Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine
Phase: NA
Conditions: Migraine
Sponsor: NYU Langone Health

16-00937: Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine 
 
PI: Mia Minen, MD, MPH 
Version: 12.23.2019 
 
NCT Number: NCT03799211 
guidance.how.to.protocol.guidelines.2016.08.docx | email irb-info@nyumc.org | phone 212.263.4110 | page 6 of 6 
Purpose of the Study and Background  
Purpose of the Study 
Migraine is a significant public health problem worldwide, and migraine has considerable 
personal and social costs, greater healthcare utilization, work absenteeism. Cognitive 
behavioral therapy, biofeedback and progressive muscle relaxation therapy for migraine are 
level A evidence-based behavioral treatments for migraine, yet attrition and suboptimal 
adherence may diminish its impact. Surprisingly little attention has been devoted to 
understanding factors associated with following physician recommendation to be treated by a 
therapist trained in these interventions and the role of adherence with these treatments. This 
study will evaluate factors associated with adherence to referral to behavioral treatment. 
Selected References 
-Trautmann E, Kroner-Herwig B. A randomized controlled trial of internet-based self-help 
training for recurrent headache in childhood and adolescence. Behav Res Ther. 2010;48:28-
37. 
-Huguet A, Stinson J, MacKay B, et al. Bringing psychosocial support to headache sufferers 
using information and communication technology: Lessons learned from asking potential users 
what they want. Pain Res Manag. 2014;19:e1-e8. 
-Donovan E, Mehringer S, Zeltzer LK. Assessing the feasibility of a web-based self-
management program for adolescents with migraines and their caregivers. Clin 
Pediatr. 2013;52:667-670. 
-Day MA, Thorn BE, Ward L, et al. Mindfulness-based cognitive therapy for the treatment of 
headache pain: A pilot study. Clin J Pain. 2014;30:152-161. 
-Matchar DB, Harpole L, Samsa GP, et al. The headache management trial: A randomized 
study of coordinated care. Headache. 2008;48(9):1294-1310. 
-Holroyd KA, Cottrell CK, O'Donnell FJ, et al. Effect of preventive (beta blocker) treatment, 
behavioural migraine management, or their combination on outcomes of optimised acute 
treatment in frequent migraine: Randomised controlled trial. BMJ. 2010;341:c4871. doi: 
10.1136/bmj.c4871 [doi]. 
-Powers SW, Kashikar-Zuck SM, Allen JR, et al. Cognitive behavioral therapy plus 
amitriptyline for chronic migraine in children and adolescents: A randomized clinical trial. 
JAMA. 2013;310(24):2622-2630. doi: 10.1001/jama.2013.282533 [doi]. 
-Campbell J, Penzien D, Wall E. Evidence-based guidelines for migraine headache: 
Behavioral and physical treatments.1999. 
http://tools.aan.com/professionals/practice/pdfs/gl0089.pdf 
-Andrasik F, Blanchard EB, Neff DF, Rodichok LD. Biofeedback and relaxation training for 
chronic headache: A controlled comparison of booster treatments and regular contacts for 
long- term maintenance. J Consult Clin Psychol. 1984;52(4):609-615. 
-Schafer AM, Rains JC, Penzien DB, Groban L, Smitherman TA, Houle TT. Direct costs of 
preventive headache treatments: Comparison of behavioral and pharmacologic approaches. 
Headache. 2011;51(6):985-991. doi: 10.1111/j.1526-4610.2011.01905.x [doi]. 
-Janssen K, Neutgens J. Autogenic training and progressive relaxation in the treatment of 
three kinds of headache. Behav Res Ther. 1986;24(2):199-208. doi: 0005-7967(86)90091-4 
[pii]. 

16-00937: Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine 
 
PI: Mia Minen, MD, MPH 
Version: 12.23.2019 
 
NCT Number: NCT03799211 
guidance.how.to.protocol.guidelines.2016.08.docx | email irb-info@nyumc.org | phone 212.263.4110 | page 6 of 6 
-Daly EJ, Donn PA, Galliher MJ, Zimmerman JS. Biofeedback applications to migraine and 
tensi n headaches: A double-blinded outcome study. Biofeedback Self Regul. 1983;8(1):135-
152. 
Study Design 
This is a prospective study to examine factors associated with adherence to referral for migraine 
behavioral treatment. 
Patients will be recruited from the New York University Medical Outpatient Setting (both in the 
FGP Neurology Group by neurologists who have large headache practices and in the private 
practice office). Consecutive subjects presenting with a chief complaint of headaches with 
migrainous features will be recruited.   
Drs. Minen, Ashina, Berk, Halpern, Newman, Levitan and Jann will be the neurologists 
recruiting for the study. Dr. Minen will begin recruitment on 5/27/16.  
All of these neurologists are part of the NYU Langone Headache Center, and are 
knowledgeable about the study. No printed information will be given to these doctors. 
Characteristics of the Research Population 
Number of Subjects 
2000 total subjects; We expect that 200 subjects will be referred to behavioral treatment. 
We are requesting to extend enrollment to 2000 people as fewer enrolled participants are being 
referred for behavioral treatment than was originally anticipated. Those who are not referred for 
behavioral treatment are no longer eligible, as that is what is being studied. 
*Of note, as of 12/10/19 only about 150 subjects who have been enrolled have been referred for 
behavioral therapy. We hope to have a total of 60 subjects who are referred to biofeedback (one 
of the forms of behavioral therapy) take part in this study.  
 
Gender of Subjects 
Both genders will be included. 
Age of Subjects 
16+ 
Racial and Ethnic Origin  
No enrollment restrictions. 
Inclusion Criteria 
Inclusion criteria are: a) age 16+ years of age; b) primary diagnosis of migraine based on the 
International Classification of Headache Disorders 3 beta criteria (documentation of migraine 
confirmed by Board Certified Neurologist) 
Patients will be screened for migraine diagnosis on the questionnaire but the diagnosis will be a 
clinical diagnosis of migraine based on the ICHD 3 beta criteria made by the neurologist during 
the patient visit. 
Exclusion Criteria 
Exclusion criteria are: a) No phone number to receive a follow-up call. 

16-00937: Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine 
 
PI: Mia Minen, MD, MPH 
Version: 12.23.2019 
 
NCT Number: NCT03799211 
guidance.how.to.protocol.guidelines.2016.08.docx | email irb-info@nyumc.org | phone 212.263.4110 | page 6 of 6 
Vulnerable Subjects 
We are including age 16+. These treatments are appropriate for children and without significant 
side effects. A recent paper by Scott Powers et al in JAMA showed that the combination of 
amitriptyline and CBT resulted in the most favorable reduction in headache days. 
Methods & Procedures 
Methods & Procedures 
Please note that “RA” stands for study research team member. We carefully select from a 
group of specially selected group of CUNY students who are part of the highly coveted 
S Jay Levy Fellowship. These students are pre-selected by CUNY for their 
professionalism and top 
grades and then the students undergo a very selective interview process by Dr. Minen. 
We also take high achieving Barnard students who are pre-health who have high grades 
and many of whom are part of the Barnard Summer Research Institute. Dr. Minen has 
been a mentor as part of this program for several years, and the students in this 
program are supposed to learn research methods from start to finish, culminating in a 
poster presentation at a minimum.  All study team members will have undergone a one 
week training intensive to understand the screening process, recruitment process, 
informed consent process and enrollment process (as described throughout this IRB). 
In brief, research volunteers will be trained during an intense one week training on 
study procedures including an emphasis on how to screen, recruit, consent, and enroll 
the participants. This is a no risk/very low risk study 
unlike other interventional studies. It is similar to many of the hundreds of 
commercial apps available on the market that people use every day. Thus, it is 
appropriate for trained research volunteers to consent these participants just as 
they would be able to do so for survey type studies. They study team members will be 
carefully observed during the initial consent process to ensure that they are doing 
it correctly. 
 
When patients check in and complete their regular intake questionnaire: 
1. They will be approached by research assistants based on their indicated chief complaint. 
Patients presenting with headache will be informed about the study and consented (as 
described below). Using the information obtained during the visit (clinical history, 
physical exam and any additional medical records), the Neurologist will confirm after the 
visit that the diagnosis is migraine. Participants will complete the initial questionnaires on 
paper or electronically directly into REDCap using an iPad. The questionnaires include: 
the Migraine Disability Assessment Scale (Lipton et al, 2001), the Migraine Quality of 
Life (MSQ v2), the Patient Health Questionnaire-8 (PHQ-8), Generalized Anxiety 
Disorder 7-item (GAD-7) and the Insomnia Sleep Index (ISI), and a brief series of 
questions regarding the headache frequency and intensity and history of which types of 
providers were previously consulted for treatment of the headaches. (All questions are 
attached). The Neurologist or research assistants will record whether the patient was 
referred for behavioral treatment. Data will then be entered into RedCap by the PI (Dr. 
Minen) or research assistant(s) (who will be listed on the IRB at a later date) if the 
diagnosis is confirmed to be migraine. 
 

16-00937: Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine 
 
PI: Mia Minen, MD, MPH 
Version: 12.23.2019 
 
NCT Number: NCT03799211 
guidance.how.to.protocol.guidelines.2016.08.docx | email irb-info@nyumc.org | phone 212.263.4110 | page 6 of 6 
2. Participants will be told that they will receive a series of follow up calls or REDCap 
emails regarding their treatment. The PI (Dr. Minen) or research assistant(s) who will be 
listed on the IRB at a later date will be the person to make the telephone call/send the 
email. 
 
Ten call attempts will be made for each participant for each f/u period (month 1, month 2, month 
3). If subjects cannot be reached by phone or text, they will be emailed to set up a convenient 
time for the follow-up phone call or they will be sent the follow-up survey directly via REDCap. 
The survey will be emailed a second time if the subject does not respond – 5 days after the first 
attempt.  
Separate documents include scripts of any messages or emails for subjects. 
 
Data Analysis and Data Monitor ing 
Analysis Plan 
Descriptive statistics for all variables will be reported. We will will evaluate differences between 
people who did and did not follow through on behavioral treatment referrals for normally 
distributed, rank, and nominal psychosocial and migraine-related variables, respectively, and we 
will examine whether they chose to pursue behavioral therapy with a therapist (Master’s or 
Doctorate level psych trained therapist or a physical therapist trained in biofeedback). The study 
does not involve us contacting or working with the PTs for the treatment. We will just collect the 
data from the questionnaire regarding the subjects' perceptions/decision making of whom to see 
for behavioral therapy. The physical therapists/psychologists may be outside of NYU. Power 
analysis suggests we have a power of .80 to detect a medium effect size, with a two-sided test 
and alpha set at .05. Qualitative analysis will include a grounded theory evaluation of responses 
to open-ended questions regarding adherence to behavioral treatment referral. 
Data Storage and Confidentiality  
Data from the questionnaires will be entered into REDCap. The questionnaires will be stored in 
a locked cabinet in the new office Dr. Minen will be in as part of the Department of Neurology on 
41st Street, in a locked cabinet later on in Dr. Halpern’s private outpatient office, and in a locked 
cabinet in the Men’s Health Center Headache Center Office. Any emails sent from the provider 
to the PI or research volunteer (to be added at a later date) about any study participants 
needing follow-up telephone calls will be sent via the HIPAA compliant NYUMC webmail system 
to only those with an NYU email address. 
Risk/Benefit Assessment 
Risk 
There is minimal harm in asking patients about their thought processes regarding behavioral 
treatments for migraine, which have very minimal risk to patients. Patients do not need to 
answer any questions which may cause anxiety or discomfort. 
Breach of confidentiality is also a risk, which will be minimized by use of the NYU email system 
only and by use of REDCap. 
Protection Against Risks  
As stated above, data will be appropriately secured. Patients will be instructed that they can 
leave the study at any time. 

16-00937: Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine 
 
PI: Mia Minen, MD, MPH 
Version: 12.23.2019 
 
NCT Number: NCT03799211 
guidance.how.to.protocol.guidelines.2016.08.docx | email irb-info@nyumc.org | phone 212.263.4110 | page 6 of 6 
Potential Benefits to the Subjects 
Patients may reconsider the possibility of doing evidence based behavioral treatment for their 
headaches. 
Investigator’s Qualifications & Experience 
Please see the attached CV. 
Subject Identification, Recruitment and Consent/Assent 
Method of Subject Identification and Recruitment  
Patients will be recruited from the New York University Medical Outpatient Setting during their 
standard Neurology medical appointment (in the FGP Neurology Group by neurologists who 
have large headache practices, in the private practice office, and Men’s Health Center 
Headache Center). 
Process of Consent 
MDs (or IRB approved RAs) participating in the study will obtain consent from potential subjects 
at their Neurology standard medical appointment. Patients will be told that we are doing a study 
examining their opinions and practices regarding some migraine treatment recommendations. 
The initial questionnaire is composed of several questionnaires and then there are brief serial 
follow-up calls in the MI group and one call in the TAU group. Participation is voluntary and will 
not affect their care whether or not they elect to participate in the study. If patients are uncertain 
and want to think about it, they can decide to come back within 48 hours to complete the study 
questionnaire. 
In those ages 16-17, the patient will be provided with the consent form along with the parent due 
to the age of the child. The purpose of the study, risk, benefits, description of the study, subjects 
right to withdraw and confidentiality will be discussed with the all subjects before consent is 
obtained. 
Subjects will be given an opportunity to ask questions and have their questions answered. Once 
the subject signs consent the subject will receive a copy of the signed consent form. 
To monitor for treatment fidelity, we are requesting to record phone conversations during which 
motivational interview techniques are employed. The PI will be reviewing these recordings to 
account for consistency across interviewers. An A/V consent form has been submitted.  
Subject Capacity 
Only patients with capacity will be asked to participate in the study. 
Subjec t/Representative Comprehension  
Patients will be asked to explain that they understand that the purpose of the study. 
Debriefing Procedures  
N/A 
Consent Forms 
Consent forms provided to the patient follow standard IRB guidelines and all subjects who agree 
to participate will receive a copy of the signed consent form. 

16-00937: Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine 
 
PI: Mia Minen, MD, MPH 
Version: 12.23.2019 
 
NCT Number: NCT03799211 
guidance.how.to.protocol.guidelines.2016.08.docx | email irb-info@nyumc.org | phone 212.263.4110 | page 6 of 6 
Documentation of Consent  
The documentation will be kept in a locked storage unit in Dr. Minen’s office on 41st St, in a 
locked cabinet later on in Dr. Halpern’s private outpatient office, and in a locked cabinet in the 
Men’s Health Center Headache Center Office. In the case a potential subject is 16 or 17 years 
of age, the parent grants permission. Consent will be documented by the signature of the parent 
after review of all consent information and questions addressed. The neurologist will also review 
the assent form with the child. Questions will be answered and a statement of assent will be 
confirmed with the signature from the child. A copy of the consent will be provided to the parent 
and child. 
Costs to the Subject 
There is no cost to the subjects. 
Payment for Participation 
There is no payment for participating in the study.