ClinicalTrials.gg
CompletedNCT03771235Updated Apr 29, 2024

Online Mindfulness-based Tic Reduction (Phase Two)

An interventional study of Mindfulness-based Intervention for Tics and Tic Information and Coping Strategies in Tourette Syndrome and Persistent Tic Disorder, sponsored by Bowdoin College. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-29.

Sponsored by Bowdoin College · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Tourette Syndrome
  • Persistent Tic Disorder

Keywords

  • Tourette Syndrome
  • Tic Disorder
  • Online
  • Adults
  • Mindfulness
  • Therapy
03

In context

Tourette Syndrome

240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.

This study's enrollment of 37 is close to the median of 36 across 183 interventional studies indexed under Tourette Syndrome.

Browse Tourette Syndrome studies →

Lead sponsor

Bowdoin College is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. be 18 years of age or older,
  2. possess a primary diagnosis of Tourette Syndrome or Persistent Tic Disorder,
  3. be fluent in English
  4. reside 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

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. 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).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Mindfulness-based Intervention for Tics

    8-week group-based mindfulness-based program

    Behavioral: Mindfulness-based Intervention for Tics

  • Active comparator
    Tic Information and Coping Strategies

    8-week group-based educational and supportive therapy program

    Behavioral: Tic Information and Coping Strategies

Interventions

  • BehavioralMindfulness-based Intervention for Tics

    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.

  • BehavioralTic Information and Coping Strategies

    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.

06

What researchers measure

Primary outcomes

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

    Clinician-rated measure of tic severity

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

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

07

Study locations

2 sites
  • Bowdoin College
    Brunswick, Maine 04011, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2018 to primary completion in Dec 2020, 24 months.

Of 65 non-industry interventional studies with no phase under Tourette Syndrome, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 50. This study's 24 months is below that.

Counting every sponsor, half of 65 studies reached it within 33 months; a quarter within 22 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 7, 2018
First posted
Dec 11, 2018
StartActual
Nov 9, 2018
Primary completionActual
Dec 2, 2020
CompletionActual
Dec 2, 2020
Last update
Apr 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03771235
Lead sponsor
Bowdoin College
Responsible party
Hannah Reese (Assistant Professor, Bowdoin College) — Principal investigator
First posted
Dec 11, 2018
Start date
Nov 9, 2018
Primary completion
Dec 2, 2020
Completion
Dec 2, 2020
Last update
Apr 29, 2024

Study contacts

Hannah Reese, Ph.D.
principal investigator · Assistant Professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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