Reaching and Engaging Depressed Senior Center Clients
Phase: NA
Conditions: Depression, Unipolar, Mental Health Disorder
Sponsor: Weill Medical College of Cornell University

Reaching and Engaging Depreed Senior Center Client (REDS) 
Principal Inve:gator Dr. Patricia Marino, Ph.D., Weill Cornell Medicine 
IRB Protocol # 1704018114 
ClinicalTrial.gov Iden:ﬁer 03246789 
Crrent Verion April 26, 2021 
Prior Verion Date 
Jly 16, 2018 
Jly 15, 2019 
Jne 9, 2020 
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BACKGROUND 
Approximately 10,000 enior center operate in the US and erve 1.25 million peron na:onwide.1 
Mot of their client have low income,2-4 and in NYC, 68% are non-Cacaian.5 Abot 10% have 
clinically igniﬁcant depreion5 bt mot receive no care6. We developed SMART-MH,7 a commnity 
care model that can be embedded in enior center to improve recogni:on of depreion, referral, and 
adherence to depreion treatment. We alo developed Engage, a tepped-care therapy, treamlined 
baed on the amp:on that a dyfnc:on of the reward network i central to the pathogenei of 
depreion and ing "reward expore" a it principal interven:on. Engage alo target nega:vity bia, 
apathy, and inadeqate emo:on regla:on if they act a barrier to reward expore.8 With or enior 
center partner and or mobile technology team, we redeigned Engage-M o that it can be ed in a 
grop format by licened clinical ocial worker (LCSW) of Senior Center. Mobile technology provide 
probe for client adherence and oﬀer to therapit eay to review mmary record of mood, ac:vity, 
and ocial interac:on that can be ed to target their eion. We have integrated the SMART-MH 
model and Engage-M into a comprehenive commnity care model "Reaching and Engaging Depreed 
Senior Center Client" (REDS). We will compare the performance of REDS with a comparion condi:on in 
for enior center, two randomly aigned to REDS and two to a comparion condi:on. The comparion 
center will e SMART-MH for recogni:on of depreion and referral to mental health ervice pl 
weekly grop mee:ng on "Wellne of Mind and Body" (W-MH). Or rela:onhip with the NYC Dept. 
for Aging (DFTA) oﬀer the opportnity to embed and rapidly deploy REDS in NYC Senior Center, and 
may make the REDS model part of a tainable ervice reimbrable by Medicare.  
STUDY DESIGN 
In repone to the large nmber of enior center client who ﬀer from ntreated depreion, we have 
partnered with the NYC Department for the Aging (DFTA) to develop SMART-MH, a commnity care 
model that can be embedded in enior center to improve recogni:on, referral, and adherence to 
depreion treatment. We alo developed and teted Engage, a tepped-care therapy treamlined to e 
"reward expore" a it principal interven:on baed on the amp:on that dyfnc:on of the reward 
network i central to the pathogenei of depreion. With or enior center partner and or mobile 
technology team, we redeigned Engage-M o that it can be ed in a grop format by licened clinical 
ocial worker (LCSW) of Senior Center. Mobile technology provide probe for client adherence and 
oﬀer to therapit eay to review mmary record of mood, ac:vity, and ocial interac:on that can be 
ed to target their eion. We have integrated SMART-MH and Engage-M into a comprehenive 
commnity care model "Reaching and Engaging Depreed Senior Center Client" (REDS). The peciﬁc 
aim of thi developmental project are to 1. Finalize the REDS protocol and ae feaibility of training; 
2. Prepare an Opera:on' Manal; 3. Examine reach, feaibility, and acceptability of REDS; 4. Examine 
engagement of behavioral target and preliminary eﬀec:vene; and 5) Collect informa:on on REDS 
cot, barrier to implementa:on, and poten:al aving in health care :liza:on. We will randomly aign 
for enior center to oﬀer either Engage-M (N=40), the treatment oﬀered by REDS (1 individal and 8 
weekly grop eion) or 8 grop eion "Wellne in Mind and Body" pl mental health referral (W-
MH; N=20). The par:cipant will have clinically igniﬁcant depreive ymptom (PHQ-9&gt;10) and will 
be older and middle-aged adlt (55+); 12.6% of the NYC enior center client are aged 55-65 year. 
Client will be iden:ﬁed by enior center taﬀ trained in SMART-MH trategie. We will oﬀer addi:onal 
training to taﬀ of all center on SMART-MH otreach, depreion creening, and treatment 
engagement. We will train and provide weekly perviion to 2 or more LCSW per center of the two 
center aigned to Engage-M. We will not oﬀer training or perviion to enior center taﬀ leading the 
grop of W-MH bt we will provide overight o that client receive mental health referral and are 
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encoraged to aend weekly Wellne grop mee:ng. Or ﬁnding will et be ed in a R01 tdy to 
formally tet the feaibility, acceptability, eﬀec:vene, non-billable cot, and barrier of REDS beyond 
NYC. If proven eﬀec:ve, with adminitra:ve pport, REDS can be extended na:onally and pported by 
billable ervice. 
We will con:ne to work with enior center' taﬀ and or mobile technology team to ﬁnalize REDS for 
both Englih and Spanih-peaking par:cipant. We will record the training hor to achieve cer:ﬁca:on 
in Engage-M (part of REDS), and the cce rate of LCSW engaged by the enior center to oﬀer 
behavioral ervice. 
Acro condi:on we will evalate1) Reach Nmber of client creened with PHQ-9 core greater than 
or eqal to 10 v. all eligible for creening, and thoe who receive REDS or W-MH; 2) Feaibility Nmber 
of client who ini:ate therapy and reearch procedre (eion aended, martphone e); 3) 
Acceptability to client [Client Sa:fac:on Qe:onnaire 10,11 (CSQ), eion comple:on rate] at 
baeline, 6, 9, and 12 week. Sa:fac:on of LCSW, center taﬀ will be aeed every 6 month 
throghot the tdy. Benchmark Feaibility >80% will par:cipate in each eion of Engage-M. 
Acceptability Engage-M par:cipant will have a mean CSQ core &#8805; 3 (ot of 4) at the end of 
treatment. 70% of Engage-M client will enter their martphone ra:ng in more than 70% of tdy day 
(59 ot of the 85 day). 
We will be recri:ng 60 bject in total from all ite (WCMC only ite) and ix licened clinical ocial 
worker bject. 1. Recritment and referral orce We are working with Grace Brandi and Jaqelin 
Berman of the NYC Department for the Aging (DFTA) to plan implementa:on of the REDS project at 4 
NYC enior center. Older and middle-aged (55+) enior center client with elevated depreive 
ymptom (LCSW training phae n=10 client; Eﬀec:vene Pilot n=60) will be recrited from the 4 
par:cipa:ng enior center. Client in the tartp phae, dring which LCSW are trained, will be 
recrited from each of 2 center randomly aigned to REDS (n=10) over a 4-month period. For the RCT, 
20 client will be recrited from each of 2 center randomly aigned to REDS (n=40), and 10 from each 
of 2 center aigned to the Wellne grop pl mental health referral (W-MH; n=20) over 
approximately a 14-month period. We have choen to partner with enior center that repreent client 
from divere backgrond. Each partnering enior center docment at leat 800 ac:ve member each, 
with a daily par:cipa:on rate of at leat 200 member. Given an expected 10% rate of eligible client 
(PHQ-9 > 10), we expect at leat 80 client at each center to meet inclion criteria to be referred to the 
tdy. Exclding thoe with evere mental illne or demen:a a aeed via reearch meare, we 
an:cipate that over 60 client at each center will meet inclion criteria for the RCT. Thi tdy will 
recrit from for enior center overeen and fnded by the Department for the Aging in New York City. 
We e:mate that or ample will be imilar to the ample of the demographic proﬁle of NYC enior 
center member indicate a mean age of 76 year; 67% women; 32% White, 26% Hipanic, 23% Aian, 17% 
African-American, and 2% other. Spport ervice to inve:gator and project will be organized by the 
Reearch Method Core (RMC) Data Grop, directed by Dr. Banerjee aited by two data manager C. 
Pollari, MPH, and A. Ar:, MS, MPH. The Team will meet weekly to 1) review the pace and qality of 
data entering; 2) determine priori:e; and 3) provide conlta:on and condct analye. Inve:gator 
will join the Work Grop a needed to inform the Grop of their progre and need and to be directed 
to oﬀer their pecialized exper:e to other Center pported tdie. We have ed thi model 
cceflly over 20 year in or NIMH pported Center. Intrment Sharing The Interven:on 
Management Work Grop (IMG) of the Adminitra:ve Core conlt with inve:gator ing Center 
reorce to enre that they elect from mearement intrment ed in the Center' ongoing 
tdie o that relt can be compared acro tdie. Data Collec:on Form In addi:on to 
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harmonizing the elec:on of intrment acro tdie, inve:gator will alo be encoraged to e 
data element (e.g. demographic deﬁni:on and variable name) that have been ed on previo 
tdie. Thi again will harmonize the tdy data to allow eaier merging of data acro tdie for 
hypothei genera:on and exploratory analye for ftre tdie. Prototype Databae We have 
developed a rela:onal databae ytem and a tracking ytem in Microos Acce that erve a the 
prototype for implemen:ng each Center tdy databae. Or databae ytem enre that the 
procedre are tandardized and adminitered a intended by the deign and that the collec:on of other 
data element i tandardized. The tracking ytem monitor pa:ent appointment and aement and 
prodce report of miing and delinqent data. Data from Commnity Agencie We have worked with 
commnity agencie to facilitate the tranfer of de-iden:ﬁed data to Weill Cornell. Each agency compile 
pa:ent data from it databae (e.g., CMS OASIS, Medica:on, Service U:liza:on) according to or 
peciﬁca:on and remove iden:fying informa:on. 
INCLUSION AND EXCLUSION CRITERIA 
Client Inclion Criteria Referral to tdy (tage 1) 1. Age at leat 55 year. 2. PHQ-9 core of 10 or 
higher via ro:ne creening by enior center taﬀ 3. Englih or Spanih peaking. Reearch aement 
(tage 2) 1. MOCA greater than or eqal to 24. 2. Capacity to provide wrien conent for both reearch 
aement and the Engage-M interven:on. 
Client Exclion Criteria 1. Crrent ac:ve icidal idea:on deﬁned by MADRS Sicide Item 10 greater 
than or eqal to 4 (Probably beer oﬀ dead. Sicidal thoght are common, and icide i conidered a 
a poible ol:on, bt withot peciﬁc plan or inten:on). 2. Preence of pychiatric diagnoe other 
than nipolar, non-pycho:c major depreion or generalized anxiety diorder by SCID-V. 3.Severe or life-
threatening medical illne (e.g., end tage organ failre). 
DATA AND SAFETY MONITORING PLAN 
We will monitor depreive ymptom and fnc:oning for each par:cipant via clinical reearch 
aement throghot the tdy period. Feedback will be collected from par:cipant on their e of 
the data collec:on app. In addi:on, a DSMB board aembled for the en:re ALACRITY Center NIMH 
grant (1 P50 MH113838-01, PI Alexopolo) will review the tdy deign, IRB protocol, advere event, 
and interim report of the ongoing tdy. 
If inve:gator note increaing rate of advere event or icidal idea:on, we wold top the tdy. We 
do not an:cipate thi will be the cae. 
Some par:cipant may ﬁnd the daily qe:on of the HR applica:on boring or tedio, or they may be 
bothered by the phone baery age reqired to keep the app rnning, and may chooe to dicon:ne 
ing the applica:on or withdraw from the tdy. Par:cipant may become erioly medically ill and 
decide not to par:cipate. In addi:on, if new pychiatric ymptom develop or change in everity, we may 
recommend removal from the tdy and provide referral for the appropriate treatment needed. 
Referral will inclde pychotherapy or medica:on management referral in the commnity. 
Cornell reearch taﬀ will alo ae change in depreive ymptom at reglar interval. Pa:ent' 
health and clinical care will alway take priority over tdy par:cipa:on. Par:cipant may not want to 
con:ne comple:ng daily qe:on via the HR app and will be free to dicon:ne age at any :me. 
Par:cipant will alo have the op:on to diable celllar data e for the app throgh their device 
eung. 
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Stdy interviewer will be Weill Cornell reearch taﬀ who are trained in aement with older adlt. 
They will peciﬁcally inqire abot depreive ymptom, fall, and hopitaliza:on. Stdy therapit are 
alo trained to monitor the par:cipant' mental tate and will report ymptom everity to Weill Cornell 
taﬀ and the principal inve:gator. If any moderate to evere ymptom change (or new ymptom) are 
noted, we will conider alterna:ve op:on to maximize the par:cipant' well-being. In addi:on, we will 
ak all par:cipant abot the brden of ac:ve and paive ening and daily martphone age, to 
iden:fy any poten:al nega:ve coneqence of ing the HR app. We do not expect any addi:onal rik 
of advere event by adding ac:ve and paive ening data collec:on.  
Referral to external mental health agencie will be oﬀered to par:cipant who drop ot of the tdy in 
order to addre any ongoing depreive ymptom. For thoe bject who are removed from the tdy 
de to ac:ve icidal idea:on or clinically worening ymptom of depreion referral will be provided 
for the appropriate treatment needed. Referral will inclde pychotherapy or medica:on management 
referral in the commnity. 
The tdy will adhere to the advere event grading gideline provided by Weill Cornell' Oﬃce of 
Reearch Integrity and Arance. All advere event will be reported to the Weill Cornell IRB in the 
:meline indicated by the Weill Cornell Hman Reearch Protec:on Program Immediate Repor:ng Policy. 
We will periodically report advere event to the DSMB, in addi:on to repor:ng to the IRB a per Weill 
Cornell' policy.
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