Online Mindfulness-based Tic Reduction

NCT03525626 | Completed

• 1 other identifier: 2017-37
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Tourette Syndrome; Tic Disorders

Keywords

Tic Disorders; Mindfulness; Meditation; Online; Internet-based; Treatment

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction Questionnaire

  week 9

Secondary Outcomes (7)

• Homework Compliance Questionnaire

  Weeks 1-8

• Attrition Form

  Weeks 1-8

• Adverse Events Monitoring Form

  Weeks 1-9

• Yale Global Tic Severity Scale (YGTSS)

  Week 0, Week 9

• Adult Tic Questionnaire

  Weeks 0-9

Other Outcomes (9)

• Yale-Brown Obsessive Compulsive Scale

  Week 0, Week 9

• Attention Deficit Hyperactivity Disorder Rating Scale

  Week 0, Week 9

• Patient Health Questionnaire-9

  Week 0, Week 9

Study Arms (1)

Online Mindfulness-based Tic Reduction

EXPERIMENTAL

Behavioral: Online Mindfulness-based Tic Reduction

Interventions

Online Mindfulness-based Tic Reduction BEHAVIORAL

8-week online group mindfulness-based intervention for tics

Online Mindfulness-based Tic Reduction

Eligibility Criteria

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

You may qualify if:

• years of age or older,
• possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,
• fluent in English
• residing in the United States,
• 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

You may not qualify if:

• be receiving concurrent psychotherapy for the duration of the study
• have prior extensive experience with mindfulness and/or meditation and
• 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).

Sponsors & Collaborators

• Bowdoin College: lead
• Massachusetts General Hospital: collaborator

Study Sites (2)

Bowdoin College

Brunswick, Maine, 04011, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 33757602 DERIVED

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders

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

Study Officials

• Hannah Reese, Ph.D.

  Bowdoin College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 15, 2018
• Study Start: April 4, 2018
• Primary Completion: August 7, 2018
• Study Completion: August 7, 2018
• Last Updated: July 9, 2019

Record last verified: 2019-07

Locations

US (2)