SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
Phase: NA
Conditions: Alzheimer Disease
Sponsor: BrightOutcome

 
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Study Protocol and Statistical Analysis Plan 
 
 
SAGE LEAF: Reducing Burden in Alzheimer's Disease Caregivers through 
Positive Emotion Regulation and Virtual Support 
 
 
RCT #NCT05562583 
 
August 26, 2021 
 
 
 
 

 
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STUDY TITLE: 
SAGE LEAF: Reducing Burden in Alzheimer's Disease Caregivers through Positive 
Emotion Regulation and Virtual Support. 
 
PRINCIPAL INVESTIGATOR: 
Name: Judith T. Moskowitz, PhD, MPH 
Department: Medical Social Sciences 
 
CO-INVESTIGATORS: 
Name: Elizabeth Addington, PhD 
Department: Medical Social Sciences 
 
Name: Emily Rogalski, PhD 
Department: Psychiatry and Behavioral Sciences 
 
Name: Darby Morhardt, PhD 
Department: Preventive Medicine 
 
Name: David Victorson, PhD 
Department: Medical Social Sciences 
 
STUDENT INVESTIGATOR (complete this section only if the project is 
student-initiated): 
Name: NA 
Department: NA 
 
 
Are you an: 
 
☐ Undergraduate Student 
 
☐ Graduate Student or Medical Student 
 
 
 
VERSION DATE: 
08/26/21 
 
RELATED STUDIES:  
If there any related NU IRB applications that provide context for the activities covered 
by this IRB submission, please explain and provide the IRB study numbers for those 
related applications.  (For example, if you plan to use samples or data collected by 
another study, recruit participants from a registry established by a colleague’s research 
activity, or conduct a continuation of a prior study.) 
Check any applicable boxes in the table below – you will be asked for 
further detail on these topics later in the protocol form: 
 

 
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Indicate Vulnerable 
Population(s) to be Enrolled 
☐ Children  
☐ Cognitively Impaired Adults   
☐ Pregnant Women (IF the research activities will affect    
the pregnancy or the fetus) 
☐ Prisoners (or other detained/paroled individuals)  
 
International Research 
(check this box if you will 
collect data from 
individuals located outside 
the United States) 
 
 
☐ 
Research involving external 
collaborators (some 
research activities will be 
carried out by individuals 
not employed by 
Northwestern or NU 
affiliates) 
 
 
 
☒ BrightOutcome will be designing and 
engineering the online intervention. 
 
Research has U.S. Federal 
government funding via 
direct award or a sub-
award (e.g., NIH, NSF, other 
federal agencies or 
departments) 
 
☐ 
 
 
 
1.0 
Purpose and rationale of the study: 
 
Social Augmentation of self-Guided Electronic delivery of the Life Enhancing Activities 
for Family caregivers (SAGE LEAF) is a socially enhanced, online intervention to reduce 
stress in caregivers of individuals with Alzheimer’s disease. The intervention will be 
adapted from a prior version of a positive emotion intervention for dementia caregivers, 
LEAF 2.0 (1R01AG05613-01). The project will comprise the two phases of 1) user 
testing and 2) pilot testing. 
 
The persistent and progressive nature of Alzheimer’s disease (AD) has deleterious 
effects not only for the care recipient, but the caregiver as well; adversely impacting key 
aspects of psychosocial functioning.2-3 The protracted burdens of caregiving may lead to 
an increased risk of developing psychiatric disorders like depression or anxiety,4 with 
increased duration and severity of AD symptoms heightening this risk among 
caregivers.5 These outcomes have a tandem effect on outcomes for care recipients, 
where increased caregiving burden and stress results in diminished quality of care and 
quality of life for the patient.6 

 
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To address the issue of caregiver burden, researchers are now utilizing new technologies 
to deliver efficacious and effective resources to caregivers. One such study that we 
conducted is LEAF (R01NR014435; Life Enhancing Activities for Family caregivers – 
LEAF), an online positive-emotion intervention delivered through videoconferencing. A 
randomized control trial of the intervention found that participation lead to significant 
increases in positive emotion (d = .58; p < .01) and positive aspects of caregiving (d = 
.36; p < .01), as well as decreased symptoms of depression (d = -.25; p = .02) and anxiety 
(d = -.33; p < .01) compared to an emotion-reporting waitlist control group.7 During this 
study, participants met one-on-one with a trained facilitator. However, such delivery 
formats can be costly in terms of the time, effort, and logistics required to meet with 
participants individually. Hence, it is an imperative to explore new formats of delivery 
that might be more efficiently distributed, while maintaining a high level of interactivity 
and engagement.  
 
One such format that has been widely adopted is the self-guided online intervention, 
where participants have access to the content on their own with minimal guidance 
provided. Previously, we utilized this medium to deliver a positive emotion intervention 
for individuals with elevated depression symptomatology.8 But while such interventions 
reduce barriers for participation, they are beset by high rates of attrition and poor 
adherence.910 Parallel research on other self-guided resources, namely Massive Open 
Online Courses (MOOCs), have found that the construct of social presence – or the 
ability to perceive others in an online environment – can enhance retention and 
engagement.11 Social presence may include features like providing welcome messages, 
displaying participant profiles, and facilitating online discussion amongst participants.12 
Hence, eHealth and mHealth interventions are likely to benefit from the application of 
these social features. 
 
With these considerations in mind, such social features may be particularly beneficial for 
caregiver participants; who experience higher levels of social isolation and loneliness 
compared to their peers.13-14 Hence, the objective of this proposal is to adapt the 
existing positive emotion intervention for SAGE LEAF – a socially enhanced, online 
intervention for Alzheimer’s caregivers. If successful, SAGE LEAF may be scaled as an 
online resource that caregivers could utilize to better cope with the stressors of 
caregiving. 
 
For the 1) user test, we will be evaluating the SAGE LEAF platform’s usability and 
usefulness. Non-Alzheimer’s dementia caregivers recruited from the Northwestern 
Cognitive Neurology and Alzheimer's Disease Center (CNADC) (N=20) will participate in 
an extended user test where they will receive full access to the SAGE LEAF intervention, 
and provide their feedback through surveys and interviews on the platform’s usability 
and usefulness upon conclusion of the 6-week program. Subsequently, the necessary 
refinements to the platform will be made based on the feedback received. 
 

 
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Next, we will conduct a (N=30) single-arm pre-post 2) pilot test / feasibility study of 
SAGE LEAF for AD caregivers. Participants will receive access to the SAGE LEAF platform 
and complete the positive emotion skills intervention over 6 weeks. We will evaluate 
the number and percentage of participants retained at the post assessment as well as 
the means and ranges for the proportion of intervention content completed (i.e., 
number of pages viewed out of the total possible pages across all skills and lessons in 
the intervention) and participants’ acceptability ratings (i.e., participants’ ratings of 
whether they would recommend SAGE LEAF to other AD caregivers). 
 
2.0 
Enrollment Criteria (who can be in your study and who would not 
be eligible to participate in your study): 
 
 
1) User Test Inclusion criteria: 
• Age 18 and over 
• Speaks and reads English 
• Identifies as the primary family caregiver of a person with non-Alzheimer’s 
dementia. 
• Have access to high-speed internet. 
 
2) Pilot Test Inclusion criteria: 
• Age 18 and over 
• Speaks and reads English 
• Identifies as the primary family caregiver of a person with Alzheimer’s disease. 
• Have access to high-speed internet. 
 
Exclusion criteria: none 
 
3.0 
Sample Size: 
 
We will recruit a total of 50 participants: 1) 20 participants for the user test and 2) 30 
participants for the pilot test. These sample sizes are commensurate with the exploratory 
nature of this preliminary research. 
 
 
 

 
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4.0 
Recruitment and Screening Methods: 
 
For the 1) user tests, we aim to recruit non-Alzheimer’s dementia caregivers from 
Northwestern Memorial Hospital’s Cognitive Neurology and Alzheimer’s Disease Center 
(CNADC), and for the 2) pilot testing, we aim to recruit AD caregivers from CNADC. 
 
For both phases, potential participants will be sent an email containing study details and 
a link to an online screener survey. Participants who are eligible will see a message that 
says a member of the study team will reach out to schedule a phone call. Participant flow: 
 
Online-Pre-Screener -> Screener Phone Call with Study Staff -> Consent / Baseline (T1) 
 
Online Pre-Screener Link 
This link leads to a REDCap pre-screener questionnaire that helps determine eligibility. A 
copy of the pre-screener questionnaire has been attached with this submission. These 
questions verify whether an individual has met the study criteria to participate. If an 
individual does not meet the criteria, they will see a message after completing the pre-
screener that thanks for them their time, but notifies them that unfortunately, they are 
ineligible to participate. If an individual is eligible, they will be informed that a member of 
the study team will reach out to schedule the screener phone call. 
 
Data collected from the pre-screener link will be stored on a secure, HIPAA-compliant, 
and password-protected server at the Feinberg School of Medicine. We will flag identifiers 
on the REDCap platform, so that these variables will be excluded from any data exports.  
For example, we will flag First Name, Last Name, phone number, and email address. 
Outside of REDCap, identifying information will never be linked with the data from the 
pre-screener. Only de-identified data will be exported from REDCap and saved on the 
password-protected FSM server. Only IRB-approved individuals will be able to access the 
data on REDCap.  This de-identified data will be aggregated and used only for the 
purposes of gauging recruitment trends. 
 
Phone Screen (~30 minutes) 
Subsequently, study staff will contact eligible participants to explain the requirements of 
the study and seek informed consent. Study staff contact information will be provided 
to participants so that they can call or email if they have any questions about their 
participation. Participants will also be reminded that they may opt out of the study or 
decline to answer any of the questions: 
 
A copy of the phone screen script has been uploaded to the Supporting Documents 
section of the IRB application. The pre-screener information from eligible individuals will 
feed into the REDCap database and dashboard, where the Project Director (PD) can view 
eligible individuals to schedule phone calls. The PD or a member of the study team will 
then reach out to the individual to schedule a ~30 minute phone call to reiterate what the 
study entails, including time commitment, timing, survey, feedback interview, and overall 

 
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summary of the SAGE LEAF course – while emphasizing that the focus of the study will be 
on feedback about the social features of the intervention. This allows the individual to ask 
questions, discuss any concerns, and confirm whether or not they want to be in the study. 
Consenting individuals will then be provided access to the SAGE LEAF platform through a 
sign-up email prompting them to set up their password. 
 
After the phone screen, if the participant is determined to be eligible, they will be sent 
an email to the online consent form through REDCap. Participants will be instructed to 
contact study staff if they have any questions about the study. 
 
Consent, Baseline Assessment (T1) 
Consent will be time-stamped and participants will be able to save, download, and/or 
print a copy of the consent form for their records.  Participants will consent electronically 
by entering the date and by typing their full name into the form, which will represent their 
electronic signature.  Participants will be considered “consented” only if they provide 
both items (date and electronic signature). Participants may also email the project 
director to request a copy of the consent form at any time. 
 
Consent scenarios: 
• If a user test participant consents “Yes,” they will be sent a welcome email 
containing instructions for setting up their password on the SAGE LEAF platform. 
If a pilot test participant consents “Yes,” they will automatically continue on to 
complete the baseline assessment. Upon completion they will be sent the 
welcome email containing instructions for setting up their password on the SAGE 
LEAF platform. 
• If an individual does not respond to the consent form, our study team will 
follow-up with a reminder up to 3 times by phone or email using information 
provided on the screener. 
• If an individual responds “No” and declines to participate, they will see a 
message thanking them for their time. 
 
5.0 
Research Locations: 
 
All research will be based at Northwestern University’s (NU) Feinberg School of Medicine 
through the Department of Medical Social Sciences (MSS) as the lead research site. NU 
holds the IRB of record. However, the development of the SAGE platform will be managed 
by Bright Outcome (https://www.brightoutcome.com/), a company experienced in 
designing online platforms for patient reported outcomes research. Bright Outcome has 
a proven track record of collaboration and delivery of technology products/services to 
investigators at the Feinberg School of Medicine. 
 
6.0 
Multi-site Research (research that involves external collaborating 
institutions and individuals):  

 
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SAGE LEAF is a single-site study. 
 
7.0 
International Research (where data collection will occur outside the 
United States and U.S. territories, including online activities) 
 
N/A 
 
8.0 
Procedures Involved: 
 
Please check the boxes for all applicable data collection procedures you plan to use: 
☒One-on-one interviews 
☒Focus Groups 
☒Questionnaires/surveys 
☐Analysis of secondary data (medical record data, educational records, government or 
private sector datasets, etc.) 
☐Ethnographic observation 
☐Physiological measurements (e.g., EEG, EKG, MRI) 
☐Biospecimen collection (saliva samples, blood draws, hair samples, etc.) 
☐Mobile applications/data collection devices (e.g., Fitbits, actigraphs, etc.) 
☐Behavioral decision making tasks (e.g., puzzles, interactive games, etc.) 
☐Physical activities such as walking and other forms of exercise 
☐Other procedures (briefly list types of procedures here if not covered by the check-
boxes above): ______________________________________________ 
 
 
Procedures for Phase 1: User Test 
 
Upon providing informed consent and completing the phone screen, consented 
individuals will then be provided access to the SAGE LEAF platform through a sign-up 
email prompting them to set up their password. 
 
6 Sessions over 8 weeks: approx. 30 minutes/online module 
Week Self-Guided Intervention “Online Lessons” 
The SAGE LEAF online lessons consist of 6 modules for the intervention; one module 
unlocked per week over 6 weeks, but participants will have an 8-week period to complete 
the 6-module intervention. The intervention content, emotion reporting forms, and 
assessment questionnaires are all mobile-enabled and, thus, can be completed on 
desktop, laptop, tablet, or smartphone. In this self-guided intervention, skills will be 
delivered within 8 weeks. Participants will also have access to social features, which 
include the discussion board, didactic videos from study staff, virtual awards, etc. 
 

 
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Participants can participate from their home computer, smartphone, or a tablet from a 
location with wifi. A week will consist of 1-2 days of didactic material and 5-6 days of real-
life skills practice and reporting. Participants cannot skip ahead, and can only progress to 
the next lesson if they have completed the current one, but they can return to old lessons 
or exercises if they wish to. Participants will receive email or text notifications throughout 
the study, and will have access to a control panel to configure their preferences. As part 
of the daily home practice, intervention participants will be asked to complete the daily 
stress and emotion questions. Other data collected from the Bright Outcome platform 
will be securely stored on Northwestern servers, accessible only to IRB-approved study 
staff. These data include number of log-ins, completed home exercises, number of skills 
completed, data from the daily emotion reporting surveys, number of awards earned, 
discussion posts, etc. 
 
Time Commitment 
The estimated time commitment for participating in the SAGE LEAF Study is up to 9 
hours over 8 weeks. 
 
Event 
Time 
Commitment 
Screener + Phone Screen + Consent + 2 surveys (up to 1 hour each) 
~3 hours 
6 SAGE LEAF Sessions 
<3 hours 
Daily Home Practice / Emotion Check-In 
~3 hours 
Feedback Survey + Interview 
<2 hours 
Total Hours Over 8 Weeks <9 hours 
 
Bright Outcome Platform 
 
Bright Outcome “Discussion” Feature 
Participants accessing the “Online Lessons” on the platform will have a tab called 
“Discussion” where they can discuss topics related to the study.  These topics will be 
based on the Skills.  For example, there will be a discussion thread called “Gratitude” so 
that participants can post there about their comments/thoughts on practicing gratitude. 
The discussion threads will be moderated by a staff member on the research team.  The 
moderator will post weekly prompts to generate discussion, moderate the discussions to 
stay on-topic, and address and respond to any signs of distress or suicidal ideation.  All 
posts will be tied to a SAGE LEAF Study ID and an avatar. No identifiable information will 
be posted/shared. Guidelines will include refraining from posting personal/identifiable 
information such as names and contact information, and refraining from bullying or using 
harsh/offensive language online. We have prepared a data safety and monitoring plan for 
the Discussion posts (in addition to a plan for handling a range of distress revealed to us 
at any point in the study), based on our previous online studies with an online forum such 
as LEAF, MARIGOLD, and LARKSPUR. (See Section 17.0 Data Monitoring Plan to Ensure 
Safety of Participants for more details.)  

 
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Profile Page  
Participants will have access to a profile page where they will be able to select an avatar 
and fill out additional profile information (e.g. hobbies, challenges that they are facing as 
a caregiver, etc.) that they have the option of displaying if they choose to do so. No 
identifiable information will be posted/shared. 
 
Virtual Awards Feature 
Participants accessing the “Online Lessons” on the platform will have a page called 
“Awards” where they will receive virtual badges for reaching certain goals e.g. logging in 
daily for 7 days, completing home practice for 4 consecutive days, or completing an online 
module. They will also be able to view their achievements in relation to others. This data 
will also be collected on Bright Outcome.  Each participant will be able to see their earned 
badges as an incentive to proceed and engage with the study. 
 
SAGE LEAF Positive Emotion Skills 
Please see the table below for an overview of the intervention’s skills, goals, and home 
practice exercises, administered via the Bright Outcome online platform. 
 
The total time involved from the beginning to the end of the study is approximately 8 
weeks. 
 
Overview of Intervention sessions, Goals, and Home Practice.   
 
Skills 
Goals of session  
Home Practice 
Session 1: Positive Events, 
Savoring, Gratitude 
Recognize positive events and the associated positive 
emotion; practice ways to amplify the experience of 
positive events; and learning to practice gratitude.  
 
 
 
 
 
 
Noting a positive event 
each day and writing 
about it (savoring); 
starting a daily gratitude 
journal and daily 
emotion reports. The 
gratitude list home 
practice continues 
through the rest of the 
intervention period.  
Session 2: Everyday 
Mindfulness and 
Mindfulness Meditation 
Learn and practice the awareness and nonjudgment 
components of mindfulness. 
 
Daily informal 
mindfulness activities, a 
10-minute formal breath 
awareness activity, 
continuing the gratitude 
journal and daily 
emotion reports.  
Session 3:  Positive 
Reappraisal 
Understanding positive reappraisal and the idea that 
different forms of positive reappraisal can all lead to 
increased positive emotion in the face of stress. 
 
Reporting a relatively 
minor stressor each day, 
then listing ways in 
which the event can be 
positively reappraised. 
The daily formal 
mindfulness practice, 
gratitude journal, and 

 
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the emotion reports 
continue. 
Session 4: 
Self-Compassion   
Participant learns about how to show compassion for 
the self, especially in the context of a caregiver. 
Understanding how self-compassion relates to the skills 
throughout the rest of the SAGE LEAF course. 
Listing an act of self- 
compassion for each 
day. The 10-minute 
mindful breathing, 
gratitude journal, and 
daily emotion reports 
continue. 
Session 5:  Personal 
Strengths, Attainable 
Goals  
Participant lists his or her personal strengths and notes 
how they may have used these strengths recently; 
understanding characteristics of attainable goals and 
setting some goals for the week. 
 
Listing a strength each 
day and how it was 
“expressed” 
behaviorally, working 
toward one of the 
attainable goals, and 
noting progress each 
day. The 10-minute 
mindful breathing, the 
gratitude journal, and 
the daily emotion 
reports continue.  
Session 6: Skills Summary 
 
Participants will receive a summary of the SAGE LEAF 
course as a whole. Participants will identify which skills 
they enjoyed or did not enjoy and why. They will make 
a plan to practice the positive emotion skills beyond the 
SAGE LEAF course. 
Course wrap-up. The 10-
minute mindful 
breathing, the gratitude 
journal, and the daily 
emotion reports 
continue. 
Catch-Up Week 
No new skills introduced. Participants continue with 
daily emotion reports and catch up on any home 
practice exercises. 
Daily emotion reports 
continue. 
Catch-Up Week 
No new skills introduced. Participants continue with 
daily emotion reports and catch up on any home 
practice exercises. 
Daily emotion reports 
continue. 
 
Measures 
Participants will complete self-report questionnaires at 2 time points over approximately 
8 weeks. The assessments will be named by their time point “T”, e.g. T1 (baseline) and T2 
(approx. 6-8 weeks from baseline). At T3 (8 weeks from baseline), participants will 
participate in a 45-60 min feedback interview (see attached interview guide) through 
videoconferencing with a member of the study team. All self-report assessments will be 
completed from home via tablet, a home computer, or mobile device. All instruments will 
be uploaded to this application for NU IRB approval. In addition to the self-report 
measures (listed below), we will also assess the following demographic variables, 
including age, gender, and race/ethnicity. We will assess the following self-report 
measures in each assessment: 
 
Table of Measures 
 
Full Name of Measure 
Administered at: 
In reference to: 
1 
Demographics (see uploaded 
instruments) 
Baseline (T1) only 
 
2 
Technology Survey 
Baseline (T1) only 
Technology/Usability 
3 
System Usability Scale (SUS) 
T2  
Technology/Usability 
4 
Perceived Usefulness Scale (PSU) 
T2 
Technology/Usability 

 
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5 
Technology Acceptance Model (TAM) 
T2 
Technology/Usability 
6 
Recommendations & Skill Use 
T2  
Technology/Usability 
7 
Zarit Burden Interview 
All timepoints 
Psychological 
Adjustment 
8 
Oberst Caregiving Burden Scale 
(OCBS) 
All timepoints 
Psychological 
Adjustment 
9 
Positive Aspects of Caregiving Scale 
All timepoints 
Psychological 
Adjustment 
10 
Caregiver reaction assessment 
All timepoints 
Psychological 
Adjustment 
11 
Caregiving Mastery subscale of the 
Caregiving Appraisal Measure 
All timepoints 
Psychological 
Adjustment 
12 
Loneliness/social isolation 
All timepoints 
Psychological 
Adjustment 
13 
Psychological wellbeing (NIH Toolbox) 
All timepoints 
Health Behaviors 
14 
PROMIS measures (anxiety, 
depression, perceived stress, life 
satisfaction, self-efficacy, and meaning 
and purpose) 
All timepoints 
Psychological 
Adjustment 
15 
Cohen’s perceived stress scale 
All timepoints 
Psychological 
Adjustment 
16 
Differential Emotions Scale 
Daily Throughout 
Intervention 
Psychological 
Adjustment 
 
 
Procedures for Phase 2: Pilot Test 
 
Upon providing informed consent and completing the phone screen, consented 
individuals will then be provided access to the SAGE LEAF platform through a sign-up 
email prompting them to set up their password. 
 
6 Sessions over 8 weeks: approx. 30 minutes/online module 
The format and content of the SAGE LEAF pilot test will be the same as the user test. 
The same online platform will also be used, with minor refinements made based on 
feedback from the user tests.  
 
Time Commitment 
The estimated time commitment for participating in the SAGE LEAF Study is up to 15 
hours over 8 weeks. 
 
Event 
Time 
Commitment 
Screener + Phone Screen + Consent + 2 surveys (up to 1 hour each) 
~7 hours 
6 SAGE LEAF Sessions 
<3 hours 
Daily Home Practice / Emotion Check-In 
~3 hours 
Feedback Survey + Interview 
<2 hours 
Total Hours Over 8 Weeks <15 hours 

 
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Measures 
Participants will complete self-report questionnaires at 2 time points over approximately 
8 weeks. The assessments will be named by their time point “T”, e.g. T1 (baseline) and T2 
(approx. 6-8 weeks from baseline). At T3 (8 weeks from baseline), participants will 
participate in a 45-60 min feedback interview (see attached interview guide) through 
videoconferencing with a member of the study team. All self-report assessments will be 
completed from home via tablet, a home computer, or mobile device. All instruments will 
be uploaded to this application for NU IRB approval. In addition to the self-report 
measures (listed below), we will also assess the following demographic variables, 
including age, gender, and race/ethnicity. We will assess the following self-report 
measures in each assessment: 
 
Table of Measures 
 
 
Full Name of Measure 
Administered at: 
In reference to: 
1 
Demographics (see uploaded 
instruments) 
Baseline (T1) only 
 
2 
Technology Survey 
Baseline (T1) only 
Technology/Usability 
3 
System Usability Scale (SUS) 
T2  
Technology/Usability 
4 
Perceived Usefulness Scale (PSU) 
T2 
Technology/Usability 
5 
Technology Acceptance Model (TAM) 
T2 
Technology/Usability 
6 
Recommendations & Skill Use 
T2  
Technology/Usability 
7 
Zarit Burden Interview 
All timepoints 
Psychological 
Adjustment 
8 
Oberst Caregiving Burden Scale 
(OCBS) 
All timepoints 
Psychological 
Adjustment 
9 
Positive Aspects of Caregiving Scale 
All timepoints 
Psychological 
Adjustment 
10 
Caregiver reaction assessment 
All timepoints 
Psychological 
Adjustment 
11 
Caregiving Mastery subscale of the 
Caregiving Appraisal Measure 
All timepoints 
Psychological 
Adjustment 
12 
Loneliness/social isolation 
All timepoints 
Psychological 
Adjustment 
13 
Psychological wellbeing (NIH Toolbox) 
All timepoints 
Health Behaviors 
14 
PROMIS measures (anxiety, 
depression, perceived stress, life 
satisfaction, self-efficacy, and meaning 
and purpose) 
All timepoints 
Psychological 
Adjustment 
15 
Cohen’s perceived stress scale 
All timepoints 
Psychological 
Adjustment 
16 
Differential Emotions Scale 
Daily Throughout 
Intervention 
Psychological 
Adjustment 
 
 
9.0 
Research with Vulnerable Populations  
 

 
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This research does not involve the vulnerable populations indicated. 
 
10.0 Incomplete Disclosure or Deception: 
 
N/A 
 
11.0 Consent Process:  
 
For both phases, online consent will take place through a REDCap electronic consent 
form.  Consent will be time-stamped and participants will be able to save, download, 
and/or print a copy of the consent form for their records.  Participants will consent 
electronically by entering the date and by typing their full name into the form, which will 
represent their electronic signature.  Participants will be considered “consented” only if 
they provide both items (date and electronic signature). Participants may also email the 
project director to request a copy of the consent form at any time. 
 
If a participant chooses to withdraw during the study, their data will be retained up until 
their point of withdrawal. When a participant withdraws, they will no longer receive 
future assessments and they will no longer receive daily reminders to log-in to the 
website.  Participants can consent to be contacted for future studies. They can also 
consent to receive SMS text messages to receive their survey assessments. Please refer 
to the consent form. Study staff will monitor the REDCap project daily in order to track 
any new completed consent documents and update study tracker. 
 
12.0 Waiver of Participant Signature on Consent Form: 
 
N/A 
 
13.0 Waivers and Alterations of Consent Information: 
 
N/A 
 
14.0 Financial Compensation: 
 
For both phases of the study, SAGE LEAF participants will receive escalating incentives in 
the form of e-gift cards: $20 for the completion of both assessments at T1 and T2; $30 
for the feedback interview for a total of $50 per participant. 
 
15.0 Audio/Video Recording/Photography 
 
Our sources of research material include the video recordings from the feedback 
interviews that will be conducted through Zoom videoconferencing. Once the video files 

 
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have been transferred and saved to the MSS server (identified only by StudyID), these 
video files will be transcribed with identifying information removed, and the video files 
will be permanently deleted. 
 
16.0 Potential Benefits of this Research:  
 
There is no guaranteed benefit from participating in SAGE LEAF, however participants 
might enjoy the skills taught and continue practicing them beyond the online course e.g. 
keeping a gratitude journal, completing everyday chores mindfully, or listening to a breath 
awareness meditation recording. Participants may gain mindfulness skills, regularly 
capitalize on positive events, or use positive reappraisal to reassess daily stressors. Even 
after completing the course, participants are encouraged to keep using their favorite 
skills, whether formally through the website and/or journaling about their experiences, 
or informally in their everyday lives. 
 
On a broader scale, we predict that the skills taught in SAGE LEAF may help AD caregivers 
increase their positive affect and lower depression, anxiety, caregiver burden, and 
perceived stress.   
 
17.0 Potential Risks to Participants: 
 
Minimal Risk; Possible discomfort while interacting with the SAGE LEAF platform 
SAGE LEAF is relatively easy to administer and is a low cost intervention compared to 
existing interventions. A potential risk of discomfort might arise with participants who 
have less experience using the internet, a tablet/computer, or mobile device.  Participants 
might experience frustration or delayed onboarding if they are less familiar with using 
computer applications, browsing the internet, or connecting to wireless internet.  All 
participants will receive clear instructions for website/technology use, and guidance on 
how to use the hardware/software required to participate in the study to ensure lack of 
online experience is not a barrier to participation. 
 
Minimal Risk; Possible discomfort when responding to questions 
The risks of participating in SAGE LEAF are minimal. In past research, we have not 
observed any participants experiencing serious or lasting distress in response to similar 
interventions or assessments. The intervention has been user-tested to remove any 
material/content that might be upsetting or insensitive, to reduce the chances of using 
those questions in future versions.  Therefore, risk of discomfort is extremely low. 
However, some might experience slight discomfort when asked about their emotions, 
coping, anxiety, and stressful events, or reflecting upon experienced negative emotions. 
Participants are notified that they may skip any questions they do not wish to answer.  
 

 
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SAGE LEAF study staff who are interacting with participants or monitoring their 
responses to study procedures will be alert to indicators of elevated distress or possible 
suicidality.  If a SAGE LEAF study staff member observes a possible sign of significant 
distress and/or suicidal ideation, they will follow an established safety protocol 
(attached), working together with designated team members to evaluate the severity of 
the situation, generate a tailored response, and complete final responding and 
reporting. 
 
“Pollyanna” 
The risk of proclaiming the importance of positive affect in the stress and coping process 
is that it may appear to minimize the pain and serious individual and societal 
consequences associated with major stressful events. We are not advocating a simplistic 
“don’t worry-be happy” approach, nor do we believe that simply increasing positive 
emotion will prove to be a cure-all for the very real and complex issues facing caregivers. 
Such a Pollyanna-ish stance could easily degenerate into blaming the caregiver for not 
thinking the positive thoughts that may prevent depression or other negative 
consequence of enduring stress. However, we argue that an intervention to increase 
positive emotions sets the stage for adaptive coping. Ultimately, given the high levels of 
caregiver burden, depression, and anxiety documented in AD caregivers, we consider 
increasing positive emotion to be an inherently worthwhile intervention goal. 
 
While our study focuses on positive emotion, we emphasize that SAGE LEAF is not a 
replacement for therapy, nor is it considered a treatment for depression or anxiety.  
Participants are encouraged to follow the guidelines of their health care provider and 
advised that they should not put off starting therapy and/or medication or stop 
treatments recommended by their health care provider. 
 
Withdrawal of participants 
If a participant wishes to withdraw, he/she can communicate this on the phone or via 
email to the project director.  Study staff will also be monitoring communications and 
potentially withdrawal requests coming through on the study website or study email. The 
participant will then be promptly withdrawn from the study, their data collected and 
eventually analyzed only up until the point of withdrawal.  No further data will be 
collected after a participant has been withdrawn. We will document the reason for 
withdrawing. 
 
18.0 Provisions to Protect Participant Privacy and Data Confidentiality: 
 
Confidentiality in data 
The risk of loss of confidentiality is extremely low. Identifiable information will be 
collected using REDCap which uses industry-standard encryption to protect participants’ 
information while in transit from the moment data is entered to the moment it is stored 
on HIPAA compliant servers. Data is never fed back to participants or displayed on the 
participant website. Access to REDCap is granted to key personnel and all study staff 

 
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handling personally identifiable information will have taken the CITI Human Subjects 
Training Course. Participants will be assigned and identified by a unique Study ID on the 
SAGE LEAF platform, and their information will be stored in encrypted form on 
Northwestern computers. Any hard-copy documents will be stored in locked cabinets in 
the Department of Medical Social Sciences and all electronic copies of data, study emails, 
or records will have double-protection through password-protected access for NU servers 
and to REDCap. Even if a participant’s account is later compromised, submitted 
information on the website is protected and not released. 
 
The REDCap instance at Northwestern supports the SMS text messages. We are using 
REDCap’s feature to integrate SMS text messaging with Twilio to send the assessments.  
Access to the phone numbers are password-protected and secure. The same data 
protections that exist for the REDCap PHI exists for the SMS messaging feature as well.  
Assessment data will not be stored locally on the phone or any device.  If receiving an 
assessment via text, the message will include a link to a web-based survey (protected and 
hosted by NUCATS).  If issues arise with the SMS feature, we will immediately contact the 
REDCap administrators at Northwestern University to resolve any issues. 
 
The SAGE LEAF online platform is hosted by Bright Outcome and is protected by end-to-
end encryption and password measures. Participants will be able to access the SAGE LEAF 
intervention on their computer, tablet or mobile phones with an internet connection. 
Participants will submit their home practice through the website (i.e. gratitude journal) 
and submit their feedback for the lessons, since participants are encouraged to visit the 
site every day.  IRB-approved NU study staff will be able to access the data collected 
through the platform through direct export.  No data will be stored locally on participants’ 
devices.  
 
Confidentiality in general 
Once a participant is enrolled in the study, there is the chance someone might see a 
participant filling out assessments or reading the positive emotion skills on the platform.  
To protect participant privacy, we encourage all participants to find a private room with 
a closed door and to use headphones (if needed) when completing online modules or 
participating in the feedback interview.  We will also encourage participants to be mindful 
and aware of their location (i.e., in a public or crowded space) when filling out their online 
assessments. Since the assessments are completed online, this allows for flexibility and 
participants can answer the questions from the comfort and privacy of their own home 
on their mobile device/tablet computer/laptop etc.   
 
19.0 Data Monitoring Plan to Ensure the Safety of Participants: 
 
We have developed the following data and safety monitoring plan. Our goal is to collect 
data on acceptability, adherence, and retention of the intervention through self-report 

 
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measures and by tracking website usage and engagement. We aim to do so in a way that 
protects and ensures participants safety and confidentiality. 
 
The assessments and intervention sessions pose no more than minimal risk to 
participants. The data and safety-monitoring plan identifies the PI as the primary monitor 
of risks to human subjects in the form of data and safety related risks.  The study’s 
biostatistician is the back-up data custodian to the PI, advising and providing support in 
data decisions. Any serious adverse events will be promptly reported to the institution’s 
IRB and project officer of the funding source by the study PI. Risks, monitoring 
procedures, and reporting and action plans are described below for both data and safety 
related risks. 
 
Data Risks and Monitoring 
 
Data related risks. Data related risks to participants could consist of circumstances where 
an insufficient amount of data was collected to answer the research questions, or a 
breach of confidentiality where the safety of identifiable data has been compromised. 
 
Data monitoring procedures. The PI, Dr. Judith Moskowitz will be the primary data 
custodian for SAGE LEAF. Overall recruitment goals, missing data, and follow-up failures 
will be monitored by the project manager, and the PI will receive regular updates and 
maintain constant communication with the project manager, and the rest of the team; at 
first bi-weekly, then monthly as needed. The biostatistician will also provide ongoing 
monitoring of study progress and advise with proposed changes and precautions, if 
necessary (i.e. updates to protocol to meet recruitment goals, etc.). Post-doctoral fellows 
and co-Investigators who will be assisting with data analysis will be added to the IRB. 
 
Data risk reporting and action plan. The project manager will oversee the data safety and 
monitoring plan, data management, and data security. She will work alongside the PI and 
the Project Director to compile the recruitment numbers during all phases of the study 
and responsible for assuring completion of required assessments, maintaining databases, 
and identifying missing data and missing follow-up assessments. 
 
Safety Risks and Monitoring 
 
Safety related risks. Safety related risks could consist of: 
1) Emotional discomfort while using the SAGE LEAF platform 
2) Emotional discomfort while completing assessments 
3) Loss of confidentiality in data 
4) Loss of confidentiality in general 
5) “Pollyanna” effect and mistaking the intervention as therapy 
6) Signs of distress or revealing identifying information on the “Discussion” forum 
 

 
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Safety monitoring procedures. All safety related risks will be monitored routinely 
throughout the study. (1-2) It will be made clear to participants that they are allowed to 
skip any exercises or questions that may cause them emotional distress. Participants are 
provided instructions on how to use the website, log-in, access the course, and are given 
the contact information of the Project Director, PI, and the designated study email.  
Guidelines and videos to use the website are provided.  Participants can email or call study 
staff and the study is generally staffed Monday-Friday 9am-5pm except holidays, etc. 
 
Dr. Elizabeth Addington is on the SAGE LEAF study team and she is a clinical psychologist. 
She is also a Research Professor in the Department of Medical Social Sciences, Feinberg 
School of Medicine.  She will be the main point of contact and the study advisor for 
questions regarding safety concerns. She will help the team make recommendations and 
take research precautions to ensure the safety of our participants. 
 
Study staff are monitoring the website weekly and will be trained to respond immediately 
to participant needs and/or questions on technology and the platform. There is also a 
FAQ page on the website for frequently asked questions.  If a question is not 
listed/answered on the FAQ page, participants may call or email study staff. Based on our 
experience conducting prior trials of online self-guided delivery of positive affect skills 
(e.g. MARIGOLD, LARKSPUR), the study team is well versed in handling/managing 
instances that might require providing caregivers with additional resources. The PD will 
be the main point of contact and the study advisor for questions regarding safety 
concerns. She will help the team make recommendations and take research precautions 
to ensure the safety of our participants. 
 
(3) The security of confidential information will be monitored regularly. Participants will 
be informed that their responses will be kept confidential and not used against them in 
any legal, online modules in a private space and to be mindful of where they complete 
their online assessments, so as to limit the chance of someone overseeing their answers 
and to limit exposures of their responses from their computer/tablet/phone screen. 
 
(5-6) In the event that a participant contacts the study directly to report severe distress 
or suicidality, or reveals this information online in an email or via the website’s 
“Discussion” feature, the project manager or study team member will immediately alert 
the PI. The PI will review the situation and take immediate, appropriate steps.  If the 
situation is serious, designated research staff will promptly respond to a distressed 
participant with appropriate information about how to seek help. In previous studies, we 
have developed monitoring plans for responding to signs of distress in an online forum. 
Study staff have the ability to archive/delete messages that are inappropriate to keep the 
discussion board related to discussing topics on SAGE LEAF. Based on our past experience 
conducting online studies with a discussion feature (e.g. MARIGOLD, LARKSPUR), the risk 
of these occurrences is minimal and the study team is well versed in handling/managing 
these instances, if they happen. 
 

 
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Safety risk reporting and action plan.  Any participant in need of treatment due to distress 
will be referred for appropriate services by the project manager.  In severe cases, the PI 
will be informed immediately. The project director will report breach of confidentiality 
risks incurred by participants to the PI. The PI will be responsible for informing the IRBs 
and the Project Officer immediately of any life threatening incidents (although this risk is 
very low and not expected to happen). The PI will take appropriate action to stop the 
study, release a participant from the study, or modify procedures to reduce and/or 
eliminate the occurrence of the abovementioned risks occurring at an unacceptable level.  
 
Adverse events. Due to the nature and scope of this study, we do not anticipate any 
adverse events.  However, in the case that an adverse event arises, it will be tracked and 
the PI informed within 24 hours to assess the situation and follow-up. An adverse event 
form will be developed detailing the problem, actions taken, supervisor notes, and follow-
up steps performed. The form will be immediately sent to appropriate agencies, including 
the IRB and NIH. Any action recommended by one of the IRBs will be conveyed to the NIH. 
The PI will be responsible for the monitoring and reporting of any adverse events. The co-
investigators will be consulted as appropriate. 
 
All problems having to do with subject safety will be reported by the Principal Investigator 
to the IRB within ten working days. Specifically, the following will be reported, in writing: 
1) all serious adverse events associated with the study procedures, and/or 2) any 
incidents or problems involving the conduct of the study or participation, including 
problems with the recruitment and/or consent processes. The Principal Investigator will 
provide a discussion of any problems noticed during each year in the course of the study 
to the IRB and NIH on an annual basis. 
 
If, during the course of communicating with study staff (e.g., synchronously on phone or 
asynchronously via email), a participant indicates severe elevation of distress or possible 
suicidal ideation, study staff will follow the attached Safety Protocol, which has been 
developed based on procedures used in their prior studies of positive emotion skills 
delivered online. Staff who are responsible for communicating directly with participants 
will be trained on the Safety Protocol by Dr. Moskowitz and/or the PD. Trainees will be 
responsible for reading the entire Safety Protocol prior to training. Then training will 
include: a discussion/review of all elements of the Safety Protocol; time for all trainees to 
discuss any relevant experience and ask questions; and the opportunity to role play using 
the telephone template responses. 
 
20.0 Long-term Data and Specimen Storage and Sharing:  
 
Dr. Moskowitz, PI, is involved in the development of the online intervention, analysis, data 
interpretation and manuscript write-up.  She will have secure access to the data housed 
at NU.  No other Northwestern personnel will have access to the data unless he/she is 
listed on the IRB as study personnel. Dr. Moskowitz and her NU collaborators will also use 

 
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statistical programming on FSM desktops/computers and store analysis documents on 
FSM servers. 
Data, manuscript drafts, forms and other study-related documents will be stored on 
secure FSM servers through the Department of Medical Social Sciences (MSS).  For the 
information that must be identifiable for the purposes of the study (i.e. name, phone 
number, email address for facilitator/participant contact), this information will have 
added layers of protection (via password access to the file).  Participants will be coded 
and identified by a unique participant ID. 
Data input, processing, tracking and storage will happen at Northwestern University.  Dr. 
Moskowitz has oversight over each part of the process. Path to storage: Bright Outcome 
platform REDCap platform à Northwestern HIPAA-compliant server (storage and 
analysis) on the FSMFILES MSS Departmental Server. 
Identifiable data will only be shared internally amongst researchers listed on the IRB. Only 
IRB-approved individuals will have access to data through encrypted networks like the 
FSMFILES network or have permission to download datasets directly from REDCap (i.e. 
the PI, the biostatistician, the project director, IRB-approved study staff).  De-identified 
data might be shared with collaborators for the purposes of data analysis, secondary data 
analysis, manuscript-writing, using Northwestern Box. We will take precautionary 
measures to protect the confidentiality of our participants. 
 
21.0 Qualifications of Research Team to Conduct the Research: 
 
Northwestern University (NU), whose component schools and clinical affiliates form the 
foundation of this proposal, supports and promotes a vibrant and ever-growing 
community of clinical and translational scientists that is passionately committed to 
improving human health. Northwestern is one of the premier undergraduate and 
graduate universities in the world. It is ranked 12th among US national universities by US 
News &World Report, and is ranked in the top 30 world-wide. NU has notable strengths 
in medicine, public health, chemistry, nanotechnology, life sciences, engineering, 
communications, law and business/management. Northwestern’s sponsored research 
awards grew to $620 million in fiscal year 2015, the largest amount in the University’s 
history and a 4 percent increase over 2014’s $593.9 million. NU is located in Evanston and 
Chicago, Illinois. The University has a long history of leadership in interdisciplinary 
research programs and centers. More than 90 school-based centers and 26 University 
centers support interdisciplinary research that spans a wide spectrum of areas. 
Investigators with a Northwestern affiliation have access to the Galter Health Sciences 
Library at Northwestern University’s Feinberg School of Medicine and all other 
Northwestern University libraries, including the Pritzker Research Library at Children’s 
Memorial Hospital. 
 

 
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The proposed project will be based in FSM’s Department of Medical Social Sciences 
(MSS). MSS was established in 2009, with Dr. David Cella as founding and current chair, 
and provides a unique scientific home for applied researchers, integrating biomedical and 
social science approaches to improvement of health and health care delivery in diverse 
populations across the lifespan. Research themes include health measurement, quality of 
life measures, developmental mechanisms of health and disease and statistical tools to 
support clinical research with strength in application to specific disease processes such as 
cancer, neurologic disease, and early onset psychopathology. MSS is a catalyst for 
scientific integration across biomedical and social / life sciences campuses. MSS research 
cuts across traditional disciplinary boundaries, with collaborative ties with a broad range 
of research institutes and clinical departments across the University. 
 
Within MSS, there is adequate office space and computer work stations for all planned 
staff and secure data storage (paper and electronic) designated for the proposed study. 
MSS has its own internal Information Technology group that manages all hardware, 
software, and support needs for the department. Department computers are generally 
on a three year replacement cycle and use whatever technology is current at the time of 
replacement. The computers use either Windows or MacOS operating systems and run 
individual firewalls, antivirus, backups, and disk encryption that are centrally managed. 
Servers, while managed by the department IT group, are hosted at the University Data 
Centers that are shared by all departments. Servers provide web services, database 
services, file storage, and print services. These are secured behind Data Center firewalls 
with specific ports open for each specific service. Network access is limited to authorized 
University IDs. Physical access is limited to specific IT personnel using three factor 
authentication including biometrics. Files are backed up daily and databases are backed 
up every two hours. The department currently utilizes 24 servers in a combination of 
physical machine and virtual machine configurations. Protected health information and 
personally identifiable information that are stored on MSS database servers and on MSS 
file servers are layered with various physical and electronic access protections and 
policies to ensure HIPAA compliance. There are approximately 120 laptop and desktop 
computers utilized by department faculty and staff for day to day computing needs, along 
with over 50 laptops dedicated to specific studies. 
 
In addition, we will be working with Bright Outcome, a healthcare technology company 
that has built successful collaborations with other investigators at MSS. They have 
worked with other clients such as the Centers for Disease Control and Prevention, the 
National Institute of Mental Health, the National Institute of Nursing Research, and the 
National Cancer Institute. 
 
22.0 Statistical Analysis:  
 
Statistical Analyses 

 
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We will calculate the medians and interquartile range (IQR) for primary measures that 
assessed the (1) usability, (2) usefulness, (3) feasibility, and (4) acceptability of the SAGE 
LEAF platform. In addition, we will calculate supplementary user metrics based on data 
collected by the platform (e.g., percentage of home practice activities completed and 
percentage of videos watched) that reflect various aspects of engagement. We calculated 
the means and SDs for the Social Presence Scale and applied them as a correlate with 
measures of usability, usefulness, feasibility, and acceptability. For measures related to 
preliminary outcomes, we will perform paired, 1-tailed t tests on the data collected during 
the baseline and postintervention assessments to examine changes in means. Analyses 
will be conducted using Excel (Microsoft Corporation) and R Studio (Posit).