Online Mindfulness-based Tic Reduction (Phase Two)

NCT03771235 | Completed DMC

• 1 other identifier: 2018-30
• Study Type: interventional
• Target: 37
• 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 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.

Conditions

Tourette Syndrome; Persistent Tic Disorder

Keywords

Tourette Syndrome; Tic Disorder; Online; Adults; Mindfulness; Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score

  Clinician-rated measure of tic severity

  Screening, Week 0, Week 9, Week 13, Week 35

Secondary Outcomes (16)

• Clinical Global Impressions Scale

  Weeks 0, 9, 13, 35

• Adult Tic Questionnaire

  Weeks 0, 9, 13, 35

• Yale-Brown Obsessive Compulsive Scale

  Weeks 0, 9, 13, 35

• Attention-Deficit Hyperactivity Rating Scale

  Weeks 0, 9, 13, 35

• Depression Anxiety Stress Scale

  Weeks 0, 9, 13, 35

Study Arms (2)

Mindfulness-based Intervention for Tics

EXPERIMENTAL

8-week group-based mindfulness-based program

Behavioral: Mindfulness-based Intervention for Tics

Tic Information and Coping Strategies

ACTIVE COMPARATOR

8-week group-based educational and supportive therapy program

Behavioral: Tic Information and Coping Strategies

Interventions

Mindfulness-based Intervention for Tics BEHAVIORAL

Psychological intervention that focuses on cultivating awareness of urges to tic and developing a different relationship to those urges through meditation and other mindfulness practices.

Mindfulness-based Intervention for Tics

Tic Information and Coping Strategies BEHAVIORAL

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.

Tic Information and Coping Strategies

Eligibility Criteria

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

You may qualify if:

• be 18 years of age or older,
• possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,
• be fluent in English
• reside 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
• 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

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders

Interventions

Coping Skills

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

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hannah Reese, Ph.D.

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: December 11, 2018
• Study Start: November 9, 2018
• Primary Completion: December 2, 2020
• Study Completion: December 2, 2020
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)