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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
mindfulness-based intervention for tics (MBIT)
Other interventionPsychological 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 interventionPsychological 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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).
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.
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.
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.
Other outcomes
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
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.
Sponsors and contacts
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Johns Hopkins University
Lead sponsor
Bowdoin College
Collaborator
National Center for Complementary and Integrative Health (NCCIH)
Collaborator