
  • Self Compassion Scale [Срок оценки: 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)]
  • Affective Reactivity Index [Срок оценки: 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)]
  • Brief Irritability Test [Срок оценки: 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)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Johns Hopkins University School of Medicine — Baltimore

Идентификаторы

NCT: NCT06408662 · IRB00413599 · R01AT012455

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗