Remote Delivery of a Mindfulness-based Intervention for Tics

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

be ≥18 years of age;

meet diagnostic criteria for a primary or co-primary diagnosis of Tourette Syndrome or a Persistent Motor or Vocal Tic Disorder on a structured clinical interview;

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 medication free and/or on a stable dose of psychiatric medication 8 weeks prior to study participation;

Disqualifiers

a current diagnosis of substance use disorder, psychosis, mania or another condition that requires another form of care;

severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention;

concurrent psychotherapy for TS;

prior extensive experience with mindfulness and/or meditation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • mindfulness-based intervention for tics (MBIT)

    Other intervention

    Psychological intervention that focuses on cultivating awareness of urges to tic and developing a different relationship to those urges through meditation and other mindfulness practice

  • psychoeducation with relaxation and supportive therapy (PRST)

    Other intervention

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: mindfulness-based intervention for tics (MBIT)Experimental treatment 1 intervention
Group B: psychoeducation with relaxation and supportive therapy (PRST)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score

The YGTSS is a clinician-administered measure of tic symptom severity (0-50) and impairment (0-50). Greater scores are reflective of greater severity and/or impairment.

Time frame
Screen, Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)

Secondary outcomes

1

Clinical Global Impressions Scales of Severity and Improvement (CGI-S & CGI-I)

In order for a participant to be considered a treatment responder, he or she must receive a score of 1 (not ill or very much improved) or 2 (borderline mentally ill or much improved).

Time frame
Screen, Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
2

Adult Tic Questionnaire (ATQ)

Higher ATQ scores reflect a worse outcome. For each tic present in the past week, its severity score is the sum of its frequency score (0-4, 4 worst, occurring "almost all the time during the day") and its intensity score (0-4, 4 worst). The ATQ severity score is the sum of the severity score for each of up to 27 tics present in the past week. The minimum possible severity score on the ATQ is 0, indicating that no tics were present in the past week. The maximum possible severity score on the ATQ indicates is 216, indicating that a tic of each of the 27 types listed was present in the past week, each with an item severity score of 8 = 4 + 4.

Time frame
Screen, Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
3

Yale-Brown Obsessive Compulsive Scale-II

A clinician-administered measure of OCD severity that has shown good psychometric properties. The total score ranges from 0 to 50, with greater total score reflective of greater severity.

Time frame
Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
4

Attention-Deficit Hyperactivity Rating Scale (ADHD-RS)

A self-report measure of ADHD severity that has shown good psychometric properties in TS studies. The total score ranges from 0 to 72, with greater scores indicating greater ADHD severity.

Time frame
Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)

Other outcomes

1

Individualized Premonitory Urge to Tic Scale (I-PUTS)

The I-PUTS is a clinician-administered scale that parallels the YGTSS symptom checklist. The clinician assesses each tic that is present in the past week for premonitory urges. The urges are rated on the dimensions of frequency (1-4) and intensity (1-4), with the frequency and intensity summed to create a total premonitory urge severity score

Time frame
Screen, Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)
2

Depression Anxiety and Stress Scale (DASS)

The Depression Anxiety and Stress Scale (DASS) is a self-report measure of depression, anxiety, and stress. The 21-items are rated on a scale from 0 to 2, with a total score ranging from 0 to 42. Greater scores are reflective of worse symptom severity.

Time frame
Screen, Baseline (Week 0), Mid-treatment (Week 5), Post-treatment (Week 9), 1-month follow-up (Week 13), 3-month follow-up (Week 22), and 6-month follow-up (Week 35)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

Bowdoin College

Collaborator

National Center for Complementary and Integrative Health (NCCIH)

Collaborator