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OpenTrials
Completed

NCT Number: NCT03525626

Online Mindfulness-based Tic Reduction

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.

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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

  • 18 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

Exclusion criteria

  • 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).

Treatment and study plan

Online Mindfulness-based Tic Reduction

Behavioral

8-week online group mindfulness-based intervention for tics

Primary outcomes

  1. Patient Satisfaction Questionnaire

    Time frame: week 9

Secondary outcomes

  1. Homework Compliance Questionnaire

    Time frame: Weeks 1-8

  2. Attrition Form

    Time frame: Weeks 1-8

  3. Adverse Events Monitoring Form

    Time frame: Weeks 1-9

  4. Yale Global Tic Severity Scale (YGTSS)

    Time frame: Week 0, Week 9

  5. Adult Tic Questionnaire

    Time frame: Weeks 0-9

  6. Clinical Global Impressions Scale-Severity

    Time frame: Week 0, Week 9

  7. Clinical Global Impressions Scale-Improvement

    Time frame: Week 9

Other outcomes

  1. Yale-Brown Obsessive Compulsive Scale

    Time frame: Week 0, Week 9

  2. Attention Deficit Hyperactivity Disorder Rating Scale

    Time frame: Week 0, Week 9

  3. Patient Health Questionnaire-9

    Time frame: Week 0, Week 9

  4. Work and Social Adjustment Survey

    Time frame: Week 0, Week 9

  5. Five Facet Mindfulness Questionnaire

    Time frame: Weeks 0-9

  6. Credibility and Expectancy Questionnaire

    Time frame: Week 3

  7. Self Compassion Scale

    Time frame: Week 0, Week 9

  8. Affective Reactivity Index

    Time frame: Week 0, Week 9

  9. Brief Irritability Test

    Time frame: Week 0, Week 9

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 One)

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 15, 2018
Registry last updated
Jul 9, 2019

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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