Optimizing Implementation of Mental Health Intervention Within Orthopedic Care
Phase: NA
Conditions: Anxiety, Depression, Back Pain, Neck Pain
Sponsor: Washington University School of Medicine

 
 
 
 
 
 
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Addressing Mental Health in Orthopedic Care 
CPMH R03: Protocol 
 
Principal Investigator:   
Abby Cheng, MD 
 
 
 
Version Date/Number: 
January 11, 2022/ Version 4 
 

 
 
 
 
 
 
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TABLE OF CONTENTS 
 
A 
INTRODUCTION ............................................................................................................................... 3 
A1 
STUDY ABSTRACT ......................................................................................................................... 3 
A2 
PRIMARY HYPOTHESIS ................................................................................................................... 3 
A3 
PURPOSE OF THE STUDY PROTOCOL .............................................................................................. 4 
B 
BACKGROUND .................................................................................................................................. 4 
B1 
PRIOR LITERATURE AND STUDIES .................................................................................................. 4 
B2 
RATIONALE FOR THIS STUDY ......................................................................................................... 5 
C 
STUDY OBJECTIVES........................................................................................................................ 8 
C1 
PRIMARY AIM ................................................................................................................................ 8 
C2 
RATIONALE FOR THE SELECTION OF OUTCOME MEASURES ........................................................... 8 
D 
STUDY DESIGN ................................................................................................................................. 9 
D1 
OVERVIEW OR DESIGN SUMMARY ................................................................................................. 9 
D2 
SUBJECT SELECTION AND WITHDRAWAL....................................................................................... 9 
2.a 
Inclusion Criteria ..................................................................................................................... 9 
2.a 
Exclusion Criteria ..................................................................................................................... 9 
2.b 
Subject Recruitment Plans and Consent Process ..................................................................... 9 
2.c 
Randomization Method ............................................................................................................. 9 
2.d 
Risks and Benefits ....................................................................................................................10 
2.e 
Early Withdrawal of Subjects ..................................................................................................11 
D3 
STUDY DEVICE .......................................................................ERROR! BOOKMARK NOT DEFINED. 
3.a 
Description ................................................................................ Error! Bookmark not defined. 
3.b 
Treatment Regimen ..................................................................................................................11 
3.c 
Method for Assigning Subjects to Treatment Groups ..............................................................11 
E 
STUDY PROCEDURES ....................................................................................................................11 
E1 
SCREENING FOR ELIGIBILITY ........................................................................................................11 
E2 
SCHEDULE OF MEASUREMENTS ....................................................................................................13 
E3 
VISIT 1 ..........................................................................................................................................13 
E4 
FOLLOW UP. ..................................................................................................................................14 
E5 
SAFETY AND ADVERSE EVENTS ....................................................................................................14 
5.a 
Safety and Compliance Monitoring .........................................................................................14 
5.b 
Definitions of Adverse Events ..................................................................................................14 
5.c 
Classification of Events ...........................................................................................................14 
i 
Relationship .......................................................................................................................................... 14 
ii 
Severity .................................................................................................................................................. 14 
iii 
Expectedness ....................................................................................................................................... 15 
5.d 
Data Collection Procedures for Adverse Events .....................................................................15 
5.e 
Reporting Procedures ..............................................................................................................15 
5.f 
Adverse Event Reporting Period ..................................................................................................16 
F 
STATISTICAL PLAN ........................................................................................................................16 
F1 
SAMPLE SIZE DETERMINATION AND POWER .....................................................................................16 
F2 
INTERIM MONITORING AND EARLY STOPPING ..................................................................................16 
F3 
STATISTICAL METHODS ....................................................................................................................16 
G 
DATA HANDLING AND RECORD KEEPING .............................................................................16 

 
 
 
 
 
 
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G1 
CONFIDENTIALITY AND SECURITY ................................................................................................17 
G2 
TRAINING......................................................................................................................................17 
G3 
RECORDS RETENTION ...................................................................................................................17 
H 
STUDY ADMINISTRATION ...........................................................................................................17 
H1 
FUNDING SOURCE AND CONFLICTS OF INTEREST ..........................................................................17 
 
A Introduction 
A1 Study Abstract 
Depression and anxiety heighten musculoskeletal pain and negatively impact 
outcomes after orthopedic surgery. This phenomenon is especially prevalent in 
older adults. Our ongoing pilot work demonstrates promise that an established 
digital mental health intervention (Wysa) can improve orthopedic patients’ mental 
health symptoms, but we also encountered implementation barriers related to 
discussing mental health in an orthopedic setting. The long-term goal of this line of 
research is to enable the provision of true comprehensive care to improve both the 
physical and mental health of orthopedic patients. The goals of this project are to 
address the implementation barriers we encountered in our ongoing pilot work and 
to prepare for a definitive trial to assess the effectiveness of a digital mental health 
intervention in the context of orthopedic care.  
The specific aims are to:  
1.) identify the contextual determinants of implementation success for addressing 
patients’ mental health in the context of orthopedic care ;  
2.) conduct usability testing for two mental health interventions which can feasibly 
be implemented in a real-world orthopedic setting: a digital mental health 
intervention (Wysa) and a novel printed resource guide; and  
3.) identify the intermediate mechanisms through which a digital mental health 
intervention (Wysa) improves mental health symptoms in orthopedic patients. 
Using standard qualitative methods and guided by the Consolidated Framework 
for Implementation Research (CFIR) and the COM-B model of behavior change, 
two stakeholder groups will be interviewed: orthopedic providers and older adult 
orthopedic spine patients.  
In addition to addressing specific needs and preferences related to discussing 
mental health in the setting of orthopedic care, patient stakeholders will complete 
usability testing of Wysa and of the novel printed guide of local and online mental 
health resources.  
Next, the patient stakeholders will receive one month of access to Wysa. They will 
complete measures of clinical effectiveness (self-reported depression, anxiety, 
pain interference, physical function) and hypothesized behavioral targets 
(behavioral activation, pain acceptance, sleep quality) at baseline and one-month 

 
 
 
 
 
 
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follow-up. The study findings will facilitate design of a subsequent clinical 
effectiveness trial that is designed for equitable dissemination and effective 
implementation of mental health intervention within the context of orthopedic care. 
A2 Primary Hypothesis 
The expected results of this project are:  
 
1.) identification of stakeholder-informed implementation strategies for mental health 
interventions tailored for the orthopedic setting,  
 
2.) refined digital and printed mental health interventions that are scalable and 
acceptable to older patients, and  
 
3.) requisite planning data to facilitate successful completion of a subsequent clinical 
trial.  
 
A3 Purpose of the Study Protocol 
 
The goals of this project are to:  
 
1.) identify effective implementation strategies to introduce mental health intervention in 
the context of real-world orthopedic care,  
 
2.) optimize the usability of two mental health interventions (Wysa and a novel printed 
resource guide) for older adult orthopedic patients, and  
 
3.) identify the intermediate mechanisms through which Wysa has an effect.  
 
B Background 
B1 Prior Literature and Studies 
Depression and anxiety heighten musculoskeletal pain and negatively impact outcomes 
after orthopedic surgery.1-5 Targeted mental health treatment can improve both physical 
and mental health in these patients,6-8 but a gap remains in effectively and routinely 
engaging orthopedic patients in mental health care in an acceptable, sustainable, and 
scalable fashion. Barriers include: 1.) limited orthopedic provider time and knowledge to 
discuss mental health resources,9 2.) patient concerns regarding cost, transportation, 
and time necessary for mental health treatment,10-13 and 3.) a national shortage of mental 
health professionals.14 These barriers disproportionately affect minority groups of all 
types.15 
 
Our ongoing, funded pilot work suggests that an established digital mental health 
intervention (Wysa) based on behavioral activation, mindfulness, and sleep health 
meaningfully improves PROMIS Depression and Anxiety scores in orthopedic patients 
across the adult age spectrum at one- and two-month follow-up. However, the clinical 
context (e.g., team member leading the discussion, words used to discuss mental 

 
 
 
 
 
 
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health, volume of information already discussed during the encounter) influences 
providers’ likelihood of discussing the intervention and patients’ interest in trying it. 
 
 
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Among Adults with Arthritis - United States, 2015-2017. MMWR Morb. Mortal. 
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B2 Rationale for this Study 
Depression and anxiety worsen musculoskeletal pain and reduce the effectiveness of 
traditional orthopedic treatments. Nevertheless, addressing mental health is not currently 
a part of standard treatment for orthopedic conditions. The purpose of this study is to 
identify strategies to address mental health in the context of orthopedic care in a manner 
that is feasible, effective, and acceptable to patients and clinicians. 
C Study Objectives 
C1 Primary Aim 
Aim 1: Identify the contextual determinants of implementation success for 
addressing patients’ mental health in the context of orthopedic care. 
Using standard qualitative methods, two stakeholder groups will be interviewed: WU 
orthopedic providers and orthopedic spine patients ≥ 18 years old, with a focus on 
patients 65 years and older. Using purposive sampling, a goal of at least half of patient 
stakeholders will be women, and one quarter will identify as an under-represented 
minority. In semi-structured interviews guided by the Consolidated Framework for 
Implementation Research (CFIR) and the COM-B model of behavior change, providers 
and patients will describe needs and preferences related to addressing mental health in 
a clinical and research context (e.g., recruiting and retaining orthopedic patients in a 
mental health related randomized controlled trial). 
 
Aim 2: Conduct usability testing for two mental health interventions which can 
feasibly be implemented in a real-world orthopedic setting: a digital mental health 
intervention (Wysa) and a novel printed resource guide. 
Using semi-structured interviews and the System Usability Scale (SUS), orthopedic 
patients will participate in an iterative user design process to refine the delivery of Wysa 
and a printed guide of local and online mental health resources. The printed guide is 
being prepared as an “enhanced usual care” control intervention for a subsequent R01 
randomized controlled trial proposal.17 ,18 
 
Aim 3: Identify the intermediate mechanisms through which a digital mental health 
intervention (Wysa) improves mental health symptoms in orthopedic patients. 
In a pilot prospective cohort study, patients will receive one month of access to 
Wysa. Measures of clinical effectiveness (self-reported PROMIS Depression, Anxiety, 
Pain Interference, and Physical Function19) and hypothesized behavioral targets 
(Behavioral Activation for Depression Scale-SF, Chronic Pain Acceptance 

 
 
 
 
 
 
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Questionnaire-8, and Athens Insomnia Scale) will be collected at baseline and one-
month follow-up.20-26 
 
C2 Rationale for the Selection of Outcome Measures 
Depression and anxiety can worsen musculoskeletal pain and reduce the effectiveness 
of traditional orthopedic treatments. Nevertheless, addressing mental health is not 
currently a part of standard treatment for orthopedic conditions. The purpose of this 
study is to identify strategies to address mental health in the context of orthopedic care 
in a manner that is feasible, effective, and acceptable to patients and clinicians.   
D Study Design  
D1 Overview or Design Summary 
This study will utilize qualitative cross-sectional and quantitative longitudinal methods. 
In semi-structured interviews, orthopedic providers and patients with spine conditions 
will discuss their overall perspectives, specific needs, and preferred solutions to 
addressing mental health impairment in the context of orthopedic care and research. In 
these sessions, patient stakeholders will also user test two specific mental health 
interventions: a customized version of a commercial digital mental health intervention 
(Wysa) and a prototype of a print-based mental health resource guide. The patient 
stakeholders will be provided one month of Wysa access, and they will complete 
baseline and follow-up measures related to usability, clinical effectiveness, and 
intermediate behavioral mechanisms through which Wysa is hypothesized to act.  
Wysa usage data will be obtained from the app company. Delivery of Wysa and the 
printed resource guide will be iteratively refined based on user feedback. 13 ,29 ,34-42 
D2 Subject Selection and Withdrawal  
Inclusion Criteria  
o WU Orthopedics patients who are presenting to a spine specialist for 
neck and/or back pain (spine surgeon, physiatrist, or APP within either of 
those two divisions) for new or return evaluation 
o 18+ years old 
o Musculoskeletal pain for 3+ months 
 
Exclusion Criteria  
o Routine post-op visit, with no plans for further surgery at this time 
o Endorses mental health crisis (active suicidal or homicidal ideation, 
psychosis) 
o Cognitive impairment which would interfere with meaningful engagement 
with research interview, questionnaires, and/or intervention 
2.a 
Subject Recruitment Plans and Consent Process 
Providers: 
- 
Eligible providers are already known, through departmental contacts 
- 
E-mail will be sent to eligible providers in batches until enough interviews have 
been scheduled and performed to reach data saturation 

 
 
 
 
 
 
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- 
*Verbal consent (waiver of written consent) requested for providers, since they 
will just be participating in semi-structured interviews. 
Patients: 
- 
Prospectively and/or retrospectively review clinic schedules for surgical and non-
operative orthopedic spine providers 
- 
To reach purposive sampling goals, some potentially eligible patients may be 
called prior to appointment date to notify them of the study, assess preliminary 
interest, and ask to plan staying 60-90 minutes after clinic visit in order to 
participate in study. Also offer to assist with parking expenses (eg parking 
validation ticket at CAM). 
- 
Patients will officially be screened at the time of and/or after their orthopedic 
clinic visit to verify eligibility. 
- 
*Written consent for patients when consent is obtained in clinic. Request the 
option for verbal consent if the participant is consented over the phone/Zoom. 
 
Contact procedures / permission: 
Providers: 
- 
Participants will be e-mailed to be invited to participate. 
- 
They will be asked to complete a brief “demographics” descriptive questionnaire. 
Patients: 
- 
Participants will be called or approached in person to be invited to participate. 
- 
During the consent process, they will be asked whether they agree for e-mail 
and/or text messages to be sent to them. Based on their response, a link to the 
follow-up REDCap survey will be sent via e-mail and/or text message. 
Participants will also be called, e-mailed, and/or text messaged as necessary for 
reminders to complete the survey. 
 
2.b 
Randomization Method  
No randomization method.  No control group. 
2.c 
Risks and Benefits 
Risks: 
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.  
 
Although very unlikely, subjects participating in this study may feel inconvenienced from 
completion of multiple surveys and/or uncomfortable answering some of the survey 
questions. This risk is minimal because participants will be informed of the estimated 
time commitment and general content of the survey questions before they consent to 
participate. The seriousness of this risk is low because participants can withdraw from 
the study at any time.  
 
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. 
 

 
 
 
 
 
 
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Benefits: 
You will not benefit from being in this study. 
 
However, we hope that, in the future, other people might benefit from this study because 
information obtained from this study may lead to a better understanding of how to treat 
patients in an orthopaedic clinic who also experience depression and/or anxiety. 
2.d 
Early Withdrawal of Subjects  
If a participant would like to withdraw from this study, they can contact the study 
coordinator who will document when the patient called to withdraw that their data will not 
be included in any future data analysis from the time of withdrawal.   
2.e 
Treatment Regimen  
After agreeing to participate, patient participants will continue their participation in their 
orthopedic care plan, as directed by their healthcare provider.  We will also assist the 
participant in downloading the Wysa app to their smartphone or other electronic device, 
if desired. Through the Wysa app, participants can track and manage their emotions, 
and they can learn research-based techniques to help them feel better and manage any 
stress or pain they may be dealing with. Participants will have access to research-based 
wellness tools such as supportive listening, deep breathing techniques, guided 
meditation, yoga, and more. Participants can communicate with a virtual artificial 
intelligence (AI) chatbot, and/or they can message a highly trained and qualified human 
well-being coach. The intended use of the Wysa app is to encourage mental well-being 
as an early intervention tool in a self-help context. The Wysa app is considered 
investigational, which means that it has not been approved by the U.S. Food and Drug 
Administration. 
 
Participants will have access to the Wysa app services for one month, and they can use 
any or all of the services as much or as little as they find useful. No one on the 
Washington University study team will read participants’ chats to the Wysa chatbot. Any 
chats with a human Wysa well-being coach will remain between just the participant and 
their coach. The study team will only receive information on whether the participant used 
the Wysa app, how much they used each feature and/or found it helpful. Participants will 
be e-mailed and/or sent a text message to the follow-up survey link after one month. The 
surveys will ask them about their current level of wellness and whether they found the 
app helpful. 
 
 
  
2.f 
Method for Assigning Subjects to Treatment Groups  
No control group.  Everyone in the provider group, gets the same treatment, and 
everyone in the patient group will get the same treatment. 
E Study Procedures  
E1 Screening for Eligibility 
 

 
 
 
 
 
 
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Recruitment of orthopedic provider stakeholders: 
Three of the study investigators are faculty members within the WU Department of 
Orthopaedic Surgery. As such, they have professional and personal relationships with 
the vast majority of the 70+ orthopedic clinicians and their support staff at WU. These 
relationships will facilitate a high rate of rapid recruitment from this group of stakeholders 
into the study. In addition to universal secure, virtual meeting capabilities among this 
group (Zoom-HIPAA), all orthopedic faculty members have dedicated, secure academic 
office space in which private semi-structured interviews can be conducted in person. 
 
Recruitment of orthopedic patient stakeholders: 
The study PI (Dr. Cheng) is one of over 15 spine care subspecialists within the WU 
Department of Orthopaedic Surgery. She and her colleagues manage patients with a 
range of sociodemographic backgrounds at multiple clinic sites across the St. Louis 
metro region including the Barnes-Jewish Center for Advanced Medicine, Barnes-Jewish 
Hospital Center for Outpatient Health, Barnes-Jewish West County Hospital, and the 
Barnes-Jewish Center for Advanced Medicine – South County. Furthermore, all of the 
WU Orthopedics spine patients complete depression and anxiety measures as standard 
care during each clinical encounter (PROMIS CAT Depression and Anxiety), and Dr. 
Cheng’s research coordinator has specifically enrolled older adult orthopedic patients 
with spine conditions into mental health related research studies by using these 
measures as screening items. This patient base and the mental health screening 
measures will facilitate seamless recruitment of patient stakeholders with a range of self-
reported depression and anxiety symptom severity. Additionally, Dr. Cheng and several 
other spine providers have adequate clinical space to allow patient rooms to be used for 
research during clinic hours, and her team has experience recruiting, consenting, and 
enrolling patients into research studies in person and virtually (via phone or Zoom-
HIPAA), from her own clinics and from those of her clinical colleagues. The in-person 
and virtual participation options will allow patients to participate in the semi-structured 
interview and usability testing in whichever format is preferred. When convenient for the 
participant, study recruitment, consent, and the interview can be completed within 
approximately one hour of the patient’s clinical encounter.   

 
 
 
 
 
 
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E2 Schedule of Measurements 
 
E3 Visit 1  
Providers: 
- 
Interviews will occur face-to-face (in a private room) or via Zoom, 
whichever the participant prefers. Interviews will be audio and possibly video 
recorded, using WU-HIPAA Zoom technology, handheld audio recorder(s), 
and/or other similar device. The recordings will be used to transcribe the 
interview conversation. After the interview, the recording will then be reviewed by 
a study team member, and all personal identifiers will be removed prior to being 
uploaded into Rev.com to be transcribed into text for qualitative analysis. 
Patients: 
- 
Whenever possible, interviews will occur face-to-face immediately after  
the participant’s orthopedic clinic visit (before the patient has left the  
clinic) 
- 
If not possible, the participant will be given the option to return to campus  
for an in-person interview or to complete the study remotely via Zoom. Interviews will be 
audio and possibly video recorded, using WU-HIPAA Zoom technology, handheld audio 
recorder(s), and/or other similar device. The recordings will be used to transcribe the 
interview conversation. After the interview, the recording will then be reviewed by a study 
team member, and all personal identifiers will be removed prior to being uploaded into 
Rev.com to be transcribed into text for qualitative analysis. 
Contact procedures / permission: 
Providers: 
- 
Participants will be e-mailed to be invited to participate. 
- 
 
Patients: 
- 
Participants will be called or approached in person to be invited to  
participate. 
- 
During the consent process, they will be asked whether they agree for e- 
mail and/or text messages to be sent to them. Based on their response, a 
link to the follow-up REDCap survey will be sent via e-mail and/or text 
message. Participants will also be called as necessary for reminders to 
complete the survey.. 
 
Proposed events chart: 
Providers: 
 
Baseline 
Follow-up 
Intake survey 
X 
 
Interview 
X 
X (If needed) 
 
Patients: 
 
Baseline 
1 Month 
Intake survey 
X 
 
Interview 
X 
 
Usability testing of Wysa and 
X 
 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
 
 
14
printed guide 
System Usability Scale (printed 
guide) 
X 
 
System Usability Scale (Wysa) 
X 
X 
BADS-SF 
X 
X 
CPAQ-8 
X 
X 
Athens Insomnia Scale (AIS) 
X 
X 
PROMIS measures 
X (Standard care) 
X 
Follow-up survey 
 
X 
 
E4 Follow up.  
A link to the follow-up REDCap survey will be emailed and/or text messaged to patient 
participants at one month. These surveys, listed in the chart above, will be the system 
usability scale (Wysa), BADS-SF, CPAQ-8, Athens Insomnia Scale (AIS), PROMIS 
measures, and a follow up survey.  This will be for the patient participats only, and the 
only follow up that will occur. 
E5 Safety and Adverse Events  
 
5.a 
Safety and Compliance Monitoring 
The research coordinator will document any adverse events reported and review these 
adverse events with the principal investigator as they arise.   
 
If excessive adverse events are reported, the principal investigator will evaluate weather 
a participant should be removed from the study to ensure the study participants are not 
being injured. 
5.b 
Definitions of Adverse Events 
Any unfavorable medical occurrence in a human subject including any abnormal sign, 
symptom, or disease. 
5.c 
Classification of Events 
i 
Relationship 
The adverse event will be considered related to the study if it was determined to be due 
to using the Wysa app. 
ii 
Severity 
Any adverse experience occurring at any time that results in any of the following 
outcomes: 
o Death 
o A life-threatening experience 
o Inpatient hospitalization or prolongation of existing hospitalization 
o A persistent or significant disability/incapacity (i.e., a substantial disruption of a 
person’s ability to conduct normal life functions) 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
 
 
15
o A congenital anomaly/birth defect 
o Any other experience which, based upon appropriate medical judgment, may 
jeopardize the subject and may require medical or surgical intervention to 
prevent one of the outcomes listed above 
iii 
Expectedness 
Any adverse event, the specificity or severity of which is not consistent expected risks in 
this study. 
 
Risks: 
Participants 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.  
 
Although very unlikely, subjects participating in this study may feel inconvenienced from 
completion of multiple surveys and/or uncomfortable answering some of the survey 
questions. This risk is minimal because participants will be informed of the estimated 
time commitment and general content of the survey questions before they consent to 
participate. The seriousness of this risk is low because participants can withdraw from 
the study at any time.  
 
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. 
 
Unanticipated problem involving risks to participants or others 
 
o Are unexpected (in terms of nature, severity, or frequency) given (a) the research 
procedures that are described in the study-related documents, such as the IRB-
approved research study and informed consent document; and (b) the 
characteristics of the subject population being studied; and 
o Are related or possibly related to participation in the research; and 
o Suggest that the research places participants or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 
5.d 
Data Collection Procedures for Adverse Events 
The research coordinator will document any adverse events reported in a spreadsheet 
that is password protected and only available to be viewed by the study team. 
 
All adverse events will be reviewed by the principal investigator as they arise. 
5.e 
Reporting Procedures 
Events will be reported per the Washington University Institutional Review Board 
Procedures.   
 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
 
 
16
5.f 
Adverse Event Reporting Period 
Events that qualify for immediate reporting described above will be reported within the 
following timeframe: 
a. 10 working days of the occurrence of the event or notification to the PI or 
research team of the event.  
b. The death of a research participant should be reported within 1 working day of 
the occurrence of the event or notification to the PI or research team of the event.  
 
Adverse events/other events that do not require immediate reporting will be provided to 
the IRB in summary format at the time of continuing review. 
F Statistical Plan  
F1  Sample Size Determination and Power 
No power calculation was performed for this study because the primary aim involves 
a qualitative analysis. The sample size will be determined by reaching data 
saturation from the provider and patient stakeholder interviews. 
F2  Interim Monitoring and Early Stopping 
The Principal Investigator will take responsibility for monitoring patient safety.  Patients 
in the study will be monitored on an as needed basis to assure that they are doing well.  
 
Adverse events will be assessed by Dr. Cheng to determine if they are serious, 
unexpected and related to the study procedures.    
 
If a complication should arise, the patient would be previously instructed how to contact 
the research coordinator.  
F3  Statistical Methods  
Interviews will be audio recorded and professionally transcribed. Using inductive and 
deductive coding approaches based on CFIR and COM-B, a codebook will be developed 
by one team member, and one or more team members will code all transcripts using 
NVivo. Group discussion among the research team will be used to resolve coding 
discrepancies, confirm data saturation has been reached, and organize codes into 
themes. Scores on the System Usability Scale will be used to iteratively refine both 
mental health interventions under investigation. Longitudinal PROMIS score changes will 
be compared between “high” and “low” Wysa users (defined by total Wysa interactions), 
and associations between changes in behavioral targets (behavioral activation, pain 
acceptance, sleep quality) and clinical outcomes (depression, anxiety) will be assessed.  
. 
 
G Data Handling and Record Keeping  
 

 
 
 
 
 
 
______________________________________________________________________________________ 
 
 
 
17
G1 Confidentiality and Security 
Plans to protect the privacy interests of the participants during the conduct of the study: 
1) Only the minimum necessary private information is collected for the purposes of 
the study 
2) Any procedures or interventions conducted as part of the study will be conducted 
in private setting to the extent possible 
3) Recruitment/consent will occur in a private setting 
4) Participants will be able to ask questions in a private setting 
 
 
Project uses paper and hard copy consents, surveys, data collection forms, research 
subject binders, or other hard copy materials: 
 
1) All materials are stored in secured environment 
2) Access is limited to research team members only 
3) Transported securely/shipped with tracking mechanism 
 
 
Project collects, stores and/or transmits electronic data on mobile devices, desktop 
computers, servers including cloud servers, email, or any other information in electronic 
form:  
1) Password protected 
2) Access is limited to research team only 
3) Data in Redcap 
4) Data in Box 
5) eCRF system 
6) Transmitted using recognized security for electronic submission 
7) Recordings taken during interviews with providers and patients will be reviewed 
by a study team member, and all personal identifiers will be removed prior to 
being uploaded into Rev.com to be transcribed into text for qualitative analysis. 
 
Other 
 
G2 Training  
Study coordinator was trained in the Wysa software, and is able to explore the app with 
the participants in the patient population for use on their own.  No formal training is 
necessary for this study. 
G3 Records Retention 
All research data will be retained in a locked office in a locked cabinet for 10 years after 
the closure of the study. 
H Study Administration 
H1 Funding Source and Conflicts of Interest 
This study is funded by a WU Center for Perioperative Mental Health R03 Pilot and 
Feasibility Award. The study start date was 12/1/2021.