Clinical trial NCT03771235: Online Mindfulness-based Tic Reduction (Phase Two)
Official title: Online Mindfulness-based Tic Reduction: Development and Testing (Phase Two)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tourette Syndrome
Persistent Tic Disorder
Keywords: Tourette Syndrome
Tic Disorder
Online
Adults
Mindfulness
Therapy
Lead sponsor: Bowdoin College
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2018-12-11
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: Tourette Syndrome (TS) and Persistent Tic Disorder (PTD) are chronic and potentially disabling neurobiological conditions. Although a range of pharmacological and psychosocial treatments exists, a significant number of individuals either do not respond to the current treatments or find them unacceptable. Thus, it is essential that researchers continue to develop and test novel treatment approaches.

In this randomized controlled trial the investigators will compare two different online group-based interventions for tics: a mindfulness-based program (Mindfulness-based Intervention for Tics (MBIT), and a psychoeducational and supportive therapy program (Tic Information and Coping Strategies (TICS)). The purpose of this study is to determine which intervention is more helpful for adults with a tic disorder.


Eligibility criteria: Inclusion Criteria:

1. be 18 years of age or older,
2. possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,
3. be fluent in English
4. reside in the United States,
5. either not be taking any tic suppressant medication or other psychotropic medication or be at a stable dose for 8 weeks prior to the baseline assessment and throughout the study

Exclusion Criteria:

1. be receiving concurrent psychotherapy for the duration of the study
2. have prior extensive experience with mindfulness and/or meditation and
3. have another medical or psychological condition that would prevent the individual from fully engaging in the study or require a higher level of care (e.g., suicidality).

Primary outcomes:
measure: Change in Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score
timeFrame: Screening, Week 0, Week 9, Week 13, Week 35
Secondary outcomes:
measure: Clinical Global Impressions Scale
timeFrame: Weeks 0, 9, 13, 35
measure: Adult Tic Questionnaire
timeFrame: Weeks 0, 9, 13, 35
measure: Yale-Brown Obsessive Compulsive Scale
timeFrame: Weeks 0, 9, 13, 35
measure: Attention-Deficit Hyperactivity Rating Scale
timeFrame: Weeks 0, 9, 13, 35
measure: Depression Anxiety Stress Scale
timeFrame: Weeks 0, 9, 13, 35
measure: Premonitory Urge to Tic Scale
timeFrame: Weeks 0, 9, 13, 35
measure: Tic Rating Form
timeFrame: Weeks 1-8
measure: Problem Rating Form
timeFrame: Weeks 1-8
measure: Patient Health Questionnaire-9
timeFrame: Weeks 0, 9, 13, 35
measure: Work and Social Adjustment Survey
timeFrame: Weeks 0, 9, 13, 35
measure: Five Facet Mindfulness Questionnaire
timeFrame: Weeks 0, 4, 8, 9, 13, 35
measure: Credibility and Expectancy Questionnaire
timeFrame: Week 3
measure: Patient Satisfaction Questionnaire
timeFrame: Week 9
measure: Self Compassion Scale
timeFrame: Weeks 0, 9, 13, 35
measure: Affective Reactivity Index
timeFrame: Weeks 0, 9, 13, 35
measure: Brief Irritability Test
timeFrame: Weeks 0, 9, 13, 35
Other outcomes:
Locations:
city: Brunswick
country: United States
facility: Bowdoin College
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Assistant Professor
name: Hannah Reese, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: