Mindfulness-Based Intervention for Tics
(MBIT Trial)
Recruiting in Palo Alto (17 mi)
Overseen byJoseph F McGuire, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: Substance use disorder, Psychosis, Mania, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This research study is being done to compare a mindfulness-based intervention for tics (MBIT) to psychoeducation with relaxation and supportive therapy (PRST) for individuals with Tourette's syndrome or Persistent Tic Disorders (collectively TS). It is the investigator's hope that this information cam be used to improve current treatments for individuals with TS.
Will I have to stop taking my current medications?
You can continue taking your current medications if they are psychiatric and you have been on a stable dose for at least 8 weeks before joining the study.
What data supports the effectiveness of the treatment Mindfulness-Based Intervention for Tics?
Research suggests that mindfulness-based treatments can be beneficial for tic disorders, as seen in studies where mindfulness approaches were combined with habit reversal training, showing potential benefits in reducing tic symptoms. Additionally, mindfulness-based stress reduction has been tested for Tourette Syndrome and Chronic Tic Disorder, indicating it may be a feasible and acceptable treatment option.
12345Is Mindfulness-Based Intervention for Tics safe for humans?
There is limited information on the safety of Mindfulness-Based Interventions (MBIs) specifically for tics, but MBIs are generally used in various clinical settings with little attention to potential adverse effects. More research is needed to fully understand their safety profile.
678910How is the Mindfulness-Based Intervention for Tics treatment different from other treatments for tics?
The Mindfulness-Based Intervention for Tics (MBIT) is unique because it combines mindfulness practices with psychoeducation and relaxation techniques, focusing on increasing awareness and acceptance of tics rather than trying to suppress them, which is different from traditional treatments that often focus on reducing tic frequency.
6891011Eligibility Criteria
This trial is for individuals with Tourette's syndrome or Persistent Tic Disorders. Participants should be interested in trying mindfulness-based therapy or psychoeducation with relaxation and supportive therapy to manage their tics.Inclusion Criteria
Have moderate or greater tic severity as evidenced by a YGTSS Total Tic Score of >14 (when motor and vocal tics are present) or >10 (when only motor or vocal tics are present)
Be fluent in English
Have access to a smart phone and/or tablet
+4 more
Exclusion Criteria
A current diagnosis of substance use disorder, psychosis, mania or another condition that requires another form of care
Prior extensive experience with mindfulness and/or meditation
I do not have severe thoughts of harming myself or others that need medical help.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either an 8-week mindfulness-based intervention for tics (MBIT) or psychoeducation with relaxation and supportive therapy (PRST) delivered via telehealth
8 weeks
Weekly virtual sessions
Follow-up
Participants are monitored for sustained therapeutic improvement focusing on tic severity, tic-related impairment, co-occurring psychiatric symptoms, and quality of life
6 months
Assessments at 1-month, 3-month, and 6-month intervals
Participant Groups
The study compares two approaches: a Mindfulness-Based Intervention for Tics (MBIT) and Psychoeducation with Relaxation and Supportive Therapy (PRST). The goal is to see which method better helps people manage the symptoms of Tourette's syndrome or chronic tic disorders.
2Treatment groups
Experimental Treatment
Active Control
Group I: mindfulness-based intervention for tics (MBIT)Experimental Treatment1 Intervention
This is an 8-week mindfulness-based group intervention delivered via telehealth. It consists of mindfulness and meditative practice, didactics, inquiry, discussion and weekly therapeutic exercises and assignments (i.e., homework).
Group II: psychoeducation with relaxation and supportive therapy (PRST)Active Control1 Intervention
This is an 8-week educational and supportive therapy group intervention delivered via telehealth. It consists of psychoeducation, relaxation, discussion, and weekly therapeutic exercises and assignments (i.e., homework).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins University School of MedicineBaltimore, MD
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
Bowdoin CollegeCollaborator
National Center for Complementary and Integrative Health (NCCIH)Collaborator
References
Feasibility and acceptability of an online mindfulness-based group intervention for adults with tic disorders. [2021]Preliminary research suggests that a mindfulness-based treatment approach may be beneficial for adults with tic disorders. In the present study, we report on the feasibility, acceptability, safety, and symptomatic effect of a novel online mindfulness-based group intervention for adults with Tourette syndrome or persistent tic disorder. Data from this study will directly inform the conduct of a funded randomized controlled trial comparing the efficacy of this intervention to another active psychological intervention.
European clinical guidelines for Tourette syndrome and other tic disorders. Part III: behavioural and psychosocial interventions. [2022]This clinical guideline provides recommendations for the behavioural and psychosocial interventions (BPI) of children and adolescents with tic disorders prepared by a working group of the European Society for the Study of Tourette Syndrome (ESSTS). A systematic literature search was conducted to obtain an update on the efficacy of BPI for tics. Relevant studies were identified using computerised searches of the Medline and PsycINFO databases and the Cochrane Library for the years 1950-2010. The search identified no meta-analyses, yet twelve (systematic) reviews and eight randomised controlled trials provided evidence for the current review. Most evidence was found for habit reversal training (HRT) and the available but smaller evidence also supports the efficacy of exposure with response prevention (ERP). Both interventions are considered first line behavioural treatments for tics for both children and adults and should be offered to a patient, taking into account his preference. Treatments that are considered second line or add-on behavioural treatments are contingency management, function based interventions and relaxation training. Neurofeedback is still experimental. Almost no research was identified that examined the efficacy of psychosocial interventions, e.g., psychoeducation and group work. Based on clinical practice, this guideline recommends behavioural treatment as first line offer to patients in most cases. It should be embedded within a psychoeducational and supportive context and can be combined with drug treatment.
The therapeutic effect of habit reversal training for Tourette syndrome: a meta-analysis of randomized control trials. [2021]Comprehensive behavioral intervention for tics (CBIT) and habit reversal training (HRT) are forms of cognitive behavioral therapy that can effectively reduce tic symptoms in patients with tic disorders, but their efficacies and potential moderators were needed to be clarified.
Protocol of a randomized controlled trial to investigate the efficacy and neural correlates of mindfulness-based habit reversal training in children with Tourette syndrome. [2022]Tourette syndrome (TS) is a developmental neuropsychiatric disorder. Behavior therapy, especially habit reversal training (HRT), has gradually become regarded as one of the core therapies for TS. Mindfulness approaches can improve psychological adjustment and reduce stress and anxiety, suggesting potential benefits when incorporated into behavior therapy. To improve the efficacy of HRT, we combined it with mindfulness, an approach named mindfulness-based habitual reversal training (MHRT). The aim of this protocol is to investigate the efficacy and neural mechanisms of MHRT for TS.
Mindfulness-based stress reduction for Tourette Syndrome and Chronic Tic Disorder: a pilot study. [2022]In this pilot study we sought to develop and test a modified form of mindfulness-based stress reduction (MBSR-tics) for the treatment of Tourette Syndrome (TS) and Chronic Tic Disorder (CTD). Our specific aims were: 1) To determine the feasibility and acceptability of an 8-week trial of MBSR-tics in individuals 16 and older with TS or CTD and 2) To determine the efficacy of an 8-week trial of MBSR-tics in individuals 16 and older with TS or CTD.
The Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC): reflections on implementation and development. [2020]The Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC) is a tool for supporting good practice in mindfulness-based teaching, training supervision and research contexts. It has been taken up in practice in teacher training organizations worldwide. The MBI:TAC sits within the wider consideration within research contexts of building methodological rigor by developing robust systems for ensuring intervention integrity. Research on the tool is at an early stage and needs development. The process of implementation needs careful attention to ensure reliability and good practice. Future research is needed on the tool's reliability, validity and sensitivity to change, and on the relationships between mindfulness-based teaching, participant outcomes and key contextual factors, including the influence of participant population, culture and context.
Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]Mindfulness-Based Interventions (MBIs) are widely used in clinical and non-clinical populations, but little attention has been given to potential adverse effects (AEs).
A Brief Measure of Fidelity for Mindfulness Programs: Development and Evaluation of the Concise Fidelity for Mindfulness-Based Interventions Tool. [2023]Mindfulness research and clinical programs are widespread, and it is important that mindfulness-based interventions are delivered with fidelity, or as intended, across settings. The MBI:TAC is a comprehensive system for assessing teacher competence, yet it can be complex to implement. A standardized, simple fidelity/engagement tool to address treatment delivery is needed.
Can We Agree What Skilled Mindfulness-Based Teaching Looks Like? Lessons From Studying the MBI:TAC. [2022]The Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC) is a widely used tool for assessing fidelity in mindfulness-based program (MBP) research and training. It also supports MBP teacher reflective and skill development. MBI:TAC assessors review MBP teaching and rate the teaching on 6 domains. The MBI:TAC yields individual domain and overall scores, using 6 levels of competence. Although the MBI:TAC is widely used in MBP research and training, research is at an early stage.
Implementing the Mindfulness-Based Interventions; Teaching Assessment Criteria (MBI:TAC) in Mindfulness-Based Teacher Training. [2021]The Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC) was originally developed as a tool to assess the teaching competence of mindfulness-based program (MBP) teachers. The tool was made freely available and has since been used by mindfulness-based teacher training organisations internationally. During this time the MBI:TAC has evolved in its usage, from an assessment tool to one which informally supports how MBP teachers are trained. In this article, we first examine the rationale for implementing the MBI:TAC in MBP teacher training; second, we offer practical guidance on ways of integrating the tool into teacher training pathways with awareness of its potential and possible pitfalls; and third, we offer guidance on using the tool as a framework for giving effective feedback to trainees on their teaching practice. Implementing the MBI:TAC in teacher training may support the quality and integrity of MBP teacher training, and thus ensure high quality MBP teachers graduating. In turn this may help avoid the 'implementation cliff' - that is, the quality of an intervention delivery is delivered in optimal conditions when it is being researched, and drops in quality when delivered in sub-optimal, 'real world' conditions.
Pilot study of Mindfulness-Based Cognitive Therapy for trainee clinical psychologists. [2019]It is recommended that Mindfulness-Based Cognitive Therapy (MBCT) instructors should undertake MBCT themselves before teaching others.