Mindfulness-Based Intervention for Tics

(MBIT Trial)

Overseen By Lauren Browning

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Substance use disorder, Psychosis, Mania, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

150 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{6 8 9 10 11}

Research Team

Joseph F McGuire, PhD

Principal Investigator

Johns Hopkins University

Hannah Reese, PhD

Principal Investigator

Bowdoin College

Eligibility 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

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.

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

Treatment Details

Interventions

• Mindfulness-based Intervention for Tics
• Psychoeducation with relaxation and supportive therapy

Trial Overview 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.

Participant Groups

Group I: mindfulness-based intervention for tics (MBIT) Experimental Treatment 1 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 Control 1 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).

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Bowdoin College

Collaborator

Trials

5

Recruited

8,300+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

An 8-week online mindfulness-based group intervention for adults with Tourette syndrome showed feasibility and acceptability, indicating that participants found it manageable and satisfactory, despite lower-than-expected adherence to home practice.

While there were modest improvements in mindfulness and tic severity after the intervention, the study suggests that modifications are needed to enhance participant engagement and optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of an online mindfulness-based group intervention for adults with tic disorders. Reese, HE., Brown, WA., Summers, BJ., et al.[2021]

Habit reversal training (HRT) is the most supported behavioral intervention for treating tic disorders in children and adolescents, based on a systematic review of 12 reviews and 8 randomized controlled trials.

Exposure with response prevention (ERP) is also effective and recommended as a first-line treatment, while other methods like neurofeedback remain experimental and psychosocial interventions lack sufficient research support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European clinical guidelines for Tourette syndrome and other tic disorders. Part III: behavioural and psychosocial interventions. Verdellen, C., van de Griendt, J., Hartmann, A., et al.[2022]

A meta-analysis of 10 randomized controlled trials involving 586 patients found that habit reversal training (HRT) is effective in reducing tic symptoms, with a small to medium effect size (SMD of -0.43).

The efficacy of HRT was influenced by the type of behavioral therapy used in the control group, indicating that different comparison conditions can affect treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The therapeutic effect of habit reversal training for Tourette syndrome: a meta-analysis of randomized control trials. Yu, L., Li, Y., Zhang, J., et al.[2021]

A randomized control trial will assess the efficacy of mindfulness-based habit reversal training (MHRT) in 120 patients with Tourette syndrome (TS) over 12 weeks, comparing it to traditional habit reversal training (HRT) and psychoeducation.

The study aims to explore the neural mechanisms behind MHRT by analyzing changes in brain connectivity networks, particularly the default mode network and salience network, which may correlate with reductions in tic severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol of a randomized controlled trial to investigate the efficacy and neural correlates of mindfulness-based habit reversal training in children with Tourette syndrome. Li, Y., Yan, J., Cui, L., et al.[2022]

The modified mindfulness-based stress reduction program (MBSR-tics) was found to be feasible and acceptable for treating Tourette Syndrome (TS) and Chronic Tic Disorder (CTD) in a pilot study involving 18 participants aged 16 to 67.

Participants showed significant improvements in tic severity and related impairment, with 58.8% responding positively to treatment, and these benefits were maintained at a one-month follow-up, suggesting potential efficacy of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for Tourette Syndrome and Chronic Tic Disorder: a pilot study. Reese, HE., Vallejo, Z., Rasmussen, J., et al.[2022]

The Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC) is a promising tool designed to enhance the quality of mindfulness teaching and training, and it is already being used by teacher training organizations globally.

Further research is essential to establish the MBI:TAC's reliability, validity, and its effectiveness in improving participant outcomes, while also considering the impact of different cultural and contextual factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC): reflections on implementation and development. Crane, RS., Kuyken, W.[2020]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

The development of the Concise Fidelity for Mindfulness-Based Interventions (CoFi-MBI) tool demonstrated high inter-rater reliability (77-100%) for assessing key session components and participant engagement in online mindfulness programs, indicating it is a reliable method for ensuring fidelity in treatment delivery.

In a study involving 105 sessions of an online mindfulness program for chronic low back pain, key session components were delivered as intended in 94-100% of sessions, and participant engagement was rated positively in 95% of sessions, highlighting the tool's effectiveness in monitoring and improving mindfulness intervention fidelity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Measure of Fidelity for Mindfulness Programs: Development and Evaluation of the Concise Fidelity for Mindfulness-Based Interventions Tool. Greco, CM., Dore, GA., Weinberg, JM., et al.[2023]

A training program for 31 senior mindfulness-based program (MBP) teachers successfully improved their ability to assess teaching competence using the MBI:TAC tool, demonstrating high interrater reliability (0.67 to 1.0) after training.

The training was well-received and helped align assessors from different regions on the key elements of MBP teaching, indicating that a standardized approach to assessing mindfulness teaching can be effectively implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can We Agree What Skilled Mindfulness-Based Teaching Looks Like? Lessons From Studying the MBI:TAC. S Crane, R., Hecht, FM., Brewer, J., et al.[2022]

The Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC) has evolved from a simple assessment tool to a supportive framework for training mindfulness-based program teachers, enhancing the quality of their training.

Implementing the MBI:TAC in teacher training can help maintain high standards for mindfulness teachers, potentially preventing a decline in the quality of mindfulness interventions when they are applied in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing the Mindfulness-Based Interventions; Teaching Assessment Criteria (MBI:TAC) in Mindfulness-Based Teacher Training. Griffith, GM., Crane, RS., Baer, R., et al.[2021]

Trainee clinical psychologists who participated in a modified Mindfulness-Based Cognitive Therapy (MBCT) program showed significant improvements, including decreased rumination and increased self-compassion and mindfulness, based on pre- and post-questionnaires from 20 participants.

The study found that more frequent home practice of mindfulness techniques led to greater reductions in stress and anxiety, and 85% of participants reported that the MBCT experience positively impacted their clinical work, enhancing their understanding of clients and themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of Mindfulness-Based Cognitive Therapy for trainee clinical psychologists. Rimes, KA., Wingrove, J.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of an online mindfulness-based group intervention for adults with tic disorders. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

European clinical guidelines for Tourette syndrome and other tic disorders. Part III: behavioural and psychosocial interventions. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The therapeutic effect of habit reversal training for Tourette syndrome: a meta-analysis of randomized control trials. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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]

5. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for Tourette Syndrome and Chronic Tic Disorder: a pilot study. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC): reflections on implementation and development. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

A Brief Measure of Fidelity for Mindfulness Programs: Development and Evaluation of the Concise Fidelity for Mindfulness-Based Interventions Tool. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Can We Agree What Skilled Mindfulness-Based Teaching Looks Like? Lessons From Studying the MBI:TAC. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Implementing the Mindfulness-Based Interventions; Teaching Assessment Criteria (MBI:TAC) in Mindfulness-Based Teacher Training. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Pilot study of Mindfulness-Based Cognitive Therapy for trainee clinical psychologists. [2019]