Randomized Trial of a Technology-based Positive Emotion Intervention for Informal Caregivers of Individuals With Alzheimer's Disease
Phase: NA
Conditions: Caregivers
Sponsor: Northwestern University

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PROTOCOL TITLE:
Life Enhancing Activities for Family Caregivers (LEAF) 2.0
PRINCIPAL INVESTIGATOR:
Judith T. Moskowitz, PhD, MPH
Professor || Department of Medical Social Sciences || Northwestern University
Director of Research || Osher Center for Integrative Medicine
Director || BSIS Core, Third Coast Center for AIDS Research
judith.moskowitz@northwestern.edu
312-503-7712
CO-INVESTIGATORS:
Elaine Cheung, PhD
Research Assistant Professor
Department of Medical Social Sciences || Northwestern University
elaine-cheung@northwestern.edu
312-503-4388
Elizabeth Addington, PhD
Assistant Professor
Department of Medical Social Sciences || Northwestern University
elizabeth.addington@northwesterne.edu
312-503-3808
VERSION DATE:
December 10, 2020
IRB #: STU00206756-MOD0014 Approved by NU IRB for use on or after 7/18/2022

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1.0 Purpose of the study:
The Life Enhancing Activities for Family Caregivers (LEAF) 2.0 Course is an intervention
containing a series of positive emotion skills for the family caregivers of individuals with
Alzheimer's Disease (AD) (1R01AG05613-01). LEAF 2.0 builds upon the LEAF 1.0
intervention (R01NR014435) in that it specifically targets positive emotion, focuses on the
caregiver, is a multicomponent intervention that offers an array of skills, and offers online
delivery (either facilitated or self-guided) which makes the intervention accessible and
convenient.
We will conduct a 3-arm randomized controlled trial with 500 total caregivers of
individuals with AD. 200 will be assigned to the web-based facilitated LEAF program
(Condition 1), 200 assigned to the web-based self-guided LEAF program (Condition 2),
and 100 will be assigned to the emotion reporting waitlist-control condition (Condition 3)
with crossover to the either the facilitated version or to the self-guided version; 50 in each
condition, respectively. The crossovers take place after approximately 7 months into the
study.  Participation in the study lasts about 14 months.
LEAF 2.0's three main aims are:
Aim 1: To compare the effect of online self-guided and facilitator-guided delivery
modes of LEAF to an emotion-reporting control condition on positive affect,
depression, anxiety, and perceived stress.
Aim 2: To explore the effects of LEAF on caregiving burden, self-efficacy, positive
aspects of caregiving, quality of care, and AD patient quality of life and assess
whether these effects on outcomes are mediated by improvements in positive
emotion.
Aim 3: To test whether caregiver age, gender, or baseline stress (dementia severity)
moderate the effects of the intervention.
2.0 Background / Literature Review / Rationale for the study:
Currently there are 5.5 million people in the United States diagnosed with Alzheimer’s
disease (AD) and this number could rise as high as 16 million by 2050. The average life
expectancy post diagnosis is 8 to 10 years, although some people live as long as 20 years,
experiencing increased functional, psychological, and physical dependence as the disease
progresses.1 Family members provide the vast majority of informal care to people with
dementia and report significant stress as a result. Caregiving-related stress contributes to
mental and physical illness and increases the risk of caregiver death.2-6 As the number of
people diagnosed with AD increases, there is a growing need for interventions that can
effectively buffer these deleterious psychological and physical consequences in informal
caregivers. Currently, most caregiver interventions focus on reducing burden stress, and
negative emotions.  However, positive emotion is uniquely associated with beneficial
health outcomes, independent of the effects of negative emotion,7-11 and holds promise for
countering the negative psychological and physical health effects of caregiving. We
IRB #: STU00206756-MOD0014 Approved by NU IRB for use on or after 7/18/2022

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developed an intervention that specifically targets positive emotion12-14 for people
experiencing various types of life stress, including the stress of dementia caregiving.15 The
theory and empirically-based program includes eight skills (noticing and capitalizing on
positive events, gratitude, mindfulness, positive reappraisal, personal strengths, attainable
goals, and acts of kindness), can be delivered by a trained facilitator in person or via the
web, and also has a self-guided online format.  Across delivery modes and type of
participant stress, the intervention has shown good feasibility, acceptability, and
efficacy.12-17
The intervention is based on revised Stress and Coping Theory20 and the Broaden-and-
Build Theory of positive emotion. The preliminary data for the proposed study consists of
1) A randomized trial of the online facilitator-delivered LEAF skills intervention (N = 86)
compared to a waitlist-control (N=84); 2) Pilot data from the self-guided online positive
emotion skills intervention in people coping with health related stress; and 3) Development
work in which we are testing three “enhancements” to increase adherence and retention to
the self-guided online positive emotion skills intervention and built-in structure to support
continued practice of the skills.
The goal of the proposed intervention, called LEAF (Life Enhancing Activities for Family
Caregivers) is to reduce burden and increase well-being in Alzheimer’s Disease caregivers
through the practice of positive emotion skills. We will evaluate two methods of online
delivery of LEAF: facilitated and self-guided and compare them to an emotion-reporting
waitlist control condition. If effective, the LEAF program can be disseminated to
Alzheimer’s caregivers nation-wide.
3.0 Inclusion and Exclusion Criteria:
Inclusion criteria:
•
Age 18 and over
•
Identifies as the primary family caregiver of a person with Alzheimer’s Disease
(AD)
•
Speaks and reads English
•
Has access to high speed internet connection at home or in a location where they
can speak privately with a facilitator (e.g. a library)
4.0 Sample Size:
We will recruit a total of 500 participants nationwide into the LEAF 2.0 randomized
controlled trial. Once participants complete the online consent and baseline questionnaire,
they will be randomized 2:2:1 to Facilitated LEAF (N = 200), Self-guided LEAF (N = 200)
or emotion reporting waitlist control (N = 100).  The waitlist control group will crossover
during the study to receive either the Facilitated LEAF (N = 50) or the Self-guided LEAF
(N = 50).
5.0 Research Locations:
IRB #: STU00206756-MOD0014 Approved by NU IRB for use on or after 7/18/2022

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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.
The
research
will
involve
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 Multiple sites:
Northwestern University is the lead (primary) research site for the LEAF 2.0 Study. The
University of California San Francisco (UCSF) is the secondary research site for the LEAF
2.0 Study. The Principal Investigator (Dr. Judith Moskowitz), co-Investigators (Dr.
Elizabeth Addington and Dr. Elaine Cheung), the NU Project Director (Eva Shiu) are at
NU, in addition to the several team members who are doctoral students mentored by Dr.
Moskowitz, and other research assistants on the project.  Only IRB-approved staff will
have contact with participants.
The co-Investigator is at the UCSF School of Nursing (Dr. Glenna Dowling) and the
Project Director (Karin “Kari” Snowberg) manages recruitment, phone screening, and the
technology orientation at UCSF. Paul Cotten is also a study team member, LEAF 2.0
facilitator and is at UCSF.  
Northwestern and UCSF will be working collaboratively on this project and we will rely
on the Northwestern IRB as the IRB of record. The management of tablets (shipment,
technology training, etc.) will take place at Northwestern.  We have weekly all-team
meetings that include everyone from both sites.  Subs-groups also meeting weekly or every
other week (e.g. content development or the measures team) to review and discuss relevant
topics.  The frequency and length of the all-team meeting and sub-group meetings will
adapt as the study launches.
NU and UCSF are jointly working towards our recruitment goal of N = 500. There will not
be a recruitment distinction between sites, since we are collectively recruiting caregivers
nation-wide and there is no in-person contact with participants.  All modifications will be
jointly discussed between NU-UCSF, but first submitted and approved through the NU
IRB (IRB of record). Once changes have been approved through the NU IRB, then we will
send the Modification Approval Letter to UCSF for UCSF IRB approval.
7.0 Reliance Agreements/Single IRB:
LEAF 2.0 is a multi-site study with reliance on a single IRB through Northwestern’s Social
and Behavioral Research Panel.  We will be pursuing a reliance agreement with UCSF
through SMART IRB. No research activities at UCSF will take place until the submission
to modify the study with the reliance agreement is approved by the IRB.
8.0 Procedures Involved:
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This study has been registered with clinicaltrials.gov and the NCT number is:
NCT03610698. The clinicaltrials.gov registration number (NCT) will be listed on the
consent forms and recruitment materials and approved by the NU IRB prior to starting
recruitment.
Online Pre-Screener Link
Interested individuals will click on an online link posted on our various recruitment outlets.
The 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 is eligible, they will see a message that says a member of the study team will
reach out to schedule a phone call. 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 in the LEAF study. Ineligible
individuals will, however, be asked if they would like to be contacted about a study that
utilizes a similar positive emotion skills platform called SAGE LEAF (STU00215548) that
is open to all dementia caregivers rather than just caregivers of those with Alzheimer’s
diseaseThe following question will be added to the screen failure message: “Would you
like us to contact you about a similar study that teaches positive emotion skills and is open
to all dementia caregivers?” Participant will indicate yes or no, with a written statement
that specifies a response of “yes” gives the study team permission to maintain their pre-
screener information in REDCap and reach out to them within 6 months.
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.  Any
data from the pre-screener will only be for purposes of gauging the reach of our national
recruitment efforts such as zip code and assessing trends or characteristics among those
who take the screener e.g. whether the pool of interested individuals are women mainly
caring for their husbands with Alzheimer’s Disease (relationship with the care recipient)
or women who mostly found out about the study based on a referral from an in-person
support group (method of recruitment). 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)
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 discuss what
the LEAF 2.0 study entails, including time commitment, timing and number of
assessments, overall summary of the LEAF 2.0 course, randomization, and the use of a
tablet or computer to complete study activities. If participant does not have a tablet or
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computer at home, study staff will take down mailing address to send a Samsung tablet via
Fedex. This allows the individual to ask questions, discuss any concerns, and decide
whether or not they want to be in the study.
Consent, Baseline Assessment (T1), Randomization
After the phone screen, and if the individual wants to continue, the PD or study staff
member will email the individual a link to the online consent form through REDCap.
Consent scenarios:
•
If a participant consents “Yes,” they will automatically continue on to complete
the online baseline assessment (T1).
•
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 (based on information
provided on the screener.
•
If an individual responds “No” and declines to participate, they will see a message
thanking them for their time, and answer a brief (optional) question about why
they declined.
Consenting individuals will continue to take the baseline assessment (T1) which takes up
to 1 hour. Once the baseline assessment is complete, participants will be randomized to
either the Facilitated LEAF “Video Session” Group (N=200), Self-guided LEAF “Online
Lessons” Group (N=200), or an emotion reporting waitlist control. Both the “Online
Lessons” and “Video Sessions” consists 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 emotion reporting control group reports their daily
emotions for 8-weeks (equivalent to the 8-week intervention period), and then crosses over
to receive the intervention at time point 4 (T4) as either the “Video Sessions” (N=50) or
“Online Lessons” (N=50), after a waiting period of 7 months. Home practice exercises and
the daily emotion check-ins will be done over the internet on the Bright Outcome platform
for all research arms (N=500). The intervention content, emotion reporting forms, and
assessment questionnaires are all mobile-enabled so can be completed on desktop, laptop,
tablet, or smartphone.
Randomization:
Condition 1: one-on-one video sessions with a facilitator
Condition 2: self-guided online lessons
Condition 3: emotion reporting condition that will get either the one-on-one video
sessions or self-guided online lessons later
Mailing and Receiving a Tablet
During the screening call, study staff will assess whether participant has a device at home
with which they can access study activities (computer, tablet, or smartphone). After a
participant has been randomized, the PD will mail a tablet to participants who do not have
a device they can use to access study activities, and arereceiving the LEAF 2.0 intervention
right away e.g. those randomized to the “Videos Sessions” Condition 1 or “Online
Lessons” Condition 2 (NOT in the emotional reporting control group).  Emotion-reporting
participants (Condition 3) who need a study tablet will receive the tablet at T4 when they
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complete the waitlist portion of the study and just prior to the beginning of the intervention.
The PD will mail and track the delivery of a tablet to the participants who opt in to receiving
one.
6 Sessions over 8 Weeks: 60 min/session
Facilitator-Guided Intervention “Video Sessions”
Since the intervention is delivered online, caregivers will participate in a place of their
choosing that offers privacy and comfort. Facilitators will participate in a private room in
their work setting. The sessions will take place over approximately 8 weeks (6 weekly
modules and online home practice with 2 weeks of “catch-up”).  Sessions will be conducted
on an encrypted internet connection and all sessions will be video-recorded on Zoom for
both quality assurance and intervention evaluation. They will also complete daily stress
and emotion questions included in the control condition.  Between training sessions,
participants in the facilitator-guided sessions will complete home exercises and write daily
experiences on the Bright Outcome online platform.  Bright Outcome data we are
collecting also include number of log-ins, progress in the course, completed home
exercises, number of audio plays on the meditation file, content page access, etc.  These
data will be securely stored on Northwestern servers, accessible only to IRB-approved
study staff.
6 Sessions over 8 weeks: approx. 30 minutes/online module
Week Self-Guided Intervention “Online Lessons”
In the self-guided version of LEAF, the skills will be delivered within 8 weeks (6 weekly,
hour-long sessions, scheduled with a facilitator within an 8-week period) via video-
conference on a device of their choice. Caregivers can participate from their home
computer, smartphone, or a study supplied tablet if they opt to receive one, 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. As part of the daily home practice, intervention participants will
be asked to complete the daily stress and emotion questions included in the control
condition. Data from participants engaged in the self-guided LEAF skills condition
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.
Waitlist/Emotion Reporting Control Condition
In past research we have established that emotion reporting is acceptable as a control
condition and that participants perceive it as being beneficial. Participants will be asked
to log on to the website daily for 8 weeks, comparable to the 8 week intervention period.
They will be prompted to report on positive and negative emotions and stressful events
experienced in the past day. Based on past studies, we expect that this reporting will be
about 5 minutes per day. Note that participants in the LEAF intervention conditions will
also be completing the daily reporting of emotions and stress as part of their home
practice.  Data from the emotion reporting will also be tracked/exported from the Bright

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Outcome platform and securely stored on Northwestern servers, accessible only to IRB-
approved staff.
Time Commitment
The estimated time commitment for participating in the LEAF Study is up to 30 hours
over 14 months, depending on research condition.  Conditions 1 and 2 (who receive the
LEAF Skills right away) will spend up to 25.5 hours in the study. Condition 3 (who wait
7 months before receiving the LEAF Skills) will spend up to 30 hours in the study.
Conditions 1 and 2: <24.5 hours
Event
Time
Commitment
7 surveys (up to 1 hour each)
7 hours
6 LEAF Sessions
<6 hours
Daily Home Practice + Daily Check-in During the LEAF Sessions
11.5 hours
Total Hours over 14 months
<25.5 hours
Condition 3: <30 hours
Event
Time
Commitment
8 weeks of Daily Emotion Check-in
4.5 hours
7 surveys (up to 1 hour each)
7 hours
6 LEAF Sessions
<6 hours
Daily Home Practice + Daily Check-in During the LEAF Sessions
11.5 hours
Total Hours over 14 months
<30 hours
Bright Outcome Platform
Depending on the research arm the participant is assigned to, the participant will have
access to different features on the platform.  Below, the check-marks indicate the website
features available on the platform based on the research arm assigned.
Research Arm:
Daily
Emotion
Check-In
Skills Review  
(“Review” on
Dashboard = 1-2
sentences for skill
summary)
Home
Practice
Home
Practice
Review
Self-
Guided:
LEAF
Skills
Discussion
Awards
Condition 1:
Facilitated
“Video
Sessions”

8 weeks


Condition 2:
Self-Guided
“Online
Lessons”

8 weeks






Condition 3:
Waitlist Control
 “Video
Sessions”

8 weeks

Unlock at 7
months

Unlock at 7
months
Condition 3:
Waitlist Control







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 “Online
Lessons”
8 weeks
Unlock at 7
months
Unlock at 7
months
Unlock at
7 months
Unlock at
7 months
Unlock at
7 months
Unlock
at 7
months
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 LEAF Study ID and an avatar.  No identifiable information will be
posted/shared.  All participants in this arm will watch a video and receive instructions on
how to use the Discussion feature on the website.  Guidelines will include refraining
posting personal/identifiable information such as names and contact information, and
refraining from bullying or using harsh/offensive language online. We will develop, tailor,
and prepare 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 MARIGOLD and LARKSPUR.  
These will be internal team documents. (See Section 17.0 Data Monitoring Plan to
Ensure Safety of Participants for more details).  
Bright Outcome “Awards” Feature
Participants accessing the “Online Lessons” on the platform will have a tab 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.  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.
Self-Report Assessments (T1, T2, T3, T4, T5, T6, T7)
Self-report data will be collected via online assessments (administered through REDCap)
at 7 time points, emailed to participants at baseline (Time point 1) each approximately 2
months apart from baseline (T1).  These assessments take approximately 1 hour to
complete each time. They will be emailed to the participant (default setting), but we will
offer participants the option to receive the assessments via SMS text message.  The
participant can choose their preference. If a participant consents to receive SMS text
messages for the study, we will send participants periodic text reminders about their
assessments and other research-related reminders. All data used for analysis will be de-
identified. No identifiable data will ever be stored locally on staff computers, and no data
are ever stored locally on participants’ devices (tablet, home computer, or mobile device).
All measures will be completed from home via tablet, a home computer, or mobile device.
Administration of most of these measures has been shown to be feasible and acceptable to
caregivers of dementia patients in LEAF 1.0 with caregivers (R01NR014435). In addition
to the self-report measures of psychological well-being, frequency of positive and negative
emotion and various caregiving outcomes, we will also assess the following demographic
variables: age, gender, urban/rural residence, race/ethnicity, education, household income,
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caregiver relationship to patient (spouse, partner, family member), time since dementia
diagnosis, and how long the caregiver has been providing care to the patient.
Participant Timeline & Time Commitment Based on Research Arm
Time Commitment
Name of event
15 minutes
Pre-screener Link
30 minutes
Phone Screen
60 minutes
Consent & T1 (T1 = “Assessment at Timepoint 1”)
N/A
Randomization
30-60 minutes
Technology Phone Call
(duration 8 weeks; time
commitment varies by arm)
“Video Sessions”
Condition 1
6 Sessions (60
minutes each)
conducted within 8
weeks; daily home
practice & emotion
check-in (10-30 min
daily)
“Online Lessons”
Condition 2
6 Sessions (30 min
each) accessed over
8 weeks; daily
home practice &
emotion check-in
(10-30 min daily)
Emotion
Reporting Control
Condition 3
8 weeks of daily
emotion check-in
(~5 min daily)
Emotion
Reporting Control
Condition 3
8 weeks of daily
emotion check-in
(~5 min daily)
60 minutes
T2*
T2
T2
T2
60 minutes
T3
T3
T3
T3
60 minutes
T4
T4
T4
T4
(duration 8 weeks; time
commitment varies by arm)
N/A
N/A
Cross-over to
“Video Sessions”
Cross-over to
“Online Lessons”
60 minutes
T5
T5
T5
T5
60 minutes
T6
T6
T6
T6
60 minutes
T7
T7
T7
T7
Closing Message and Thank you
*Note: Each time point is approximately 8 weeks apart from T1 to T2, T2 to T3, etc.
**Please see the specific timelines for each condition, uploaded on supporting
documents. We will be providing these timelines to participants, based on the
condition to which they’re assigned.
LEAF 2.0 Positive Emotion Skills
Please see the table below for an overview of the intervention’s skills, goals, and home
practice exercises.  The Bright Outcome online platform will be used for all research arms
of the study: the self-guided, facilitator-guided, and emotion reporting control versions.
The online platform will be tailored depending on the group to which the participant has
been randomized. The content (facilitator-guided and self-guided versions) have been
uploaded to the IRB.
The total time involved from the beginning to the end of the study is approximately 14
months.  This includes the baseline assessment (T1), a few weeks for scheduling phone
calls for the phone screen, mailing a study tablet if applicable, the 6-session intervention
over 8 weeks (or emotion-reporting control condition), and the subsequent assessments at
T2, T3, T4, T5, T6, T7.
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
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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 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 LEAF 2.0 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 LEAF
2.0 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 LEAF 2.0 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.
Participants in the “Video Sessions” group will have up to 8 weeks to schedule all 6
sessions. This timeline allows for some flexibility for the caregiver e.g. if they need to
reschedule due to vacation, travel, doctors appointment, etc. Participants in the “Online
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Lessons” group will have up to 8 weeks to complete the online course. The daily emotion
reporting period will stop after Week 8 in both of these groups.
Measures
Caregivers will complete self-report questionnaires at 7 time points over approximately 15
months. The assessments will be named by their time point “T”, e.g. T1 (baseline), T2,
(approx. 2 months from baseline), T3 (approx. 2 months from T2), T4 (approx. 2 months
from T3), T5 (approx. 2 months from T4), T6 (approx. 2 months from T5), T7 (approx.. 2
months from T6). All 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. Administration of most of these measures has been shown to be feasible and
acceptable
to
caregivers
of
dementia
patients
in
LEAF
1.0
with
caregivers
(R01NR014435). In addition to the self-report measures (listed below), we will also assess
the following demographic variables: age, gender, urban/rural residence, race/ethnicity,
education, household income, caregiver relationship to patient (spouse, partner, family
member), time since dementia diagnosis, and how long the caregiver has been providing
care to the patient. We will assess the following self-report measures in each assessment:
•
Psychological Well-being
o
Psychological well-being will assessed using measures drawn from
NIH Toolbox87,95 and the related PROMIS measurement system.96,97 We will
use the short-form measures of anxiety and depression from the PROMIS
measurement system. In addition, we will assess the following additional
indicators of psychological well-being from the NIH Toolbox: perceived stress,
life satisfaction, self-efficacy, and meaning and purpose.
o
Frequency of positive and negative emotion will be assessed using
a modified version of the Differential Emotions Scale (DES).90,98 This version
of the DES was modified by Fredrickson to include a wider range of positive
emotions. The full scale assesses interest, enjoyment, surprise, sadness, anger,
disgust, contempt, fear, guilt, shame, shyness, amusement, awe, contentment,
gratitude, hope, love, pride, sympathy, and sexual feelings. Participants will be
asked to respond to each item in terms of how frequently they felt that particular
affect in the past week on a 4-point scale: 0 = never, 1 = hardly, 2 = some of the
time, 3 = often, and 4 = most of the time.The scale can be scored for total
positive and negative emotion, grouped according to where they would fall on
the circumplex model of affect (e.g., high activation vs. lower activation), or
individual emotions can be examined.
•
Caregiving Outcomes
o
Problematic Patient Behaviors will be our proxy for dementia
severity and will be assessed using the Revised Memory and Behavior
Problems Checklist.99 The Revised Memory and Behavior Problems Checklist
is a 24-item scale completed by caregivers that measures the frequency of
problematic behaviors exhibited by patients with dementia and the caregiver’s
reactions to these behaviors.

Page 13 of 28
o
Caregiving burden will be measured using a brief version of the
Zarit Burden Interview.89 This is a 12-item inventory that assesses subjective
feelings of the impact of caregiving on emotional and physical health function,
social life, and financial status and performs as well as the full 22-item Zarit
Burden scale.
o
Caregiving self-efficacy will be measured using the Caregiving
Mastery subscale, Short Form, by Lawton, et al.100 The Caregiving Mastery
subscale is a 6-item measure that assesses the caregiver’s sense of efficacy with
caregiving, such as their confidence in handling problems when caring for the
patient and being able to figure out what the patient needs.
o
Positive aspects of caregiving will be measured with the Positive
Aspects of Caregiving Scale.91 This is an 11-item scale that identifies positive
consequences of caregiving such as feeling more useful, feeling appreciated,
and strengthening relationships with others.  
o
Quality of care provided will be measured using the Satisfaction
with One’s Own Performance as a Caregiver subscale of the Sense of
Competence Questionnaire.101 The Satisfaction with One’s Own Performance
as a Caregiver subscale is a 12-item subscale that measures the caregiver’s self-
evaluations of their caregiving effectiveness, such as how useful they feel in
their interactions with the patient and their capability in caring for the patient.
o
Quality of Life of Care Recipient will be assessed with the Quality
of Life in Alzheimer’s Disease scale.102 This 13-item scale, completed by the
caregiver regarding the individual living with AD’s QOL, assesses several
domains on a scale from 1 (poor) to 4 (excellent):  physical health, energy,
mood, living situation, memory, family, marriage, friends, self, ability to do
chores, ability to do things for fun, money, and life as a whole.  Scores on the
QOL-AD show reasonable correlations with activities of daily living and
patient depression.102
Some of the instruments will only be administered based on branching.  For example, if a
participant reports that their care recipient has passed away (via the caregiving status
question), subsequent questions regarding caring for their loved one will no longer be
asked.  In this case, questions related to caregiving will be hidden using branching.
For the Medical Outcomes Study (MOS) on general adherence, we have added a “Not
applicable” response.  For example, “In the past month, how often did you take your
medications as the doctor prescribed?” We added a response that says “Not Applicable –
or—my doctor has not told me that I should take any medications.”
Table of Measures
Full Name of Measure
Abbrev.
Name of
Measure
Administered at:
In reference to:
1
Demographics (see uploaded
instruments)
Baseline (T1) only
2
Technology Survey
Right before
intervention content
*Timing based on
Technology/Usability
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Research Arm**
3
System Usability Scale
SUS
T2 (all research arms)
and T5 (arms 3 and 4
only)
Technology/Usability
4
Differential Emotions Scale also called
the “Daily Emotion Check-in”
DES
All timepoints**
(T1, T2, T3, T4, T5,
T6, T7); and daily
during the 8-week
intervention period
Psychological
Adjustment
5
Daily Inventory of Stressful Events
DISE
All timepoints**
(T1, T2, T3, T4, T5,
T6, T7); daily during
the 8-week intervention
period; daily during the
8-week emotion
reporting control period
Psychological
Adjustment
6
Dementia Severity Rating Scale
DSRS
All timepoints
Quality of Life of
Care Recipient
7
PROMIS SF v1.0-Depression 8a
All timepoints
Psychological
Adjustment
8
PROMIS Anxiety v1.0 8a
All timepoints
Psychological
Adjustment
9
Profile of Emotional Competence
Scale
PEC
All timepoints
Psychological
Adjustment
10
Emotional Complexity Scale
ECS
All timepoints
Psychological
Adjustment
11
modified Perceived Partner
Responsiveness
mPPR
T2 (all research arms)
and T5 (arms 3 and 4
only)
Psychological
Adjustment
12
Caregiving Status
All timepoints except
T1
Caregiving Status
13
PROMIS SF v1.1 – Global Health
All timepoints
Psychological
Adjustment
14
PROMIS SF v1.0 – Sleep Disturb 8b
All timepoints
Psychological
Adjustment
15
PROMIS SF v1.0 – Meaning and
Purpose 8a
All timepoints
Psychological
Adjustment
16
Healthcare Utilization
HU
All timepoints
Health Behaviors
17
Oberst Caregiving Burden
OCBS-15
All timepoints
Caregiving Burden
18
Positive Aspects of Caregiving
PAC
All timepoints
Positive Aspects of
Caregiving
19
Perceived Stress Scale
PSS-4
All timepoints
Psychological
Adjustment
20
Satisfaction with Life Scale
SWLS
All timepoints
Psychological
Adjustment
21
Satisfaction with one’s own
performance as a caregiver
SCQ
All timepoints
Quality of Care
Provided
22
Self-Compassion (Neff), short form
SCS
All timepoints
Psychological
Adjustment
23
Quality of life of Care Recipient
QOL-AD
All timepoints
Quality of Life of
Care Recipient
24
Revised Memory and Behavior
Checklist
RMBC
All timepoints
Problematic Patient
Behaviors
25
COMBO Health Behavior Measures
COMBO
All timepoints
Health Behaviors
26
Five Facet Mindfulness Questionnaire
FFMQ-15
All timepoints
Psychological
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Adjustment
27
Zarit Burden Interview
ZBI-6
All timepoints
Caregiving Burden
28
Co-morbidity check-list
All timepoints
Comorbidity
29
Medication Adherence, single-item
from Heart and Soul Study (Sin et al
2015)
medadhere
All timepoints
Health Behaviors
30
6-item Caregiving Mastery Subscale,
SF
CM
All timepoints
Caregiving Self-
Efficacy
31
PROMIS Positive Affect 15a
All timepoints
Psychological
Adjustment
32
Recommendations & Skill Use
T2 or T5 based on
research arm
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Schedule of Measurements by Timepoint:ER
Power
Simple group comparisons for single time points or pre-post comparisons between the
facilitated (n=200) and self-guided (n=200) groups will have 80% power to detect effect
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sizes of d=.28 (R2=.019), below the observed effect sizes for positive emotion, negative
emotion, stress, depression, and anxiety in our previous LEAF trial. Comparisons between
the wait-list control group (n=100) and the LEAF interventions individually (n=200) or
taken together (n=400) will have 80% power to detect effect sizes of d=.34 (R2=.029) and
d=.31 (R2=.024), respectively.
Our design of seven time points and 500 individuals exceed established minimums for
detecting predictors of individual differences108 and for detecting associations between
parallel growth processes.109 Power for these models was estimated by Monto Carlo
simulation to account for our longitudinal experimental design. Effects of observed
predictors (i.e., LEAF group, Aim 1) had 80% power for effects of d=.27 (R2=.018).
Parallel growth curves showed 80% power for slope correlations of r=.14 (R2=.019), and
comparable power for indirect effects of (r=.15, R2=.021), consistent with previous work
on mediational power.110
Missing Data
Although our previous test of LEAF showed high adherence rates and minimal dropout,
all longitudinal analyses must plan for missing data. All proposed models will be fit with
full information maximum likelihood, which yields unbiased parameter estimation under
common missing data mechanisms. Multiple imputation will be used in any cases where
covariates predict missingness but would otherwise not be included in proposed models.
9.0 Incomplete Disclosure or Deception:
N/A
10.0
Recruitment Methods:
We plan to recruit participants over the period of 42 months.  Recruitment efforts will target
the 2 major national organizations servicing patients with dementia and their caregivers: 1)
the Alzheimer’s Association and 2) the Family Caregiver Alliance: National Center on
Caregiving.
We will also use print, radio, and websites at the national and local level of these
organizations to access a geographically and age diverse cohort. Subjects will also be
recruited from the Northwestern University Alzheimer’s Center, the University of
California San Francisco Memory and Aging Center, The New Normal, and the NUCATS
recruitment tool. We will also recruit on Alzheimer’s-related websites that give us
permission to post.
We will create and maintain a study website and Facebook page. In addition, we recruit on
Twitter and on Research Match (an online database of open research studies and
individuals seeking to participate in research studies) and Reddit online discussion boards
on caregiving, Alzheimer’s, and dementia.  Both Research Match and Reddit have been
previously used to successfully recruit participants online for positive emotion intervention
studies. All recruitment text will be uploaded to the NU IRB for approval prior to starting
recruitment.
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Update December 2020: Due to difficulty in hitting target recruitment numbers, likely
impacted by the pandemic, we will be utilizing the expertise of Recruitment Partners, LLC,
a firm that specializes in recruitment for research studies related to Alzheimer’s disease.
Recruitment Partners (RP) will be collaborating in a consultant capacity, and will not be
involved in consenting participants. They will spend a month getting familiar with our
study and building a campaign to engage appropriate partners within the RP Network of
care, adult day centers, patient and advocacy organizations, providing preliminary
information about the study to generate enthusiasm and gauge interest from our community
partners. RP will provide information about the LEAF study team and instruct on caregiver
enrollment. RP will educate key contacts in the RP Network on the study, provide
marketing materials, and coordinate strategic recruitment outreach with the care
communities and organizations.
Based on the demographics of AD caregivers nationally, we expect our sample to be
approximately 66% White, 10% African American, and 8% Hispanic. We anticipate
about 75% of the sample will be female.  
11.0
Consent Process:
Online consent will be taken 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. If a participant indicated in the screening call that they would need a study tablet
to be sent to them withdraws and has not yet received their computer tablet from the
study, they will not be sent a computer tablet.
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
updated consent form.
12.0
Financial Compensation:
There is no financial compensation for completing this study. We hope that
participants retain some benefit from learning thecoping skills that help reduce stress
and increase positive mood.
13.0
Audio/Video Recording
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The facilitator-guided LEAF sessions will be digitally video- and audio-recorded using a
secure, encrypted internet connection on a password-protected platform such as Zoom.  
Each participant in the facilitator-guided intervention will have approximately 6 audio-
recorded sessions (one for each  intervention session, 6 total), recorded for quality
assurance purposes and to evaluate the intervention. These recordings will be securely
stored on Northwestern password-protected servers, accessible only to IRB-approved staff.
The videos will be labeled by Study ID.
Fidelity will be assessed qualitatively with a checklist and comments for each component
of a session as we have done in LEAF 1.0 and other face-to-face delivery of the
intervention. Sessions will be reviewed by the project director to assess adherence to the
protocol, delivery, facilitator/participant rapport, and session flow.  All sessions of the first
three participants (for each facilitator) will be reviewed immediately.  This will be followed
by regular (weekly, then monthly) reviews of selected sessions thereafter.
14.0
Potential Benefits to Participants:
There is no guaranteed benefit from participating in LEAF 2.0, however participants might
enjoy the skills taught in LEAF 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 LEAF 2.0 may help family caregivers
of dementia patients increase their positive affect and lower depression, anxiety, and
perceived stress.  We will explore the effects of this intervention on caregiving burden,
caregiving efficacy, positive aspects of caregiving, quality of care, and AD patient quality
of life.  We will assess whether these effects on outcomes are mediated by improvements
in positive emotion.
15.0
Risks to Participants:
Minimal Risk; Possible discomfort while interacting with the LEAF platform
LEAF is relatively easy to administer and is a low cost intervention compared to existing
caregiver interventions. Many of the existing interventions require in-person interaction
whereas LEAF can be delivered by a trained lay person via video conferencing. A potential
risk of discomfort might arise with participants who do not have extensive 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.  We will provide any participant who does
not have their own wifi compatible device and wants one with a tablet computer.  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
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online experience is not a barrier to participation.
Minimal Risk; Possible discomfort when responding to questions
The risks of participating in LEAF 2.0 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
related to caregiving duties, or reflecting upon experienced negative emotions. Participants
are notified that they may skip any questions they do not wish to answer. Declining to
answer any questions, declining to participate in the study, or declining to continue with
the study once enrolled, will not have any impact on a participant’s medical care at
Northwestern Hospital, Northwestern University Alzheimer’s Center, the University of
California San Francisco Memory and Aging Center or any affiliated specialty or primary
clinics.
Potential loss of 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
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
LEAF 2.0 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
be 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 new 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 LEAF 2.0 online platform is hosted by Bright Outcome and is protected by end-to-end
encryption and password measures. Participants will be able to access LEAF 2.0
intervention on their computer browser or on their 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
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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 mobile phones
nor participants’ computers. All data will be collected directly through the website and
stored on password-protected, secure NU servers.  For participants who may receive a hard-
copy version of the workbook, they will complete their home practice exercises directly on
their workbook, mail their workbook back to Northwestern via self-addressed envelope for
photo-copying, and then their workbook will be returned to them.  Precautionary measures
will be taken to track packages and ensure delivery arrives only for the persons intended to
receive the study materials.
Potential loss of confidentiality in general
Once a participant is enrolled in the study, there is the chance someone might overhear the
facilitator-guided sessions, or 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 they have their scheduled facilitator-guided sessions.  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.  All LEAF
facilitators will be trained on the intervention content and will conduct the guided LEAF
sessions in a private setting with the door closed and with headphones on.
“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 AD caregivers. Such a Pollyanna-
ish stance could easily degenerate into blaming the victim 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 in caregivers sets the
stage for a cascade of adaptive consequences, including reduced burden and improved
quality of care. Ultimately, given the high levels of stress and depression documented in
dementia caregivers, we consider increasing positive emotion to be an inherently
worthwhile intervention goal.
While our study focuses on positive emotion, we emphasize that LEAF 2.0 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.  A participant can also notify their LEAF facilitator during a LEAF
session, email their facilitator, or send an email to the designated study email.  Study staff
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will also be monitoring communications and potentially withdrawal requests coming
through on the study website, study email, or Facebook page. 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. We do not foresee any
circumstances under which participants will be withdrawn from the research without their
consent.
16.0
Provisions to Protect the Privacy and Confidentiality of
Participants and the Research Data:
The research team is committed to the protection of human participants. All study staff will
participate in initial training, follow-up training, and ongoing monitoring and supervision
to ensure understanding of ethical issues involved in this research. This includes, but is not
limited to, the CITI Human Subjects course, training on HIPAA, and measures to protect
confidentiality.  The research team will also be trained on how to use the REDCap
Database, which is encrypted, password-protected, and maintained by the Northwestern
University Clinical and Translational Sciences Institute (NUCATS).
All data is stored and handled in a confidential manner and will only be stored on HIPAA
compliant, password-protected servers accessible to IRB-approved study staff. Participants
will not be identified by name on study documents or data shared with outside
collaborators. Participants will be assigned and identified by their Study ID and all
documents will be held to strict confidentiality and HIPAA compliant standards in double
locked facilities. Confidentiality will be maintained through all phases, including data
analysis and publication.
17.0
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
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.
Prompt reporting of serious adverse events will be 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.
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Data monitoring procedures. The PI, Dr. Judith Moskowitz will be the primary data
custodian for LEAF 2.0. Overall recruitment goals, missing data, and follow-up failures
will be monitored by the project director in conjunction with the biostatistician, and the PI
will receive regular updates and maintain constant communication with the biostatistician,
the project director, 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 backup to the primary custodian (Dr. Elaine
Cheung, the study’s biostatistician) 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. Upon recognition of unacceptable recruitment, follow-
up rates, or missing data, Dr. Moskowitz (PI) and Dr. Cheung (Biostatistician) will
intervene with strategies to remedy the shortcomings or provide additional monitoring.
Safety Risks and Monitoring
Safety related risks. Safety related risks could consist of:
1) Emotional discomfort while using the 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
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.
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. For the first version of this study
LEAF 1.0, the PD developed a list of resources for the caregivers when they show signs of
distress or if they are experiencing loss of their partner/dementia patient.  We will be
updating and tailoring these materials for LEAF 2.0. Based on our experience conducting
LEAF 1.0 and prior trials of online self-guided delivery of positive affect skills (e.g.
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MARIGOLD, LARKSPUR), the study team is well versed in handling/managing instances
that might require providing caregivers with additional resources.
Dr. Elizabeth Addington is on the LEAF 2.0 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.
(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, medical treatment, or any other manner. (4) Research facilitators are trained to
deliver the intervention in a private setting with a closed door for participant
confidentiality. Participants are encouraged to participate in the facilitator-guided session
in a private space and to be mindfully 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 director (Karin Snowberg at UCSF and Eva Shiu at NU) or study team
member will immediately alert the clinical psychologist (Dr. Elizabeth Addington) so that
PDs and Dr. Addington are immediately aware.  Dr. Addington and the PDs will work
together to assess the situation and take immediate, appropriate steps.  If the situation is
serious, we will inform the PI. 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 related to LEAF 2.0. Based on our past
experience conducting online studies with a discussion feature (e.g. MARIGOLD,
LARKSPUR), the risk of these occurrences are minimal and the study team is well versed
in handling/managing these instances, if they happen.
Safety risk reporting and action plan.  Any participant in need of treatment due to distress
will be referred for appropriate services by the project director.  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, supplemented by regular session notes will be immediately sent to
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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/video 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 by Dr. Moskowitz (PI) and Dr. Addington (Co-I and licensed
clinical psychologist), 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 Dr. Addington.
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.
18.0
Data, and if applicable, Specimen Banking:
•
Pre-screener and consent data will be collected and housed via REDCap at
Northwestern University.
•
Assessment data at 7 time points (T1-T7) will be collected through REDCap
hosted by Northwestern University and managed under the Northwestern
University Clinical and Translational Sciences Institute (NUCATS). This secure
server is password-protected, HIPAA-compliant, and protected by end-to-end
encryption.
•
Adherence data and daily emotions/stress reporting will be collected through the
online platform hosted by Bright Outcome and overseen by LEAF 2.0 study staff
at Northwestern University. The NU platform will be a tailored version of a course
previously designed for an online intervention for people with depressive
symptoms (MARIGOLD R34). Participants will be able to take the online
intervention through the platform accessible via the website on their computer
browser, or the website on their mobile phones.  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.  Study staff will then be able to access and export the data collected through
the platform.  No data will be stored on mobile phones.  All data will be collected
directly through the website and stored on secure NU servers. The online platform
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is also HIPAA-compliant, password-protected, and secured by end-to-end
encryption.
•
All participants will be able to access the website on their mobile phone and web
browsers, but data will not be stored locally on mobile phones nor on web
browsers. All data will be collected directly through the website and stored on
secure NU servers.
•
Dr. Moskowitz, PI, is involved in the development of the online intervention,
oversight of intervention sessions, 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
statistical programming on FSM desktops/computers and store analysis documents
on FSM servers.
•
Data, video recordings, 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, and audio/video
recordings (input/collection)  Northwestern HIPAA-compliant server (storage
and analysis) on the FSMFILES MSS Departmental Server.
•
Path to storage for recorded video sessions (for quality control/quality assurance):
Zoom  FSMFILES MSS Departmental Servers. Only IRB-approved research
study team members will have access to FSMFILES MSS Departmental Servers.
19.0
Data Sharing:
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.
20.0
Qualifications to Conduct Research and Resources Available:
Northwestern University (NU), whose component schools and clinical affiliates form the
foundation of this proposal, supports and promotes a vibrant and ever-growing community
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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.
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.
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In addition, we will be working with Bright Outcome, a healthcare technology company
led by DerShung Yang, PhD (President), who has built successful collaborations with
other investigators at MSS. Dr. Yang has been head of Bright Outcome since 2003 and
has 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.
IRB #: STU00206756-MOD0014 Approved by NU IRB for use on or after 7/18/2022