Clinical trial NCT03525626: Online Mindfulness-based Tic Reduction
Official title: Online Mindfulness-based Tic Reduction: Development and Testing (Phase One)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tourette Syndrome
Tic Disorders
Keywords: Tic Disorders
Mindfulness
Meditation
Online
Internet-based
Treatment
Lead sponsor: Bowdoin College
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2018-05-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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, find them unacceptable, or cannot access them. Thus, it is essential that researchers continue to pursue novel treatment approaches that can also be easily disseminated to those in need.

Initial pilot data suggest that a mindfulness-based intervention may be beneficial for adults with tic disorders. In the present study, the researchers aim to further develop this mindfulness-based intervention, adapt it to be delivered online and pilot test the intervention with a small group of participants. The data from this pilot test will inform a subsequent randomized controlled trial comparing online mindfulness-based tic reduction to online psychoeducation, relaxation, and supportive therapy.

The specific aim is to determine the feasibility and acceptability of Online Mindfulness-based Tic Reduction in 6 adults with TS or PTD.

The researchers hypothesize that Online Mindfulness-based Tic Reduction will be feasible and acceptable to adults with tic disorders as measured by participant satisfaction, qualitative participant feedback, home practice compliance, dropout, and adverse events.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older,
2. possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,
3. fluent in English
4. residing 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. cannot 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: Patient Satisfaction Questionnaire
timeFrame: week 9
Secondary outcomes:
measure: Homework Compliance Questionnaire
timeFrame: Weeks 1-8
measure: Attrition Form
timeFrame: Weeks 1-8
measure: Adverse Events Monitoring Form
timeFrame: Weeks 1-9
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: Week 0, Week 9
measure: Adult Tic Questionnaire
timeFrame: Weeks 0-9
measure: Clinical Global Impressions Scale-Severity
timeFrame: Week 0, Week 9
measure: Clinical Global Impressions Scale-Improvement
timeFrame: Week 9
Other outcomes:
measure: Yale-Brown Obsessive Compulsive Scale
timeFrame: Week 0, Week 9
measure: Attention Deficit Hyperactivity Disorder Rating Scale
timeFrame: Week 0, Week 9
measure: Patient Health Questionnaire-9
timeFrame: Week 0, Week 9
measure: Work and Social Adjustment Survey
timeFrame: Week 0, Week 9
measure: Five Facet Mindfulness Questionnaire
timeFrame: Weeks 0-9
measure: Credibility and Expectancy Questionnaire
timeFrame: Week 3
measure: Self Compassion Scale
timeFrame: Week 0, Week 9
measure: Affective Reactivity Index
timeFrame: Week 0, Week 9
measure: Brief Irritability Test
timeFrame: Week 0, Week 9
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: Bowdoin College
name: Hannah Reese, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reese HE, Brown WA, Summers BJ, Shin J, Wheeler G, Wilhelm S. Feasibility and acceptability of an online mindfulness-based group intervention for adults with tic disorders. Pilot Feasibility Stud. 2021 Mar 24;7(1):82. doi: 10.1186/s40814-021-00818-y.