Tourette SyndromeNCT03525626
Online Mindfulness-based Tic Reduction
A study testing Online Mindfulness-based Tic Reduction in people with Tourette Syndrome and Tic Disorders, 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, find them unacceptable, or cannot… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tourette Syndrome, Tic Disorders
- What is being tested?
- Online Mindfulness-based Tic Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Apr 2018to 7 Aug 2018
- 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
- 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
Who cannot join
- 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).
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 One)
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.
Read more
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.
- Conditions
- Tourette Syndrome, Tic Disorders
- Being tested
- Online Mindfulness-based Tic Reduction
- Keywords
- Tic Disorders, Mindfulness, Meditation, Online, Internet-based, Treatment
- 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.
Online Mindfulness-based Tic ReductionBehavioural
8-week online group mindfulness-based intervention for tics
| Study group | Role | What they receive |
|---|---|---|
| Online Mindfulness-based Tic Reduction | Experimental | Not described Receives: Behavioral: Online Mindfulness-based Tic Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction Questionnaire
Measured: week 9
Secondary outcomes (7)
Homework Compliance Questionnaire
Measured: Weeks 1-8
Attrition Form
Measured: Weeks 1-8
Adverse Events Monitoring Form
Measured: Weeks 1-9
Yale Global Tic Severity Scale (YGTSS)
Measured: Week 0, Week 9
Adult Tic Questionnaire
Measured: Weeks 0-9
Clinical Global Impressions Scale-Severity
Measured: Week 0, Week 9
Clinical Global Impressions Scale-Improvement
Measured: Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start4 Apr 2018
- Primary completion7 Aug 2018
- Study completion7 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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, Bowdoin College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525626
- Sponsor's protocol ID
- 2017-37
- Status last verified
- Jul 2019
- First submitted
- 24 Apr 2018
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reese HE, Brown WA, Summers BJ, Shin J, Wheeler G, Wilhelm S. Feasibility and acceptability of an online mindfulness-based group intervention for adults with tic disorders. Pilot Feasibility Stud. 2021 Mar 24;7(1):82. doi: 10.1186/s40814-021-00818-y.
PubMed 33757602
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Mindfulness-based Tic Reduction: Development and Testing (Phase One)
- ClinicalTrials.gov ID
- NCT03525626
- Acronym / sponsor ID
- 2017-37
- Conditions
- Tourette Syndrome, Tic Disorders
- Keywords
- Tic Disorders, Mindfulness, Meditation, Online, Internet-based, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Bowdoin CollegeUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 7 Aug 2018 (actual)
- Study completion
- 7 Aug 2018 (actual)
- First posted
- 15 May 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, 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online Mindfulness-based Tic Reduction | Experimental | Behavioral: Online Mindfulness-based Tic Reduction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
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
- 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).
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 |
|---|---|---|
| Online Mindfulness-based Tic Reduction8-week online group mindfulness-based intervention for tics | Behavioural | Online Mindfulness-based Tic Reduction |
Primary outcome
Patient Satisfaction Questionnaire
Time frame: week 9
7 secondary outcomes
Homework Compliance Questionnaire
Time frame: Weeks 1-8
Attrition Form
Time frame: Weeks 1-8
Adverse Events Monitoring Form
Time frame: Weeks 1-9
Yale Global Tic Severity Scale (YGTSS)
Time frame: Week 0, Week 9
Adult Tic Questionnaire
Time frame: Weeks 0-9
Clinical Global Impressions Scale-Severity
Time frame: Week 0, Week 9
Clinical Global Impressions Scale-Improvement
Time frame: Week 9
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 9 Jul 2019.
- Derived from this study: PubMed 33757602Reese HE, Brown WA, Summers BJ, Shin J, Wheeler G, Wilhelm S. Feasibility and acceptability of an online mindfulness-based group intervention for adults with tic disorders. Pilot Feasibility Stud. 2021 Mar 24;7(1):82. doi: 10.1186/s40814-021-00818-y.
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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
Bowdoin College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Mindfulness-based Tic Reduction in people with Tourette Syndrome and Tic Disorders, 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 9 Jul 2019. 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?
Patient Satisfaction Questionnaire (time frame: week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03525626, which also lists 1 linked publication.
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 9 Jul 2019.