Mobile Web-based Behavioral Intervention for Improving Caregiver Well-being
Phase: NA
Conditions: Depressive Symptoms, Stress, Psychological
Sponsor: University of California, San Diego

PROJECT TITLE: Mobile Web-based Behavioral Intervention for 
Improving Caregiver Well-being 
 
Date: 9/1/2019 
NCT Number: NCT03506945 
PROTOCOL ID: 180454  
STUDY PROTOCOL                  
AND                               
STATISTICAL ANALYSIS PLAN 
 

 
 
Page 1 
 
PROJECT TITLE 
Mobile web-based behavioral intervention for improving caregiver 
PRINCIPAL INVESTIGATOR  
Brent T Mausbach, PhD 
 
DURATION OF THE STUDY 
5 years 
 
LAY LANGUAGE SUMMARY OR SYNOPSIS 
Caregivers of persons with dementia suffer great amounts of distress that significantly impacts their mental and 
physical well-being, and ability to care for the patient at home without resort to nursing home placement. Yet, 
caregivers’ access to quality, evidence-based interventions to assist them is currently very limited. We propose 
to test the efficacy of a web-based Behavioral Activation intervention called the Pleasant Events Project 
(mPEP) that has potential to significantly improve caregiver well-being. 
 
SPECIFIC AIMS 
Aim 1: Test the efficacy of wBA for improving caregiver well-being.  
 
H1: Caregivers receiving the mPEP intervention will report improved positive affect, reduced negative affect, and 
improved mental and physical well-being compared to caregivers receiving a web-based bibliotherapy 
intervention. 
 
Aim 2: Assess mechanisms of the mPEP intervention that promote well-being. 
 
H2: Via data collected in the web-based portal, greater engagement in pleasant activities (i.e., treatment 
adherence) will be associated with greater improvement of caregiver well-being outcomes.  
 
Aim 3: Assess the influence of the mPEP intervention for promoting physical health. 
 
H3: Caregivers assigned to the mPEP intervention will show greater reduction in blood pressure relative to those 
assigned to a web-based bibliotherapy intervention.  
  
BACKGROUND AND SIGNIFICANCE 
The primary aim of this study is to conduct a stage II randomized clinical trial to test the efficacy of a newly 
adapted web-based Behavioral Activation treatment called the mobile Pleasant Events Project (mPEP), that can 
be widely disseminated at low cost and in a convenient manner to caregivers of persons with Alzheimer’s 
Disease and Related Dementias (ADRD). Our lab has demonstrated that a face-to-face version of this 
intervention is efficacious for promoting well-being in caregivers, and we also have preliminary evidence that 
the mechanisms associated with the intervention (i.e., greater engagement in pleasant activities) are associated 
with improved blood pressure in this population. Over 15 million men and women provide informal caregiving 
services to family members who have dementia. The literature is replete with evidence that caregiving results in 
high rates of distress, and potentially high rates of physical morbidity. Caregivers consistently report increased 
distress and reduced well-being relative to their non-caregiving peers, and increased distress is associated with 
physical health consequences (e.g., cardiovascular disease). Thus, efficacious interventions that are more easily 
accessible to caregivers are critical for improving mental and physical well-being in this population. 
Although much research has been conducted evaluating the efficacy of psychosocial interventions for reducing 

 
 
Page 2 
distress in this population, caregivers continue to have difficulty accessing these treatments. Currently, most 
caregiver intervention frameworks require caregivers to meet with a therapist in one of four formats: a) face-to-
face meetings with a therapist outside the caregiver’s home, b) face-to-face meetings with a therapist in the 
caregiver’s home, c) in-person, group-based meetings (e.g., support groups, group therapy) where the caregiver 
receives treatment with other caregivers, or d) phone-based interventions in which caregivers call a therapist or 
support group. While possibly efficacious in reducing caregiver distress, these therapeutic formats are limited 
because: a) community agencies serving caregivers do not offer Evidence-Based Therapies (EBTs), b) the 
interventions are often not accessible to caregivers who reside outside the care network, c) they require 
caregivers to attend therapy sessions on specific days and at specific times that may not be convenient for them, 
or d) they may require caregivers to find alternate care for their care recipients while they attend the therapy. To 
address these limitations, we adapted our existing, evidence-based and brief face-to-face Behavioral Activation 
intervention, into a mobile web application. Our intervention was designed to help caregivers understand 
factors that contribute to and maintain their distress symptoms and to implement strategies designed to help 
them create positive, rewarding environments that promote mental and physical well-being. In the newly 
developed mPEP intervention, caregivers will learn and apply specific behavioral strategies to promote well-
being, and be able to receive feedback, on their mobile phones, on how these behavioral strategies are working 
to promote their well-being. Of particular advantage to the mPEP intervention over other potential intervention 
adaptations are: a) The theoretical background of behavioral activation is intuitive to end-users, and 
implementation of the principles of the intervention are simple and straightforward, making it highly scalable 
and acceptable to both caregivers and community-based organization who may implement it, and b) The ability 
to capture real-time data allows caregivers and researchers to better understand the mechanisms by which the 
intervention reduces distress and improves well-being (i.e., behavioral activation). Overall, the current proposal 
seeks to increase caregivers’ access to quality care by demonstrating that our adapted, scalable, evidence-based 
intervention (i.e., mPEP) is efficacious via delivery through a web-based portal, while simultaneously allowing 
for better scientific understand of intervention mechanisms. 
 
RESEARCH DESIGN AND METHODS 
SUBJECTS 
 
   Setting: Because some CG find it difficult to leave home and find alternate care arrangements for 
their spouse in order to participate in research, assessments will take place  online using the online survey tool 
Qualtrics. This design increases participation and retention. Further, by bringing the research closer to the real-
life circumstances of caregiving, we enhance the study’s ecological validity.  
 
   Sample: The study will enroll 200 participants, with the following inclusion criteria: a) English-speaking; b) 
at least 40 years of age; c) have access to a web-based device (e.g., computer; smartphone); d) be in-home 
caregivers of a loved-one with probable Alzheimer’s Disease or related dementia (ADRD), e) be living with 
their care recipients; and f) providing a minimum of 20 hours of care per week. Participants are required to 
speak English because a) our web-based materials are only available in English, b) we do not have staff or 
resources to conduct the intervention or assessments in Spanish; and c) assessment tools, surveys, 
questionnaires or psychological tests are only available in English. Participants will be excluded if: a) the 
caregiver or AD patient is diagnosed with a terminal illness with a life expectancy of less than 1 year, b) 
caregivers are cognitively impaired as measured by a brief screen for cognitive functioning; i.e., a Mini Mental 
State Exam (MMSE) score of <27, c) caregivers are enrolled in another intervention study or are already 
receiving psychotherapy to improve well-being or reduce distress. The sample will be recruited from: a) the 
UCSD Alzheimer’s Disease Research Center, b) community-based organizations with whom our research team 
already has well-established relationships (e.g., the San Diego chapter of the Alzheimer’s Association; the 
Southern Caregiver Resource Center); and c) community support groups. Participants will be of varied gender 

 
 
Page 3 
and ethnicity. 
  
   Assessments: Outcomes will be collected at 4 times: a) Pre-intervention, b) mid-therapy (3-months), c) post-
therapy (6-months), and 6-months post-intervention. Assessment will be completed online via UCSD’s 
Qualtrics Survey software (https://ucsd.co1.qualtrics.com/ControlPanel/). Qualtrics offers a high level of 
security including 256-bit encryption and HIPAA Compliant Certification. The testing will be via the secured 
UCSD Qualtrics website and the participant will be given a random digit access code and password via e-mail 
which will not have any identifying information associated with it (including email address) when the survey is 
completed/returned. Again, to maintain confidentiality, no identifiable information will be included on the 
assessment survey. 
 
Details of the survey provided to participants are as follows: 
 
Measures  
 
Blood Pressure: Blood pressure will be collected using an Omron HEM 907XL IntelliSense Professional 
Digital Blood Pressure Monitor sent to participants using US Mail or similar format. Blood pressure will be 
self-assessed by participants at baseline, 3-, 9-, and 15-months. 
 
The following section details the information to be collected from caregivers via online administration. Further, 
we detail the specific time-points at which the information will be collected: 
 
Depressive Symptoms (Primary Outcome): Symptoms of depression will be assessed using the Center for 
Epidemiological Studies Depression Scale—Revised (CESD-R). The CESD-R is a 20-item scale that asks 
patients to rate the degree to which they have experienced several symptoms of depression over the past week. 
Scores of ≥16 correlate highly with a diagnosis of depression. The scale was revised to better reflect the 
diagnostic criteria of the DSM-5, and the scale continues to good psychometric properties. This scale addresses 
RFA-AG-18-030, as depressive symptoms is a key well-being outcome in caregivers. This scale will be 
administered at baseline, 3-, 9-, and 15-months. 
 
Positive and Negative Affect. We will utilize the Positive and Negative Affect Schedule (PANAS) to assess 
positive (PA) and negative affect (NA). The PANAS contains 20 items assessing PA and NA. Alpha reliability 
is excellent, ranging from .83-.90 for the PA scale and .85-.90 for NA.37 This scale addresses RFA-AG-18-
030, which lists positive and negative affect as key outcomes to be assessed. This scale will be administered at 
baseline, 3-, 9-, and 15-months. 
 
Mental and Physical Well-Being: Mental and physical well-being will be assessed using the SF-12 scale, which 
is a multi-purpose, short form health survey consisting of 12 questions. Test-retest and internal reliability 
exceed 0.70 in studies of this scale’s psychometric properties. The SF-36 also has excellent content, criterion, 
and predictive validity. This scale will be administered at baseline, 3-, 9-, and 15-months. 
 
Caregiver Stress: Stress will be assessed using the short form of the Zarit Burden Interview (ZBI), which 
consists of 12 items asking caregivers to rate stress specifically associated with being a caregiver. The has 
excellent reliability and validity in caregiver populations. Daily stress will be assessed using the Role Overload 
scale37 and will be administered via the mPEP program. The Role Overload scale consists of 4 items in which 
participants are asked to rate the extent to which they feel globally overloaded by life responsibilities. This 
scale will be administered at baseline, 3-, 9-, and 15-months. 
 
Care Recipient Functioning. We will assess multiple aspects of care recipient (patient) functioning including 

 
 
Page 4 
cognitive status, problem behaviors, and problems with daily functional tasks (i.e., ADLs and IADLs). To 
assess patient cognitive functioning, we will utilize the Clinical Dementia Rating (CDR) scale. This scale is 
administered to the caregiver only, and is a report of the caregivers experience regarding their loved one’s 
cognitive functioning. The CDR will be administered at baseline and 15 months only. ADLs and IADLs will be 
assessed using the Activities of Daily Living Questionnaire (ADLQ). This scale consists of 28 items, 
administered to the caregiver, asking about their loved-one’s functioning in 6 domains. This scale will be 
administered at baseline, 3-months, 9-months, and 15-months. Problem behaviors of patients will be assessed 
using the Revised Memory and Behavior Problem Checklist (RMBPC). This scale will be administered at 
baseline, 3-months, 9-months, and 15-months. 
 
 
Randomization Procedures: Once the candidate is eligible, willing to participate, and signs our consent form, 
he/she will be randomly assigned to one of the two intervention groups via a randomization table. 
 
   Interventions: As described above, participants will be randomized to one of two intervention conditions. 
Below are descriptions of the two conditions. 
 
     a. Web-based Pleasant Events Project intervention (mPEP) – The mPEP intervention is designed to be 
primarily self-administered via mobile technology, with an initial phase-in period whereby caregivers receive 
phone coaching and check-ins every two weeks. The mPEP intervention is ideographic in nature; accounting 
for individual differences in the pleasantness of individual activities across caregivers and the impact of such 
activities on individual well-being states. The overarching theme of the mPEP intervention is that participants 
have weekly goals for experiencing positive activities and events which, in the parlance of our app, is 
characterized by “hearts.” Similar to a Fitbit® sports watch, which sets daily goals for steps and helps 
individuals track progress toward these goals, our participants receive weekly goals for “obtaining hearts”, 
whereby hearts are assigned to various activities they personally enjoy, and each time they participate in those 
activities, they achieve a certain number of hearts (i.e., 1-5 hearts/activity). The mPEP app then helps 
participants visually see their progress toward their weekly hearts goal, which provides motivation to seek out 
and participate in more activities if needed. The protocol is also programmed to be adaptable and idiographic to 
each caregiver. That is, if participants achieve a particular week’s hearts goal, but do not see benefit to their 
moods, the app will use an algorithm to increase the hearts goal for the subsequent week. If individuals do not 
meet their hearts goal for a week, but achieve mood benefit, the app will adapt and set the next week heart goal 
slightly lower. 
 
A key element to keep participants engaged in the program is the use of text reminders. Each night, at a time of 
the participant’s choosing, a text is sent to participants with a hyperlink to their individualized web-portals. 
Along with the hyperlink is a message asking users to provide an update on their progress toward their goals for 
the week. In addition, for the first three months of using the mPEP intervention, participants will receive bi-
monthly 10-minute “check-in” calls from a coach to answer questions on how to use the web site, problem-
solve any barriers to participating in activities, and encourage participants to do their best to achieve their 
weekly goals. So as not to overburden caregivers, these check-in calls will be scheduled between the coach and 
caregiver at a time of the caregiver’s choosing. Participants complete a total of three phases in the project, 
which are (sample screen shots presented in Figure 3):  
 
Phase 1: This phase involves self-monitoring activities over the course of one week. This phase is designed to 
capture activities the participants already engages in (and when), to help increase awareness of how balanced 
their lives are with regard to self-care activities vs caregiving activities. At the end of each day, participants 
complete an activity detailing when they woke up, activities they completed throughout the course of the day, 
and ratings of how enjoyable/pleasant each activity was. Each activity is entered into a personalized calendar so 

 
 
Page 5 
they can visually see how they spent their day, as well as how many hearts they received from each activity. 
 
Phases 2 and 3: These phases involve the selection and engagement in activities designed to promote overall 
well-being for the caregiver. In Phase 2, the participant completes a mood questionnaire of their positive and 
negative affect over the previous week. This is designed to provide participants with a baseline assessment of 
their well-being, on which to track progress as they move through the stages of the application. Following 
completion of the questionnaire, the participant receives feedback on all activities during phase 1 that were 
rated  
as at least moderately pleasurable (i.e., rated as 3 hearts). Then, the participant will be provided with a 
structured group of tasks to help identify treatment goals, including: a) select new activities from several life 
domains (e.g., hobbies) that may increase access to rewarding experiences, and b) create a weekly goal for 
“hearts” designed to help participants start with achievable activities that are most likely to produce successful 
attainment of goals. This helps maintain motivation by taking a  stepwise goal-setting approach while helping 
reduce barriers to treatment compliance. During phase 3, participants track their daily engagement in activities , 
with each participated activity adding to their weekly hearts goal. At the completion of one week of activities, 
participants again complete their weekly mood questionnaire. Particpants then see their weekly 
accomplishment
s for hearts 
achieved and 
overall mood 
score. The 
mPEP algorithm 
then computes 
the following 
week’s hearts 
goal based on 
hearts achieved 
and overall 
mood. Finally, 
participants 
repeat phases 2 and 3 until completion of the program.           
 
     b. Information and Support Intervention - Participants randomized to this condition will have personalized 
web access to a comprehensive resource guide containing materials on coping with specific CG stresses (e.g., 
developing problem-solving skills; managing care receiver problem behaviors; improving communication), and 
services available for caregivers in San Diego County (i.e., adult day care services; legal services for seniors; 
respite services). In this intervention, caregivers choose information most relevant to their current 
circumstances, accessible any time convenient to them. To ensure equivalent contact and support, for the first 
three months of using this intervention, participants will receive “check-in” calls every two weeks to answer 
questions on how to use the web site, problem-solve any barriers to participating in activities, and provide 
information and any referral to services. In addition, participants will receive a unique log-in key associated 
with their participant identification number, which will allow us to evaluate treatment compliance data and 
exposure to the treatment information (e.g., information accessed; time spent logged-in). Further, to ensure 
similarities in treatment delivery, participants will receive nightly text reminders to access and apply 
information learned at the web-site. 
 
Screening Procedures: Screening will occur in person and will consist of a formal screening questionnaire 
assessing participant eligibility. In addition to the screening questionnaire, participants will be administered the 
mini-mental state exam (MMSE) to determine cognitive function and eligibility as per our eligibility criteria. 
Figure 3. 
Screenshots from 
mPEP.  
Left = Phase 1 
(self-monitoring), 
Middle = Phase 2 
(activity selection; 
Right = Phase 3, 
activity tracking.  

 
 
Page 6 
Participants scoring <27 on the MMSE will be informed they are not eligible to participate in the project. 
 
Statistical Analyses: All hypotheses will be two-sided at the 0.05 level and intent-to-treat with data included 
for all subjects completing at least one post-baseline assessment. Data analyses will employ generalized 
additive mixed models (GAMMs) tailored for longitudinal data. GAMMs allow for potentially nonlinear effects 
of independent variables on outcomes; the nature of the nonlinearity and degree of smoothness is data-
determined for each independent variable. Models will include as covariates variables that differ significantly 
by condition. We will use Akaike Information Criterion (AIC) to determine covariance structures and variable 
selection. To control for inflated Type I error rates from multiple testing within each hypothesis, we will use the 
Westfall-Young step down maxT randomization procedure, which adjusts p-values for significance in multiple 
comparisons while taking into account the correlation of the outcomes. In this way we can control for an overall 
family-wise error rate of .05 while achieving more power than Bonferroni adjustments. Missing Data: Follow-
up data will be obtained on all participants, regardless of treatment completion. We will perform sensitivity 
analyses for impact of potentially informative missing data via pattern mixture models47 extended to 
incorporate random effects. We anticipate 15% dropout between each time point, accounting for an overall 
(cumulative) dropout rate of 39%. 
 
Hypothesis testing: Hypothesis 1: Caregivers receiving mPEP will report reduced depression, improved 
positive affect, reduced negative affect, and improved well-being compared to caregivers receiving a web-based 
bibliotherapy intervention. Dependent Variables: Depressive Symptoms, Positive and Negative Affect; SF-36 
scores. Independent Variables: Condition and Time (Baseline, 3-, 9-, and 15-months). Statistical Analysis: 
This hypothesis will use GAMMs. Condition will be entered as a fixed-effect predictor along with time and 
their interaction. If the smoothed interaction of condition x time is significant at the .05 level (determined by an 
F test of relevant coefficients in the model) we will test for pairwise differences with Westfall-Young adjusted 
p values. 
Power Analysis: Because the mPEP intervention is based upon our in-person version of PEP for caregivers, we 
anticipate effect sizes to be comparable to those seen in our previous trials. Accordingly, we powered our study 
based results showing an effect size of 0.4 (small to moderate) in favor of mPEP with an active comparator. 
Sample size estimates were based on the Hedeker, et al. method for various covariance structures for mixed 
effects models. For the proposed study, we assumed an autoregressive covariance structure, with a correlation 
between sequential assessments set at 0.5 based on our previous trial in caregivers. Using this methodology, 
assuming an alpha level of 0.05, we have a minimum 90% power to detect an effect size of 0.4 with 15% 
attrition between each time-point (39% cumulative drop-out rate), when there are 100 subjects per each 
condition. 
 
Hypothesis 2: Greater treatment-associated change in behavioral activation will be associated with greater 
improvement of caregiver well-being outcomes.  
Statistical Analysis: For this hypothesis, multilevel (mixed) models will be used. To test for mediation, we 
will utilize the analytic strategy described by Krull and MacKinnon. In this approach, four conditions are 
tested: a) the relationship between intervention condition and the dependent variables (e.g. Depressive 
symptoms), b) the relationship between intervention condition and mediatior (behavioral activation), c) the 
relationship between behavioral activation and the outcome, and d) the relationship between intervention 
condition and outcome after controlling for the proposed mediator. Mediation will be tested using the Monte 
Carlo Method for Assessing Mediation (MCMM). Power Analysis: The proposed study will be powered to 
detect if treatment-related change in behavioral activation mediates treatment-related change in depressive 
symptoms. Therefore, power is based upon the strength of both the ‘a’ path (i.e., mPEP significantly increases 
behavioral activation relative to our control condition) and ‘b’ path (i.e., change in behavioral activation is 
significantly associated with change in depressive symptoms). As per our pilot data, we conservatively estimate 
a small-to-medium effect (r=.20) between mPEP and behavioral activation (r=.20) between mPEP and 

 
 
Page 7 
depressive symptoms, and a medium effect (r=.50) between change in behavioral activation and change in 
depressive symptoms. With N = 200 and alpha of 0.05, we have 81% power to detect a significant mediation 
effect. These power estimates are based on 15% attrition between time-points (39% overall project attrition).  
 
Hypothesis 3: Caregivers assigned to the mPEP intervention will show greater reduction in blood pressure 
relative to those assigned to a web-based bibliotherapy intervention. 
Dependent Variables: Systolic and Diastolic Blood Pressure. Independent Variables: Condition and Time 
(Baseline, 3-, 9-, and 15-months). Moderator: Age.  
Statistical Analysis: This hypothesis will be tested using GAMMs. Condition will be entered into the model as 
a fixed-effect predictor along with time and their interaction. Because age is a known predictor of blood 
pressure we will enter age as a covariate and moderator of treatment efficacy in analyses. If the smoothed 
interaction of treatment condition and time is significant at the .05 level (determined by an F test of the relevant 
coefficients in the model) we will test all pairwise differences with Westfall-Young adjusted p values. Power 
Analysis: Power estimates were calculated using the Hedeker, et al. method for various covariance structures 
for mixed effects models. For the proposed study, we assumed an autoregressive covariance structure. An 
estimated correlation of 0.4 was assumed between sequential assessments based on our pilot data. Using this 
methodology, assuming an alpha level of 0.05 and 200 subjects (100 per treatment arm), and 15% attrition 
between time-points (39% cumulative dropout across time-points), we have 80% power to detect a small-to-
medium effect size of 0.32.  
 
 
 
HUMAN SUBJECTS 
The study will enroll 200 participants, with the following inclusion criteria: a) at least 18 years of age; b) have 
access to a web-based device (e.g., computer; smartphone); c) be in-home caregivers of a loved-one with 
probable Alzheimer’s Disease (AD) or related dementia, d) be living with their care recipients; and e) providing 
a minimum of 20 hours of care per week. Participants will be excluded if: a) the caregiver or ADRD patient is 
diagnosed with a terminal illness with a life expectancy of less than 1 year, b) caregivers are cognitively 
impaired as measured by a brief screen for cognitive functioning; i.e., a Mini Mental State Exam (MMSE) 
score of <27, c) caregivers are enrolled in another intervention study or are already receiving psychotherapy to 
improve well-being or reduce distress. The sample will be recruited from: a) the UCSD Alzheimer’s Disease 
Research Center, b) community-based organizations with whom our research team already has well-established 
relationships (e.g., the San Diego chapter of the Alzheimer’s Association; the Southern Caregiver Resource 
Center); and c) community support groups. Participants will be of varied gender and ethnicity.  
 
RECRUITMENT AND PROCEDURES PREPARATORY TO RESEARCH 
The primary referral source is the UCSD Alzheimer’s Disease Research Center (ADRC). Added recruitments 
occur following informational meetings with various community based organizations serving the Alzheimer 
community and the elderly. At the ADRC caregivers will either be assessed by ADRC staff to determine if they 
are appropriate for inclusion in this study when they are enrolled into the ADRC, or by our staff. The ADRC 
has evaluated over 2,000 Alzheimer Disease patients to date, and these individuals are often brought by their 
caregivers to appointments. Thus, in this situation, ADRC staff will explain our study to the caregiver and, if 
the caregiver is appropriate for inclusion into the study, a staff member will describe the study to the potential 
participant.  
 
Subjects will also learn of the study via IRB-approved online advertisements, through our lab web site, or 
through web sites such as Research Match or ClinicalTrials.gov. In these cases, subjects will call our lab phone 
number and will be screened over the phone and, should they meet inclusion criteria and express interest in 
joining the study, they will be sent the consent form via mail, e-mail, or fax. A member of our research lab 

 
 
Page 8 
witllwill go over the consent form verbally with the participant, and participants will then complete the consent 
form and return either by US Mail, e-mail (by scanning a copy of their consent and e-mailing), or by fax. 
 
In all cases, fully informed consent will be obtained, and Dr. Mausbach and other co-investigators will be 
directly available to clarify questions should any be raised by the participant. Signed consent forms will be kept 
on file in a specially secured cabinet. All of the investigators have completed the required federal human 
subjects certification. 
 
 
INFORMED CONSENT 
If a subject is appropriate for inclusion into the study, a staff member describes the study, including 
questionnaires, assessments, and the glucose measurement. The consent will detail the purpose of the project 
and its minimal risks. Also, participants will be informed that participation in the project is voluntary and they 
will be afforded the opportunity to discontinue their participation without consequences at any time during the 
project. Signed consent forms will be printed and kept on file in a specially secured cabinet. Participants who 
call in to our lab from online recruitment advertisements, from our lab web site, Research Match, or 
Clinicaltrials.gov will be screened over the phone for eligibility, and a copy of our consent form will be mailed, 
e-mailed, or faxed to them. A member of our research team will go over the consent verbally by phone, and a 
signed copy of the consent will be mailed, e-mailed, or faxed back to our lab. Those participants who wish to 
discontinue the project will be provided referrals to other agencies that can provide them with services.  
 
ALTERNATIVES TO STUDY PARTICIPATION 
The alternative to participation is not to participate. 
 
POTENTIAL RISKS 
We anticipate the risks associated with this study will be minimal. However, participation in this study may 
involve some added risks or discomforts. These include the following: 
 
1) Boredom and fatigue – Participation in the online assessments may require time and attention, and 
participants may become bored or fatigued. If this happens, participants will have the right to take a break to 
rest. They may also discontinue the interview and resume at a later date..  
 
2) Distress – During the assessments, we will be asking questions about stress and mood experiences. 
Discussion of these experiences may be distressing. If this occurs, they have the right to take a break and rest, 
to not to answer questions that produce distress, or to discontinue the assessment. Again, staff will proactively 
inquire to participants every 20-30 minutes if they would like to take a break, discontinue, or postpone the 
assessment. Staff will also be trained by the PI to recognize non-verbal cues of discomfort and will be informed 
to discontinue assessments where clear distress is displayed by participants.  
 
3) Loss of Confidentiality - There is a small potential for the loss of confidentiality but the following steps will 
be taken to minimize it: Assessment interviews will be conducted online and participants will receive a user-
specific code allowing them to complete their personal set of questionnaires. Questionnaires completed online 
will be encrypted for added security and stored data will be behind a data firewall for added security. Access to 
data will be through password that only study personnel will have.  
Privacy of data will be maintained by using a code identifier rather than participant name on any/all data and 
the codes will be unlinked with personal information. Only authorized personnel from the laboratory will have 
access to the data.. For the purposes of reports and publications, participant data and results will be presented 
only in pooled form, with no personal identifiers.  
However, there are some circumstances under which information may not be kept confidential. Specifically, if 

 
 
Page 9 
our team believes there is reasonable risk that participants will harm themselves (e.g., commit suicide) or 
others, or if our team believes there is reason to believe abuse or neglect is being conducted toward anyone 
being reported on in this study (e.g., either the caregiver or the care recipient), we are required by law to inform 
authorities so that steps can be taken to reduce this risk. Therefore, confidentiality cannot be maintained in 
these circumstances. 
 
4) Unknown Risks - Because this is a research study, there may be some unknown risks that are currently 
unforeseeable.  
 
 
RISK MANAGEMENT PROCEDURES AND ADEQUACY OF RESOURCES 
1) Boredom and fatigue – Participation in the interviews may require time and attention, and participants may 
become bored or fatigued. If this happens, participants may may take a break in order to rest. They may also 
ask to discontinue theassessment and resume at a later date.   
 
2) Distress – During the assessentsassessments, we will be asking questions about caregivers experiences, 
including some of the stresses they have faced while providing care to their loved ones. AnseringAnswering 
these questions  may be distressing. If this occurs, they have the right to take a break and rest, to skipskip 
questions that produce distress, or to discontinue the assessmentassessment.  
 
3) Suicidal Ideation - We have a standardized protocol for assessing and managing risk for suicidality. Our 
brief description of this protocol is as follows: During participant screening, participants will be assessed for 
suicidal ideation. Participants will be asked if they have recently (within the past month) had thoughts of (or 
considered) harming themselves or others. ‘Yes’ responses will be followed with clinical assessment of the 
nature of these thoughts, including whether the potential participant has the means of completing a suicide (e.g., 
access to a gun) or hurting others, and a plan (e.g., knows when and where he/she will act). Participants 
endorsing harm to self or to others will be managed clinically and will be referred to an appropriate mental 
health provider for further care. Participants endorsing clinically significant symptoms of depression (≥8 on the 
HADS) will be monitored throughout therapy via regular check-ins by phone to evaluate the potential for 
suicidal ideation or self-harm. Participants with active suicidal thoughts or intent will be managed clinically, 
referred for appropriate psychiatric care, and discontinued from participation in this study. 
 
PRIVACY AND CONFIDENTIALITY CONSIDERATIONS INCLUDING DATA ACCESS AND MANAGEMENT 
Loss of Confidentiality: Confidentiality will be maintained by keeping identifying information (such as names 
and phone numbers) in a separate location as the study results.  Except for a contact form, research results will 
be identified by a subject number rather than by name.  A number system will be used for identification of 
subjects; the key that links the number to the subject will be kept in a password protected Excel file, which will 
be stored on a removable medium so to not expose the file to potential attacks to networked computers.  Study 
information will be stored in locked file cabinets inside a locked office as well as a password protected 
windows computer with a password protected file system. Qualtrics data will not contain any identifying 
information, including e-mail addresses. Only study personnel will have access to the identifying data, and only 
study personnel will have access to Qualtrics data. Subject identity will not be disclosed to any person, except 
in the event of a medical emergency or if required by law.   
 
POTENTIAL BENEFITS 
Participants may not receive direct benefit from participation in the project. The potential benefits of the 
research to the subjects themselves are a reduction in distress and improvement to overall mental and physical 
well-being. The benefits of the research to others might include an increased understanding of the effects of 
web-based behavior therapy on distress and well-being in ADRD caregivers. 

 
 
Page 10 
 
RISK/BENEFIT RATIO 
We judge the importance of knowledge resulting from this study and the potential for improving overall well-
being among caregivers to be potentially significant. The risks are estimated to be minimal and therefore the 
risk to benefit ratio is low. 
 
EXPENSE TO PARTICIPANT 
N/A 
 
COMPENSATION FOR PARTICIPATION 
Participants will be paid $50 in cash for completing each of the 4 assessments (up to $200 total for full project 
participation). If a participant does not complete the full 2-hour assessment, partial compensation will be 
$25/hour completed, up to the maximum of $50. 
 
CONFLICT OF INTEREST 
None 
 
PROCEDURES FOR SURROGATE CONSENT AND/OR DECISIONAL CAPACITY ASSESSMENT 
To assess decisional capacity of each participant, we will administer the UCSD Brief Assessment of Capacity 
to Consent (UBACC). After participants go over the informed consent in detail, they will complete an online 
set of  7 items assessing his/her understanding and appreciation of the information concerning a research 
protocol. For each answer provided by the participant, the research assistant scores participants on a scale of 0 
(clearly incapable) to 2 (clearly capable response). For the current study, only participants scoring ‘2’ for each 
of the 7 items will be enrolled in the study. Participants who do not score a ‘2’ on the first try will be provided a 
second opportunity to score a ‘2’. Total time to administer this assessment is approximately 5 minutes.