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OpenTrials
Completed

NCT Number: NCT03771235

Online Mindfulness-based Tic Reduction (Phase Two)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bowdoin College, Brunswick, Maine, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Screening, Week 0, Week 9, Week 13, Week 35

    Clinician-rated measure of tic severity

Secondary outcomes

  1. Clinical Global Impressions Scale

    Time frame: Weeks 0, 9, 13, 35

  2. Adult Tic Questionnaire

    Time frame: Weeks 0, 9, 13, 35

  3. Yale-Brown Obsessive Compulsive Scale

    Time frame: Weeks 0, 9, 13, 35

  4. Attention-Deficit Hyperactivity Rating Scale

    Time frame: Weeks 0, 9, 13, 35

  5. Depression Anxiety Stress Scale

    Time frame: Weeks 0, 9, 13, 35

  6. Premonitory Urge to Tic Scale

    Time frame: Weeks 0, 9, 13, 35

  7. Tic Rating Form

    Time frame: Weeks 1-8

  8. Problem Rating Form

    Time frame: Weeks 1-8

  9. Patient Health Questionnaire-9

    Time frame: Weeks 0, 9, 13, 35

  10. Work and Social Adjustment Survey

    Time frame: Weeks 0, 9, 13, 35

  11. Five Facet Mindfulness Questionnaire

    Time frame: Weeks 0, 4, 8, 9, 13, 35

  12. Credibility and Expectancy Questionnaire

    Time frame: Week 3

  13. Patient Satisfaction Questionnaire

    Time frame: Week 9

  14. Self Compassion Scale

    Time frame: Weeks 0, 9, 13, 35

  15. Affective Reactivity Index

    Time frame: Weeks 0, 9, 13, 35

  16. Brief Irritability Test

    Time frame: Weeks 0, 9, 13, 35

Sponsors and collaborators

Lead sponsor

Bowdoin College

Other

Collaborators

  • Massachusetts General Hospital

Registry information

Official study title

Online Mindfulness-based Tic Reduction: Development and Testing (Phase Two)

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 11, 2018
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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