Tourette SyndromeNCT03771235
Online Mindfulness-based Tic Reduction (Phase Two)
A study testing Mindfulness-based Intervention for Tics and Tic Information and Coping Strategies in people with Tourette Syndrome and Persistent Tic Disorder, run by Bowdoin College at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tourette Syndrome, Persistent Tic Disorder
- What is being tested?
- Mindfulness-based Intervention for Tics and Tic Information and Coping Strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Nov 2018to 2 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Bowdoin College
Brunswick, Maine, 04011
About this study
Official title: Online Mindfulness-based Tic Reduction: Development and Testing (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.
- Conditions
- Tourette Syndrome, Persistent Tic Disorder
- Being tested
- Mindfulness-based Intervention for Tics, Tic Information and Coping Strategies
- Keywords
- Tourette Syndrome, Tic Disorder, Online, Adults, Mindfulness, Therapy
- Medical subject headings
- Tourette Syndrome, Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Intervention for TicsBehavioural
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 StrategiesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Intervention for Tics | Experimental | 8-week group-based mindfulness-based program Receives: Behavioral: Mindfulness-based Intervention for Tics |
| Tic Information and Coping Strategies | Active comparator | 8-week group-based educational and supportive therapy program Receives: Behavioral: Tic Information and Coping Strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score
Clinician-rated measure of tic severity
Measured: Screening, Week 0, Week 9, Week 13, Week 35
Secondary outcomes (16)
Clinical Global Impressions Scale
Measured: Weeks 0, 9, 13, 35
Adult Tic Questionnaire
Measured: Weeks 0, 9, 13, 35
Yale-Brown Obsessive Compulsive Scale
Measured: Weeks 0, 9, 13, 35
Attention-Deficit Hyperactivity Rating Scale
Measured: Weeks 0, 9, 13, 35
Depression Anxiety Stress Scale
Measured: Weeks 0, 9, 13, 35
Premonitory Urge to Tic Scale
Measured: Weeks 0, 9, 13, 35
Tic Rating Form
Measured: Weeks 1-8
Problem Rating Form
Measured: Weeks 1-8
Patient Health Questionnaire-9
Measured: Weeks 0, 9, 13, 35
Work and Social Adjustment Survey
Measured: Weeks 0, 9, 13, 35
Five Facet Mindfulness Questionnaire
Measured: Weeks 0, 4, 8, 9, 13, 35
Credibility and Expectancy Questionnaire
Measured: Week 3
Patient Satisfaction Questionnaire
Measured: Week 9
Self Compassion Scale
Measured: Weeks 0, 9, 13, 35
Affective Reactivity Index
Measured: Weeks 0, 9, 13, 35
Brief Irritability Test
Measured: Weeks 0, 9, 13, 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start9 Nov 2018
- Primary completion2 Dec 2020
- Study completion2 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bowdoin College
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Hannah Reese, Bowdoin College
- Investigators
- Hannah Reese, Ph.D., Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771235
- Sponsor's protocol ID
- 2018-30
- Status last verified
- Apr 2024
- First submitted
- 7 Dec 2018
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Mindfulness-based Tic Reduction: Development and Testing (Phase Two)
- ClinicalTrials.gov ID
- NCT03771235
- Acronym / sponsor ID
- 2018-30
- Conditions
- Tourette Syndrome, Persistent Tic Disorder
- Keywords
- Tourette Syndrome, Tic Disorder, Online, Adults, Mindfulness, Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Bowdoin CollegeUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Intervention for Tics | Experimental | Behavioral: Mindfulness-based Intervention for Tics8-week group-based mindfulness-based program |
| Tic Information and Coping Strategies | Active comparator | Behavioral: Tic Information and Coping Strategies8-week group-based educational and supportive therapy program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Intervention for TicsPsychological intervention that focuses on cultivating awareness of urges to tic and developing a different relationship to those urges through meditation and other mindfulness practices. | Behavioural | Mindfulness-based Intervention for Tics |
| Tic Information and Coping StrategiesPsychological 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. | Behavioural | Tic Information and Coping Strategies |
Primary outcome
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
16 secondary outcomes
Clinical Global Impressions Scale
Time frame: Weeks 0, 9, 13, 35
Adult Tic Questionnaire
Time frame: Weeks 0, 9, 13, 35
Yale-Brown Obsessive Compulsive Scale
Time frame: Weeks 0, 9, 13, 35
Attention-Deficit Hyperactivity Rating Scale
Time frame: Weeks 0, 9, 13, 35
Depression Anxiety Stress Scale
Time frame: Weeks 0, 9, 13, 35
Premonitory Urge to Tic Scale
Time frame: Weeks 0, 9, 13, 35
Tic Rating Form
Time frame: Weeks 1-8
Problem Rating Form
Time frame: Weeks 1-8
Patient Health Questionnaire-9
Time frame: Weeks 0, 9, 13, 35
Work and Social Adjustment Survey
Time frame: Weeks 0, 9, 13, 35
Five Facet Mindfulness Questionnaire
Time frame: Weeks 0, 4, 8, 9, 13, 35
Credibility and Expectancy Questionnaire
Time frame: Week 3
Patient Satisfaction Questionnaire
Time frame: Week 9
Self Compassion Scale
Time frame: Weeks 0, 9, 13, 35
Affective Reactivity Index
Time frame: Weeks 0, 9, 13, 35
Brief Irritability Test
Time frame: Weeks 0, 9, 13, 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: No
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Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
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Integrating Exposure and Response Prevention and Habit Reversal Techniques to Treat a Tourettic Subtype of Obsessive-Compulsive Disorder (Tourettic OCD)
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RecruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Reese, Ph.D. principal investigator
Assistant Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Intervention for Tics and Tic Information and Coping Strategies in people with Tourette Syndrome and Persistent Tic Disorder, run by Bowdoin College at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (time frame: Screening, Week 0, Week 9, Week 13, Week 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.