Developing an Optimized Conversational Agent or "Chatbot" to Facilitate Mental Health Services Use in Individuals With Eating Disorders
Phase: NA
Conditions: Eating Disorders
Sponsor: Washington University School of Medicine

Developing an Optimized Conversational Agent
or "Chatbot" to Facilitate Mental Health
Services Use in Individuals with
Eating Disorders
DR. ELLEN E. FITZSIMMONS-CRAFT, PHD
WASHINGTON UNIVERITY IN ST. LOUIS SCHOOL OF MEDICINE
NCT04806165
February 1, 2021

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APPENDIX
PART I.
PART II.
PROTOCOL
STATISTICAL ANALYSIS PLAN
(P. 2-19)
(P. 20-22)
PART III. INFORMED CONSENT FORM
(P. 23-34)
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PART I: PROTOCOL
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Developing an Optimized Conversational Agent or "Chatbot" to
Facilitate Mental Health Services Use in Individuals with Eating
Disorders
Study 2
Ellen Fitzsimmons-Craft, PhD – Principal Investigator
Washington University School of Medicine
VERSION 3
February 1, 2021
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TABLE OF CONTENTS
A. List of Abbreviations
5
B. Introduction                                                                                                                                                6
B1.      Study Abstract                                                                                                                                  6
B2.      Primary Hypothesis                                                                                                                         6
C. Background                                                                                                                                                 6
C1.      Rationale for this Study                                                                                                                  6
C2.      Prior Literature and Studies                                                                                                          7
D. Study Objectives                                                                                                                                        8
D1.     Study Aim                                                                                                                                         8
D2.     Rationale for the Selection of Outcome Measures                                                                  8
E. Study Design                                                                                                                                                8
E1.     Overview or Design Summary                                                                                                      8
E2.     Subject Selection and Withdrawal                                                                                            10
E2.A.     Inclusion Criteria                                                                                                                   10
E2.B.     Exclusion Criteria                                                                                                                   10
E2.C.     Ethical Considerations                                                                                                          10
E2.D.     Participant Recruitment Plans and Consent Process                                                     11
E2.E.     Randomization Method                                                                                                       11
E2.G.     Early Withdrawal of Subjects                                                                                             12
E2.H.     When and How to Withdraw Participants                                                                       12
E2.I.     Data Collection and Follow-up for Withdrawn Subjects                                                12
F. Study Procedures                                                                                                                                     13
F1.     Screening for Eligibility                                                                                                                 13
F2.     Schedule of Measurements                                                                                                         13
F3.     Data Collection and Reporting Procedures for Adverse Events                                       15
F4.     Study Outcome Measurements and Ascertainment                                                              15
G. Data Handling and Record Keeping                                                                                                     15
G1.     Confidentiality and Security                                                                                                       15
H. Study Administration                                                                                                                             16
H.1.       Funding Source and Conflicts of Interest                                                                               16
H.2.       Participant Payment                                                                                                                  16
H.3.      Study Timeline                                                                                                                             16
I. References
16
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A. List of Abbreviations
DSM-5
The Diagnostic and Statistical Manual of Mental Disorders
ED(s)
Eating Disorder(s)
EDE-Q
Eating Disorder Examination Questionnaire
MI
Motivational Interviewing
MOST
Multiphase Optimization Strategy
NEDA
National Eating Disorders Association
NIH
National Institutes of Health
NIMH
National Institute of Mental Health
PI
Principal Investigator
SUS
System Usability Scale
SWED
Stanford-Washington University Eating Disorder Screen
USE
Usefulness, Satisfaction, and Ease of Use Questionnaire
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B. Introduction
B1.
Study Abstract
Eating disorders (EDs) are serious mental illnesses associated with high morbidity and mortality,
clinical impairment, and comorbid psychopathology. Although evidence-based treatments for
EDs have been established, the treatment gap is wide. Indeed, <20% of individuals with EDs
receive treatment. We need a novel solution not only to identify individuals with ED but also to
encourage mental health services use and to address treatment barriers. We propose a research
agenda to design a conversational agent or “chatbot” that is optimized to increase mental
health services use among individuals with EDs through such features as: 1) providing a
personalized recommendation for seeking intervention; 2) engaging the user in motivational
interviewing to overcome barriers to care; 3) repeated check-ins with the user to encourage
follow-up with care; and 4) education on the seriousness and consequences of EDs. Study 2 will
utilize a randomized optimization trial with adults who have completed screening on the
National Eating Disorders Association (NEDA) website and screen positive for an ED but are not
in treatment to determine chatbot feasibility and to generate data on the effect of the chatbot
on motivation for treatment and mental health services use at follow ups. This trial will employ
the Multiphase Optimization Strategy framework, using a 24 full factorial design, to randomly
assign participants to a combination of the three proposed intervention components (n=16
conditions) to isolate the active ingredients. Results from the proposed study will be used to
optimize the chatbot, which will then be tested in a subsequent R01 randomized controlled trial.
B2.
Primary Hypothesis
We will determine the feasibility of delivering the chatbot and generate data on the effect of the
chatbot components on motivation for treatment and mental health services use.
C. Background
C1.
Rationale for this Study
Clinical or subclinical EDs impact 10% of individuals in their lifetime, which translates to at least
30 million people in the U.S.1 Although evidence-based treatments for EDs have been
established,2 <20% of individuals with EDs receive treatment,3;4 which is problematic given that
lack of or delays in treatment result in poorer prognosis and greater relapse.5 While few
individuals with an ED receive treatment specifically for their disorder, these individuals exhibit
elevated health services use and costs compared to those without an ED.6 The problem of access
to care for EDs is even worse amongst racial/ethnic minority individuals.7-9 Receiving services for
a psychiatric disorder involves multiple steps, with identifying or learning one’s symptoms are
something in need of help being a crucial first step.4 Yet even once symptoms are identified,
individuals with EDs may experience numerous barriers to care, including stigma, denial of
illness severity, lack of knowledge about resources, and practical barriers such as cost.10 We
need a novel solution to not only identify individuals with EDs but to also encourage mental
health services use and address treatment barriers.
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C2.
Prior Literature and Studies
A conversational agent or “chatbot” has great potential for increasing mental health services use
among those with EDs. People respond psychologically to chatbots as if they are people, even
when they are aware they are conversing with a robot.11;12 In one study, when people talked to
an automated chatbot, they were less fearful of self-disclosure and displayed more intense
sadness compared to those who thought the chatbot was human-controlled.13 There is
optimism regarding a role for chatbots in mental health;11;14 the scalability, cost-effectiveness,
and anonymity they provide make them ideal for delivering mental health interventions.
Pilot work has demonstrated chatbots may be capable of instigating change in symptoms and
behaviors related to health and mental health. College students with depression and anxiety
who were assigned to a chatbot that delivered cognitive-behavioral therapy (CBT) self-help
content reduced their depression over the course of 3 weeks, more so than the control.15
Chatbots have also demonstrated success with promoting medication adherence for individuals
with schizophrenia over 1 month.16 Another study demonstrated sustained activity levels in
overweight individuals when provided with a chatbot that set goals and gave personalized
feedback, compared with a decline in activity in the control.17 Overall, a 2017 scoping review
identified 49 studies on conversational agents; none addressed EDs.18 The review concluded
that most studies show good usability and acceptability but that more research on clinical
effectiveness is needed.18
In order to be successful, our novel chatbot would require the following features. First, we
would need the capability to provide easily accessible ED screening that would allow for the
identification of large numbers of individuals with EDs. Currently, many ED cases go undetected.
A majority of individuals who ultimately receive treatment for an ED are first seen by their
primary care physician, but 92% of these providers believe they have missed ED diagnoses.19
This highlights the need for widely available online ED screening. Second, we would need the
capability to provide personalized recommendations for seeking intervention while taking into
account participant characteristics and addressing treatment barriers. Research has
demonstrated that among college students at elevated risk for suicide, completion of an online
mental health screen, accompanied by personalized feedback and the option to engage in brief
online motivational interviewing (MI)-based counseling to address treatment barriers
(“eBridge”), resulted in greater treatment readiness and linkage with treatment versus screen
feedback only.20 Relatedly, recent work with a number of patient populations (e.g., autism,
severe mental illness) has demonstrated success with “navigator models” whereby a health care
professional or paraprofessional assists patients in navigating health care systems and in
overcoming gaps in service delivery.21-24 A current NIMH initiative encourages research in this
area (PAR-18-428) as a potential solution to the wide treatment gap for psychiatric disorders.25
Third, the solution needs to be scalable to large user populations, for which mobile approaches
hold great promise.26 Although in-person navigator models have demonstrated some success in
increasing services use, 21-24 high labor costs limit scalability.
There are very promising preliminary data on mental health chatbots built by X2AI, our chatbot
design collaborator for this study. In one study, those with access to “Tess,” X2AI’s chatbot
designed to target depression and anxiety using CBT, experienced reductions in depression and
anxiety over 2-4 weeks with a d=.68 reported for depression.27 One large health system in the
U.S. customized X2AI’s chatbot to deliver interventions based on MI and behavioral activation to
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reinforce weight management goals in adolescents with pre-diabetes, with users rating the
chatbot useful 96% of the time.28 Third, our group has begun work with X2AI to develop a
chatbot called “Tessa” to serve as an automated moderator for our well-established indicated
ED prevention program, StudentBodies.29-31 While still in development, preliminary user
feedback has been very positive.
Research has shown support for the components proposed for inclusion in the chatbot: 1) meta-
analytic findings have indicated that tailored messages have a greater impact on health behavior
than control (r=.074)32 and that text message based health promotion messages have an effect
of d=.33, with greater efficacy for those using personalization (p=.001);33 2) a review of meta-
analytic findings found that MI is significantly more effective than no treatment (ds up to .57)
for a wide variety of problems and increasing treatment engagement;34;35 3) meta-analytic
findings have indicated that reminder systems improve medication adherence in chronic disease
(d=.41)36 and other issues;37 and 4) a meta-analytic study found psychoeducation to reduce
symptoms of depression and psychological distress (d=.2)38.
D. Study Objectives
D1.
Study Aim
Aim 1) To determine chatbot feasibility and to generate preliminary data on the effects of the
chatbot components on motivation for treatment and services use, employing the MOST
framework. Aim 2) To test whether the chatbot components interact to predict outcomes.
Data will inform the development of an optimized chatbot, which I will test in an ensuing R01
randomized controlled trial.
D2.
Rationale for the Selection of Outcome Measures
The goal is to determine the feasibility of delivering the chatbot and to generate data on the
effect of the chatbot components on motivation for treatment and mental health services use.
Motivation for treatment and mental health services use are the two main outcomes that will
provide data for which chatbot components are most efficacious in promoting help seeking
behaviors. We will also explore if the chatbot components interact to predict outcomes, which
will also inform an optimized chatbot to be tested in a subsequent R01 trial.
E. Study Design
E1.
Overview or Design Summary
We have used a user-centered design approach to create a single chatbot prototype, which
includes four key features: 1) providing a personalized recommendation for seeking
intervention; 2) engaging the user in motivational interviewing to overcome barriers to care; 3)
education on the seriousness and health consequences of eating disorders; and 4) repeated
check-ins with the user to encourage follow-up with care.
Study 2 will use a 24 full factorial trial design to test the four binary chatbot components. Thus,
there are 16 experimental conditions, and participants will be randomized to 1 of those 16
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conditions. Participants can be assigned to intervention (“yes”) or control (“no”) conditions for
each chatbot component.
Participants will be recruited from those who complete the NEDA online screen and who meet
eligibility criteria of screening positive for a clinical/subclinical ED, at least 18 years old, and not
currently in treatment for an ED. For a period of time on the NEDA site, eligible users will be
offered the chatbot. Interested individuals will be taken to a Qualtrics screen wherein those who
endorse owning a smartphone and being a U.S. resident will be given access to participate in our
study. Data from the NEDA eligibility screen will be collected. The consent form will be shown
via Qualtrics and will encourage interested individuals to call a member of our research team to
discuss the study. Once a participant completes the baseline measures, they will be randomized
using Qualtrics. Once the baseline measures are completed, participants will be given
information on how to access the chatbot and their unique chatbot start code.
Participants will engage with the chatbot for between 5-20 minutes, dependent on condition.
Participants who are randomized to the repeated administration module will complete
approximately 3 new conversations over the course of 2 weeks. The chatbot will automatically
reach out to a participant if they do not complete a conversation within 1 day.
Assessments will occur online and may include data from the initial ED screen completed on the
NEDA website. Assessments will take place at baseline (i.e., prior to chatbot use), and at
approximately 2, 6, and 14 weeks after baseline completion via Qualtrics (see F.2 Schedule of
Measurements).
We will document recruitment rates (i.e., percent of those offered participation in the study
who sign up), as well as study retention rates, to assess appropriateness of follow-up
procedures. Demand for the chatbot will be measured as: 1) number of texts to the chatbot; and
2) engagement at repeated administrations (if randomly assigned to this condition).
To validate receipt of treatment, a study team member will contact a random subset of
participants (i.e., approximately 10%) who reported engaging in some kind of treatment to
solicit additional details on their service use and experience through phone/Zoom call or online
questionnaire, which will provide additional validation, and when possible, participants will also
be asked to provide some kind of documentation for the services they reported using (e.g., send
receipt of therapy session or provide email indicating they signed up for a recommended online
program).
Participants will receive invitation and reminders via email, phone, and/or text message for each
assessment, and if they have not completed the conversation with the chatbot. Participants may
receive thank you messages for completing assessments.
PHI discussions via email will use WashU guidelines: 1) a test email will be sent to the participant
to verify their identify (confirm correct recipient) and that this email will be sent in a secure
manner (i.e., [secure] in subject line); 2) The body of the email will instruct the participant to
send all information as a response to this thread and to not remove the "[secure]" from the
subject line; 3) document in our research records the participant's agreement to provide
information over email.
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E2.
Subject Selection and Withdrawal
E2.A.
Inclusion Criteria
U.S. resident; English-speaking; age 18 years or older; own a smartphone; screen positive for a
DSM-5 clinical or subclinical eating disorder; not receiving treatment for an eating disorder
E2.B.
Exclusion Criteria
We will exclude participants who are currently receiving treatment for an eating disorder given
the goal to increase access to services for those not receiving help. In addition, we do not plan
on enrolling individuals who screen for Avoidant Restrictive Food Intake Disorder.
E2.C.
Ethical Considerations
All key personnel involved in the design or conduct of research involving human subjects will
receive the required education on the protection of human research participants prior to the
start of the study. Participants will be informed that they do not have to answer any questions
that make them uncomfortable. There are minimal risks for participating in testing.
Participants will be provided with the contact information of the research staff. As a clinical
psychologist, the PI is trained in how to address safety issues. If any participant appears to be in
crisis, they will be given information to call emergency services and will be notified that the
chatbot is not designed to provide crisis support. Any adverse event will be reported promptly
to the mentorship team, the NIH, and the IRB.
Confidentiality: Participant confidentiality will be maintained in compliance with HIPAA privacy
protected servers. Study IDs will be linked with participant names, email addresses, and phone
numbers in a separate password-protected file stored on a secure, password-protected server
that only key study personnel have access to. All employees of the study with access to
protected health information (PHI) are required to complete HIPAA training and comply with the
privacy procedures in place at Washington University.
X2AI (x2ai.com), our chatbot collaborator, is a HIPAA-compliant mental health chatbot company
with a dedicated and talented team of software engineers who are experienced in building
chatbots that support mental health. X2AI will host the proposed chatbot and all data collected
within the chatbot. X2AI will comply with the rules regarding handling of PHI under HIPAA.
Adverse Events: For the purpose of this study, adverse events will be defined as unanticipated
problems involving risks to the study participants. A serious adverse event will be defined as any
untoward occurrence that results in death, is life-threatening, or creates persistent and
significant disability. The PI will consult with mentors to identify serious adverse events. Any
potentially adverse events will be evaluated by the PI within 72 hours. All serious adverse events
will be immediately reported to the IRB. All adverse events and study withdrawals, together
with a detailed explanation of the event and withdrawal, will be provided to the mentorship
team.
It is important to note that in previous similar clinical trials of digital health interventions, the
procedures outlined above have been used to protect against and minimize potential risks to
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participants, and they have proved effective in preventing emotional and physical complaints as
well as adverse events.
E2.D.
Participant Recruitment Plans and Consent Process
We plan to enroll approximately 200 English-speaking adults ≥18 years with a DSM-5 clinical or
subclinical eating disorder who own a smartphone and are not in treatment for an eating
disorder.
Participants will be recruited from the NEDA online screen. Once an individual screens positive
for a clinical/subclinical ED, is not currently in treatment, and is ≥18 years old, they will be given
a link to the Qualtrics eligibility screen. If an individual endorses owning a smartphone and being
a U.S. resident, they will be shown the consent form in Qualtrics and will be asked to either
agree to or decline participation in the study. Individuals will be encouraged to call a member of
our research team to discuss the study.
E2.E.
Randomization Method
Study 2 will use a 24 full factorial trial design to test the four binary chatbot components:
psychoeducation, motivational interviewing, personalized recommendations, and repeated
administration. Thus, there are 16 experimental conditions, and participants will be randomized
to 1 of those 16 conditions. Participants can be assigned to intervention (“yes”) or control (“no”)
conditions for each chatbot component.
Risks
There are minimal risks for participants.
Physical Risks: N/A
Psychological Risks: Our proposed chatbot designed to facilitate mental health problems may
promote increased focus on mental health symptoms in some individuals. It is also possible that
participants may feel uncomfortable disclosing information about certain behaviors such as
disordered eating. However, we have asked questions of a similar nature in several studies in
the past and have not had participants report discomfort.
Social Risks: There may be some embarrassment related to completing questions related to
disordered eating symptoms.
Financial Risks: N/A
Legal Risks: N/A
Risks to Privacy: We will go to great lengths to keep participant information private and
confidential. Participant confidentiality will be maintained in compliance with HIPAA regulations.
Other Risks: N/A
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Alternative Treatments: N/A -- Participants in the current study will be participating in usability
testing to inform the development of a chatbot for facilitating mental health services use in
individuals with eating disorders not currently in treatment. The proposed chatbot is designed
to increase the likelihood that individuals will seek mental health care. There are no other
widely available digital tools designed for this purpose. All participants who participate in the
usability testing will be offered referral information for in-person/ telehealth treatment.
Benefits
The benefits to participants in this study and to society are expected to be great. In terms of
possible benefits to participants, they include potential improved uptake of services. In addition,
if successful, this study could demonstrate the potential of utilizing a chatbot to bridge the
treatment gap for individuals with eating disorders by connecting them to treatment. Therefore,
the potential risks that are associated with this study are reasonable when considering the many
benefits that participants and society may gain.
Importance of the Knowledge to be Gained: Eating disorders are serious mental illnesses
associated with high morbidity and mortality, clinical impairment, and comorbid
psychopathology. Although evidence-based treatments for eating disorders have been
established, the treatment gap is wide. Indeed, <20% of individuals with eating disorders receive
treatment, which is problematic given that lack of or delays in treatment result in prolonged
illness, poorer prognosis, and greater likelihood of relapse. Thus, developing a scalable, digital
intervention to address this wide treatment gap is crucial. Furthermore, applying user-centered
design and usability testing will result in a chatbot that aligns with users’ needs, which may
increase engagement and improve outcomes. Once established, the proposed chatbot has the
potential to be a scalable tool that can facilitate mental health services use for individuals with
eating disorders and also has great potential to be applied for use with other psychiatric
disorders as well.
E2.G.
Early Withdrawal of Subjects
Informed consent will make clear that participants may withdraw at any time with no penalty.
E2.H.
When and How to Withdraw Participants
Taking part in this research study is voluntary. Participants may choose not to take part in this
research study or may withdraw their consent at any time. They may withdraw by telling the
research team they are no longer interested in participating in the study or they may send in a
withdrawal letter. There will be no penalty or loss of benefits to which they were otherwise
entitled.
E2.I.
Data Collection and Follow-up for Withdrawn Subjects
When a participant withdraws from the study, the research team will stop collecting data from
them.
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F. Study Procedures
F1.
Screening for Eligibility
Eligibility will be assessed using the NEDA eating disorder screen and eligibility questions in
Qualtrics.
F2.
Schedule of Measurements
Measure
 NEDA
Screen
Baseline
Assessment
Chatbot
Use
2 Week
6 Week
14 Week
Explanation/ Primary
Purpose
To determine if the
individual has a
SWED
X
clinical/subclinical ED
and to determine if
they are in treatment.
Demographic
Questions
X
X
Recruitment
Rates
X
X
To determine if
individuals are 18 years
or older. To obtain
demographic
information for
analyses.
To obtain the
percentage of those
offered participation
who enroll.
Retention
Rates
To obtain the
percentage of follow-
X
X
X
up completion.
Demand for
Chatbot
X
Number of texts sent to
the chatbot and
engagement with
repeated
administration, if
applicable.
SUS and USE
X
X
To examine usability of
the chatbot.
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Target
measure:
motivation for
treatment and
X
mental health
services use
questions
Target
measure: SE-
X
KNOW
Target
measure:
X
personal
relevance
question
Target
measure:
X
Dissonance
Thermometer
Target
measure:
X
opportunity
question
Target
measure: EDs
X
Literacy Scale
To determine
motivation for
treatment and mental
X
X
X
health services use.
To determine self-
X
X
X
efficacy in help seeking.
To determine efficacy
X
X
X
of personalized
recommendation
component.
To determine efficacy
X
X
X
of motivational
interviewing
component.
To determine efficacy
X
X
X
of repeated
administration
component.
To determine efficacy
X
X
X
of psychoeducation
component.
EDE-Q
X
EDs Quality of
X
Life Scale
Patient Health
X
Questionnaire
9
Generalized
X
Anxiety
Disorder 7
Treatment
X
and Barriers to
Care
Questions
X
X
X
X
X (if no
to
receiving
treatme
nt)
X
X
X
X
X (if no
to
receivin
g
treatme
To examine ED
symptoms.
To examine quality of
life.
To examine depression.
To examine anxiety.
To determine any
barriers to treatment
utilization.
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nt)
F3.
Data Collection and Reporting Procedures for Adverse Events
For the purpose of this study, adverse events will be defined as unanticipated problems
involving risks to the study participants. A serious adverse event will be defined as any untoward
occurrence that results in death, is life-threatening, or creates persistent and significant
disability. The PI will consult with mentors to identify serious adverse events. Any potentially
adverse events will be evaluated by the PI within 72 hours. All serious adverse events will be
immediately reported to the IRB. All adverse events and study withdrawals, together with a
detailed explanation of the event and withdrawal, will be provided to the mentorship team.
F4.
Study Outcome Measurements and Ascertainment
The goal is to determine the feasibility of delivering the chatbot and to generate data on the
effect of the chatbot components on motivation for treatment and mental health services use.
We will also explore if the chatbot components interact to predict outcomes. Data will inform
developing an optimized chatbot, which we will test in a subsequent R01 trial.
The goal of this optimization trial is to inform an R01 randomized controlled trial of an optimized
chatbot vs. a control condition. We will achieve that goal by evaluating feasibility and generating
effect sizes of each component on outcomes, which will inform which components to retain in
the optimized chatbot and be used to power a subsequent R01 trial.
G. Data Handling and Record Keeping
G1.
Confidentiality and Security
Participant confidentiality will be maintained in compliance with HIPAA privacy protected
servers. Study IDs will be linked with participant names and email addresses in a separate
password-protected file stored on a secure, password-protected server that only key study
personnel have access to. All employees of the study with access to protected health
information (PHI) are required to complete HIPAA training and comply with the privacy
procedures in place at Washington University.
X2AI (x2ai.com) is a HIPAA-compliant mental health chatbot company with a dedicated and
talented team of software engineers who are experienced with building chatbots focused on
supporting mental health. X2AI will host the proposed chatbot and all data collected within the
chatbot. X2AI and Washington University are in a Business Associate agreement. X2AI will
comply with the rules on handling of PHI under HIPAA.
Training: All staff personnel are trained and comply with HIPAA regulations. All study team
members will complete the CITI training and Good Clinical Practice training.
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Performance Monitoring: The Data and Safety Monitoring Plan for this trial includes close
monitoring by the PI and her mentoring team. Any adverse event will be reported promptly to
the NIH and to the IRB.
H. Study Administration
H.1.
Funding Source and Conflicts of Interest
This study is funded by NIH. Any potential financial conflicts of interest for individual research
team members are reported according to the IRB requirements and procedures.
H.2.
Participant Payment
Participants will receive a $5 electronic gift card for completion of the baseline assessment, a
$10 electronic gift card for completion of the 2 week assessment, a $10 electronic gift card for
completion of the 6 week assessment, and a $20 electronic gift card for completion of the 14
week assessment.
H.3.
Study Timeline
As detailed in the table below, recruitment and enrollment for the randomized pilot trial (Study
2) will begin in the middle of Year 2. It is anticipated that enrollment will continue for one year,
into the middle of Year 3. All enrolled participants will receive access to chatbot designed to
facilitate health care utilization. Engagement with the chatbot will occur for up to approximately
2 weeks. Participants will complete a baseline assessment, and follow up assessments about 2
weeks, 6 weeks, and 14 weeks after baseline completion.
I. References
1.
 Hudson JI, Hiripi E, Pope HG, Kessler RC. The prevalence and correlates of eating
disorders in the National Comorbidity Survey Replication. Biological Psychiatry.
2007;61(3):348-58. PMCID: PMC1892232.
2.
 Hay P. A systematic review of evidence for psychological treatments in eating disorders:
2005-2012. Int J Eat Disord. 2013;46(5):462-9. PMID: 23658093.
3. Eisenberg D, Nicklett EJ, Roeder K, Kirz NE. Eating disorder symptoms among college
students: Prevalence, persistence, correlates, and treatment-seeking. J Am Coll Health.
2011;59(8):700-7. PMCID: PMC3721327.
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4.
 Kazdin AE, Fitzsimmons-Craft EE, Wilfley DE. Addressing critical gaps in the treatment of
eating disorders. Int J Eat Disord. 2017;50(3):170-189. PMCID: PMC6169314.
5. American Psychiatric Association. Treatment of patients with eating disorders, third
edition. American Psychiatric Association. Am J Psychiatry. 2006;163(7 Suppl):4. PMID:
16925191.
6. Striegel Weissman R, Rosselli F. Reducing the burden of suffering from eating disorders:
Unmet treatment needs, cost of illness, and the quest for cost-effectiveness. Behav Res
Ther. 2017;88:49-64. PMID: 28110676.
7. Becker AE, Franko DL, Speck A, Herzog DB. Ethnicity and differential access to care for
eating disorder symptoms. Int J Eat Disord. 2003;33(2):205-12. PMID: 12616587.
8. Cachelin FM, Striegel-Moore RH. Help seeking and barriers to treatment in a community
sample of Mexican American and European American women with eating disorders. Int J
Eat Disord. 2006;39(2):154-61. PMID: 16252278.
9. Marques L, Alegria M, Becker AE, Chen Cn, Fang A, Chosak A, et al. Comparative
prevalence, correlates of impairment, and service utilization for eating disorders across
US ethnic groups: Implications for reducing ethnic disparities in health care access for
eating disorders. Int J Eat Disord. 2011;44(5):412-20.
10. Ali K, Farrer L, Fassnacht DB, Gulliver A, Bauer S, Griffiths KM. Perceived barriers and
facilitators towards help-seeking for eating disorders: A systematic review. Int J Eat
Disord. 2017;50(1):9-21. PMID: 27526643.
11. Miner AS, Milstein A, Hancock JT. Talking to Machines About Personal Mental Health
Problems. JAMA. 2017;318(13):1217-8. PMID: 28973225.
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new media like real people and places. Cambridge University Press; 1996.
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willingness to disclose. Comput in Human Behav. 2014;37:94-100.
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cutting-edge science to improve the world's mental health. Oxford University Press;
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with symptoms of depression and anxiety using a fully automated conversational agent
(Woebot): A randomized controlled trial. JMIR Ment Health. 2017;4(2):e19. PMCID:
PMC5478797
16. Bickmore TW, Puskar K, Schlenk EA, Pfeifer LM, Sereika SM. Maintaining reality:
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coach to promote physical activity adherence in overweight adults: Randomized
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18. Provoost S, Lau HM, Ruwaard J, Riper H. Embodied conversational agents in clinical
psychology: A scoping review. J Med Internet Res. 2017;19(5). PMCID: PMC5442350.
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19. Linville D, Benton A, O'Neil M, Sturm K. Medical providers' screening, training and
intervention practices for eating disorders. Eat Disord. 2010;18(2):110-31. PMID:
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screening and intervention with college students: a pilot randomized controlled trial. J
Consult Clin Psychol. 2015;83(3):630-6. PMCID: PMC4446155.
21. Gryczynski J, Nordeck CD, Mitchell SG, Page KR, Johnsen LL, O’grady KE, et al. Pilot
studies examining feasibility of substance use disorder screening and treatment linkage
at urban sexually transmitted disease clinics. J Addict Med. 2017;11(5):350-6. PMCID:
PMC5610078.
22. Kelly E, Fulginiti A, Pahwa R, Tallen L, Duan L, Brekke JS. A pilot test of a peer navigator
intervention for improving the health of individuals with serious mental illness.
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23. Robinson-White S, Conroy B, Slavish KH, Rosenzweig M. Patient navigation in breast
cancer: A systematic review. Cancer Nurs. 2010;33(2):127-40. PMID: 20142736.
24. Roth BM, Kralovic S, Roizen NJ, Spannagel SC, Minich N, Knapp J. Impact of autism
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30. Taylor CB, Kass AE, Trockel M, Cunning D, Weisman H, Bailey J, et al. Reducing eating
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31. Beintner I, Jacobi C, Taylor CB. Effects of an Internet-based prevention programme for
eating disorders in the USA and Germany--A meta-analytic review. Eur Eat Disord Rev.
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interventions for health promotion: A meta-analysis. Soc Sci Med. 2013;97:41-8. PMID:
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practice-friendly review of four meta-analyses. J Clin Psychol. 2009;65(11):1232-45.
PMID: 19739205.
35. Burke BL, Arkowitz H, Menchola M. The efficacy of motivational interviewing: A meta-
analysis of controlled clinical trials. J Consult Clin Psychol. 2003;71(5):843-61. PMID:
14516234.
36. Thakkar J, Kurup R, Laba T, et al. Mobile telephone text messaging for medication
adherence in chronic disease: A meta-analysis. JAMA Intern Med. 2016;176(3):340-9.
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Healthcare information technology interventions to improve cardiovascular and
diabetes medication adherence. Am J of Manag Care. 2010;16(12):SP82-SP92. PMID:
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39. Nielsen J. The usability engineering life cycle. Computer. 1992;25(3):12-22.
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PART II: STATISTICAL ANALYSIS PLAN
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Statistical Analysis Plan
Data will be analyzed using R version 4.2.1.
Primary Outcome: Chabot Component Effects on Self-Reported Receipt of Treatment and/or
Services Utilization
Analyses will be executed using discrete time survival analysis and will reflect the proportional
increase in odds of treatment and/or services utilization corresponding to receiving each
chatbot component (motivational interviewing, psychoeducation, personalized
recommendations, repeated administration). This approach estimates the effect of independent
variables (i.e., chatbot components) on the occurrence of an event (i.e., treatment utilization).
Models will be fit with treatment use regressed on follow-up time (2-week, 6-week, or 14-week)
and each chatbot component. Models will not incorporate an intercept; this allows for
estimation of treatment utilization odds among participants who have yet to report seeking
treatment. The model will be estimated using a logit link, and for all coefficients, odds ratios and
95% confidence intervals will be computed. Parameters of primary interest include the time
effects, which reflect odds of treatment seeking at each time point, as well as the main effects
of each chatbot component. Censoring and missing data were accommodated using maximum
likelihood estimation.
Primary Outcome: Time Effect on Help-Seeking Attitudes (Motivation and Willingness to Change
and Seek Help)
Data on help-seeking attitudes will be collected via items in each of the baseline, 2, 6, and 14-
week follow-up assessments) on change in motivation (comprised of importance and readiness
items) and change in willingness to seek psychotherapy for eating, shape, or weight concerns.
These variables reflect putative psychological antecedents of treatment seeking and are not
relevant for participants who have already sought treatment; therefore, data will be analyzed
only among the subset of participants who do not report seeking treatment at any of the 2, 6
and 14-week follow-up assessments. Analyses will be conducted using multilevel models, which
will estimate the effect of each chatbot component and all interactions among chatbot
components on changes from baseline on each outcome at each timepoint.. Models will be fit
with a given outcome regressed on follow-up time (baseline to 2-week, baseline to 6-week, or
baseline to 14-week) and each chatbot component. The effects of primary interest are the
interactions between the chatbot components and time, which indicate whether a component is
associated with change from baseline in the outcome variable. Models will include fixed and
random intercepts to accommodate nesting of repeated measurements within participants, and
missing data will be accommodated using maximum likelihood estimation.
As a standardized effect size metric for these models, Cohen’s d will be calculated as
2(ᵄᵄ√)1−(ᵄᵄ√)2‾‾‾‾‾‾‾‾‾‾‾√2(
)1−(
)2
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, where Z = b / SE. Cohen’s d values of 0.2, 0.5, and 0.8 represent benchmarks for small,
medium, and large effects, respectively. We will define sufficiently large main effects as those
with p values ≤ .05 or with 95% confidence intervals that do not include 0.
Of note, all models will include estimates of interaction effects in addition to main effects of
each chatbot component. To guide the interpretation of interaction effects, we will follow the
guidelines of Collins et al. (2014). These guidelines suggest that significant interaction effects in
factorial experiments have a bearing on decision-making regarding the best overall treatment
package if at least one of the components involved in the interaction has a sufficiently large
main effect. We define sufficiently large main effects as those with p values ≤ .05 or with 95%
confidence intervals that do not include 0. Thus, interaction effects will be probed and
interpreted if at least one component involved in the interaction has a significant effect alone.
References
1. Collins, L. M., Trail, J. B., Kugler, K. C., Baker, T. B., Piper, M. E., & Mermelstein,
R. J. (2014). Evaluating individual intervention components: Making decisions
based on the results of a factorial screening experiment. Translational Behavioral
Medicine, 4, 238–251.
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PART III: INFORMED CONSENT FORM
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INFORMED CONSENT FORM
Project Title:
Developing an Optimized Conversational Agent or "Chatbot" to Facilitate Mental
Health Services Use in Individuals with Disordered Eating
Principal Investigator:
Dr. Ellen Fitzsimmons-Craft
Research Team Contact:
Bianca DePietro (Phone Number: 1-(314)-399-9218)
This consent form describes the research study and helps you decide if you want to participate.
It provides important information about what you will be asked to do during the study, about
the risks and benefits of the study, and about your rights and responsibilities as a research
participant.
You should read and understand the information in this document including the procedures,
risks and potential benefits.
If you have questions about anything in this form, you should ask the research team for more
information before you agree to participate.
• You may also wish to talk to your family or friends about your participation in this study.
• Do not agree to participate in this study unless the research team has answered your
questions and you decide that you want to be part of this study.
This is a research study conducted by Dr. Ellen Fitzsimmons-Craft which aims to test if a
“chatbot” (a computer program that simulates conversation) can increase mental health service
use among individuals with eating disorders. You should carefully consider the information in
this consent document and discuss it with the research team. You should understand why you
might want to participate, or why you might not want to participate. You may choose to
participate or not.
If you agree, you will be volunteering to participate in the research study. As a voluntary
participant, you will complete an online baseline assessment and will be asked to use our
chatbot for up to approximately two weeks. You will complete online assessments 2 weeks, 6
weeks, and 14 weeks after you complete the baseline assessment. These assessments will ask
questions related to your experience using the chatbot and your eating behaviors. You will
complete all research activities on your own time and anywhere you have access to your
smartphone. The main risk to you if you participate is emotional discomfort in using and
providing feedback on a chatbot that talks about eating disorders.
You may benefit from volunteering because the chatbot may increase your motivation to seek
care and/or provide you with resources for help for your eating, shape, or weight concerns.
There is no cost to you and you will receive a $5 electronic gift card for completion of the
baseline assessment, a $10 electronic gift card for completion of 2 week assessment, a $10
electronic gift card for completion of the 6 week assessment, and $20 electronic gift card for
completion of the 14 week assessment. In addition, if you complete all four assessments, you
will be entered into a sweepstakes to win one of three $100 electronic gift cards. All of this
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information is listed in more detail in this consent document. The research team must give you a
copy of this consent document.
WHAT IS THE PURPOSE OF THIS STUDY?
This is a research study. We invite you to participate in this research study because you
screened positive for disordered eating symptoms, are currently not receiving treatment for
your eating, shape, or weight concerns , are at least 18 years old, a U.S. resident, and own a
smartphone.
The purpose of this research study is to test a chatbot with the goal of ultimately increasing
mental health services use in individuals who have disordered eating symptoms. Individuals with
eating disorders often do not receive any treatment and this study aims to find new ways to
increase access to mental health care.
The chatbot is considered investigational, which means that it has not been approved by the
U.S. Food and Drug Administration.
WHAT WILL HAPPEN DURING THIS STUDY?
You will be randomized (assigned by chance, like rolling dice) into one of sixteen conditions.
Each condition will either include or exclude components of psychoeducation (education on
health), motivational interviewing (help with ambivalence toward help), personalized
recommendations (personalized resources for help), and follow ups to see if you received the
help you want. You have an equally likely chance to be assigned to any of the 16 study
conditions.
If you participate you will be testing how well our chatbot works.
1) After you agree to participate, you will complete a few short questionnaires. You are
free to skip any questions you prefer not to answer.
2) Once you complete the questionnaires, you will send a text message to the chatbot.
3) You will complete the initial conversation with the chatbot. After the initial
conversation, the chatbot may contact you approximately three times to start a new
conversation over approximately two weeks.
4) Approximately two weeks after you have completed the first set of questionnaires, a
member of our research team will send you the second set of questionnaires to complete.
You are free to skip any questions you prefer not to answer.
5) A member of our research team will send you follow up questionnaires approximately 6
and 14 weeks after you have completed the first set of questionnaires. You are free to skip
any questions you prefer not to answer.
You may be selected for an additional interview/questionnaire after you receive your final
follow up set of questionnaires.
Research activities will all take place during your own personal time in any place of your choice
that has internet or mobile phone service.
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A member of our research team may call, text message, and/ or email you if you do not respond
to a message from the chatbot or from our team within approximately one day of receipt. In
addition, if you do not complete the first set of questionnaires/ start talking to the chatbot
within approximately one day of agreeing to participate, you will be contacted by our research
team. To protect your confidentiality, we suggest you prepare your phone and email with
personal privacy settings in anticipation of contact from our research team.
Will you save my research information to use in future research studies?
We would like to use the data we are obtaining in this study for studies going on right now as
well as studies that are conducted in the future. These studies may provide additional
information that will be helpful in understanding how to help individuals with disordered eating
or other diseases or conditions, including research to develop investigational tests, treatments,
drugs or devices that are not yet approved by the U.S. Food and Drug Administration. It is
unlikely that what we learn from these studies will have a direct benefit to you. There are no
plans to provide financial compensation to you should this occur. By allowing us to use your
data you give up any property rights you may have in the data.
Your data will be stored without your name or any other kind of link that would enable us to
identify what data is yours. Therefore, it will be available for use in future research studies
indefinitely and cannot be removed.
If you use the application Recovery Record, we may obtain your data from this application for
research purposes.
Audio/Video Recording or Photographs
You may be asked to participate in one aspect of this study which involves making audio/ video
recordings of you. To verify receipt of help for your eating/ body image concerns, we will audio
and/ or video record you during a phone or Zoom interview. Only the principal investigator and
the designated research team will have access to the recordings, which will be stored on a
secure server identified only by a study ID number. The study team does not plan to destroy the
recordings and they will be kept indefinitely.
HOW MANY PEOPLE WILL PARTICIPATE?
Approximately 200 people will take part in this study conducted by investigators at Washington
University.
Approximately 20 of the 200 participants may be selected for an additional
interview/questionnaire to verify receipt of help, if applicable.
HOW LONG WILL I BE IN THIS STUDY?
If you agree to take part in this study, your involvement will last for approximately four months
from completing the first assessment..
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● You will complete the first online assessment and initiate conversation with the chatbot
today and complete the first conversation. The chatbot may initiate contact with you
approximately three separate times over approximately two weeks to start a new
conversation. The chatbot will automatically reach out if you do not finish a conversation
within one day.
● You will be contacted to complete online assessments approximately 2 weeks after you
complete the first assessment, and approximately 6 and 14 weeks after you complete the
first assessment.
● You may be contacted after you receive your final assessment to verify receipt of help via
phone/ Zoom interview or online questionnaire. We may ask you to provide us with digital
or scanned receipts, screenshots, emails, or verification of the like to verify the help you
received.
WHAT ARE THE RISKS OF THIS STUDY?
You may experience one or more of the risks indicated below from being in this study. In
addition to these, there may be other unknown risks, or risks that we did not anticipate,
associated with being in this study.
· There are minimal psychological risks of participating. It is also possible that you may
feel uncomfortable disclosing certain information about behaviors such as disordered
eating.
· There may be some embarrassment related to completing questions about
disordered eating symptoms.
Breach of Confidentiality
One risk of participating in this study is that confidential information about you may be
accidentally disclosed. We will use our best efforts to keep the information about you secure.
Please see the section in this consent form titled “How will you keep my information
confidential?” for more information.
WHAT ARE THE BENEFITS OF THIS STUDY?
You may or may not benefit from being in this study.
However, we hope that, in the future, other people might benefit from this study because we
are determining what parts of the chatbot are most successful in increasing motivation to seek
care and mental health services use. The ultimate goal of the chatbot is to increase mental
health services use in individuals with disordered eating symptoms.
WHAT OTHER OPTIONS ARE THERE?
The chatbot is designed to increase the likelihood that individuals will engage with mental
health services. There are no other widely available digital tools designed for this purpose. You
will be offered referral for in-person/ telehealth treatment at the end of this document.
WILL IT COST ME ANYTHING TO BE IN THIS STUDY?
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You will not have any costs for being in this research study. You will be required to use SMS text
messaging to interact with the chatbot, message and data rates may apply.
WILL I BE PAID FOR PARTICIPATING?
You will be paid for being in this research study. You will need to provide your social security
number (SSN) in order for us to pay you. You may choose to participate without being paid if
you do not wish to provide your social security number (SSN) for this purpose. If your social
security number is obtained for payment purposes only, it will not be retained for research
purposes.
You will receive a $5 electronic gift card for completion of the baseline assessment, a $10
electronic gift card for completion of the 2 week assessment, a $10 electronic gift card for
completion of the 6 week assessment, and $20 electronic gift card for completion of the 14
week assessment. In addition, if you complete all four assessments, you will be entered into a
sweepstakes to win one of three $100 electronic gift cards.
If you are selected for the additional receipt of help interview, you will receive an additional $5
electronic gift card for your participation.
The maximum amount you could be paid for study participation is $150. If you do not complete
all parts of the study you will be paid for those you do complete.
WHO IS FUNDING THIS STUDY?
The National Institutes of Health (NIH) is funding this research study. This means that the
Washington University is receiving payments from the NIH to support the activities that are
required to conduct the study. No one on the research team will receive a direct payment or
increase in salary from the NIH for conducting this study.
WHAT IF I AM INJURED AS A RESULT OF THIS STUDY?
Washington University investigators and staff will try to reduce, control, and treat any
complications from this research. If you feel you are injured because of the study, please contact
the investigator at 1-(314)-286-2074 and/or the Human Research Protection Office at 1-(800)-
438-0445.
Decisions about whether payment for medical treatment for injuries relating to your
participation in research will be made by Washington University. If you need to seek medical
care for a research-related injury, please notify the investigator as soon as possible.
HOW WILL YOU KEEP MY INFORMATION CONFIDENTIAL?
Other people such as those indicated below may become aware of your participation in this
study and may inspect and copy records pertaining to this research. Some of these records could
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contain information that personally identifies you. We will keep your participation in this
research study confidential to the extent permitted by law.
● Government representatives (including the Office for Human Research Protections) to
complete federal or state responsibilities
● The U.S. Food and Drug Administration
● The NIH
● Hospital or University representatives to complete Hospital or University responsibilities
● Information about your participation in this study may be documented in your health care
records and will be available to anyone with access to your health care record, including
your health insurance company. This information may also be released as part of a release
of information request.
● Washington University’s Institutional Review Board (a committee that oversees the conduct
of research involving human participants) and the Human Research Protection Office. The
Institutional Review Board has reviewed and approved this study.
● Any report or article that we write will not include information that can directly identify you.
The journals that publish these reports or articles require that we share your information
that was collected for this study with others to make sure the results of this study are
correct and help develop new ideas for research. Your information will be shared in a way
that cannot directly identify you.
To help protect your confidentiality, we will use Health Insurance Portability and Accountability
Act (HIPAA) privacy protected servers to store study information. Study IDs will be linked with
participant names and email addresses in a separate password-protected file stored on a secure,
password-protected server that only key study personnel have access to. All employees of the
study with access to protected health information (PHI, information that identifies you) are
required to complete HIPAA training and comply with the privacy procedures in place at
Washington University. Our chatbot collaborator, X2AI (x2ai.com) is a HIPAA-compliant mental
health chatbot company. X2AI will host the chatbot and all data collected within the chatbot.
This includes information such as your name, phone number, and any messages you send to the
chatbot. X2AI will comply with the rules on handling of PHI under HIPAA. X2AI and Washington
University are in a Business Associate Agreement. Qualtrics is the online survey platform that
will be hosting some of your PHI. Qualtrics and Washington University are in a Business
Associate Agreement.
To further protect your privacy, this research is covered by a Certificate of Confidentiality from
the federal government. This means that the researchers can refuse to disclose information that
may identify you in any legal or court proceeding or to anyone who is not connected with the
research except if:
● there is a law that requires disclosure, such as to report child abuse and neglect, or harm to
self or others;
● you give permission to disclose your information, including as described in this consent
form; or
● it is used for other scientific research allowed by federal law.
You have the right to share your information or involvement in this study with anyone at any
time. You may also give the research team permission to disclose your information to a third
party or any other person not connected with the research.
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Are there additional protections for my health information?
Protected Health Information (PHI) is health information that identifies you. PHI is protected by
federal law under HIPAA (the Health Insurance Portability and Accountability Act). To take part
in this research, you must give the research team permission to use and disclose (share) your
PHI for the study as explained in this consent form. The research team will follow state and
federal laws and may share your health information with the agencies and people listed under
the previous section titled, “How will you keep my information confidential?” 
Once your health information is shared with someone outside of the research team, it may no
longer be protected by HIPAA.
The research team will only use and share your information as talked about in this form or as
permitted or required by law. When possible, the research team will make sure information
cannot be linked to you (de-identified). Once information is de-identified, it may be used and
shared for other purposes not discussed in this consent form. If you have questions or concerns
about your privacy and the use of your PHI, please contact the University’s Privacy Officer at
866-747-4975.
Although you will not be allowed to see the study information, you may be given access to your
health care records by contacting your health care provider.
If you decide to decline participation in this study, it will not affect
o your treatment or the care given by your health provider.
o your insurance payment or enrollment in any health plans.
o any benefits to which you are entitled.
However, it will not be possible for you to take part in the study.
If you decide to participate in this study:
o You authorize the use of your PHI for this research
o This authorization does not expire.
You may later change your mind and not let the research team use or share your
information (you may revoke your authorization).
o To revoke your authorization, complete the withdrawal letter, found in the
Participant section of the Human Research Protection Office website at
https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ or you may
request that the investigator send you a copy of the letter.
§ If you revoke your authorization:
§ The research team may only use and share information already collected
for the study.
§ Your information may still be used and shared as necessary to maintain
the integrity of the research, for example, to account for a participant’s
withdrawal from the research study or for safety reasons.
§ You will not be allowed to continue to participate in the study.
IS BEING IN THIS STUDY VOLUNTARY?
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Taking part in this research study is completely voluntary. You may choose not to take part at
all. If you decide to be in this study, you may stop participating at any time. Any data that was
collected as part of your participation in the study will remain as part of the study records and
cannot be removed.
If you decide not to be in this study, or if you stop participating at any time, you won’t be
penalized or lose any benefits for which you otherwise qualify.
What if I decide to withdraw from the study?
You may withdraw by telling the study team you are no longer interested in participating in the
study or you may send in a withdrawal letter. A sample withdrawal letter can be found at
https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ under Withdrawing from a
Research Study.
Will I receive new information about the study while participating?
If we obtain any new information during this study that might affect your willingness to continue
participating in the study, we’ll promptly provide you with that information.
Can someone else end my participation in this study?
Under certain circumstances, the investigator might decide to end your participation in this
research study earlier than planned. This might happen for no reason or because in our
judgment, it would not be safe for you to continue, because the funding for the research study
has ended, or if you have disengaged with the study.
REFERRAL TO IN-PERSON/ TELEHEALTH CARE
Please see resources below to find in-person or telehealth care.
1) National Eating Disorders Association Helpline
Phone number: +1 (800) 931-2237
Hours of operation: Mondays-Thursdays 11 AM - 9PM ET; Fridays 11 AM - 5PM ET
2) Please visit https://map.nationaleatingdisorders.org to find eating disorder treatment
providers near you.
WHAT IF I HAVE QUESTIONS?
We encourage you to ask questions. If you have any questions about the research study itself,
please contact: Bianca DePietro, 1-(314)-399-9218. If you feel that you have been harmed in any
way by your participation in this study, please contact Dr. Ellen Fitzsimmons-Craft, 1-(314)-286-
2074.
If you have questions, concerns, or complaints about your rights as a research participant please
contact the Human Research Protection Office at 1-(800)-438-0445, or email hrpo@wustl.edu.
General information about being a research participant can be found on the Human Research
Protection Office website, http://hrpo.wustl.edu. To offer input about your experiences as a
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research participant or to speak to someone other than the research staff, call the Human
Research Protection Office at the number above.
This consent form is not a contract. It is a written explanation of what will happen during the
study if you decide to participate. You are not waiving any legal rights by agreeing to participate
in this study. As a participant you have rights and responsibilities as described in this document
and including:
· To be given enough time before agreeing to weigh the risks and potential
benefits and decide if you want to participate without any pressure from the
research team or others.
· To understand all of the information included in the document, have your
questions answered, and receive an explanation of anything you do not
understand.
· To follow the procedures described in this document and the instructions of
the research team to the best of your ability unless you choose to stop your
participation in the research study.
· To give the research team accurate and complete information.
· To tell the research team promptly about any problems you have related to
your participation, or if you are unable to continue and wish to stop
participating in the research study.
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QUALTRICS CONSENT FORM EXAMPLE
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