The purpose of this research study is to compare two different online group-based interventions for tics: a mindfulness-based program (Mindfulness-based Intervention for Tics (MBIT), and a psychoeducational and supportive therapy program (Tic Information and Coping Strategies (TICS)). We aim to determine which intervention is more helpful for adults with a tic disorder.
If you agree to participate in this study, you will be asked to:
- complete five assessments and
- be randomly assigned to complete one of the two interventions.
The study is being conducted by researchers from Bowdoin College and Massachusetts General Hospital. The research will be conducted online. All study meetings will occur on zoom.us, a secure online videoconferencing platform.
If you are interested in participating in this study, you should first contact our office by phone or email. We can tell you a little bit more about the study, answer any questions you may have, and ask you a few questions to determine if you might be eligible.
If it appears that you are eligible for the study, then you will first be scheduled for a conversation with the study principal investigator, Hannah Reese, Ph.D. Dr. Reese will discuss the study with you and answer any questions you may have so you have all the information you need to decide whether you want to participate or not.
If you agree to participate you will then be scheduled for a screening assessment. The screening assessment will involve meeting with a member of our study team. During this meeting, you will be asked a series of questions about your tics and any other mental health concerns you have or may have had in the past. This assessment will tell us if you are indeed eligible to participate in this study.
If you are eligible to participate in the study then you will be assigned to a group of participants waiting to begin one of the study interventions. Once we have 6-8 participants in the group, we will randomly assign the group to receive one of the two study interventions. This means that you will have a 50% chance of receiving either intervention.
In the week before your group starts the study intervention, you will be asked to complete a 1-hour baseline assessment. During this assessment you will again meet with a member of our study team and be asked a series of questions about your tics and other aspects of your health and well-being. You will also be asked to complete a series of online questionnaires.
Your group will then begin the intervention. Both interventions are 8 weeks long and involve 8 weekly 90 minute videoconferences and approximately 15 minutes a week of online questionnaires. The videoconferences will be facilitated by a member of our study team. If you are assigned to MBIT you will also be asked to complete approximately 30 minutes of home practice 4-6 days a week.
MBIT will focus on cultivating awareness of urges to tic and developing a different relationship to those urges through meditation and other mindfulness practices. TICS will focus 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.
After the study interventions have ended, you will be asked to complete three more one-hour assessments. These will be similar to the baseline assessment and will occur one-week, one-month, and 6-months after the intervention has ended.
Participation is this study will last approximately 9 months. During this time you will spend approximately 6 hours completing assessments (2 hours for the screening visit, 1 hour each for the baseline assessment and the 3 post-intervention assessments) and approximately 2-5 hours per week for 8 weeks completing the intervention and self-report questionnaires.
It is possible that you will experience mild emotional distress due to the personal nature of some of the questions. With the exception of questions necessary to determine your eligibility for the study, you may skip any questions that you do not feel comfortable answering.
It is also possible that you will experience mild physical discomfort when practicing relaxation, mindful movement, and/or meditations. You should only engage in these practices at a level that feels comfortable for you.
It is also possible that you will experience temporary tic worsening when conversing with others who have tics in the group videoconferences.
Meditation and Supportive Therapy can also be challenging and may make you more aware of negative aspects of your life. Additionally, although unlikely, intense or prolonged meditation could cause or worsen symptoms in people who have certain psychiatric problems.
If you experience any adverse effects from this study we ask that you please inform the study investigators immediately. You are also free to stop the study at any time.
It is possible that you will not directly benefit from this study. It is also possible that you will experience a reduction in tic severity, intensity, or related impairment and/or positive changes in anxiety, mood, attention, irritability, or your quality of life.
You will receive a gift card for $200 for completing the entire study ($10/week for the weekly self-report questionnaires, $30 for the baseline assessment, and $30 for each of the three assessments after the intervention). If you stop the study before completing it you will be paid for the assessments that you have completed.
WHAT OTHER TREATMENTS ARE AVAILABLE FOR TICS:
You do not have to take part in this research study to be treated for tics.
Other treatments that are available to treat tics include:
- Medications (e.g., dopamine D2-blockers, haloperidol (Haldol), or alpha2-agonists (guanfacine (Tenex))
- Therapy (e.g., Comprehensive Behavioral Intervention for Tics (CBITS), Habit Reversal Training (HRT))
Talk to the Principal Investigator if you have any questions about any of these treatments.
DATA STORAGE TO PROTECT CONFIDENTIALITY:
All information gathered about you will be kept strictly confidential. You will be assigned a confidential study ID number which will be used to identify the information you provide to us online. The key linking your name to the study ID will be kept in a password protected file. Data will be stored on secure servers and/or in locked offices. All questionnaires will be administered via Qualtrics, a secure online data collection platform. All videoconferences will be conducted via zoom.us, a secure, HIPAA-compliant web-based videoconferencing platform.
This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information or documents that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information or documents protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if 1) there is a federal, state, or local law that requires disclosure (such as to report child abuse, elder abuse, intent to hurt yourself or others but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); 2) if you have consented to the disclosure, including for your medical treatment; or 3) if it is used for other scientific research, as allowed by federal regulations protecting research subjects.
The Certificate cannot be used to refuse a request for information that is needed for auditing or program evaluation by personnel of the United States federal or state government agency sponsoring the project or the Tourette Association of America which is funding this project or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA). You should understand that a Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it.
Portions of your study assessments will be audiotaped. We audiotape the assessments to ensure consistency in the evaluations. This means that some of the recordings will be listened to by Dr. Reese, the principal investigator. All audio recordings will be labeled with a code number and not your name, in order to protect your confidentiality. All recordings will be stored in locked file cabinets within locked offices or on a secure, password-protected computer network. Only members of study staff will have access to the recordings. The recordings will be destroyed as soon as we have completed our assessment of the consistency of the evaluations.
We are required by the Health Insurance Portability and Accountability Act (HIPAA) to protect the privacy of health information obtained for research. This is an abbreviated notice, and does not describe all details of this requirement (see Partners Privacy Notice*). During this study, identifiable information about you or your health will be collected and shared with the researchers conducting the research. In general, under federal law, identifiable health information is private. However, there are exceptions to this rule. In some cases, others may see your identifiable health information for purposes of research oversight, quality control, public health and safety, or law enforcement. We share your health information only when we must, and we ask anyone who receives it from us to protect your privacy.
*Partners HealthCare Notice for Use and Sharing of Protected Health Information
HOW WILL RESULTS BE USED:
The results of this study may be presented at scientific conferences and/or published in the scientific literature. However, you will not be personally identified in any presentation of the results. Your de-identified information (that is, information that cannot be linked back to your identity), may also be combined with de-identified information from other research studies to answer additional research questions.