The Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment
Phase: NA
Conditions: Depressive Symptoms, Anxiety Generalized
Sponsor: University of Pennsylvania

Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment 
NCT04011540 
January 6, 2022 
 
 
1
Trial Protocol and Statistical Analysis Plan 
 
 
Final protocol ................................................................................................................................................... 
Final statistical analysis plan ............................................................................................................................ 
Summary of statistical analysis plan changes .................................................................................................. 
 

Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment 
NCT04011540 
January 6, 2022 
 
 
2
Abstract 
Due to the widespread use of social media, behavioral health providers have increasingly interacted 
and/or reviewed patients social media activity. This project seeks to harness social media data in a 
clinical mental health setting by partnering with both patients and their providers. We will work with 
these two groups to create social media and digital data dashboard that can be shared before or during 
clinical encounters. Our objective is to explore and evaluate how a patient-centered personalized social 
media summary dashboard could be used in a behavioral health therapy session to improve depressive 
symptoms and anxiety and if a social media dashboard improves patient and provider therapeutic 
alliance and engagement.  
 
Background 
Last year, approximately 4 million adults and 2 million adolescents received any mental health care. 
Mental health treatment can be highly effective in reducing symptoms and improving functioning of 
people in psychiatric distress. The nature of the clinical encounter is such that there can be a 
disconnection between it and the rest of the patients life. That is, patients may meet for 50 minutes 
with their therapist once a month or in rarer cases once a week. The therapist relies almost solely on 
patient report of thoughts, mood and behavior, and the events that preceded and followed them. Recall 
bias, social desirability bias, and the nature of the therapeutic relationship all may affect the accuracy, 
completeness and quality of the information the patient shares with his/her therapists. Poor accuracy of 
this communication then can affect the quality and outcomes of therapy. In some cases, changes in 
mood and adverse life-threatening events may be missed. It is not uncommon for patients to share 
written communication (e.g. a letter) with their therapist that occurred between the patient and a third 
party. These artifacts can be helpful to the therapist in assessing the patients mental state at the time of 
the communication and in providing feedback and advice regarding relationships. It is increasingly likely 
that this written communication will be electronic. Electronic communication, including emails, texts 
and social media, are now ubiquitous in our society. Approximately 2.4 million emails are sent per 
second, 22 billion texts per day. More than 79% of US adults actively use Facebook and use across other 
platforms like Twitter and Instagram is growing exponentially. These communications may offer an 
exciting way to support the effectiveness of mental health treatment. They can offer insight into 
patients mood, thoughts, lifestyle, and behavior that may not be available otherwise. This area of study 
raises several questions such as: How can clinicians best make use of the huge volume of raw, 
unstructured data that are available through social media and electronic communication (i.e. texts, 
emails)? How do therapists incorporate this data in the most productive way, without disrupting the 
therapeutic process? We strongly believe that there will be value in linking individual level information 
on social media to health outcomes and behavior; a better understanding actual patient willingness to 
share online data output could help to significantly improve our understanding of applications of digital 
data for health research. Our assumption is that ultimately this information will have tremendous utility 
for supporting more measurement-based care. In our ongoing work at Penn (Penn IRB 819442) we have 
enrolled over 6000 patients to share access to social media and EMR data. Of individuals who use social 
media and are willing to participate in research, approximately 85% of patients agree to share social 
media and EMR data. To date we have used this data to predict differences in medical diagnoses (e.g. 
hypertension, depression). We have also generated patient dashboards of general information about 
their health and social media use (Penn IRB: 819442)  
 

Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment 
NCT04011540 
January 6, 2022 
 
 
3
Overall Objectives 
Our objective is to explore and evaluate how a patient-centered personalized social media summary 
dashboard could be used in a behavioral health therapy session to improve depressive symptoms and 
anxiety and if a social media dashboard improves patient and provider therapeutic alliance and 
engagement. 
Aims 
Primary Aims  
Determine the impact of incorporating digital data and electronic communication dashboard in 
behavioral health treatment on patient reported health-related quality of life (SF-36) compared to usual 
care  
Secondary Aims  
Determine the impact of incorporating digital data and electronic communication dashboard in 
behavioral health treatment on patient-reported depressive (PHQ-8) and anxiety (GAD-7) symptoms 
compared to usual care.  
Determine the impact of incorporating digital data and an electronic communication dashboard in 
behavioral health treatment on therapeutic alliance (WAI-SR) compared to usual care.  
Determine the impact of incorporating digital data and an electronic communication dashboard in 
behavioral health treatment on the CIS checklist compared to usual care. 
Primary Outcome Variable 
Examine self-report of health-related quality of life (SF-36), specifically mental health (vitality, social 
functioning, role-emotional and emotional well-being) under the intervention and control conditions 
and the change over the study period. 
Secondary Outcome Variables 
Examine depression (PHQ-8), anxiety (GAD-7), and therapeutic alliance (WAI-SR) under the intervention 
and control conditions and the change over the study period.  
Examine the therapeutic alliance (WAI-SR) and frequency digital data and electronic communication is 
discussed in therapy (CIS checklist) under the intervention and control conditions and the change over 
the study period.  
Study Design 
Phase 
Not applicable  
Design  
A randomized controlled trial for patients and their mental or behavioral health provider from Penn 
Medicine, Hall Mercer, and/or Horizon House or greater Philadelphia mental health practices and clinics 
to investigate the impact of incorporating digital data and electronic communication dashboard in 
behavioral health treatment session. Patient and provider participants will be randomized to receive the 

Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment 
NCT04011540 
January 6, 2022 
 
 
4
treatment (having a digital health dashboard to be used at least two therapy sessions over a 2-month 
period) or the control (usual care). Participants who consent to share their social media and digital data, 
we will use a Facebook application previously designed for this purpose, Instagram API to access data, 
and Google take-out file. Patients will visit on an incognito browser https:// 
donate.centerfordigitalhealth.upenn.edu to safely and securely download social media and digital data. 
The data collection platform was reviewed by Penn Medicine IS team, please approval attached to this 
submission. Participants who agree to share their social media data will log in to their own Facebook 
account and download an application. When users first activate the application, they grant the right to 
researchers to access the information contained in their Facebook profiles. They will then be directed to 
a Facebook application called Penn Image Station that was designed for the purposes of this study. The 
Penn Image Station application will gather information from their Facebook public profile, status 
updates, personal description, and likes. The application will not affect their usual use of Facebook nor 
will it post to their page. Facebook data will be collected historically (all data that ever existed) and 
prospectively for 60 days. If they share their Google take-out, they will download a zip file of their 
google searches and YouTube activity. Google take-out data is only historical and retrospective. If the 
participant shares their Instagram posts, they will be directed to an Instagram application called Penn 
Social Mediome. They will read a brief statement, either agree or disagree with the statement, and then 
log on to their Instagram account. Their Instagram posts and photos will be extracted by the Penn Social 
Mediome application and will be collected historically and 60 days prospectively. No passwords would 
be collected by the study team. Patient participants will be asked to download AWARE, a free app on 
their smartphone. AWARE is an Android framework dedicated to instrument, infer, log and share mobile 
context information, for application developers, researchers and smartphone users. AWARE captures 
hardware-, software-, and human-based data. The data is then analyzed using AWARE plugins. AWARE is 
compatible on iPhone, Android, and Google phones. The use of the AWARE app in Penn research 
projects has been previously approved IRB #83254, The Networks of Daily Experiences (NODE) Study: 
Within-Person Change in Curiosity and Implications for Well-Being, (PI: Danielle S. Bassett, Ph.D). When 
subjects download the application, they will enter a Study ID number, which will be used to link their 
data with survey responses from Way to Health unique ID number. AWARE. Aware data will be included 
for only 60 days prospectively. This application and methodology has been previously used by 
investigators in this protocol for research within the World Well Being Project at the Positive Psychology 
Center at the University of Pennsylvania (prior Penn IRB protocols #816091, 813820, 819442, 824493). 
After completing the survey, donating their digital data, and downloading AWARE app, participants will 
be enrolled in Way To Health, a HIPAA compliant research infrastructure to receive complete day 60 and 
day 90 surveys. Patient participants will be contacted up to 5 times to complete each survey. If patient 
participants are randomized to the intervention arm, they will be prompted to complete text message 
prompts before each therapy session. The text message prompts entail appointment reminders and how 
to contribute screenshots to populate their electronic communication and digital data dashboard. The 
informed consent documents outline how patients will not contribute any PHI data through the Way to 
Health texting platform and how to only respond to the text message prompts. Additionally, if patients 
are randomized to the intervention arm, they will also be coached and briefed on text message 
confidentiality and privacy best practices. After approximately seven days from when digital data is 
received, the patients randomized to the intervention group will receive their first electronic 
communication and digital data dashboard summarizing findings from their historical social media, 
google take-out, and AWARE data. For example, electronic communication and digital data dashboard 
will include information such as average amount of time spent on smartphone during 12am-4am, 
physical activity callouts (i.e., most and least moved days), and most commonly used words on Google 

Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment 
NCT04011540 
January 6, 2022 
 
 
5
search and YouTube. If patients want to share additional digital data, they will text in screenshots via 
Way to Health (safety and privacy measures are noted above). The provider participants randomized to 
the intervention arm will receive a brief training on the dashboard components and safety and privacy 
practices. Providers will watch a 3-minute video explaining how they will receive the dashboard each 
week and what data is being included. For example, the video breaks down each module. For the late-
night phone activity module, it states late night phone activity is the amount of time your patients 
phone screen is on. The amount of time one spends on their phone is relative to each person and there 
is no right or wrong amount of time. No specific post or activity will be highlighted on the dashboard; 
rather trends and summaries will be displayed. The research team will work closely with the patient 
participant and their provider to distribute the dashboard before the patients next behavioral health 
appointment. The provider participants randomized to the intervention arm, will be emailed their 
patients dashboard via Penn +Box, a cloud-based collaboration service for securely managing and 
sharing files and folders within the Penn community and externally. Penn+Box also ensures that 
University data and intellectual property are securely protected. In addition, Penn Medicine providers 
can elect to have the dashboard delivered to their office, 3535 market, each morning at 9:30 am or 
before they see their patient. Dashboards will be delivered in a sealed envelope and delivered to the 
clinic front desk person or directly to the therapist. There will be no medical advice or evaluation will be 
included in a dashboard. If a dashboard is unable to be generated, the patient will be prompted to bring 
their smartphone into session and to discuss something from it, if applicable. 
Method for Assigning Subjects to Groups  
Patient participants will be randomized after they donate digital data sources and complete baseline 
survey. We will use Way to Health’s computer-generated algorithm to randomize patient participants in 
block sizes of 2, 4, and 6. Patient participants will be randomly assigned to control (usual care) or 
experimental group (use of digital health dashboard over the 2-month study period). Study assignments 
will be stored in Way to Health. The study will be single-blinded. The research team will know which 
participants are receiving the active medication or treatment and which are not. The participants will 
not be blinded to their assignment. Provider participants will be enrolled in the arm of their patient. 
There is possibility that provider participants are exposed to the intervention for 1 patient and usual 
care for another, despite this limitation, we will control for contamination in analyses. The study 
biostatistician will determine when to unblind the study. 
 
Study Duration  
This entire study will last approximately 2 years. Randomized controlled trial participants, both patient 
and providers, involvement is approximately 3 months, 90 days. 
Facilities 
Our team is diverse and multi-disciplinary. Dr. Raina Merchant is an Associate Vice President at Penn 
Medicine and an Associate Professor of Emergency Medicine at the University of Pennsylvania. She has 
secondary appointments in the Department of Internal Medicine and Department of Anesthesia and 
Critical Care. Dr. David Mandell is a Professor of Psychiatry at the University of Pennsylvania, where he 
directs the Center for Mental Health Policy and Services Research. He also is Vice-Chair for Research. He 
has a 30-year history of partnering with mental health providers in Philadelphia to improve care. Dr. 
Sharath Guntuku is a postdoctoral researcher and his research leverages large-scale social media image 
and text data to model social health outcomes and psychological traits. Dr. Rinad Beidas is an Assistant 
Professor of Psychology in Psychiatry in the Perelman School of Medicine, University of Pennsylvania. 

Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment 
NCT04011540 
January 6, 2022 
 
 
6
She is the Director of Implementation Research for the Center for Mental Health Policy and Services 
Research and the Director of the Implementation Science Working Group at the University of 
Pennsylvania. Dr. Brenda Curtis is an Assistant Professor of Psychology in Psychiatry at the University of 
Pennsylvania. Dr. Curtis is the recipient of a research project grant (R01) awarded from the Collaborative 
Research on Addiction at NIH (CRAN) in which she is using social media data to predict alcohol and other 
drug relapse and treatment completion among patients who have recently entered community 
outpatient treatment programs. She is also currently serving as an investigator on several R01 grants 
funded by NIAAA, NCI, and NIDA including a placebo-controlled trial of bupropion for smoking cessation 
in pregnant women using SMS text messaging to promote medication adherence and a trial examining 
the impact of a smart-phone based continuing care app for alcohol dependence. Rachelle Schneider 
received her Bachelor of Science in Criminology from Pennsylvania State University and will start a part-
time Master of Social Work course of study in the fall at the University of Pennsylvania. She has 
extensive experience recruiting for clinical trials across various sites. Lauren Southwick received her 
Master of Public Health from the Harvard T.H. Chan School of Public Health in the Department of Social 
and Behavioral Sciences where she concentrated in health communication and social/behavioral change 
theories. Prior to joining the CDH, Lauren worked at the New York University College of Global Public 
Health in the Division of Social Epidemiology. She graduated from Franklin & Marshall with a Bachelor of 
Arts in Sociology. We hold weekly team meetings to keep all team members abreast with updates and 
protocol. We also circulate weekly meeting minutes and actions steps to enumerate research related 
duties and responsibilities. We also allow adequate sufficient time for the researchers to conduct and 
complete the research. There are adequate facilities for the research as our team is based out of PCAM 
and 3535 Market street offices. 
Key Inclusion Criteria  
Patient Inclusion - Between 18-65 years of age - Primarily English speaking (for language analysis) Willing 
to share at least one digital data source this includes Facebook, Google searches, YouTube searches, or 
screen time by downloading a free application (app) on their smartphone. - Has a mental or behavioral 
health provider and currently enrolled in mental or behavioral therapy - Attends therapy at least once a 
month and expected to remain in therapy for the next three months - Willing to share social media 
dashboard with their behavioral health provider - Able to provide informed consent - Regular activity 
viewing and posting on social media sites, defined as once a month posting - Owns an Smartphone -
Willing to download and keep an app on their phone for 3 months  
Provider Inclusion - 18 years of age or older - Primarily English speaking - Provides therapy for patient 
participant - Willing to review a summarized social media dashboard before or in a therapy session 
Intends to complete post therapy weekly surveys  
Key Exclusion Criteria  
Patient Exclusion - Under 18 years of age - Non-English speaker - Patient is in severe distress, e.g. 
respiratory, physical, or emotional distress - Patient is intoxicated, unconscious, or unable to 
appropriately respond to questions - Not currently enrolled in therapy or does not attend at least 
monthly - Not expected to remain in therapy for the next three months - Not a regular social media 
poster, or does not use Facebook, Instagram and/or not willing to share - Unwilling to share social media 
summary dashboard with behavioral health provider - Patient with diagnosed psychosis -Does not own a 
smartphone - Unwilling to download and keep an app on their phone for 3 months.  

Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment 
NCT04011540 
January 6, 2022 
 
 
7
Provider Exclusion - Under 18 years of age - Non-English speaker - Not a registered behavioral health 
provider - Not provider for a RCT participant - Unwilling to review a social media summary dashboard 
before or during in a therapy session with RCT participant - Unwilling to complete weekly surveys  
Subject Recruitment  
Target Population  
The target population is participants 18 years and older, primarily English speaking, a self-report of 
anxiety and/or depression, seeking mental health therapy at outpatient Penn Medicine clinics, Hall 
Mercer, and/or Horizon House; Center for Cognitive Therapy, Center for the Treatment and Study of 
Anxiety, Department of Psychiatry at the Perelman School of Medicine, or greater Philadelphia mental 
health practices and clinics, or public/private mental health centers/clinics in the continental U.S. 
Patient patients are expected to attend therapy sessions at least once a month for 3 months. Provider 
Participant, the target population is a provider who provides therapy sessions for a patient participant. 
Patient Participant The target population is participants 18 years and older, primarily English speaking, a 
self-report of anxiety and/or depression, seeking mental health therapy at outpatient Penn Medicine 
clinics, Hall Mercer, and/or Horizon House; Center for Cognitive Therapy, Center for the Treatment and 
Study of Anxiety, Department of Psychiatry at the Perelman School of Medicine, or greater Philadelphia 
mental health practices and clinics and attends therapy sessions at least once a month for 3 months. 
Provider Participant, the target population is a provider who provides therapy sessions for a patient 
participant.  
Accrual  
We will draw upon our working relationships with our various recruitment sites. The randomized 
controlled trial will be powered on SF-36 change in the patient participant. We used PASS to calculate 
the minimum detectable score difference required for over 80% power assuming a type I error rate of 
0.05. We assumed 50 in each arm. We used the test for two means in a repeated measures ANCOVA. 
We assumed the correlation between repeated measures to be 0.60 (r2=0.36). The following values 
were used in the sample size calculations: SF36 Norms Mental Component Summary (MCS): mean = 50; 
sd = 10 Vitality: mean = 60.9; sd = 21.0 Social Functioning: mean = 83.3; sd = 22.7 Role-Emotional: mean 
= 81.3; sd = 33.0 Mental Health: mean = 74.7; sd = 18 Table: Minimum detectable score differences 
Sample Size 50 in each arm MCS 5 Vitality 10 Social Functioning 11 Role-Emotional 15 Mental Health 9 
We aim to enroll 115 participants in a randomized controlled trial, with the anticipation that there will 
be 15% attrition.  
Patient Subject Recruitment  
We will identify participants across several settings: inpatient and outpatient Penn Medicine clinics (e.g., 
Emergency Department, Internal Medicine, Center for Cognitive Therapy, PIC, LGH mental health 
clinics), flyers at 3535 market and Penn Medicine iConnect (Use of Patient Electronic Communication in 
Psychiatric Evaluation and Treatment, Study Identifier: 831246), Google ads, Facebook ads, 
ResearchMatch.org, and provider referrals. Interested patient participants will be directly approached 
by a research assistant (RA) via email, telephone or BlueJeans. Patients who are receiving care in these 
settings will receive a digital or printed flyer about the opportunity to participate in a research study. In 
outpatient units, Ras or AAs will meet regularly with the nursing coordinator, office manager, charge 
nurse, nurse/ physician team to determine the daily census and appropriateness of approaching 
patients. If necessary, research assistants will also communicate directly with patients providers 
(physicians, residents or nurses) to determine whether it is appropriate to approach the patient. 

Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment 
NCT04011540 
January 6, 2022 
 
 
8
Potentially eligible patients will be approached via email, telephone or BlueJeans to verify they meet all 
inclusion criteria and will then be asked to participate.  
Compensation  
Patient participants will receive a $50 Greenphire clincard at baseline once they complete the baseline 
survey, download AWARE, and donate digital data. At day 60, once they complete the day 60 survey and 
interview, $100 will be loaded on their Greenphire clincard. At day 90, patients will receive another $50 
if they complete a survey. Provider participants in both arms will receive $50 a month on a Greenphire 
clincard or allocated to their clinic for completing post-therapy survey and the day 60 and 90 monthly 
survey. At day 60, providers will be asked to complete a debriefing interview. Provider participants will 
receive additional $50 loaded to their Greenphire clincard or allocated to their clinic if they complete 
80% of the CIS checklist surveys, which is approximately 7 of 8 surveys  
Study Procedures 
Consent Process  
Potentially eligible patients will be approached to verify they meet all inclusion criteria and will then be 
asked to participate. A RA will approach participants and explain the study in brief via email, telephone, 
BlueJeans or in-person. Subjects will be asked to confirm whether they will share or not share their 
Facebook and or Instagram data with health researchers as described in this protocol. Patients willing to 
share will complete a consent form. All consents will be obtained in a secure and private area on UPenns 
campus or University city or online. All efforts will be made to ensure that patients understand that 
participation is voluntary and will not affect their care or treatment in any way. The RA will obtain 
informed consent using the attached paper consent form or online. The RA will describe the study in 
detail, including the survey and the use of the Facebook/Instagram application/ plugin to extract their 
posts for language and photo analysis, AWARE app, and google search download instructions. The 
participant may refuse to answer any questions for any reason, can skip any question, and can stop 
participation at any time. Subjects may uninstall the Facebook/Instagram app to stop sharing their posts 
at any time. Or they may contact the research team as described in the consent to have their 
information deleted and permanently removed from the study database. The verbal consent form 
indicates that the participant may refuse to answer any questions for any reason, can skip any question, 
and can stop at any time. The research presents no more than minimal risk of harm to subjects and 
involves no procedures for which written consent is normally required outside of the research context. 
All study activities will occur in-person during enrollment or on the Way to Health, HIPAA Compliant 
platform, stored on PMACS. The research presents no more than minimal risk of harm to subjects and 
involves no procedures for which written consent is normally required outside of the research context. 
The study is not intervening or currently changing patient care. We will tell participants that we are not 
using the data for diagnostic purposes and the identifying information we will collect includes name, 
age, race, gender, and email address, cell-phone number, home address, and social security number.  
Minimal Risk 
This study is minimal risk and there are no known risks associated with participation in this research 
beyond those of everyday life. 
Analysis Plan  
Stata, SAS, and NVivo software will be used for analyses. All data will be summarized using descriptive 
statistics (mean or median, standard deviation, or interquartile range for continuous variables, 

Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment 
NCT04011540 
January 6, 2022 
 
 
9
frequencies for categorical variables) and graphical techniques (histograms, scatterplot) as appropriate. 
Standard summary descriptive statistics to be used to analyze data from the survey. We will extract data 
from social media and wearable device platforms and aggregate to develop dashboards. Qualitative 
analysis using grounded theory will be applied for the focus group discussion, interviews, and open-
ended survey questions. We will conduct an intent to treat (ITT) analysis. The ITT analysis will include all 
randomized patients in the groups to which they were randomly assigned, regardless of their adherence 
with the entry criteria, regardless of the treatment they actually received, and regardless of subsequent 
withdrawal from treatment or deviation from the protocol. Baseline demographic and clinical 
characteristics will be reported as frequency and percent for categorical variables and median and 
interquartile range (IQR) for continuous variables. We will compare baseline characteristics between 
intervention and control arms using t-tests for continuous variables and chi-squared tests for categorical 
variables. The goal of these comparisons will be to determine if the two arms are balanced on baseline 
variables after randomization. For the primary analysis, we will use linear mixed effects models to assess 
whether average of SF 36 scores over study follow-up differ between the two arms. We will use a 
random effect to account for the correlation in repeated outcome measures over time within 
participants. We will also account for correlation in outcome measures by therapist (as participants will 
be randomized within therapist), by including additional random effects to account for the nesting of 
patients within therapists. The primary parameter of interest will be a binary indicator for treatment 
arm assignment. Models will also include a variable for time of measurement. Baseline covariates that 
are found to be unbalanced between arms may be adjusted for in the model if they were deemed to be 
potential confounders a priori to adjust for potential confounding and for efficiency gain. We will use all 
available SF 36 scores on eligible patients from randomization through the last observation. An 
advantage of the linear mixed effects model is that it is robust to missing outcome measures as long as 
the missingness mechanism is missing at random (MAR). Patterns of missingness will be assessed 
carefully and multiple imputation will be used if deemed appropriate. Robust (empirical) standard errors 
will be used. A p0.05 will be deemed statistically significant but emphasis will be placed on point 
estimates and confidence intervals. In secondary analysis, we will also include an interaction term 
between intervention arm and time in order to assess whether the intervention affects the slope of SF 
36 scores over time. We may also consider testing interactions between intervention and sex or other 
important covariates to test if there are differences in the effect of intervention by pre-specified sub- 
groups. We will use a similar approach to evaluate secondary outcomes; however, depending on the 
distributional form of the secondary outcome, we will use a generalized mixed effects model with the 
appropriate functional forms for the distribution family and link function. 
This study was deemed minimal risk and there were no stopping guidelines.  
Subject Confidentiality  
The research team will exercise extreme caution with identifiable private information. Patients are 
donating historical and prospective for 60 days digital data. We are not viewing any digital or social 
media data in real-time. Patients randomized to the intervention arm will receive weekly messages from 
Way to Health. In the patients informed consent, they are instructed and agree by signing the document 
that they will not disclose personal health information (PHI) on the Way to Health texting platform and 
only respond to the text message prompts. When patient participants (both control and intervention) 
text into the Way to Health or complete a survey, the research team will receive email notification 
immediately. The research team is instructed to review the message within 1-4 hours of delivery, 
Monday through Friday, 8 am to 5pm. The line will be closed on Saturday and Sunday however patient 

Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment 
NCT04011540 
January 6, 2022 
 
 
10
participants will receive an out of office message if they text in; the messages notes, Thank you for 
reaching out, we will get back to you when we get back in the office! and a Patient Inquiry Incident is 
created. An exception to confidentiality is if significant suicidal ideation, is exhibited through text 
message. Our approach was informed by the NIMH TOOLKIT: OUTPATIENT Brief Suicide Safety 
Assessment and Crisis text line best practices. Using Crisis Text lines list of detecting crisis words (please 
visit, https://www.crisistextline.org/blog/ava2) trigger the following response, Hi 
PARTICIPANT_FIRSTNAME, If you are having thoughts of suicide or feel unsafe and need to talk to 
someone, please go to your nearest emergency room, call 9-1-1 or call the National Suicide Prevention 
Lifeline, 1-800-273-8255, or text HOME to 741741 for 24/7 confidential services at Crisis Text Line. The 
PI and enrolled therapist will be immediately alerted and prompted to review the text message. The text 
message will be sent via Penn Medicine email with [ENCRYPT] in the subject, high priority note, and a 
read recipient. Once the PI and therapist review the text message, they will determine if the participant 
should continue in the study. The PI or Project Manager will follow up with the provider to ensure a 
safety plan. If a participant reports suicidal ideation, we composed a safety concern protocol. Please see 
SAFETY CONCERN Email / Telephone Script and the W2H safety features attached in the submission. The 
safety concern protocol, it consists of two emails contacting the participants behavioral health provider 
alerting them of these developments. If we do not receive a response, we will report our concern to 
clinic director immediately. Any participant who requires a level of care exceeding customary outpatient 
services (i.e., psychiatric hospitalization or participation in a partial hospital program), or who otherwise 
report or manifest thoughts or behaviors suggesting possible safety concern due to participation in the 
study, will be removed from the study. In addition to the safety monitoring that takes place as part of 
standard care, study staff will provide clinicians with notifications about patients of potential concern 
through a daily email. This email will be sent through the secure Penn Medicine email system. This email 
will be sent each morning (Monday - Friday). Patients will be told that the notification system is active 
only during the business week, 8 am to 5pm and emergency situations will result in update to their 
therapist. The Way to Health text line is open from Monday through Friday, 8 am to 5pm. If participants 
text in unprompted messages outside of those hours, they will receive a message, Thank you for 
reaching out, we will get back to you when we get back in the office. However, if one of the messages 
include one of the trigger words, they will be prompted with the aforementioned message. The Subject 
Confidentiality section is amended to reflect this. When therapists signed the informed consent, they 
agreed that they will be contacted if their patient exhibits significant suicidal ideation. We will consult 
the PI, Dr. Raina Merchant, ED physician to manage participant safety concerns and serve as the clinical 
contact point person. Dr. Raina Merchant is the emergency contact person if there is a crisis during 
after-hours. The data security of the applications is as follows: Facebooks General Data Protection 
Regulation - https://www.facebook.com/business/gdpr Instagram Data privacy webpage, 
https://help.instagram.com/519522125107875 Google takeouts security center - 
https://www.google.com/safetycenter/everyone/start/security-help/ We would report to the specific 
digital platform anything that violates their community standards. We will also apply existing filters (e.g. 
not safe for work) before processing image and text data. Facebook community standards: https:// 
www.facebook.com/communitystandards Instagram community standards: https:// 
help.instagram.com/477434105621119 Google takeout standards, https://www.google.com/+/policy/ 
content.html. Our data scientist will manage the collection of these social media platforms. Only our 
research team will have access to the data through the applications. For the experimental group, the 
patient and provider will seem summary trends from the social media platforms. If study participants do 
not uninstall the app after the study ended, the apps will be closed and no additional information will be 
used or collected through the app. 

Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment 
NCT04011540 
January 6, 2022 
 
 
11
Subject Privacy  
Privacy refers to the person's desire to control access of others to themselves. Privacy concerns people, 
whereas confidentiality concerns data. Describe the strategies to protect privacy giving consideration to 
the following: The degree to which privacy can be expected in the proposed research and the safeguards 
that will be put into place to respect those boundaries. The methods used to identify and contact 
potential participants. The settings in which an individual will be interacting with an investigator. The 
privacy guidelines developed by relevant professions, professional associations and scholarly disciplines 
(e.g., psychiatry, genetic counseling, oral history, anthropology, psychology). 
All encounters will take place in the outpatient clinic setting, telephone, email, BlueJeans or via Way to 
Health, HIPAA compliant platform. To enroll provider participants, we will discuss the trial during their 
team meeting and provide informed consent in-person or electronically via the Way to Health platform. 
To enroll patient participants, we will discuss the trial via email, phone calls, or BlueJeans or on other 
platforms and applications outlined on the Penn Medicine / Penn Dental / UPHS (HIPAA Covered 
Entities) Guidance on Remote Consent Discussion and Documentation Related to COVID-19 Concerns. 
During the discussion, we will give them the opportunity to sign the informed consent document online 
or in-person. They will then complete the baseline survey, and install AWARE on their iPhone 
Participants can donate their digital data in-person or virtually. Regardless of the mode, patient 
participants will be emailed a detailed study packet noting all procedures and schedule a time (in-person 
or remote) to assist them to donate their data to a secure url, http:// 
donate.centerfordigitalhealth.upenn.edu (reviewed and approved by Penn Medicine Information 
Security). Patients will receive a unique Way to Health ID. Patients who choose to share their Facebook, 
Instagram, Google takeout or other social media data will be given a unique ID that will be linked to 
identifiable information. Participants who install the application to share their Facebook posts will be 
able to opt in and out of the application at their discretion. The Facebook application will access data 
that is stored in the user profiles in the Facebook platform. When participants first click on the link to 
use the app, they will first be greeted by the Facebook consent screen that will ask the user permission 
for the application to have access to their profile information and to consent to the terms and service of 
the application. Participants would have to agree to this screen in order to use the application. They will 
have to click agree to access the application. All language data will be stored on secure severe using only 
the unique study ID which can be used to link this data to the REDCap database. This linkage will be 
stored in a double locked fashion on a password protected computer will access only by the principal 
investigator and key study personnel. The study team will not have direct access to any participants 
username/password for any digital media accounts and will not have the ability to post any messages or 
content on behalf of the user. The study team will not communicate with participants via social media or 
publicly post that the participant is involved in the study. Participants will be informed that they should 
not have any expectation of surveillance or medical advice/medical response or that any posts, 
searches, physical activity data will be responded to in real time or at any time by the study team. The 
focus group will be instructed that there are no right or wrong answers, only differing opinions. The 
session will be audio- recorded and that we ask that they please speak one at a time. The discussions are 
being used for research and everything will remain confidential and anonymous. No responses will be 
connected to a participants name and if there are any questions one does not want to answer, they do 
not have to. We will instruct all participants that the focus groups intention to keep discussion within 
the group and not to share information or details once the discussion is over. Focus group audio-
recordings will be transcribed verbatim and all identifiers will be removed. The recording and transcript 
will be kept a secure and locked area with access limited to designated researchers. After we analyze the 
recordings, we will destroy recordings after data analysis or completion of the study. The day 60 

Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment 
NCT04011540 
January 6, 2022 
 
 
12
interviews will be audio-recorded if the participant agrees, if they prefer to not be recorded, the 
interviewer will take notes. No digital data or social media displayed on the dashboard will be reviewed 
real-time. 
Data Disclosure  
Data responses from participants will be linked to participant identifying information, and data will be 
available only for listed study personnel and the IRB if requested. However, all potential subjects will be 
informed that the information they provide will be held in confidence to the extent that the law allows, 
but that the exception to this confidentiality is any disclosure of potential for immediate harm of 
themselves or others, such as active suicidal or homicidal ideation or child abuse. The participants will 
be notified prior to participation that if any of these issues are raised, the researchers will take whatever 
steps are necessary to protect the subject or others, including bringing risk of harm to the attention of 
the proper authorities. This applies only to direct verbal disclosure by the patient and not to any data 
included in social media data. Specifically, the research team will not review social media data to 
determine disclosures of suicidal, homicidal, or child abuse information that will be acted on by the 
research team. Data collected for analysis is detailed in the informed consent form and specifically 
indicates: Data extracted from Facebook will include but not be limited to past and future content: age, 
gender, language, photos, News Feed content, work history, education history, hometown, interests, 
relationship status, current city, religious or political views, number of friends, items liked, and number 
and status updates. Data from Instagram will include username/ handle, number of posts, engagement 
metrics, text captions, and messages, Google takeout includes, My Activity and YouTube, for more 
details, please see, https://takeout.google.com/.  
Data protection 
x Name 
x Street address, city, county, precinct, zip code, and equivalent geocodes 
x All elements of dates (except year) for dates directly related to an individual and all ages over 89  
x Telephone and fax number 
x Electronic mail addresses 
x Social security numbers 
Medical record numbers 
Health plan ID numbers 
Account numbers 
Certificate/license numbers 
Vehicle identifiers and serial numbers, including license plate numbers 
x Device identifiers/serial numbers 
x Web addresses (URLs) 
x Internet IP addresses 
x Biometric identifiers, incl. finger and voice prints 
x Full face photographic images and any comparable images 
x Any other unique identifying number, characteristic, or code 
Consent Process Overview 
Based on the potential risks and benefits described below, we believe this study may be considered 
minimal risk. 

Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment 
NCT04011540 
January 6, 2022 
 
 
13
Potential Study Risks 
Since participation in this research project will not alter patient management in any way, we believe that 
there will be minimal to no risk posed to participants. The most significant risk will be breach of 
confidentiality. This risk is minimal given the various safeguards embedded in our data storage and 
management. The participants will be notified prior to participation that if any of these issues are raised, 
the researchers will take whatever steps are necessary to protect the subject or others, including 
bringing risk of harm to the attention of the proper authorities. This applies only to direct verbal 
disclosure by the patient and not to any data included in social media data. Specifically, the research 
team will not review social media data to determine disclosures of suicidal, homicidal, or child abuse 
information that will be acted on by the research team. Data collected for analysis is detailed in the 
informed consent form and specifically indicates: Data extracted from Facebook will include but not be 
limited to past and future content: age, gender, language, photos, News Feed content, work history, 
education history, hometown, interests, relationship status, current city, religious or political views, 
number of friends, items liked, and number and status updates. Data from Twitter will include: handle, 
number of followers/following, tweets, geography, time/date, profile. Data from Instagram will include 
username/ handle, number of posts, engagement metrics, messages, and photos. The use of REDCap 
will also help minimize the risk of confidentiality. Additionally, the survey items are expected to cause no 
to minimal emotional distress. We do not expect physical, emotional, economic, psychological or 
societal harms that may accrue to others not in the trial. The study is designed to minimize the risk of 
harm to all participants participating by providing secure surveys and direct communication access to 
the research team and Principal Investigator. 
Potential Study Benefits  
Participants in this study may benefit directly from having a social media summary dashboard in their 
therapy sessions; in particular it may uncover interesting trends and correlations that could improve 
patient-provider communication and their engagement in treatment. It could also provide additional 
knowledge about how they communicate and use social media platforms, these summaries may be 
revealing and aid healthy behavior change and/or self-management. In addition feedback on the 
dashboard will help us better tailor future iterations to better meet the needs of our sample, both the 
patient and provider. 
Alternatives to Participation 
Considering the context of this study, there are no alternative to participation available to the 
participants outside of the research context. 
Data and Safety Monitoring  
As noted above, the research team will immediately contact the PI and enrolled therapist via Penn 
Medicine email with [ENCRYPT] in the subject, high priority note, and a read receipt. Once the PI and 
therapist review the text message, they will determine if the participant should continue in the study. 
Please see SAFETY CONCERN Email / Telephone Script and the W2H safety features attached in the 
submission. The safety concern protocol, it consists of two emails contacting the participants behavioral 
health provider alerting them of these developments. If we do not receive a response, we will report our 
concern to clinic director immediately. Additionally, all research staff will consult the National Institute 
of Mental Health (NIMH) toolkit for suicide safety assessment. Any participant who requires a level of 
care exceeding customary outpatient services (i.e., psychiatric hospitalization or participation in a partial 

Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment 
NCT04011540 
January 6, 2022 
 
 
14
hospital program), or who otherwise report or manifest thoughts or behaviors suggesting possible safety 
concern due to participation in the study, will be removed from the study. In addition to the safety 
monitoring that takes place as part of standard care, study staff will provide clinicians with notifications 
about patients of potential concern through a daily email. This email will be sent through the secure 
Penn Medicine email system. This email will be sent each morning (Monday - Friday). Patients will be 
told that the notification system is active only during the business week and expectations for emergency 
situations will be clearly set. 
 

Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment 
NCT04011540 
January 6, 2022 
 
 
15

Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment 
NCT04011540 
January 6, 2022 
 
 
16
 
Original Statistical Analysis Plan – Sent to IRB 
Stata, SAS, and NVivo software will be used for analyses. All data will be summarized using descriptive 
statistics (mean or median, standard deviation, or interquartile range for continuous variables, 
frequencies for categorical variables) and graphical techniques (histograms, scatterplot) as appropriate. 
Standard summary descriptive statistics to be used to analyze data from the survey. We will extract data 
from social media and wearable device platforms and aggregate to develop dashboards. Qualitative 
analysis using grounded theory will be applied for the focus group discussion, interviews, and open-
ended survey questions. We will conduct an intent to treat (ITT) analysis. The ITT analysis will include all 
randomized patients in the groups to which they were randomly assigned, regardless of their adherence 
with the entry criteria, regardless of the treatment they actually received, and regardless of subsequent 
withdrawal from treatment or deviation from the protocol. Baseline demographic and clinical 
characteristics will be reported as frequency and percent for categorical variables and median and 
interquartile range (IQR) for continuous variables. We will compare baseline characteristics between 
intervention and control arms using t-tests for continuous variables and chi-squared tests for categorical 
variables. The goal of these comparisons will be to determine if the two arms are balanced on baseline 
variables after randomization. For the primary analysis, we will use linear mixed effects models to assess 
whether average of SF 36 scores over study follow-up differ between the two arms. We will use a 
random effect to account for the correlation in repeated outcome measures over time within 
participants. We will also account for correlation in outcome measures by therapist (as participants will 
be randomized within therapist), by including additional random effects to account for the nesting of 
patients within therapists. The primary parameter of interest will be a binary indicator for treatment 
arm assignment. Models will also include a variable for time of measurement. Baseline covariates that 
are found to be unbalanced between arms may be adjusted for in the model if they were deemed to be 
potential confounders a priori to adjust for potential confounding and for efficiency gain. We will use all 
available SF 36 scores on eligible patients from randomization through the last observation. An 
advantage of the linear mixed effects model is that it is robust to missing outcome measures as long as 
the missingness mechanism is missing at random (MAR). Patterns of missingness will be assessed 
carefully and multiple imputation will be used if deemed appropriate. Robust (empirical) standard errors 
will be used. A p ≤ 0.05 will be deemed statistically significant but emphasis will be placed on point 
estimates and confidence intervals. In secondary analysis, we will also include an interaction term 
between intervention arm and time in order to assess whether the intervention affects the slope of SF 
36 scores over time. We may also consider testing interactions between intervention and sex or other 
important covariates to test if there are differences in the effect of intervention by pre-specified sub- 
groups. We will use a similar approach to evaluate secondary outcomes; however, depending on the 
distributional form of the secondary outcome, we will use a generalized mixed effects model with the 
appropriate functional forms for the distribution family and link function. 
 
 
 
 

Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment 
NCT04011540 
January 6, 2022 
 
 
17
 
 
Amendments to the Statistical Analysis Plan 
All amendments to the original SAP were made prior to unblinding of the data analyst and prior to 
access to outcome data.  
Based on covariate balance between the intervention arms, we amended our original statistical analysis 
plan. In addition, we originally anticipated enrolling 20-30 therapist participants with several patients 
nested within each therapist. This would have necessitated the accounting for clustering within 
therapist using random effects. However, we enrolled 69 therapist participants with cluster sizes that 
were very small, with most therapists treating 1-2 patients.  Hence, as our primary analysis, we 
conducted an unadjusted paired t-test (rather than our originally proposed linear mixed model) to 
compare mean changes on our primary outcomes from baseline to 60-day. As a secondary analysis, we 
did conduct a linear mixed effects model exactly as proposed in the original SAP. These results were 
nearly identical to the unadjusted paired t-test and would not change our conclusions. In addition, we 
conducted a complete case analysis as our primary analysis. After assessing patterns of missingness and 
determining that missing at random is a plausible mechanism in this study, we conducted multiple 
imputation. Again, our imputed results were nearly identical to the complete case analysis with identical 
conclusions.