Telehealth Behavioral Migraine Management
Phase: NA
Conditions: Migraine
Sponsor: Albert Einstein College of Medicine

IRB NUMBER: 2019-10345
IRB APPROVAL DATE: 06/12/2023
Title: Telehealth Behavioral Migraine Management
NCT03982316
ID: 2019-10345
IRB Approval Date: 06/12/2023

SYNOPSIS 
Migraine is a prevalent and disabling chronic illness that impacts approximately 40 million people in the United 
States and is a leading specific cause of years lived in disability worldwide1. Behavioral Migraine Management 
(BMM) delivered in four in-person sessions and a patient manual over three months has demonstrated efficacy 
to reduce migraine frequency and migraine-related disability2. However, access to behavioral headache 
treatments is poor; barriers include lack of local access to behavioral treatment providers and challenges in 
transportation and scheduling appointments3. The current project aims to address access to care by evaluating 
three modes of adapting the existing BMM protocol to remote delivery: a version with both telephone-based 
therapist contact and online modules (TeleBMM), a version with only telephone-based therapist contact (CBT-
HA), and a version with only online modules (ED). Remote delivery are innovative approaches to increase 
access to care, and have promise for reaching underserved populations, such as the urban poor. 
PRIMARY OBJECTIVE 
This project aims to develop the protocol and obtain feasibility and acceptability information for three remove 
delivery versions of the BMM protocol in a three-arm pre-post pilot study. I aim recruit 60 people with migraine 
from the Montefiore Headache Center in the Bronx NY. Participants will select either TeleBMM, CBT-HA, or 
ED. Adherence to the treatment protocol will be monitored. They will complete headache diaries for 12 weeks, 
complete questionnaires pre and post.
PRIMARY OUTCOME VARIABLES 
Primary outcomes will be feasibility (patient adherence to protocol) and acceptability (patient satisfaction 
survey). 
STUDY DURATION 
The study will last for approximately 6 years, beginning in July 2019 and finishing by July 2025.
STUDY DESIGN 
This is a three arm, pre-post study. 
STUDY POPULATION 
Inclusion criteria are: 1) physician diagnosis of migraine, 2) current self-reported symptoms meeting the 
International Classification for Headache Disorders – 3 (ICHD-3) criteria for migraine, 3) self-reported at least 4 
headache days per month, with at least one day without headache 4) aged 18-65, 5) can read English, and  6) 
capacity to consent. Exclusion criteria are: 1) psychiatric illness that would interfere with study participation or 
2) meeting criteria for probable medication overuse headache.
NUMBER OF PARTICIPANTS
There will be a total of 60 participants.
NUMBER OF STUDY SITES 
The study will be conducted at the Seng (Headache & Adherence) Lab, Van Etten Building, 1225 Morris Park 
Ave, Bronx, NY 10461. Participants will be recruited from the Montefiore Headache Clinic, Hutchinson Tower 
#2,1250 Waters Pl, Bronx, NY 10461.
STUDY FLOW CHART
IRB NUMBER: 2019-10345
IRB APPROVAL DATE: 06/12/2023

IRB NUMBER: 2019-10345
IRB APPROVAL DATE: 06/12/2023

1.INTRODUCTION 
1.1 Introductory Statement  
This document is a protocol for a human research study. This proposal will use mobile electronic headache 
diaries to 1) assess the roles of individual differences and conditions in adherence to preventive and acute 
migraine headache management strategies, and 2) develop a tailored Clinical Decision Support Tool to 
improve adherence to preventive and acute migraine management strategies. The purpose of this protocol is 
to ensure that this study is to be conducted according to ICH GCP guidelines (CRF 21 Part 312), applicable 
government regulations and Institutional research policies and procedures
IRB NUMBER: 2019-10345
IRB APPROVAL DATE: 06/12/2023

2. BACKGROUND 
2.1 Background/Prevalence of Research Topic 
Migraine is a chronic, painful condition with episodic attacks of head pain, nausea/vomiting, and sensitivity to 
light/sound. Migraine is common, affecting 1 in 7 Americans annually 4. Migraine is the most disabling 
neurological disease worldwide 5, and costs the U.S. healthcare system $4.3 billion annually 6. One-quarter of 
people with migraine meet criteria for being offered prevention7. Behavioral Migraine Management (BMM) is an 
evidence-based minimal contact behavioral migraine treatment that includes components of relaxation, 
cognitive behavioral therapy and biofeedback2. Previous research has demonstrated that BMM reduces 
migraine frequency compared to placebo, and migraine-related disability compared to both placebo and 
preventive medication (beta-blocker)2. 
3.RATIONALE/SIGNIFICANCE 
3.1 PROBLEM STATEMENT 
Migraine is a common 8, disabling 1, and costly 9 disorder characterized by episodic, painful symptoms. BMM 
has demonstrated efficacy to reduce migraine frequency and migraine-related disability2. However, access to 
nonpharmacologic migraine treatments such as BMM remains limited3. The original BMM protocol was a 
limited contact approach consisting of 4 in-person clinic visits, three check-in phone calls, and a physical 
patient manual. 
3.2 PURPOSE OF STUDY/POTENTIAL IMPACT 
This study will develop updated telehealth versions of the BMM protocol. For the TeleBMM arm, the patient 
manuals will be adapted to online versions and the in-clinic sessions will be adapted to telephone sessions. 
For CBT-HD arm, both the manual content and session content will be delivered through telephone sessions. 
We will also evaluate a third, more accessible behavioral treatment option of delivering content through online 
education modules only (ED). These treatments will increase access to care by reducing barriers to care 
delivery. 
3.3 POTENTIAL RISKS AND BENEFITS 
3.3.1 POTENTIAL BENEFITS 
Individual study participants, may experience reduced headache attack frequency and reduced migraine-
related disability. Societal benefits include enhanced understanding of the feasibility and acceptability of 
telehealth versions of evidence-based behavioral headache interventions.   
3.3.1 POTENTIAL RISKS 
Study risks are minimal. Participants may experience an intense emotional experience while engaging in 
relaxation or biofeedback exercises. Participants may feel uncomfortable discussing headache-related burden 
or other difficult subjects during treatment. Finally, there is a risk that a data breach could reveal private 
information collected as part of the study.
Protections Against Risk – Participants will be informed of potential risks and provided with strategies to 
address intense emotional experiences or discomfort during treatment. Participants will be given a random 
study identification number. Participants data will be collected in REDCap, a secure online data capture 
software.  Data will be de-identified and converted to electronic databases and stored in password-protected 
files on a password-protected computer in the locked lab. The list linking participant names to identification 
numbers will be kept in REDCap and destroyed immediately after the last participant information is entered in a 
de-identified database, no more than 6 months after the last day of data collection. Research assistants will 
call participants at least once per month throughout the study to assess for adverse events. The PI will also 
IRB NUMBER: 2019-10345
IRB APPROVAL DATE: 06/12/2023

monitor each participant’s recorded headache diaries monthly to assess for adverse events. If either of these 
procedures identify a potential adverse event, the PI will call the participant to assess the potential adverse 
event. If the event meets adverse event criteria, the PI will immediately inform the IRB and the NIH. If the 
adverse event requires medical or professional intervention, the PI will immediately contact the participant’s 
primary clinician at the MHC and develop an intervention plan. 
IRB NUMBER: 2019-10345
IRB APPROVAL DATE: 06/12/2023

4. STUDY OBJECTIVES 
4.1 HYPOTHESIS 
Primary: We hypothesize that TeleBMM, CBT-HA and ED will be feasible (at least half of participants will 
attend all four study sessions and complete all three self-guided modules) and acceptable (the average patient 
satisfaction rating will fall above 4 on a 5-point Likert satisfaction scale).
Secondary: We hypothesize that TeleBMM and CBT-HA will reduce headache days/month and migraine-
related quality of life as measured by the Migraine Specific Quality of Life Questionnaire (MSQ). We will also 
explore whether ED alone reduces headache days/month and MSQ.
4.2 PRIMARY OBJECTIVE 
To evaluate the feasibility and acceptability of updated versions of the BMM protocol.
4.3 SECONDARY OBJECTIVEs (if applicable)
To evaluate pre-post changes in headache days and migraine-related quality of life over a 3-month course of 
TeleBMM, CBT-HA, and ED.
IRB NUMBER: 2019-10345
IRB APPROVAL DATE: 06/12/2023

5. STUDY DESIGN
5.1 GENERAL DESIGN
5.1.1 STUDY DURATION 
The study will last for approximately 6 years, from July 2019 to July 2025. 
5.1.2 NUMBER OF STUDY SITES
This is a single site study. The study will be conducted at the Seng (Headache & Adherence) Lab, Van Etten 
Building, 1225 Morris Park Ave, Bronx, NY 10461. Participants will be recruited from the Montefiore Headache 
Clinic, Hutchinson Tower #2,1250 Waters Pl, Bronx, NY 10461.
5.2 OUTCOME VARIABLES 
5.2.1 PRIMARY OUTCOME VARIABLES 
The primary outcome variables will be 1) feasibility, as assessed by completion of online modules and 
telehealth sessions, and 2) acceptability, as assessed by the overall satisfaction question on a satisfaction 
survey. 
5.2.2 SECONDARY OUTCOME VARIABLES 
Secondary outcomes will be 1) headache days/28 days as assessed by daily headache diary, and 2) migraine-
related disability as assessed by the migraine-specific quality of life questionnaire (MSQ10).
5.3 STUDY POPULATION 
5.3.1 NUMBER OF PARTICIPANTS 
There will be a total of 60 participants in the study.
5.3.2 ELIGIBILITY CRITERIA 
Inclusion criteria are: 1) physician diagnosis of migraine, 2) current self-reported symptoms meeting the 
International Classification for Headache Disorders – 3 (ICHD-3) criteria for migraine, 3) self-reported more 
than 4 headache days/month, 4) aged 18-65, 5) can read English, and  6) capacity to consent. Exclusion 
criteria are psychiatric illness that would interfere with study participation.
Eligibility will be determined by a phone screen provided by a research assistant, supervised by the PI.
IRB NUMBER: 2019-10345
IRB APPROVAL DATE: 06/12/2023

6. METHODS 
6.1 INTERVENTION 
6.1.1 DESCRIPTION OF INTERVENTION 
Participants will complete a daily headache diary throughout the course of treatment. 
Participants have a choice to participate in one of three intervention options:
1.
Education modules: Participants will receive eight online weekly educational modules about migraine 
that will take you approximately 15 minutes to complete in the following categories: Relaxation, Early 
Warning Signs, Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, 
Biofeedback, and Relapse Prevention.
2.
CBT-HD: This treatment course follows “Cognitive Behavioral Therapy Headache Diseases: Therapist 
Manual” by Grinberg, Marth, and Seng (2021), or CBT-HD. Participants who choose CBT-HD treatment 
will receive six 50-minute telephone sessions, once every two weeks. These sessions will be provided 
by a doctoral psychology student in a clinical health psychology program covering these topics. 
Participants will complete a daily headache diary throughout the course of treatment. Participants will 
also complete brief questionnaires after each session.
3.
TeleBMM: TeleBMM is an adaptation of the evidence-based BMM program2. Participants will receive 
weekly online education sessions in the following categories: Relaxation, Early Warning Signs, 
Triggers, Medication Adherence, Reducing Migraine Impact, Stress Management, Biofeedback, and 
Relapse Prevention. Participants will receive four monthly 50-minute telephone sessions with a doctoral 
psychology student in a clinical health psychology program covering these topics, and three check-ins 
to enhance adherence to behavior change strategies. Participants will also complete brief 
questionnaires after each session.
6.1.2 METHOD OF ASSIGNMENT/RANDOMIZATION
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IRB APPROVAL DATE: 06/12/2023

This is a non-randomized, naturalistic three-arm clinical trial evaluating three different modalities of 
administration of BMM. There are three treatment arms offered, and patients will select their treatment arm: 
education-only, TeleBMM, or CBT-HD. 6.1.3 Selection Of Instruments/Outcome Measures 
All measures were selected using materials from the National Institutes of Neurologic Disorders and Stroke 
(NINDS) Common Data Elements (CDE) initiative. 
6.1.4 Intervention Administration
ED: Participants will receive education modules weekly by email for 8 weeks. 
TeleBMM: The intervention will be administered through multiple modalities.
1.
Participants will receive weekly online modules.
2.
Participants will receive monthly 50-minute telephone sessions with a doctoral-level clinical health 
psychology graduate student.
3.
Participants will receive 3 15-minute telephone check-ins to enhance adherence to behavior change.
CBT-HD: Participants will receive a 60-minute initial intake and six 50-minute follow-up telephone visits every 2 
weeks. 
For all TeleBMM and CBT-HD, the graduate student therapists have completed initial training in therapy and 
clinical health psychology treatment techniques. Therapists are all actively engaged in a lab conducting 
research on behavioral treatment of headache disorders. Therapists will be supervised by Dr. Elizabeth Seng, 
Ph.D., a licensed clinical psychologist and expert in behavioral migraine treatments. Therapists will receive 
weekly individual supervision and monthly group supervision to enhance fidelity to the treatment protocol.
6.1.5 Reaction Management 
The expected risks of the TeleBMM and CBT-HD interventions are feeling emotionally overwhelmed during 
relaxation and biofeedback, or discomfort discussing challenging topics in treatment sessions. This risk is 
considered minimal. Participants may reach out to the research assistant at any time if they experience 
discomfort or distress related to the study. For the ED intervention, the expected risk is feeling uncomfortable 
when considering the extent of disability migraine has caused in one’s life. The PI will also monitor participant’s 
headache diary recordings to evaluate reactions to the study. Participants who report, or are suspected to 
have, clinically significant discomfort or distress during the study will immediately be reported to the PI, Dr. 
Elizabeth Seng, Ph.D., clinical psychologist. Dr. Seng will assess the reaction and determine whether further 
action is warranted, such as an intervention plan or referral for treatment. 
6.2 Assessments
6.2.1 Efficacy 
Surveys
All surveys to be used have been uploaded via the iRIS website.
Demographics 
NINDS CDEs will be used to evaluate: Age; Gender; Ethnicity; Race; Sexual Orientation; Education 
Level; Marital/Partner Status; Employment Status; Household and Income; Overall Health; Medical History; 
Height and Weight. 
Migraine Symptoms
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IRB APPROVAL DATE: 06/12/2023

American Migraine Study/American Migraine Prevalence and Prevention (AMS/AMPP) 
Diagnostic Module. The AMS/AMPP Diagnostic Module 7, 11 is a survey based on the ICHD-2 criteria for 
migraine; migraine criteria remain unchanged in the updated ICHD-3b 12. The sensitivity and specificity for 
migraine are 100% and 82% respectively 11.
Medications
Preventive. Preventive medication name, dose, frequency and timing of administration, route of 
administration, and start date will be evaluated using the NINDS CDE for medications taken on a regular basis.
Acute. Acute medication name, dose, frequency, route of administration, and start date will be 
evaluated using the NINDS CDE for medications taken on an as-needed basis.
Disability/Quality of Life
Migraine Specific Quality of Life Questionnaire (MSQ) v 2.1. The MSQ 10 is a commonly-used 14-
item survey measuring quality of life in people with migraine. Items comprise three subscales (Role Restriction, 
Role Prevention, and Emotion Function) which have demonstrated adequate reliability and validity in a number 
of studies with migraine 10, 13.
Relationship Factors
Working Alliance Inventory. The Working Alliance Inventory (WAI) is an commonly used, reliable and 
valid set of two surveys given to providers (11 items) and patient (12 items) following a treatment session to 
evaluate the extent to which the therapist and patient have rapport and agree on the goals and tasks of 
treatment.16
Patient Satisfaction
Program Evaluation. The Program Evaluation survey is an 8-item, study-specific survey that evaluates 
the extent to which participants deemed the app to be effective (with response options on a 5-point Likert scale 
ranging from “not at all effective” to “very effective”) and the extent to which participants are likely to 
recommend the app to a friend with migraine (with response options on a 5-point Likert scale ranging from “not 
at all likely” to “very likely”). Items were based on the program evaluation survey from the previous BMM trial2 
Daily Diary
The daily diary will include measures assessing a) Menstruation, b) Headache Symptoms using 
ICHD-3b migraine criteria 12, c) Medication Usage with items used in other headache medication adherence 
studies 14, and d) Migraine Disability using the Migraine Disability Index, an abbreviated daily version of the 
Migraine Disability Assessment15.
6.2.1 Safety 
Safety will be evaluated by:
1)  Tracking adverse events reported by participants, and collected proactively in monthly check-ins 
conducted by the research assistant, as described below; and,
2) The PI will monitor symptoms recorded in participant’s headache diaries for any unexpected changes in 
symptoms. 
6.2.1.2 Adverse Events Definition And Reporting 
An adverse event (AE) is any troublesome medical occurrence in a subject during participation in the clinical 
study. An AE can include a sign, symptom, abnormal assessment, or any combination of these. A serious 
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adverse event (SAE) is any AE that results in one or more of the following outcomes: death, a life-threatening 
event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant 
disability/incapacity, a congenital anomaly or birth defect, or an important medical event based upon 
appropriate medical judgment. We will use the HHS/NIH/NCI Common Terminology Criteria for Adverse 
Events (Version 4.0) grading scale; for reference, we have provided the criteria for headache AEs (Grades 1-
3): Grade 1: Mild (mild headache pain); Grade 2: Moderate (moderate headache pain that limits instrumental 
activities of daily living); Grade 3: Severe or medically significant but not immediately life threatening (severe 
headache pain that limits self-care activities of daily living); Grade 4: Life-threatening consequences; Grade 5: 
death related to AE. When present, each AE will be categorized according to the likelihood that they are 
related to the CDST on a 4-point scale, ranging from definitely unrelated, possibly related, probably related, to 
definitely related.  The expected risk of the TeleBMM intervention is feeling emotionally overwhelmed during 
relaxation or biofeedback, or experiencing discomfort during therapy sessions. This risk is considered minimal.  
The research assistant will assess adverse events in monthly check-ins with participants. The PI will also 
monitor each participant’s recorded headache diaries monthly to assess for adverse events. 
If either of these procedures identify a potential adverse event, the participant will be called immediately to 
assess the potential adverse event. Participants who disclose potential adverse events to any study staff at 
any point during the study will immediately be reported to the PI, Dr. Elizabeth Seng, Ph.D., clinical 
psychologist. If the adverse event requires medical or professional intervention, the PI will immediately contact 
the participant’s primary clinician at the MHC and develop an intervention plan and referral if necessary. If a 
participant experiences an adverse event, he or she will be given an opportunity to leave the study. Any SAEs 
that are possibly related to the study intervention will be reported to the IRB and NIH within 7 days. All AEs will 
be compiled and reported to the Einstein IRB and NIH in accordance with the Einstein IRB requirements. The 
PI will be responsible for assessing, rectifying and reporting AEs directly to the Einstein IRB and the NIH. 
6.3 Study Procedures
6.3.1 Study Schedule 
Screening and Enrollment: Potential participants will be identified by their providers. Up to 100 potential 
participants will be screened to identify 60 participants eligible and interested in the study. Potential 
participants will be contacted by phone or email (see “Recruitment Phone Script and Email” attached) by the 
research assistant to be screened for inclusion criteria. 
Study Procedures: Participants will then receive an email from the research coordinator (see “App download 
email” attached) with instructions to download the study app. Participants will complete the informed consent 
and, if consent is granted, complete the baseline MSQ survey. Over the three-month study period, participants 
will complete a daily headache diary. Participants will complete the MSQ and Program Evaluation survey at the 
end of the 3-month study period. 
6.3.2 Informed Consent 
During the screening call, the research assistant supervised by the PI will inform prospective participants that 
the study seeks to evaluate the feasibility and acceptability of a telehealth version of an evidence-based 
behavioral treatment for migraine. Prospective participants will be informed about the three treatment 
modalities; if they meet inclusion criteria and are interested, they will be asked to select one. Participants will 
be informed about compensation for participation. If interested and eligible, the potential participant will be 
provided with an opportunity to provide online written informed consent (“Informed Consent” attached).
6.3.3 Screening 
During the screening call, the research assistant will use the AMS/AMPP screener to assess for current ICHD-
3 migraine symptoms, self-reported headache days/month, age, capacity to consent, self-reported psychiatric 
illness, and medication use (“Screener” attached). The research assistant will also collect basic demographics 
and clinical characteristics. 
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6.3.4 Enrollment 
After potential subjects have completed the online informed consent document, the research assistant will 
assign them a random study identification number. 
6.3.5 On Study Visits 
All study visits occur over the phone. 
TeleBMM Arm
Week
Study Visit
Visit Length
Pre-study
Screening
~20 minutes
0
Session 1: Relaxation
50 minutes
2
Phone Check-in
~15 minutes
4
Session 2: Migraine Skill Building
50 minutes
6
Phone Check-in
~15 minutes
8
Session 3: Stress Management or Biofeedback
50 minutes
10
Phone Check-in
~15 minutes
12
Session 4: Relapse Prevention
50 minutes
CBT-HA Arm
Week
Study Visit
Visit Length
Pre-study
Screening
~20 minutes
0
Session 1: Intake
50 minutes
2
Session 2: Relaxation Training
50 minutes
4
Session 3: Contributing Factors & Managing the 
Headache Threshold
50 minutes
6
Session 4: Optimizing Acute Management
50 minutes
8
Session 5: Combating Unhelpful Thoughts
50 minutes
10
Session 6: Planning Ahead
50 minutes
ED Arm
Week
Study Visit
Visit Length
Pre-study
Screening
~20 minutes
6.3.6 End of Study and Follow-Up 
At the end of week 12, participants will complete the MSQ and Program Evaluation surveys, and their study 
participation will be concluded. 
6.3.7 Removal of Subjects
Participants will be removed if they choose to voluntarily withdraw. All participants will be provided with a 
synopsis of their diary data to be used in their routine clinical care following the study. All participants will be 
able to retain access to study therapeutic materials after their participation. 
6.4 Statistical Method
6.4.1 Statistical Design 
This is a three-arm pre-post study design. Primary outcomes (feasibility and acceptability) will be described. 
Secondary outcomes (headache days/month and MSQ) will be evaluated longitudinally using mixed effects 
models for repeated measures.
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6.4.2 Sample Size Considerations 
An n of at least 15 is considered an appropriate sample size for pilot study when expecting a medium effect 
size.17 With an n=20 in each group, and assumptions of drop out of 2 per group, we will have 80% power to 
detect an odds ratio of 1.28 in adherence to treatment (feasibility). 
6.4.3 Planned Analyses 
6.4.3.1 Primary Analyses 
Basic descriptive statistics (e.g., means, standard deviations, frequencies) for variables of interest will be 
computed. Graphical approaches will be used to further explore the data where appropriate. Feasibility and 
acceptability will be described across all three arms, and in each arm individually. 
 
6.4.3.2 Secondary Objectives Analyses
Within each arm, headache days/month and the MSQ will be evaluated using linear mixed effects for repeated 
measures analysis. The fixed effect will be time (Headache days = Months 1, 2, and 3; MSQ = pre vs post). 
Random effects will be intercept and time. The best-fitting covariance structure will be determined using 
Akaike’s Information Criterion. A significant time fixed effect indicates that the outcome changed over time. 
We will explore differences across arms, with headache days/month and the MSQ will be evaluated using 
linear mixed effects for repeated measures analysis. Fixed effects will be time (Headache days = Months 1, 2, 
and 3; MSQ = pre vs post), arm (TeleBMM, CBT-HA, and ED) and their interaction. Random effects will be 
intercept and time. The best-fitting covariance structure will be determined using Akaike’s Information Criterion. 
A significant time fixed effect indicates that the outcome changed over time.
6.4.3.3 Safety 
All AEs will be described by arm. 
6.4.3.4 Analysis of Subject Characteristics 
Basic descriptive statistics (e.g., means, standard deviations, frequencies) for variables of interest will be 
computed. Graphical approaches will be used to further explore the data where appropriate.
6.4.4 Subsets and Covariates 
Models will be fitted unadjusted and adjusted for potentially relevant baseline variables: age, gender, 
education, baseline headache frequency.
6.4.5 Handling of Missing Data 
For feasibility, dropouts will be included in the analysis. For acceptability, we will evaluate acceptability both on 
completers and assuming that individuals who dropped out were not satisfied (1 out of 5). Linear mixed effects 
model take into account missing data and yield robust estimates even in situations when observations are 
missing both at random, and not at random.
7. Trial Administration
7.1 Ethical Considerations  
Subjects will be made aware that nominal payment will be provided as compensation. Gift Cards will be sent 
after participation (50 cents for each diary day).
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The proposed research does not target vulnerable populations and will not involve any of the following 
vulnerable populations: fetuses, neonates, children, pregnant women, prisoners, institutionalized individuals. 
Participants will provide data through an intake screener and electronic surveys. Participant data will be 
collected via REDCap, a secure online data capture software, through the headache diary application. Data will 
be de-identified and converted to electronic databases and stored in password-protected files on a password-
protected computer in the locked lab. A list linking participant identification numbers will be kept in REDCap 
and will be destroyed immediately after all data has been entered (no more than 6 months after the end of data 
collection). 
There is always a slight possibility that an unknown condition will be discovered during initial or follow-up 
interviews, or direct communication with the subject. If either of these procedures identify a potential condition, 
the research assistant will immediately inform the PI who will contact the participant. If the condition requires 
medical or professional intervention, the PI will immediately contact the participant’s primary clinician. If the 
discovery of the condition meets adverse event criteria, the PI will immediately inform the IRB and the NIH.
7.2 IRB Review 
This study will undergo a complete IRB review by the Albert Einstein College of Medicine IRB.  It will be 
required to have yearly renewal reviews.
7.3 Subject Confidentiality 
Each participant will be given a random study identification number. Only the PI, Research Coordinator and 
research assistant will have access to identifiable private information. Participants data will be collected 
REDCap, a secure online data capture software, through the headache diary application. 
7.4 Unanticipated Problems 
If there is any medical or psychological problem discovered, the PI will call the participant immediately to 
assess the problem. If the problem requires medical or professional intervention, the PI will immediately 
contact the participant’s primary clinician and develop an intervention plan and referral if necessary. If a 
participant experiences an adverse event, he or she will be given an opportunity to leave the study.
All adverse events, whether anticipated or not, will be compiled and reported to the Einstein IRB and NIH in 
accordance with the Einstein IRB requirements.  Any serious adverse events, whether anticipated or not will be 
reported to the IRB and NIH within 7 days.
7.5 Data Quality Assurance 
7.5.1 Data Collection 
7.5.1.1 Access to Source 
Survey and daily diary data will be entered by the participant through the daily electronic headache diary, 
collected through the Status/Post app and captured by the REDCap system, a HIPAA-compliant secure online 
data capture software.
7.5.1.2 Data Storage/Security 
The REDCap data capture system allows for transformation of data to a form that can be used with data 
analysis programs. The subject key with identifiable information will be destroyed after data collection is 
complete, no later than 6 months after data collection has concluded. We will export the de-identified data into 
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a password-protected database which will be held on the lab computer. All analyses are planned to be 
conducted by lab members named as key personnel on this protocol.
7.6 Study Records 
REDCap Database
7.6.1 Retention of Records 
The Identifiable Participant List will be destroyed no more than 6 months after data collection is finished. The 
remaining records will be retained as per Einstein Guidelines. If permission is needed to move or destroy the 
records, the PI (Elizabeth Seng) should be contacted.  
7.7 Study Monitoring 
The research assistant will conduct monthly check-ins with participants. The PI will monitor the daily headache 
diaries. 
7.8 Data Safety Monitoring Plan 
The risk of TeleBMM is considered minimal. If any of the procedures described above identify a potential 
adverse event for an individual participant, the participant will be called immediately to assess the potential 
adverse event. Participants who disclose potential adverse events to any study staff at any point during the 
study will immediately be reported to the PI, Dr. Elizabeth Seng, Ph.D., clinical psychologist. If the adverse 
event requires medical or professional intervention, the PI or will immediately contact the participant’s primary 
clinician at the MHC and develop an intervention plan and referral if necessary. If a participant experiences an 
adverse event, he or she will be given an opportunity to leave the study. Any SAEs that are possibly related to 
the study intervention will be reported to the IRB and NIH within 7 days. All AEs will be compiled and reported 
to the Einstein IRB and NIH in accordance with the Einstein IRB requirements.
7.9 Study Modification.
Any modifications to the protocol will be submitted as amendments to the Einstein IRB for review.  The change 
will be implemented after approval.
7.10 Study Discontinuation 
The study would be discontinued if a participant reports an unexpected SAE deemed to be study related.
7.11 Study Completion 
We anticipate completing data collection in February 2024 and initial data analysis in July 2024. We will notify 
the IRB as soon as data collection is completed. 
7.12 Funding Source 
This study was funded by a CTSA Catalytic Seed Grant for junior investigators with a career development 
award. 
7.13 Publication plan 
The PI (Elizabeth Seng, Ph.D.) holds primary responsibility for publishing the study results. Primary objective 
results will also be submitted for publication in a peer-reviewed journal within one year of completion of data 
collection.  
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7.2 IRB Review
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References
1.
Leonardi M, Raggi A. Burden of migraine: international perspectives. Neurol Sci. 2013;34 Suppl 1:S117-
118.
2.
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IRB NUMBER: 2019-10345
IRB APPROVAL DATE: 06/12/2023