Designing an Implementation Strategy for Delivering Routine Mental Health Screening and Treatment for Adolescents and Adults With Sickle Cell Disease
Phase: NA
Conditions: Sickle Cell Disease, Depression, Anxiety
Sponsor: University of Pittsburgh

Clinical Protocol 
 
 
Digital mental Wellness Personalized for the Lifestyles of adolescent and young adult Users 
with Sickle cell disease (RxWell PLUS) 
 
Protocol Number: 
STUDY20070307 
Version Number: 
13.0 
Version Date: 
August 26, 2022 
ClinicalTrials.gov ID Number: 
NCT04587661 
Funding Source: 
NIMH 
Clinical Coordinator Center 
Principal Investigators: 
Charles R. Jonassaint, PhD MHS 
Priniciple Investigator 
Assistant Professor, Medicine 
University of Pittsburgh 
 
 
 
 
t

 
 
 
Title: 
Designing an Implementation Strategy for Delivering Routine 
Mental Health Screening and Treatment 
Grant Number: 
R34MH125152-01 
Study Description: 
This project will develop an implementation strategy for delivering 
routine mental health screening and treatment to adolescent and 
young adults with sickle cell disease (SCD). An existing digital 
cognitive behavioral therapy (CBT) program will be adapted to be 
engaging and culturally relevant to African Americans. This will be 
the first study to test a tailored digital CBT for mental health in 
SCD, and long-term, it will inform the delivery of evidence-based 
mental health treatment in racial and ethnic minorities living with 
chronic pain. 
Objectives: 
Primary Objective: 
Determine whether an adapted digital 
CBT app will have greater uptake and 
engagement than standard digital CBT. 
Secondary 
Objectives: 
Determine feasibility of conducting a 
large scale clinical trial testing digital 
CBT among adolescents and young 
adults with SCD. 
Endpoints: 
Primary Endpoint: 
Program Engagement 
Secondary 
Endpoints: 
Pain Interference, Quality of Life 
 
Study Population: 
Male and female patients that are between 16 and 35 years of age, 
have a diagnosis of SCD (any genotype) and report significant 
depression or anxiety symptoms (i.e., Patient Health Questionnaire 
[PHQ-9] or Generalized Anxiety Disorder Scale [GAD-7] > 4). 
Phase or Stage: 
Phase1 
Description of 
Sites/Facilities 
Enrolling 
Participants: 
• 
Clinical sites: University of Pittsburgh Medical Center 
(UPMC), 
Community-based organizations: Sickle Cell 101, Children’s 
Sickle Cell Foundation 
 
Description of Study 
Intervention/Experim 
ental Manipulation: 
 
The study interventions are both cognitive behavioral therapy 
(CBT) programs delivered through a digital mobile app. 
The program provides users with brief (5-10 minute) skill building 
modules and CBT and dialectical behavioral therapy techniques 
such as relaxation, behavioral activation, distress tolerance, 
cognitive reframing, and mindfulness meditation, for depression 
and anxiety.It is for research purposes only. 
One group will use standard engagement methods while the other 
group will focus on delivering the CBT in a culturally sensitive 
manner specific to African Americans. 
Study Duration: 
1 Year 
Participant Duration: 
1 month 
1 PROTOCOL SUMMARY 
1.1 SYNOPSIS 

barriers to routine mental health screening and treatment in SCD clinics and the community. 
Specifically, we will use the Behavior Change Wheel as a validated method for identifying the 
appropriate behavior change and implementation strategies. 
AIM 2: Rapidly iterate, test, and evaluate adaptations to the implementation strategy for a 
coach-enhanced digital mental health service. Based on findings from Aim 1, we will 
systematically develop, test, and evaluate changes to how the CBT program is 
advertised/promoted, and introduced to patients and providers. We will tailor the messages and 
multimedia content that health coaches send to patients. 
AIM 3: Demonstrate that a population-specific implementation strategy improves engagement 
with a digital CBT-based mental health service. We will recruit 40 adolescents and young adults 
with SCD (ages 16-35) and comorbid depression and randomize them to either the off-the-shelf 
digital CBT program and standard implementation strategy that has no content or references to 
SCD, chronic pain, or the unique challenges facing minority groups, to adapted digital CBT with 
a SCD-specific implementation approach. 
Our hypothesis: 
We hypothesize that low-cost adaptations to a digital CBT program will have better engagement 
than digital CBT with standard implementation strategy. We expect that participants in the 
adapted digital CBT arm will complete more modules and have more interaction days with the 
digital CBT program than participants in the standard digital CBT arm. 
 
 
 
 2.2 BACKGROUND 
 
 
African Americans living with chronic health conditions are more likely to experience depression 
and other mental health disorders than their healthy counterparts.[1, 2] Compared to whites, 
African Americans are more likely to experience severe depression but less likely to be 
diagnosed or receive treatment.[3, 4] Left untreated, depression can increase disease severity 
and risk for mortality, particularly for groups already at high risk.[5-12] 
A model population for health disparities research. One remarkably vulnerable population are 
adolescents and adults living with sickle cell disease (SCD), a condition that affects millions of 
people worldwide and over 100,000 people in the United States.[13] A vast majority of the 
people affected by sickle cell are of African descent;[14] this is a racial minority group that has 
been traditionally underserved and receives lower quality health care.[15] Compared to other 
rare chronic conditions that affect primarily people of European descent, such as cystic fibrosis, 
SCD receives less funding and has more limited clinical resources.[15] Thus, this is a population 
in need of more mental health resources and access to high-quality, evidence-based care. 
Addressing comorbid pain and mental health. As adolescents and young adults navigate the 
change from pediatric to adult care, they are simultaneously managing several developmental 
and life transitions. It is not surprising that the adolescent/young adult age group (16-35) 
experiences the highest incidence of SCD-related pain crises and health care encounters 
compared to SCD patients from other age groups.[16-19] The severe and unpredictable nature 
of pain in SCD, combined with exposure to disadvantaged environments and chronic 
psychosocial stressors characteristic of disadvantaged lifestyles, makes managing mental 
health in this group challenging.[20] Indeed, adolescents and young adults living with a chronic 

disease such as SCD are at high risk for mental health disorders[18, 21-23] and suicide.[24] 
Comorbid depression in SCD is associated with increased risk of severe pain, pain-related 
hospitalizations, opioid dependence, increased medical costs, and mortality.[25] Yet SCD clinics 
are often under-resourced, and mental health is not assessed during routine SCD care visits. In 
studies where depression is assessed, 26-65% of patients with SCD meet criteria for a major 
depressive disorder.[26] Given that physicians are less likely to detect mental health problems 
in African Americans and in younger patients,[27] many SCD patients suffering from depression 
may never have their mental health assessed, let alone treated. 
Unmet need and barriers to treatment. There is an urgent need for mental health screening and 
effective, evidence-based treatment of psychological disorders in routine SCD.[28-33] Cognitive 
behavioral therapy (CBT), in particular, is the gold standard of behavioral approaches to treating 
depression. Considering the well-established gap in mental health care for SCD patients, 
however, CBT is not part of comprehensive SCD care. 
Many suggest that CBT can be an effective and cost-efficient component of SCD treatment.42- 
46 However, there are four critical barriers to providing face-to-face CBT services in routine 
care: 1) availability, 2) accessibility, 3) acceptability, and 4) adherence. There is a lack of access 
to CBT due to the expense of providing face-to-face therapy in low-resource clinical settings and 
a shortage of available CBT-trained therapists, especially those who are culturally competent to 
work with hard-to-reach, minority populations. Even when CBT is available, therapy is time 
consuming and requires travel to a clinic, which is challenging for adult patients with significant 
social and economic challenges,[34-36] and for the parents of adolescent patients. [37] 
Over the past two decades, face-to-face CBT has been adapted so it can be delivered over the 
phone, over the internet via desktop computer, and more recently, via mobile devices, first tablet 
computers (e.g., iPads) and then mobile phones. Although the delivery method has drastically 
changed, the core components of CBT have remained stable through each adaptation, and now 
CBT via the Internet and mobile technology not only improves access and availability to 
evidence-based treatment but can be as effective alternative to traditional face-to-face CBT for 
depression, other mental health disorders,[38, 39] and even pain and pain-related disability.[40] 
Given the consistent evidence from several meta-analyses showing the effectiveness of digital 
CBT (in prior literature referred to as computerized CBT), the UK’s National Institute for Health 
and Care Excellence (NICE) made digital CBT standard of care and available to all patients in 
the UK.[41, 42] Digital CBT is becoming well-established as a low-cost add-on to routine care, 
and is now being offered by several health plans in the U.S. including our partner, the University 
of Pittsburgh Medical Center (UPMC) Health Plan. 
Bridging disparities in mental health care with technology. Using digital CBT, we can now deliver 
high-quality, evidence-based behavioral mental health treatment that can be scaled to reach 
patients in under-resourced settings. Digital CBT has long been shown to be effective in white 
populations. More recently, we have shown digital CBT is effective for minorities. We found that 
digital CBT led to significant decrease in depressive symptoms among African American 
primary care[43, 44] and SCD patients.[45] Our group has also implemented digital CBT for pain 
with African American children and adolescents with SCD.[46] Thus, there is ample evidence 
that digital CBT is ready for implementation in SCD clinics and potentially, through community- 
based organizations (CBOs) via social media and the Web, creating widespread access to 
mental health care. 
Gap in evidence. No studies have demonstrated the successful implementation and sustainable 

Patients are able to stop the digital CBT program at any time, and we will frequently remind 
patients that they do not have to answer questions if it makes them uncomfortable. 
Data Security 
Coded data will be stored electronically and saved onto a separate secure database. Once the 
participant consents, the encrypted data is sent to a RedCap (or similar) secure server. There 
are two parts to the encrypted data that is transferred from the mobile device to the server: 
identifiable information upon enrollment and the non-identifiable study data. These two 
components are stored separately and linked by a unique identifier. The key linking these two 
are only accessible by the study staff. 
This study involves the collection of data over the Internet using mobile devices. Although every 
reasonable effort will be taken, confidentiality during Internet communication procedures cannot 
be guaranteed and it is possible that additional information beyond that collected for research 
purposes may be captured and used by others not associated with this study 
Patients will be encouraged to lock their device when not in use and to keep the latest security 
OS update. Patients will also be encouraged to avoid accessing untrusted sites. 
This research is necessary to understand the feasibility of a mobile-technology–based 
behavioral intervention for mental health that predominantly targets a minority population. 
Study endpoints 
Primary Outcome Measures 
Program engagement. Engagement will be measured by frequency and time on the app, 
number of lessons completed, and number of interactions (app messages) with health coaches 
over a 4-week period. 
Secondary Outcome Measures 
Pain Interference. The PROMIS Pain Interference Scale[86] is a validated questionnaire asking 
a patient how much day-to-day function is altered by pain. SCD impairs health-related quality of 
life (HR-QOL) more than most other chronic diseases. PROMIS is designed to allow 
streamlined, computer-aided administration, and has been tested in multiple populations and 
conditions including SCD. 
Quality of life and mental health. To assess changes in QOL and emotional distress, 
participants will complete the following tests at baseline and 1 month: Adult Sickle Cell Quality 
of Life Measurement Information System (ASCQ-ME); Emotional Functioning and Social Impact 
scales;[87, 88] and the Patient Health Questionnaire (PHQ-9),[89, 90] a 9-item measure of 
depressive symptoms. 
Medical Outcomes 
In preparation for a large-scale trial, we will pilot the collection of medical outcomes: opioid 
medication refills, and emergency department visits or hospitalizations for pain crisis. We will 
collect data retrospectively (from the past 12 months) and prospectively (12 months from date of 
enrollment) from patient medical records (Table 3). These data will allow us to track health care 
utilization, as well as lab values (e.g., hemoglobin level) and clinical outcomes (e.g., end-organ 
damage score). 

 4 STUDY DESIGN 
 
 
 4.1 OVERALL DESIGN 
 
 
This is a study to assess whether or not a culturally sensitive, population-specific 
implementation of an intervention increases engagement and effectiveness of a cCBT-based 
mental health service. 
Population- and setting-specific adaptations to interventions can lead to their successful 
implementation and wider use, yet no studies show how much adaptation is needed to 
effectively implement digital CBT in different settings. Qualitative data from our group and others 
show that cultural factors—lack of relatability, representation, and perceived stigma regarding 
mental health treatment—limit engagement with digital CBT programs. Our proposal will devise 
changes to advertising, promotion, and health coach communications, that will decrease stigma 
and make digital CBT more relatable and relevant to young adults with sickle cell disease 
(SCD). We hypothesize that low-cost adaptations to a digital CBT program will have better 
engagement than digital CBT with standard implementation strategy. 
Specific aims are as follows. 
Aim 1: Use implementation science (ImS) and human-centered design methods to define the 
barriers to delivering routine mental health screening and digital CBT to adolescents and young 
adults with SCD. By leveraging ImS theory, models, and frameworks, we will systematically 
collect and analyze qualitative data to define and understand stakeholder needs, and cultural 
barriers to routine mental health screening and treatment in SCD clinics and the community. 
Specifically, we will use the Behavior Change Wheel as a validated method for identifying the 
appropriate behavior change and implementation strategies. 
Aim 2: Rapidly iterate, test, and evaluate adaptations to the implementation strategy for a 
coach-enhanced digital mental health service. Based on findings from Aim 1, we will 
systematically develop, test, and evaluate changes to how the CBT program is 
advertised/promoted, and introduced to patients and providers. We will tailor the messages and 
multimedia content that health coaches send to patients. 
Aim 3: Demonstrate that a population-specific implementation strategy improves engagement 
with a digital CBT-based mental health service. We will recruit 40 adolescents and young adults 
with SCD (ages 16-35) and comorbid depression and randomize them to either the off-the-shelf 
digital CBT program and standard implementation strategy that has no content or references to 
SCD, chronic pain, or the unique challenges facing minority groups, to adapted digital CBT with 
a SCDspecific implementation approach. 
H1: We hypothesize that participants in the adapted digital CBT arm will complete more 
modules and have more interaction days with the digital CBT program than participants in the 
standard digital CBT arm. 
General Study Design 
There are two intervention groups. Both intervention groups will receive cognitive behavioral 
therapy (CBT) through a digital mobile app.The program provides users with brief (5-10 minute) 
skill building modules and CBT and dialectical behavioral therapy techniques such as relaxation, 

behavioral activation, distress tolerance, cognitive reframing, and mindfulness meditation, for 
depression and anxiety.It is for research purposes only. 
One group will use standard engagement methods while the other group will focus on delivering 
the CBT in a culturally sensitive manner specific to African Americans. 
Both intervention groups will receive weekly (more frequent if requested or needed) follow-up 
with a health coach who will reinforce CBT content and encourage session completion for at 
least 4 weeks. In the adapted digital CBT arm, the health coach will use tailored text messages 
and multimedia communications. 
The program provides users with brief (5-10 minute) skill building modules and CBT and 
dialectical behavioral therapy techniques such as relaxation, behavioral activation, distress 
tolerance, cognitive reframing, and mindfulness meditation, for depression and anxiety. It is for 
research purposes only. 
All participants will complete short surveys each week they are in the study. These surveys will 
be sent to their mobile phone as a web URL link. Each week, participants will complete a 
depression (PHQ-9) and anxiety (GAD7) symptoms questionnaire. At 1 and 4 weeks only, 
participants will also complete measures of Self-efficacy (SCSES), stigma, pain interference 
(PROMIS), and quality of life (ASCQ-ME). In addition, as part of the intervention, participants 
are asked to interact with their assigned digital CBT program at least once per week if not more. 
 
 
 4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
 
African Americans living with chronic health conditions are more likely to experience depression 
and other mental health disorders than their healthy counterparts.[1, 2] Compared to whites, 
African Americans are more likely to experience severe depression but less likely to be 
diagnosed or receive treatment.[3, 4] Left untreated, depression can increase disease severity 
and risk for mortality, particularly for groups already at high risk.[5-12] 
One remarkably vulnerable population are adolescents and adults living with sickle cell disease 
(SCD), a condition that affects millions of people worldwide and over 100,000 people in the 
United States.[13] A vast majority of the people affected by sickle cell are of African descent;[14] 
this is a racial minority group that has been traditionally underserved and receives lower quality 
health care.[15] Compared to other rare chronic conditions that affect primarily people of 
European descent, such as cystic fibrosis, SCD receives less funding and has more limited 
clinical resources.[15] Thus, this is a population in need of more mental health resources and 
access to high-quality, evidence-based care. 
As adolescents and young adults navigate the change from pediatric to adult care, they are 
simultaneously managing several developmental and life transitions. It is not surprising that the 
adolescent/young adult age group (16-30) experiences the highest incidence of SCD-related 
pain crises and health care encounters compared to SCD patients from other age groups.[16- 
19] The severe and unpredictable nature of pain in SCD, combined with exposure to 
disadvantaged environments and chronic psychosocial stressors characteristic of 
disadvantaged lifestyles, makes managing mental health in this group challenging.[20] Indeed, 
adolescents and young adults living with a chronic disease such as SCD are at high risk for 
mental health disorders[18, 21-23] and suicide.[24] 

Comorbid depression in SCD is associated with increased risk of severe pain, pain-related 
hospitalizations, opioid dependence, increased medical costs, and mortality. [25] Yet SCD 
clinics are often under-resourced, and mental health is not assessed during routine SCD care 
visits. In studies where depression is assessed, 26-65% of patients with SCD meet criteria for a 
major depressive disorder.[26] Given that physicians are less likely to detect mental health 
problems in African Americans and in younger patients,[27] many SCD patients suffering from 
depression may never have their mental health assessed, let alone treated. 
There is an urgent need for mental health screening and effective, evidence-based treatment of 
psychological disorders in routine SCD.[28-33] Cognitive behavioral therapy (CBT), in particular, 
is the gold standard of behavioral approaches to treating depression. Considering the well- 
established gap in mental health care for SCD patients, however, CBT is not part of 
comprehensive SCD care. 
Many suggest that CBT can be an effective and cost-efficient component of SCD treatment.42- 
46 However, there are four critical barriers to providing face-to-face CBT services in routine 
care: 1) availability, 2) accessibility, 3) acceptability, and 4) adherence. There is a lack of access 
to CBT due to the expense of providing face-to-face therapy in low-resource clinical settings and 
a shortage of available CBT-trained therapists, especially those who are culturally competent to 
work with hard-to-reach, minority populations. Even when CBT is available, therapy is time 
consuming and requires travel to a clinic, which is challenging for adult patients with significant 
social and economic challenges,[34-36] and for the parents of adolescent patients. [37] 
Over the past two decades, face-to-face CBT has been adapted so it can be delivered over the 
phone, over the internet via desktop computer, and more recently, via mobile devices, first tablet 
computers (e.g., iPads) and then mobile phones. Although the delivery method has drastically 
changed, the core components of CBT have remained stable through each adaptation, and now 
CBT via the Internet and mobile technology not only improves access and availability to 
evidence-based treatment but can be as effective alternative to traditional face-to-face CBT for 
depression, other mental health disorders,[38, 39] and even pain and pain-related disability.[40] 
Given the consistent evidence from several meta-analyses showing the effectiveness of digital 
CBT (in prior literature referred to as computerized CBT), the UK’s National Institute for Health 
and Care Excellence (NICE) made digital CBT standard of care and available to all patients in 
the UK.[41, 42] Digital CBT is becoming well-established as a low-cost add-on to routine care, 
and is now being offered by several health plans in the U.S. including our partner, the University 
of Pittsburgh Medical Center (UPMC) Health Plan. 
 
 
 4.3 JUSTIFICATION FOR INTERVENTION 
 
 
Bridging disparities in mental health care with technology. Using digital CBT, we can now deliver 
high-quality, evidence-based behavioral mental health treatment that can be scaled to reach 
patients in under-resourced settings. Digital CBT has long been shown to be effective in white 
populations. More recently, we have shown digital CBT is effective for minorities. We found that 
digital CBT led to significant decrease in depressive symptoms among African American 
primary care[43, 44] and SCD patients.[45] Our group has also implemented digital CBT for pain 
with African American children and adolescents with SCD.[46] Thus, there is ample evidence 
that digital CBT is ready for implementation in SCD clinics and potentially, through community- 

based organizations (CBOs) via social media and the Web, creating widespread access to 
mental health care. 
Gap in evidence. No studies have demonstrated the successful implementation and sustainable 
delivery of a digital CBT service in SCD or any other underserved population in under-resourced 
settings. This is in part because, despite promising evidence supporting the use of digital CBT 
for mental health, attrition and poor adherence with this mode of intervention are common.[47] 
Moreover, engagement with digital interventions may be especially problematic for minority 
users. Our work shows that African Americans are even less likely than whites to stick with 
digital CBT programs. African American primary care patients enrolled in our digital CBT trial 
were less likely than whites to start the program (75% vs. 87%) and to complete all 8 modules 
(29% vs. 43%). In our pilot study with SCD adults, although patients reported benefits from 
digital CBT, the average user completed only 3 of 8 possible sessions. Post-study interviews 
and a focus group revealed that while SCD patients did indeed feel the CBT skills were useful, 
the content was often not relevant or relatable and did not represent their real-world cultural and 
health experience. In addition, interventions with this population have to address cultural stigma, 
a wellknown barrier to recruitment and retention of racial/ethnic minorities in mental health 
programs. To advance the field, we need innovative approaches to remediating these barriers to 
the provision, receipt, and benefit of digital CBT-based mental health services in low-resource 
settings 
 
 
 4.4 END-OF-STUDY DEFINITION 
 
 
Patients are considered to have completed the study once they have participated in weekly 
check-ins with a health coach during the 4 weeks and completed the assessments (STIG-9, 
SCSES, PROMIS, ASCQ-ME, PHQ-9, GAD-7) at the scheduled time points. 

 5 STUDY POPULATION 
 
 
 5.1 INCLUSION CRITERIA 
 
 
To be eligible for the study, patients must: 
• 
be between 16 and 35 years of age 
• 
have a diagnosis of SCD (any genotype) 
• 
report significant depression or anxiety symptoms (i.e., Patient Health Questionnaire [PHQ- 
9] or Generalized Anxiety Disorder Scale [GAD-7] > 4). 
 
 5.2 EXCLUSION CRITERIA 
 
 
Patients are ineligible if they: 
• 
Are unable to read English or understand the consent process 
• 
Are cognitively impaired adults as determined by their treating physician 
• 
Have any condition that in the opinion of the investigator would not allow the patient to 
continue on the study 
 
 5.3 LIFESTYLE CONSIDERATIONS 
 
 
N/A 
 
 5.4 SCREEN FAILURES 
 
 
Potential participants will be screened for eligibility prior to enrolling into the study. A de- 
identified log that includes all screenings, study eligibility and consent will be completed by the 
research coordinators obtaining consent. 
 
 
 5.5 STRATEGIES FOR RECRUITMENT AND RETENTION 
 
 
At each participating clinical site (Pediatric and Adult SCD Clinics), we will use electronically- 
administered screening tools, medical record screening and if available, best practice alerts, to 
identify patients with SCD who have high risk for mental health disorders as indicated by self- 
report. Best practice alerts will flag patients with a history of mental health diagnosis or who 
have been prescribed psychopharmacological medication for mental health. In addition to 
recruitment in the local clinics, potential participants may be recruited through community-based 
organization websites, social media groups, email listservs, and patient/family meetings. The 
community-based organization websites are: Sickle Cell 101 (https://www.sc101.org/) and 
Children’s Sickle Cell Foundation (http://cscfkids.org/). 
We have access to these organizations because Sickle Cell 101 and Children’s Sickle Cell 
Foundation are investigators/consultants on the grant that funds this project. 
Electronic Screening and Consent Tool. Interested patients will access a short online screener 
on any mobile device (a compatible smartphone device is necessary to participate; loaner 
devices will be provided as needed). To be eligible, potential participants must be able to read 
the study consent and correctly answer comprehension questions; our group is currently using 

and has published data on this electronic consent process in a clinical study and a large 
multisite trial of digital CBT. 
Compensation 
Due to COVID-19, focus groups will be remote. Remote focus group participants will receive a 
$30 grub hub gift card in lieu of food provided at in person focus groups. 
If randomized to one of the intervention arms, participants will receive compensation in the form 
of $50 for the baseline assessment and starting the CBT program. Then participants will be 
compensated $50 for completion of the 1-month follow-up assessment period for a total up to 
$100. Also, travel and parking reimbursement may be received for the amount of $10 for each 
study-related visit, if applicable. 
 
 
 5.6 RECRUITMENT PLAN FOR PROSPECTIVE STUDIES 
 
 
Review of study enrollment accuracy will be collected twice weekly by research staff and 
evaluated quarterly by the principal investigator. 
The principal investigator, collaborators, and the research staff will meet on a monthly interval to 
re-evaluate study goals, subject recruitment, data coding and retention, documentation and 
identification of adverse events, complaints, and confidentiality of subjects. There will be an 
evaluation of the progress of the research study, including assessments of data quality, time 
lines, participant recruitment, accrual, and retention. If recruitment is below 50% of projected 
within the first 3 months of the study, the principal investigator will suggest a conference call for 
the study investigators to discuss methods of improving recruitment, including expanding the 
age inclusion criteria. 

 6.3 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
 
Randomization: Participants will be randomized in an equal fashion (1:1) to both study arms. 
Random permuted block randomization will be used to create an allocation list that will 
integrated within our Web-based data entry system. 
Reduce the potential for bias. The introduction to both interventions will look identical and 
participants will not be told what type of training they are receiving. We will make every effort to 
mask the intervention type; however, as with all behavioral interventions, completely blinding 
participants to the intervention is challenging. The investigative team will continue to maintain 
clinical equipoise regarding the comparative therapeutic merits of each treatment. 
Randomization will avoid selection bias as well as volunteer or referral bias. A dropout analysis 
will be carried out to determine the contribution of attrition bias. All outcomes measures will be 
collected electronically, without an interview, to avoid expectation bias. We have also found this 
mode of data collection to be superior to assessments by phone for timely follow-up. 
 
 
 
 6.4 STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
 
 
The major assumption is that patients will complete the intervention program to which they are 
randomly assigned. Although we have implemented several methods to promote engagement 
and limit dropout (e.g., health coaches), digital interventions often experience high attrition over 
time with few participants completing all assigned modules. We will track the reasons for 
noncompletion and seek patterns (e.g., moved away, died, started working and became too 
busy, people with higher cognitive level lost interest) that are amenable to statistical analysis of 
the missing data. 
Quarterly assessments will be made of data quality and timeliness, participant recruitment, 
accrual and retention, participant risk/benefit ratio, protection of confidentiality of information, 
and any other factors that affect the study. The IRB will be informed immediately on a case by 
case basis, of any adverse outcomes, while requests for modifications of the protocol will be 
submitted to the IRB on a quarterly basis. Confidentiality of the data and the results of 
monitoring will be protected. 
 
Parameters to be Monitored. The following progress will be monitored throughout the course of 
the research to ensure the safety of subjects as well as the integrity and confidentiality of their 
data. 
• 
An evaluation of the progress of the research study, including subject recruitment and 
retention, and an assessment of the timeliness and quality of the data. 
• 
A review of collected data (including adverse events, unanticipated problems, andsubject 
withdrawals), to determine whether there is a change to the anticipated benefit-to-risk 
assessment of study participation and whether the study should continue as originally 
designed, should be changed, or should be terminated. 
• 
An assessment of external factors or relevant information (e.g., pertinent scientificliterature 
reports or therapeutic development, results of related studies) that may have an impact on 
the safety and study participants or the ethics of the research study. 
• 
A review of study procedures designed to protect the privacy of the research subjects and 
the confidentiality of their research data. 

email address, etc.). Each week, participants will complete a depression (PHQ-9) and anxiety 
(GAD7) symptoms questionnaire. At 1 and 4 weeks only, participants will also complete 
measures of Self-efficacy (SCSES), stigma, pain interference (PROMIS), and quality of life 
(ASCQ-ME). 
Completion of the questionnaires is a required component of the study. Not completing 
questionnaires within 2 weeks of the due date is considered a missed follow-up. In the event 
that a follow-up assessment is not completed, every possible effort will be made by study site 
personnel to contact the subject. For each follow-up, at least three documented contact 
attempts must be made on different days to the last available telephone number. If the subject is 
still unreachable after all contact attempts, they will be considered to be lost to follow-up (LTF). 
The site should document all attempts and LTF information in the trial database. 

observations for participant by including a random effect for subject. As a secondary 
investigation, we will test group differences in pain intensity using a similar strategy. 
Medical record review will be performed at 12 months post participation. Healthcare utilization 
will be compared between study arms using generalized linear models to account for count data 
(i.e., Poisson regression) for each of the following: the number of opioid prescriptions, number 
of ED visits, and number of hospitalizations over 12 months post study entry. Predictors will 
include study arm, study site, and baseline depression level. The corresponding health care 
utilization in 12 months prior to study entry will be entered as a covariate in each model. We will 
offset each model by participant’s time on the study. 

 

University of Pittsburgh 
Center for Research on Health Care 
 
Consent to Participate in a Research Study 
 
 
Title: 
Designing an Implementation Strategy for Delivering Routine Mental 
Health Screening and Treatment for Adolescents and Adults with 
Sickle Cell Disease 
 
Principal Investigator: 
Charles Jonassaint, PHD, MHS. 
Assistant Professor of Medicine 
University of Pittsburgh, Suite 600, 230 McKee Place 
Pittsburgh, PA 15213, Tel: (412) 586-6850 
 
Source of Support 
National Institute of Mental Health 
 
 
INTRODUCTION 
 
Why is this research being done? 
We want to see how to improve mental health for adolescents and young adults (AYAs) living with 
sickle cell disease (SCD). As part of this study, we will be adapting an existing, smartphone-based, 
mental health program, to make it fit the needs of AYAs with SCD. To accomplish this we will have 
meetings with patients, family members, and SCD providers, to better understand how we can make 
mental health care, delivered through a smartphone, work for the sickle cell community. What we learn 
from these meetings will inform how we adapt the smartphone app and mental health program. We will 
next test whether the new, adapted app and mental health program are more engaging and helpful to 
AYAs with SCD than the original app and mental health program that were not designed with SCD in 
mind. To accomplish this comparison test, 40 adolescents and young adults (age 16-35) who have 
SCD and elevated symptoms of depression and/or anxiety symptoms will be randomly selected to 
either receive the adapted mental health program or the original, “off the shelf” mental health program. 
 
Who is being asked to take part in this research study? 
All adolescent and young adult patients (age 16-35) with sickle cell disease receiving treatment at the 
Pediatric and Adult Sickle Cell Disease Clinics at UPMC are being asked to participate. All participants 
will complete some short questionnaires that measure emotional and physical health. From this group, 
we will be asking at least 40 AYA with depression and/or anxiety to enroll in the intervention portion of 
this study. The interventions programs are both based on cognitive behavioral therapy (CBT), which 
aims to help individuals better manage stress through changing negative thoughts and emotions. 
Participants will test either one of the two electronic interventions: adapted CBT for SCD or original 
CBT. To qualify, patients be between 16 and 35 years of age, have a diagnosis of SCD (any 
genotype) and report significant depression or anxiety symptoms (i.e., Patient Health Questionnaire 
[PHQ-9] or Generalized Anxiety Disorder Scale [GAD-7] ฀ 5). 
 
How long will I be in the study? 
Your total participation in this study will be as long as 4 weeks. You can decide to stop participating in 
the study at any time regardless of your eligibility for the intervention arm or whichever portion of the 
study you take part in. The study doctor may take you off the study if any of the following occur: 
 
● 
You are not able to follow all the study-related instructions 
● 
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What procedures will be performed if you participate in this study? 
You will complete a short set of questionnaires to assess depression, anxiety, and the influence of 
SCD on various areas of your life, such as your emotional and physical health. Eligibility to take part in 
the study is based on the initial visit (screening visit). If you are eligible and decide to participate in the 
intervention portion of this study, we will randomize you (like pulling names from a hat) to receive 
either the adapted CBT for SCD or the original program. Whichever group you are in, you will receive 
your usual medical care while you are in the study. Participating in the intervention portion of the study 
is completely voluntary. 
If you are eligible for the study intervention arm and you choose to participate, you will be randomized 
into one of the mental health CBT programs. Twenty patients will be enrolled into the CBT program 
adapted for SCD and twenty patients will be enrolled into the original program. Neither you nor your 
doctor nor any member of the research team can determine which program you are assigned to, a 
computer program makes the assignment randomly. 
 
What is the intervention? 
In addition to receiving usual care, you will be registered to a digital mental health program and 
asked to use a smartphone to complete CBT modules through an app. The app will teach you how 
to better manage stress using cognitive behavioral therapy techniques. This approach involves 
changing your thoughts and behaviors so you can limit the negative impact of stress on your life. 
You will have access to these sessions for the 4 weeks that you are participating in the study. You 
are encouraged to use the CBT program as frequently and as long as needed, within the 4-week 
timeframe of the study. In addition to the smartphone app, you will also have a “health coach,” a 
person who will help you practice the skills you are learning and apply these skills in your 
everyday life. At the start of the study, your health coach will reach out via phone to get to know 
you and ask about your goals. After that, your health coach will message you in the app, as 
frequently as is needed to help you reach your goals. Each week, you will be sent questions in the 
app that will be used to track your depression and/or anxiety symptoms as well as your pain. 
When you finish the study, we will ask you to complete questionnaires to tell us how helpful the 
CBT program and the health coach were. 
 
Mobile phone app and assessments 
You will use your own mobile phone for the study. A member of the study team can be available 
by phone or in some circumstances, in person, to help you access and navigate the program via 
your smartphone and get you registered. Over the course of the study, you will use your 
smartphone to access your assigned CBT program. We will be using information directly from the 
app to better understand each program. Information includes (but will not be limited to): 
• 
How often the app is accessed 
• 
The number and type of modules completed 
• 
Messages sent between you and your health coach (these messages will be de-identified 
to protect your privacy) 
 
At the end of the 4 weeks, you will be asked to complete follow-up questionnaires. You will be able 
to access these on your smartphone. We will send you the link and remind you when it is time to 
complete these questionnaires. 
 
Intervention Arm Study Diagram 
 
Qualitative Interviews 
The investigator, along with a study staff person, will conduct individual and group interviews with 
patients who have been enrolled in this study. Qualitative interview questions will include (but will not 
be limited to): What did you like about the intervention program? What did you not like? Tell me about 
your experience working with the therapists or health coach? How could they improve the quality of 
care you received? How was the program helpful or not helpful for addressing your distress and pain 
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symptoms? 
The interviews will be conducted in person or over the phone. The results of the interviews will be 
used to help us understand the attitudes of patients towards the interventions, the health coach 
support, and how useful the interventions are to patients and families. We will use this information to 
fine-tune the programs. 
The qualitative portion of the study is completely voluntary. You can complete the study without it. If 
you are asked to participate it is your choice whether you would like to take part. 
What are the possible risks, side effects, and discomforts of this research study? 
Although this is a low-risk study, you should be aware of the possible risks that may arise in this study. 
They include the potential for a breach of confidentiality, and the possibility that you may feel 
uncomfortable, anxious, or embarrassed discussing personal matters. 
The discussion of personal problems can occasionally be stressful, uncomfortable, or embarrassing to 
some people. You are not obligated to answer any questions or perform any tasks that make you 
uncomfortable. Furthermore, you may choose to stop being part of our study at any time. 
No experimental medications, placebos (sugar pills) or medical devices are involved in this study. Any 
pain medications that you may receive will be prescribed by your physician(s) and taken under your 
physician’s direction, as we will neither prescribe, nor provide you with, any pain medications. 
Because your information is being used in this research study, there is a risk that information could be 
accessed by people other than members of this research team. Breaches in confidentiality involving 
medical information could impact future insurability, employability, or reproduction plans, or have a 
negative impact on family relationships, and/or result in stigmatization. To minimize these risks, all of 
the information collected and used for this research will be stored in a locked cabinet in a locked office 
or on a secure, password-protected database, which will not be accessible to anyone other than our 
research team. 
This study uses mobile devices to collect data over the Internet. Although every reasonable effort has 
been taken, confidentiality during Internet communication activities cannot be guaranteed and it is 
possible that additional information beyond that collected for research purposes may be captured and 
used by others not associated with this study. 
Text and email messages sent to you from the research team are not secure and can be read by 
someone viewing your device. To protect your privacy, messages and emails sent for study purposes 
will not contain any protected health information, sensitive subject material (e.g. health diagnosis), or 
personal identifiers. You should not send sensitive information to anyone on the research team over 
text or email. If there is something sensitive that needs to be shared, you can message your health 
coach in the mobile app or request a phone call with the study Principal Investigator. 
 
What are possible benefits from taking part in this study? 
There is no guarantee you personally will receive any benefit from being in this study. However, by 
completing this study you will be helping researchers understand the impact of online treatment 
strategies, and in the future, that may improve the care of sickle cell patients like you. 
 
What treatments or procedures are available to me if I decide not to take part in this research 
study? 
You and your doctor may decide to treat your condition with counseling, medications, and/or referral 
to a behavioral health specialist, all in accordance with your health care coverage. 
 
 
If I agree to take part in this research study, will I be told of any new risks that may be found 
during the course of the study? 
If new information, either good or bad, about this treatment develops during the course of this study 
which may cause you to change your mind about continuing in this research study, we will notify you 
promptly. 
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Will my insurance provider or I be charged for the costs of any procedures performed as part 
of this research study? 
None of the procedures you receive during this research study (study-related psychotherapy, 
interviews, and psychiatric assessments for either CBT program) will be billed to you or your health 
insurance. If you get a bill or believe your health insurance has been billed for something that is part of 
the study, notify a member of the research team. Any evaluations or drug treatments that are not part 
of this study will be your responsibility. The principle investigator or other members of the research 
team can give you more information about this. 
 
Who will pay if I am injured as a result of taking part in this study? 
If you believe that you are injured as a result of the research procedures performed, we request that 
you contact the study’s Principal Investigator, Dr. Jonassaint, whose contact information is listed on 
the first page of this form. Emergency medical treatment for injuries solely and directly related to your 
participation in this research study will be provided to you by the hospitals of UPMC. Your insurance 
provider may be billed for the costs of this emergency treatment, but none of those costs will be 
charged directly to you. If you have a research-related injury that requires medical care beyond this 
emergency treatment, you will be responsible for the costs of this follow-up care. At this time, there is 
no plan for any additional financial compensation. 
 
Will I be paid if I take part in this research study? 
If you participate in a focus group, you will be provided food in the form of a $30 Grub Hub gift card. 
 
If you are randomized to one of the intervention arms you will receive compensation in the form of $50 
for the baseline assessment and starting the CBT program. Then you will be compensated $50 for 
completion of the 1-month follow-up assessment period for a total up to $100. Also, you may receive 
travel and parking reimbursement for the amount of $10 for each study-related visit, if applicable. 
 
All compensation is taxable income to the participant regardless of the amount. If a participant 
receives $600 or more in a calendar year from one organization, that organization is required by law 
to file a Form 1099 – Miscellaneous with the IRS and provide a copy to the taxpayer. Individuals who 
do not provide a social security number may still participate in the research, but the IRS requires that 
28% of the payment be sent by the institution to the IRS for ‘backup withholding;’ thus you would only 
receive 72% of the expected payment. 
 
Who will know about my participation in this research study? 
To protect your privacy and maintain the confidentiality of information we obtain from you and from 
your medical records, all electronic records will be stored in password-protected files. On these 
records, we will identify you by a case number rather than by your name, and the code linking your 
name to the case number will be maintained separately with very limited access to research team 
members. 
 
Will this research study involve the use or disclosure of my identifiable medical information? 
We are also requesting your authorization or permission to review your past, present and/or future 
medical information from your hospital and/or other (e.g., physician office) records. Specifically, we 
will review your medical diagnoses, number/type of prescribed pain medications, number of scripts 
written 12 months before and 12 months after intervention, number of ED visits, hospitalizations and 
standard care visits and quality of life and care measures. This information will inform us on who 
benefits the most from the program. No information/data that is collected exclusively as part of this 
research study will be placed in the medical records. However, if the study staff become concerned for 
your health, they may contact your referring physician and this information may be recorded in your 
medical record. 
 
A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by US 
Law. This website will not include information that can identify you. At most, the website will include a 
 
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summary of the results. You can search this website at any time. 
 
Who will have access to identifiable information related to my participation in this research 
study? 
In addition to the investigators listed on the first page of this authorization (consent) form and their 
research staff, the following individuals will or may have access to identifiable information (which may 
include your identifiable medical information) related to your participation in this research study: 
 
● 
Authorized representatives of the University of Pittsburgh Research Conduct and Compliance 
Office may review your identifiable research information (which may include your identifiable 
medical information) for the purpose of monitoring the appropriate conduct of this research 
study. 
 
● 
Authorized representatives of the sponsor of this research study will review and/or obtain 
identifiable information (which may include your identifiable medical information) related to 
your participation in this research study for the purpose of monitoring the accuracy and 
completeness of the research data and for performing required scientific analyses of the 
research data. 
 
● 
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. This means that the researchers cannot release or use information, documents, or 
samples that may identify you in any action or suit unless you say it is okay. They also cannot 
provide them as evidence unless you have agreed. This protection includes federal, state, or 
local civil, criminal, administrative, legislative, or other proceedings. An example would be a 
court subpoena. 
 
● 
There are some important things that you need to know. The Certificate DOES NOT stop 
reporting that federal, state or local laws require. Some examples are laws that require 
reporting of child or elder abuse, some communicable diseases, and threats to harm yourself 
or others. The Certificate CANNOT BE USED to stop a sponsoring United States federal or 
state government agency from checking records or evaluating programs. The Certificate 
DOES NOT stop disclosures required by the federal Food and Drug Administration (FDA). 
The Certificate also DOES NOT prevent your information from being used for other research if 
allowed by federal regulations. 
 
● 
Researchers may release information about you when you say it is okay. For example, you 
may give them permission to release information to insurers, medical providers or any other 
persons not connected with the research. The Certificate of Confidentiality does not stop you 
from willingly releasing information about your involvement in this research. It also does not 
prevent you from having access to your own information. 
 
While the study sponsor understands the importance of maintaining the confidentiality of your 
identifiable research and medical information, UPMC and University of Pittsburgh cannot guarantee 
the confidentiality of this information after it has been obtained by the study sponsor. The investigators 
involved in the conduct of this research study may receive funding from the sponsor to perform the 
research procedures and to provide the sponsor with identifiable research and medical information 
related to your participation in the study. 
 
For how long will the investigators be permitted to use and disclose identifiable information 
related to my participation in this research study? 
The investigators may continue to use and disclose, for the purposes described above, identifiable 
information (which may include your identifiable medical information) related to your participation in 
this research study for an indefinite period of time. This authorization is valid for an indefinite period of 
time. 
 
 
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Additionally, if all information that identifies you is removed from the research data, your remaining 
research data could then be used for future research studies or distributed to another investigator for future 
studies without additional informed consent being obtained. 
 
 
May I have access to my medical information that results from my participation in this research 
study? 
In accordance with the UPMC Notices of Privacy Practices document that you have been provided, 
you are permitted access to information (including information resulting from your participation in this 
research study) contained within your medical records filed with your health care provider. 
 
Is my participation in this research study voluntary? 
Your participation in this research study, to include the use and disclosure of your identifiable 
information for the purposes described above, is completely voluntary. However, if you do not provide 
your consent for the use and disclosure of your identifiable information for the purposes described 
above, you will not be allowed, in general, to participate in the research study. Whether or not you 
provide your consent for participation in this research study will have no effect on your current or 
future relationship with the University of Pittsburgh. Whether or not you provide your consent for 
participation in this research study will also have no effect on your current or future medical care at a 
UPMC hospital or affiliated health care provider or your current or future relationship with a health care 
insurance provider. 
 
May I withdraw, at a future date, my consent for participation in this research study? 
You may withdraw, at any time, your consent for participation in this research study, to include the use 
and disclosure of your identifiable information for the purposes described above. (Note, however, that 
if you withdraw your consent for the use and disclosure of your identifiable medical record information 
for the purposes described above, you will also be withdrawn, in general, from further participation in 
this research study.) Any identifiable research or medical information recorded for, or resulting from, 
your participation in this research study prior to the date that you formally withdrew your consent may 
continue to be used and disclosed by the investigators for the purposes described above. 
To formally withdraw your consent for participation in this research study you should provide a written 
and dated notice of this decision to Dr. Jonassaint, the Principal Investigator of this research study at 
the address listed on the first page of this form. Your decision to withdraw your consent for 
participation in this research study will have no effect on your current or future relationship with the 
University of Pittsburgh, or on your current or future medical care at a UPMC hospital or affiliated 
health care provider or your current or future relationship with a health care insurance provider. 
 
************************************************************************ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
VOLUNTARY CONSENT (FOR PARTICIPANTS AGE 18 YEARS OR GREATER) 
The above information has been explained to me and all of my current questions have been 
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answered. I understand that I am encouraged to ask questions, voice concerns or complaints about 
any aspect of this research study during the course of this study, and that such future questions, 
concerns or complaints will be answered by a qualified member of the research team or by Dr. 
Jonassaint (412.586.6850). I understand that I may always request that my questions, concerns or 
complaints be addressed to Dr. Jonassaint. At any time I may also contact the Human Subjects 
Protection Advocate of the IRB Office, University of Pittsburgh (1.866.212.2668) to discuss problems, 
concerns, and questions; obtain information; offer input; or discuss situations in the event that the 
research team is unavailable. By signing this form I agree to participate in this research study, 
and allow the use and disclosure of my medical record information for the purposes described 
above. A copy of this consent form will be given to me. 
 
 
 
Print Name of Participant 
 
 
 
 
Participant’s Signature 
Date / Time 
 
 
************************************************************************ 
CERTIFICATION of INFORMED CONSENT 
I certify that I have explained the nature and purpose of this research study to the above-named 
individual(s), and I have discussed the potential benefits and possible risks of study participation. Any 
questions the individual(s) have about this study have been answered, and we will always be 
available to address future questions as they arise. I further certify that no research component of this 
protocol was begun until after this consent form was signed. 
 
 
 
Printed Name of Person Obtaining Consent 
Role in Research Study 
 
 
 
 
Signature of Person Obtaining Consent 
Date / Time 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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PARENTAL PERMISSION (For children ages 16-17 or children less than 17 who are developmentally able to 
sign his/her name when verbal assent is obtained from the child) 
 
All the above has been explained to me and all my current questions have been answered. I understand that I 
am encouraged to ask questions about any aspect of this research during my participation, and that such 
future questions will be answered by the researchers listed on the first page of this form. I understand that I 
may always request that my questions, concerns or complaints be addressed by the listed investigators. 
 
If I have any questions about my rights as a research participant, or if I wish to talk to someone other than the 
research team, I may call the University of Pittsburgh Human Subjects Protection Advocate toll-free at 866- 
212-2668. A copy of this form will be provided to me/my child. 
 
 
Printed Name of Child-Subject 
 
I understand that, as a minor (age less than 18 years), the above-named child is not permitted to participate in 
this research study without my consent. Therefore, by signing this form, I give my consent for his/her 
participation in this research study and provide my authorization to share his/her medical records with the 
research team. 
Parent’s or Guardian’s Name (Print) 
Relationship to Participant (Child) 
Parent or Guardian Signature 
Date 
 
CERTIFICATION of INFORMED CONSENT 
I certify that I have explained the nature and purpose of this research study to the above-named individual(s), 
and I have discussed the potential benefits and possible risks of study participation. Any questions the 
individual(s) have about this study have been answered, and we will always be available to address future 
questions as they arise. I further certify that no research component of this protocol was begun until after this 
consent form was signed. 
Name of Person Obtaining Consent (Print) 
Role in Research Study 
Signature of Person Obtaining Consent 
Date 
 
CHILD ASSENT 
This research has been explained to me, and I agree to participate. 
 
Signature of Child-Subject 
Date 
VERIFICATION OF EXPLANATION 
 
I certify that I have carefully explained the purpose and nature of this research to (name of child) in age 
appropriate language. He/she has had an opportunity to discuss it with me in detail. I have answered all his/her 
questions and he/she provided affirmative agreement (i.e., assent) to participate in this research. 
 
 
Signature of Person Obtaining Assent 
Date 
 
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THE BELOW ONLY NEEDS TO BE SIGNED IF THE SUBJECT IS A CHILD AND TURNS 18. 
CONSENT FOR CONTINUED RESEARCH PARTICIPATION 
 
I understand that I am currently participating in a research study. I further understand that consent for my 
participation in this research study was initially obtained from one of my parents/my authorized representative 
as a result of my inability to provide direct consent at the time that this initial consent was requested. I have 
now reached the age of 18 and I am able to provide direct consent for continued participation in this research 
study. 
 
The above information has been explained to me and all of my current questions have been answered. I 
understand that I am encouraged to ask questions, voice concerns or complaints about any aspect of this 
research study during the course of this study, and that such future questions, concerns or complaints will be 
answered by a qualified individual or by the investigator(s) listed on the first page of this consent document at 
the telephone number(s) given. 
 
I understand that I may always request that my questions, concerns or complaints be addressed by a listed 
investigator. I understand that I may contact the Human Subjects Protection Advocate of the IRB Office, 
University of Pittsburgh (1-866-212-2668) to discuss problems, concerns, and questions; obtain information; 
offer input; or discuss situations in the event that the research team is unavailable. By signing this form I agree 
to continued participation in this research study. 
 
By signing below, I agree to continue my participation in this research study and provide my authorization to 
share my medical records with the research team. A copy of this consent form will be given to me. 
 
 
 
Participant’s Signature 
Date 
 
CERTIFICATION of INFORMED CONSENT 
I certify that I have explained the nature and purpose of this research study to the above-named individual(s), 
and I have discussed the potential benefits and possible risks of study participation. Any questions the 
individual(s) have about this study have been answered, and we will always be available to address future 
questions as they arise. I further certify that no research component of this protocol was begun until after this 
consent form was signed. 
 
 
 
Name of Person Obtaining Consent (Print) 
Role in Research Study 
 
 
 
Signature of Person Obtaining Consent 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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