EM/PROTECT: Improving Depression in Elder Mistreatment Victims
Phase: NA
Conditions: Depression
Sponsor: Weill Medical College of Cornell University

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PROTOCOL TITLE: EM/PROTECT: Improving Depression in Elder Mistreatment Victims 
 
 
PRINCIPAL INVESTIGATOR: Dr. Jo Anne Sirey, PhD, Weill Cornell Medicine 
IRB Protocol #: 1703018101 
 
ClinicalTrials.gov Identifier: NCT03241225 
 
 
Current Version: November 24, 2021 
 
Prior Version Dates: 
 
Version June 12, 2020 
Version April 24, 2020 
Version September 4, 2019 
Version June 25, 2019 
Version January 2, 2019 
Version November 20, 2018 
Version October 11, 2018 
Version July 13, 2018 
Version July 10, 2018 
Version April 20, 2018 
Version March 09, 2018 
Version February 14, 2018 
Version December 04, 2017 
Version October 31, 2017 
 
 
BACKGROUND 
Elder mistreatment (EM) is prevalent and has serious adverse consequences. The CDC defines elder 
abuse or mistreatment as "an intentional act, or failure to act, by a caregiver or another person in a 
relationship involving an expectation of trust that causes or creates a risk of harm to an older adult." 
Mistreatment includes physical, financial, and psychological abuse, as well as caregiver neglect. EM is 
estimated to affect 1 in 10 older adults (60+) in the US (5,600,000 victims nationwide). In NY State, the 
Elder Abuse Prevalence Study found that 141 out of 1000 older adults experienced mistreatment since 
turning 60. Mistreatment victims are usually young-old, socially isolated women, and perpetrators are 

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often adult children or spouses. Perpetrators are likely to be male, socially isolated, unemployed, have 
substance abuse, mental or physical health problems, a police record, or financial problems. 
Mistreatment victims have high rates of depressive symptoms. Victims of EM have one of the highest 
rates of depression among older adults (http://www.aoa.acl.gov/). A population-based study found that 
mistreatment victims had significantly higher rates of depressive symptoms (31.6% vs. 6.8%) and suicidal 
ideation (16.4% vs. 3.4%) than non-mistreated older adults. In a 7.6 year follow-up of an urban sample, 
adults with concurrent mistreatment and depressive symptoms had higher rates of mortality than non-
depressed victims of mistreatment. In our own work in NYC, 34% of victims endorsed significant 
depressive symptoms and 16% reported suicidal ideation. Consistent with our Center's deployment 
focused model, EM/PROTECT has been developed through an iterative process with the NYC DFTA 
Elderly Crime Victim Resource Center (ECVRC). EM aims to install protection measures, while PROTECT 
targets the behavioral Page 23 of 34 5/9/19 1:02 PM consequences of stress on the CCN and the reward 
networks thus reducing the experience of stress. 
 
STUDY DESIGN 
EM/PROTECT, a behavioral intervention for depressed elder mistreatment (EM) victims, was designed to 
work in synergy with EM mistreatment resolution services that provide safety planning, support 
services, and links to legal services. PROTECT is built on a model which postulates that chronic stress 
promotes dysfunction of the cognitive control (CCN) and reward networks, impairing the victims' ability 
to flexibly respond to the environment and limits their rewarding activities. PROTECT therapists work 
with EM victims to develop action plans to reduce stress, and to increase rewarding experiences. 
EM/PROTECT has been designed in an iterative process with community EM providers of the New York 
City (NYC) Dept. for Aging (DFTA) to use agencies' routine depression screening and referral for service. 
We propose to collect data on feasibility and acceptability of EM/PROTECT. We will compare the 
effectiveness and target engagement of EM/PROTECT with EM enriched with training of EM staff in 
linking EM victims to mental health services (EM/MH) in order to position us for a fully powered R01. To 
ensure rigor and reproducibility, EM/PROTECT or EM/MH will be offered to randomly assigned 
depressed EM victims, and standardized assessments will be conducted by trained raters blind to 
participant assignment and our hypotheses. The training of staff and therapists will follow high 
standards of intervention fidelity. EM staff will screen using routine standardized measures and refer 
depressed victims to study staff who will describe the study and obtain consent and conduct research 
assessments. We will use brief validated instruments to assess the outcomes, explore the added value of 
mobile technology measures, and study the effect of sex in each aim. The EM agencies of NYC are 
overseen and funded by DFTA. We will Page 22 of 34 5/9/19 1:02 PM begin by working with the Elderly 
Crime Victims Resource Center (ECVRC), as we have successfully partnered with them in the past for our 
initial exploratory work (Sirey et al., 2015a and b). We will then work with DFTA to identify a second site. 
At both sites we will provide refresher training in depression screening and strategies for linking victims 
to mental health using the Open Door approach we jointly developed with DFTA. Randomization at the 
participant level will be conducted by the Methods Core (random numbers in blocks of varying size). 
Both agencies will conduct depression screening. EM workers will not be blind to treatment arm. We are 
aware that their knowledge of treatment assignment may influence the EM services they provide. For 
this reason, we will record and compare their services between the two treatment arms to inform the 
design of the R01 proposal that will follow this R34 study. 

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The primary objective of the EM/PROTECT project will be to evaluate the effectiveness of EM/PROTECT 
compared to EM/MH. We also propose to examine the reach, feasibility, and acceptability of 
EM/PROTECT for depressed EM victims. 1) Effectiveness: In both conditions, the reduction of clinically 
significant depressive symptoms (as measured on the Montgomery Asberg Depression Rating Scale 
[MADRS]) and improved quality of life. 2) Reach: In both conditions, number of clients screened vs. all 
eligible for screening, and clients who meet study criteria. 3) Feasibility: Number of victims who initiate 
EM/PROTECT, number of EM/MH victims who make contact with mental health services, number who 
attend research procedures. EM/PROTECT: session completion rate; smartphone use. 4) Acceptability: 
Victims satisfaction (CSQ) in both treatments; EM/PROTECT session completion at 6, 9, 12, and 16 
weeks. 
We plan to recruit 4.5 subjects per month over 14 months to achieve a final sample of 80 subjects. We 
will recruit 2 licensed clinical social workers to administer the PROTECT therapy sessions with clients. 
The larger number of EM/PROTECT participants will allow a better view of effectiveness and 
reach/feasibility/acceptability. Effectiveness objective: In separate linear mixed models, we will analyze 
primary (MADRS, WHOQOL assessed at baseline, 6, 9 and 12 weeks) and secondary measures of 
effectiveness (PAM, ratings of mood and anhedonia assessed daily) with a subject-specific random 
intercept and slope and fixed effects for time, treatment, EM agency, LCSW, treatment x time 
interaction. We will use model building and fitting strategies. In the final model, we will also estimate 
end of treatment improvements in outcome (from baseline) within each treatment group. As Page 24 of 
34 5/9/19 1:02 PM this is an inadequately powered R34 study, we will control for false discovery rate 
using the Benjamini-Hochberg approach, and not the Family-Wise Error Rate, to adjust for multiple 
comparisons of secondary outcomes. The focus of our analysis would be to obtain preliminary signals of 
effectiveness by estimating effect sizes (95% CI) and assessing clinical relevance. Using approaches of 
Initiative 2.1 (Methods Core), we will conduct exploratory joint analysis of primary and secondary 
longitudinal outcomes. We will also test between group differences in smartphone measures using the 
time series approach of Initiative 2.1 (Methods Core). Reach/feasibility/acceptability objective: We will 
calculate estimates and 95% CI of the following measures for all subjects and for each sex separately. 
Reach: Proportions screened and met study criteria in both conditions. Feasibility: Among EM/PROTECT 
clients, proportions of: treatment drop-outs, assessment completions, smartphone use. Proportion of 
EM/MH victims who contacted mental health services. Acceptability by clients: We will analyze victim 
satisfaction (CSQ) recorded at baseline, 6, 9, 12 and 16 weeks as in Aim 4. Benchmark tests of feasibility 
(75% session attendance rate and 70% smartphone ratings) and acceptability will be performed using 
one-sample z-test of proportions. 
 
INCLUSION AND EXCLUSION CRITERIA 
Inclusion Criteria: 1) 55 years of age or older 2) capacity to consent (per EM staff) 3) significant 
depression (per EM staff) as indicated by a score of 10 or above on the Patient Health Questionnaire-9 
(PHQ-9), a widely used screening tool routinely administered in EM agency settings (the PHQ-9 has a 
sensitivity of 88% and a specificity of 88% for major depression) 4) need for EM services.  
Exclusion Criteria: 1) Active suicidal ideation (MADRS item 10 >4) 2) inability to speak English 3) Axis 1 
DSM-5 diagnoses other than unipolar depression or generalized anxiety disorder (by SCID) 4) MOCA 

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score of 23 or less 5) Severe or life-threatening medical illness 6) EM emergency and or referral out of 
EM agency (per EM staff 
 
 
 
DATA AND SAFETY MONITORING PLAN 
Some participants may find the daily questions of the HR application boring or tedious, or they may be 
bothered by the phone battery usage required to keep the app running, and may choose to discontinue 
using the application or withdraw from the study. Participants may become seriously medically ill and 
decide not to participate. In addition, if new psychiatric symptoms develop or change in severity, or the 
abuse situation escalates, we may recommend removal from the study and provide referrals for the 
appropriate treatment needed. All EM victims will continue to receive EM resolution services from DFTA 
regardless of their participation or termination of participation in the study intervention.  
14. Describe the anticipated adverse events and risks of study intervention(s), agent(s) and/or device(s) 
in detail (e.g., potential risk of the study drug, including potential drug interactions, psychological risks; 
physical risks). Assess their seriousness and incidence of complications or adverse events when known. 
Include animal data if trials in humans have not been performed. As all participants will be DFTA clients 
receiving EM resolution services, we can expect to receive weekly updates from EM staff regarding the 
participant's depressive symptoms and functioning. Cornell research staff will also assess changes in 
depressive symptoms at regular intervals. Patient's health and clinical care will always take priority over 
study participation. Participants may not want to continue completing daily questions via the HR 
application and will be free to discontinue usage at any time. Participants will also have the option to 
disable cellular data use for the app through their device settings.  
15. Given the risks identified, describe what monitoring is needed to immediately recognize the adverse 
events that do occur. Study interviewers will be Weill Cornell research staff who are trained in 
assessments with older adults. They will specifically inquire about depressive symptoms, falls, and 
hospitalizations. DFTA EM staff are also trained to monitor the Page 18 of 34 5/9/19 1:02 PM 
participant's mental state (in addition to abusive incidents) and will report any notice of falls, 
hospitalizations, and increasing symptom severity to Weill Cornell staff and the principal investigator. If 
any moderate to severe symptom changes (or new symptoms) are noted, we will consider alternative 
options to maximize the participant's well-being. In addition, we will ask all participants about the 
burden of active and passive sensing and daily smartphone usage, to identify any potential negative 
consequences of using the HR app. We do not expect any additional risk of adverse events by adding 
active and passive sensing data collection.  
16. Describe what measures will be taken to minimize any negative impact on subjects resulting from 
study closure or a subject being terminated from the study. All participants will continue to receive EM 
resolution services from DFTA if they choose to withdraw from the study. Referrals to external mental 
health agencies will be offered to participants who drop out of the study in order to address any 
ongoing depressive symptoms.  

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17. Describe the adverse event grading based on severity, attribution, and expectedness (including 
frequency) that will be used, to whom they will be reported and how often. The study will adhere to the 
adverse event grading guidelines provided by Weill Cornell's Office of Research Integrity and Assurance. 
All adverse events will be reported to the Weill Cornell IRB in the timeline indicated by the Weill Cornell 
Human Research Protection Program Immediate Reporting Policy.  
18. In addition to the IRB, specify to whom you will be reporting unexpected adverse events to 
promptly. PLEASE NOTE all reportable AEs should be reported to the WCMC IRB as per WCMC AE 
reporting policy. We will periodically report adverse events to the DSMB, in addition to reporting to the 
IRB as per Weill Cornell's policy.  
19. Will you be using a medical monitor? No  
20. Please justify why no monitor is being used. Medical information will be self-reported by participants 
during the baseline and follow-up research assessments.