"Relief": A Behavioral Intervention for Depression and Chronic Pain in Primary Care
Phase: NA
Conditions: Chronic Pain, Depression
Sponsor: Weill Medical College of Cornell University

Relief Study Operations Manual 
May 2020 
1 
 
 
 
 
 
 
 
 
 
“Relief”:  A Behavioral Intervention for Depression 
and Chronic Pain  
 
 
NCT 03265210 
 
 
Weill Cornell Medicine  
 
 
 
 
Operations Manual 
May 2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sponsored by the National Institutes of Health (NIH) 
 
 
 
 
 
 

Relief Study Operations Manual 
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TABLE OF CONTENTS 
 
1. Site Contact Lists 
Weill Cornell Medicine………………………………………….…………...3 
Weill Cornell Internal Medical Associates.……………………….….…….5 
Weill Cornell Medicine Primary Care – East Side………………….…….7 
Weill Cornell Primary Care…..……………………………………………..9 
 
2. Background 
Description……………………………………………………………….…..10 
Study Aims…………………………………………………………………...12 
Overview of Design………………………………………………………….14 
 
3. Project Protocol……………………………………………………………………...15  
 
4. Research Assessments……………………………………………………….…...17 
 
5. Intervention………………………………………………………………………….18 
 
6. Follow up Assessments……………………………………………………………18 
 
7. Way to Health Application and Withings Watch………………………………….18 
 
8. Procedures for Treatment after Study Completion……………………………..19 
 
9. Data Management………………………………………………………………….20 
 
10. Sustainability………………………………………………………………………..20 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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STUDY SITE CONTACT LIST 
 
Weill Cornell Medicine 
 
Principal Investigator 
 
                 
Dimitris N. Kiosses, PhD 
Weill Cornell Medicine 
Department of Psychiatry 
Westchester Division 
 
21 Bloomingdale Road 
 
 
White Plains, NY 10605 
Tel: (914) 997-4381 
Cell: (914) 882-9997 
 
 
 
Fax: (914) 682-6979 
Email: dkiosses@med.cornell.edu 
 
 
 
 
 
Co-Principal Investigators  
Lisa Ravdin, PhD 
Weill Cornell Medicine  
Department of Neurology 
428 East 72nd Street 
New York, NY 10021  
Tel: (212) 746-2441 
Email: ldravdin@med.cornell.edu 
 
Manney C. Reid, MD 
Weill Cornell Medicine  
Irving Sherwood Wright Center on Aging  
Tel: (212) 746-7000 
Fax: (212) 717-8207 
Email: mcr2004@med.cornell.edu 
 
Program Manager  
Laurie Evans, MS 
Weill Cornell Medicine 
Department of Psychiatry  
Westchester Division  
21 Bloomingdale Road 
 
 
White Plains, NY 10605 
Tel: (914) 682-9100 ext. 101-2570 
Fax: (914) 682-6979 
Email: lad9011@med.cornell.edu 
 
 
 
 
Research Assistants 
Theresa I. Ebo, MA  
Weill Cornell Medicine 
Department of Psychiatry 
Westchester Division 
21 Bloomingdale Road 
White Plains, NY 10605 
Tel: (914) 682-9100 ext. 997-5863 
Fax: (914) 682-6979 
Email: the2002@med.cornell.edu 
 
Claudia Heidenreich, BS 
Weill Cornell Medicine 
Department of Psychiatry 
Westchester Division 
21 Bloomingdale Road 
White Plains, NY 10605 
Tel: (914) 682-9100 ext 101-2462 
Fax: (914) 682-6979 
Email: cgh4001@med.cornell.edu 
 
Joanna Pantelides, BS 
Weill Cornell Medicine 
Department of Psychiatry 
Westchester Division 
21 Bloomingdale Road 
White Plains, NY 10605 
Tel: (914) 682-9100 ext. 101-2903 
Fax: (914) 682-6979 
Email: jop2285@med.cornell.edu 
 
Hannah Reich, BS 
Weill Cornell Medicine 
Department of Psychiatry 
Westchester Division 
21 Bloomingdale Road 
White Plains, NY 10605 
Tel: (914) 682-6974  
Fax: (914) 682-6979 
Email: har4002@med.cornell.edu

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Social Workers 
Juliet Faber, LCSW 
Weill Cornell Medicine 
Department of Psychiatry 
Tel: (914) 997-8636 
Fax: (914) 682-6979 
Email: juf3002@med.cornell.edu 
 
Jody Monkovic, LCSW-R 
Weill Cornell Medicine 
Department of Psychiatry 
Westchester Division 
21 Bloomingdale Road 
White Plains, NY 10605  
Tel: (914) 682-9100 ext. 2454 
Fax: (914) 682-6979 
Email: jom3006@med.cornell.edu 
 
Amy Stern, LCSW-R 
Weill Cornell Medicine 
Department of Psychiatry 
Westchester Division 
21 Bloomingdale Road 
White Plains, NY 10605 
Tel: (914) 997-8636 
Fax: (914) 682-6979 
Email: afs9001@med.cornell.edu 
 
Postdoctoral Associate 
Natalie Benda, PhD 
Postdoctoral Associate 
Weill Cornell Medicine 
Department of Population Health Sciences 
Division of Health Informatics 
425 E 61st, Ste 301 
New York, NY  
Tel: (646) 962-9435 
Cell: (563) 543-2222 
Email: ncb4001@med.cornell.edu 
 
 
 

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STUDY SITE CONTACT LIST 
 
Weill Cornell Internal Medicine Associates (WCIMA)  
 
 
505 East 70th Street, Helmsley Tower, 4th Floor 
New York, NY 10021 
Tel: (212) 746-2917 
Fax: (212) 746-4609 
 
 
WCIMA Physicians and Nurse Practitioners  
 
Name 
Email Address 
Phone Number 
Ramin Asgary 
 
raa9102@med.cornell.edu 
 
(212) 746-2917 
Amanda Carmel  
als7004@med.cornell.edu 
 
(212) 746-5856 
Juan Carrillo  
ecarrill@med.cornell.edu 
 
(212) 746-2917 
Pamela Charney 
pac2029@med.cornell.edu 
 
(212) 746-2879 
Adam Cheriff 
adc9001@med.cornell.edu 
(212) 746-1358 
Harold Chin 
hchin@med.cornell.edu 
(212) 746-1388 
Byron Demopoulos  
byd2001@med.cornell.edu 
 
(212) 746-2879 
Brian Eiss 
bme9001@med.cornell.edu 
 
(212) 746-7000 
Pamela Eliach 
pae9003@med.cornell.edu 
 
(212) 746-2917 
Oliver Fein 
ofein@med.cornell.edu 
 
(212) 746-9663 
Laura Gingras  
lfg9003@med.cornell.edu 
(212) 746-5626 
John Gossey 
jtg9003@med.cornell.edu 
(212) 746-2877 
Sandra Hall-Ross 
sah2001@med.cornell.edu 
 
(212) 746-2877 
James Hollenberg 
jph2002@med.cornell.edu 
(212) 746-2873 
Peggy Leung 
Pbl9001@med.cornell.edu 
(212) 746-2942 

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Stasi Lubansky 
slubansk@med.cornell.edu 
(212) 746-2942 
Ellen Meltzer 
 
(212) 746-2917 
Robert Meyer 
brmeyer@med.cornell.edu 
(212) 746-2942 
Susana Morales 
srm2001@med.cornell.edu 
 
(212) 746-1358 
Milena Nikolova 
min9038@med.cornell.edu 
(212) 746-9663 
Fred Pelzman 
fpelzman@med.cornell.edu 
(212) 746-5858 
Erica Phillips 
erp2001@med.cornell.edu 
(212) 746-5856 
Ariel Rivera 
arr9032@med.cornell.edu 
 
(212) 746-2942 
Diana Lee Santini 
dis2002@med.cornell.edu 
(212) 746-2875 
Ryan Santos 
rsantos@med.cornell.edu 
 
(212) 746-2942 
Robert Savillo 
rls2003@med.cornell.edu 
(212) 746-2579 
Lee Shearer 
les9041@med.cornell.edu 
 
(212) 746-2917 
Ariel Silva 
afs9009@med.cornell.edu 
(212) 746-2917 
Helene Strauss 
hes9045@med.cornell.edu 
(212) 746-1358 
Judy Tung 
jut9005@med.cornell.edu 
(212) 746-5858 
Esther Wei 
ewei@med.cornell.edu 
(212) 746-1377 
Luise Weinstein 
llw2001@med.cornell.edu 
 
(212) 746-2446 
Juliet Wilson 
juw9045@med.cornell.edu 
 
(212) 746-2942 
 
 
 
 
 
 
 
 
 
 
 

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Weill Cornell Medicine Primary Care – East Side  
215 E 85th Street  
New York, NY 10028 
Tel: (646) 962-7300 
Fax: (646) 962-0409 
 
Physicians  
 
Name 
Email Address 
Phone Number 
Monica Altman 
moa9020@med.cornell.edu 
 
(646) 962-7300 
Jason Baker 
jcb2007@med.cornell.edu 
 
(646) 962-7300 
Brett Ehrmann 
 
(646) 962-7300 
Tamantha Fenster 
taf2011@med.cornell.edu 
 
(646) 962-7300 
Paul Fenyves 
paf9046@med.cornell.edu 
 
(646) 962-7300 
Gargi Gandhi 
 
(646) 962-7300 
Costas Hanjis 
 
(646) 962-7300 
Cory Kercher 
cab9033@med.cornell.edu 
 
(646) 962-7300 
Keith LaScalea 
kal9006@med.cornell.edu 
 
(646) 962-7300 
Meredith Lash-Dardia 
mfl9002@med.cornell.edu 
 
(646) 962-7300 
Joanna Loewenstein 
jel9130@med.cornell.edu 
 
(646) 962-7300 
Eric Ogden-Wolgemuth 
 
(646) 962-7300 
Suzanne Pastore 
sup9071@med.cornell.edu 
 
(646) 962-7300 
Monica Pozzuoli 
mop9007@med.cornell.edu 
 
(646) 962-7300 
Chloe Rowe 
 
(646) 962-7300 
Sheri Saltzman 
shs2001@med.cornell.edu 
 
(646) 962-7300 
Audrey Schwabe 
auo2001@med.cornell.edu 
 
(646) 962-7300 

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Adam Stracher 
arstrach@med.cornell.edu 
 
(646) 962-7300 
Nicole Tyer 
nit3001@med.cornell.edu 
 
(646) 962-7300 
Melissa Waterstone 
mbwaters@med.cornell.edu 
 
(646) 962-7300 
Johanna Weiss 
jow2002@med.cornell.edu 
 
(646) 962-7300 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Weill Cornell Medicine Primary Care – Iris Cantor Men’s and Women’s Health 
Centers 
 
 
425 East 61th Street, 11th and 12th Floors  
New York, NY 10065 
Tel: (646) 962-2399 
Fax: (646) 962-0139 
 
Primary Care Physicians  
 
Name 
Email Address  
Phone Number 
Jonathan Hugo 
jlh9008@med.cornell.edu 
 
(646) 962-2399  
Danielle Nicolo 
dan9013@med.cornell.edu 
 
(646) 962-2399 
Jill Rieger 
jir9001@med.cornell.edu 
 
(646) 962-2399 
Adam Stracher 
arstrach@med.cornell.edu 
 
(646) 962-7300 
James Stulman 
 
(646) 962-2399 
Nicole Tyer 
nit3001@med.cornell.edu 
 
(646) 962-2399  
Florence Yu 
fly9001@med.cornell.edu 
 
(646) 962-2399 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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BACKGROUND 
 
Chronic pain and depression frequently co-exist in late and mid-life and contribute to 
increased disability, high health care costs, psychiatric comorbidity, and suicide. Older 
and middle-aged depressed-pain patients: a) are mainly treated in primary care 
practices; and b) are often prescribed medication, which increases the risk for addiction 
to opioids and benzodiazepines. Despite the need - and desire by the patients and 
providers - for primary care behavioral interventions, behavioral interventions are scarce 
in primary care. To address this need, we worked with primary care practices of the 
Weill Cornell Medical Associates (WCMA), and developed Relief, a 9-session 
behavioral intervention, designed to be administered by licensed social workers 
(LCSWs) and/or nurse practitioners (NP) in primary care practices.  
 
Our conceptual model assumes that chronic pain and depression are characterized by 
an attentional bias assigning greater salience to interoceptive stimuli and to negative 
emotions along with difficulty shifting attention to goal-oriented/reward-driven state 
leading to inadequate engagement of the reward network. Accordingly, Relief aims to 
change the attentional bias of depressed-pain patients favoring interoceptive 
experiences (discomfort, negative feelings), and increase the salience of newly 
developed adaptive and rewarding behaviors. Relief also examines patients’ 
expectations of pain treatment (which may be adversely affected by depression),and 
uses techniques to reduce negative emotions associated with pain treatment, modify 
unrealistic expectations and enhance the communication between the patient and 
primary care physician. To facilitate and enhance its delivery, Relief uses easy-to 
operate smartphone applications. 
 
This project aims to meet the needs of financially, ethnically and socially diverse older 
and middle-aged primary care patients with chronic pain and depression, who are 
mostly treated in primary care and are at risk of adverse outcomes. Pharmacological 
pain interventions (e.g., antidepressants, opioids) and physical therapy are in common 
use, but offer inadequate relief, and increase the risk of abuse. Behavioral interventions 
for depression and chronic pain are scarce in primary care.  
 
Consistent with the NIMH Objective 3 for a person-centered approach using RDoC, 
Relief uses a neurobiological model to streamline and structure its interventions for use 
in primary care practices.  
 
Relief uses targeted mobile technology applications to facilitate and enhance its 
delivery, i.e. reminders to participants to perform their treatment assignments, 
summaries of behavioral graphs to help therapists target their interventions, augmented 
assessment through passive sensing, and active entries.  
 

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If effective, Relief may reduce depression and pain-related disability, break the vicious 
cycle of inactivity, and improve quality of life for this large group of patients who suffer 
and have few viable treatment options. Relief has the potential for broad uptake and 
sustainability by large practices (e.g. Affordable Care Organizations or practices with 
large caseloads of adults with pain and depression who have limited access to 
psychiatrists or pain specialists) that may employ or engage LCSWs and NPs whose 
services are reimbursable by Medicare and other insurances. 
 
 

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STUDY AIMS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The goals of the study are: 
 
MONTHS 1-3: 
 
1. Finalize the Relief Manual and establish feasibility of therapist training: We will 
continue to work with the WCMA to finalize Relief (9 sessions) and train practice 
LCSWs and NPs. We will determine the success rate of training and number of 
hours needed to achieve Relief certification.  
 
2. Develop Relief’s Operations Manual: We will work with the WCMA’s clinicians 
and managers and create an Operations Manual to guide the integration of Relief 
into the practice, i.e., procedures for screening, referral and hand-off to therapists 
and research team, communication with WCMA physicians and staff.  
 
MONTHS 4-36: 
 
3. Assess Relief’s reach, feasibility and acceptability: We will assess across 
conditions:  

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a. Reach: Number of patients screened, and those who meet inclusion 
criteria;  
b. Feasibility: Number of patients who initiate Relief or UC/RMH [referral 
(based on clinical indication) for mental health care] and research 
procedures (timely referrals, assessments);  
c. Acceptability: Patient’s treatment satisfaction at 6, 9, and 12 weeks.  
 
Benchmarks of the study progress: Feasibility: At least 75% of Relief 
participants will complete Relief. Acceptability: We will obtain treatment 
satisfaction score at the end of Relief treatment.  
 
4. Preliminary Effectiveness: Over the course of 12 weeks, Relief participants, 
compared to participants in UC/RMH [referral (based on clinical indication) for 
mental health care], will have greater (effect size) and clinically significant 
reductions in depression, pain-related disability. 
 
5. Preliminary Evidence of Target Engagement/Secondary: The differential effect of 
Relief vs. UC/RMH in reducing depression and pain-related disability will be 
independently mediated by reduction of interoceptive focus and positive and 
negative emotions. 
 

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OVERVIEW OF DESIGN 
Figure 1. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screen positive: PHQ-9 ≥ 
10 and chronic pain 
Baseline 
Randomization 
Relief 
(60 patients) 
UC/RMH 
(30 patients) 
Follow-up 
assessments at 
weeks 6, 9, and 
12 
Clinician 
evaluation at 
week 12 
Baseline 
Follow-up 
assessments at 
weeks 6, 9, and 
12 
Relief with study 
therapist once 
per week over 9 
weeks 
Educational 
Brochure and 
Mobile 
Technology 
Educational 
Brochure and 
Mobile 
Technology 

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PROTOCOL 
1. Study staff reviews the Electronic Health Records (EHR) on Electronic Privacy 
Information Center (EPIC) and will identify patients with diagnoses of chronic 
pain, a DSM 5 diagnoses of depression and anxiety, as well as patients who are 
on psychotropic and/or pain medications.  
2. Study staff will also attend meetings at each of the PCP practices every few 
months to present/review the study and ask the PCPs to write down the names 
of any patients they think may be appropriate.  
3. Study staff will then contact potential participants via phone. If they meet 
preliminary eligibility criteria (based on administering the phone screen script) 
and are interested, they will be invited to come to our offices in White Plains or 
NYC, or to schedule a video or phone appointment, depending on the 
circumstances.  During the appointment, the consenting process will take place 
first, and then if the patient consents, the research assistant will conduct the 
screening assessment (either in person or remotely).  
4. RA will then discuss the results of the assessment with Dr. Kiosses.  
5. If the patient is eligible, the RA will email the data manager with the patient 
information.  
6. The data manager will randomize the patient to either Relief or UC/RMH. 
7. The data manager will notify Dr. Kiosses and the supervising therapist (not 
administering the intervention) about the randomization.  
8. The supervising therapist will contact the physician to let them know that the 
patient is part of the study and whether they are receiving Relief or UC/RMH.  
9. The supervising therapist will notify the patient that they are receiving Relief or 
UC/RMH and will assign a therapist to the patient if randomized to Relief. 
10. Both groups will receive (from the RA or via mail): 
• Educational (TCAP) booklet 
• Withings Watch with charger 
• iPhone 7 with charger (if patient does not have a smartphone or doesn’t 
want to use their own) 
• W2H application downloaded to smartphone 
• Technology Manual 
In addition, patients randomized to Relief will receive a therapy participant guide 
from the study therapist. 
11. Team weekly meetings: 
• Review recruitment (specifically the numbers of positive screen patients)  
• Referrals 
• Tracking of all patients; we will discuss:   
o The status of assessments 
o If in Relief, the status of therapy sessions  
 RAs will leave the room to protect randomization.  
• The data manager will generate charts with recruitment progress.  

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12. The RA will conduct assessments at follow up time points: 6, 9, and 12 weeks 
after the baseline assessment. The patient will receive $25 (cash, check or gift 
card) for each assessment. 
13. The RA will periodically contact the subject to make sure he/she is using the 
phone app and Withings watch and to answer any questions they may have 
about the app. 
14. At week 12 the therapist will determine whether their subjects in Relief are 
eligible for an additional $50 gift card based on the activities they have 
completed, and will distribute gift cards accordingly. 
15. After the 12-week assessment, the patient in UC/RMH will receive an evaluation 
from a clinician.  
16. All technology lent to patients will be returned to study staff. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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RESEARCH ASSESSMENT 
The research assistant will describe the study, ask potential participants to sign 
consent, and administer a screening assessment to evaluate eligibility. Once this is 
confirmed, the research assistant will administer a baseline assessment. At this 
assessment, the research assistant will explain that follow-up assessments will be 
administered at 6, 9, and 12 weeks. The research assistant will also explain that the 
participants will be compensated $25 for each completed assessment. The research 
assistant will then facilitate a referral to the data manager, who will identify the 
participant’s group and notify Dr. Kiosses, who will notify the appropriate social worker 
to schedule a meeting. 
 
Inclusion Criteria:  
1. 50 years or older 
2. PHQ-9 score ≥ 10  
3. Chronic pain (most days over the past 3 months) 
4. Capacity to consent  
 
Exclusion Criteria: 
1. DSM-5 Axis 1 diagnoses other than depression and anxiety disorders (by SCID) 
2. Montreal Cognitive Assessment (MoCA) < 24 
3. Active suicidal ideation (MADRS item 10≥4) 
4. Severe or life-threatening medical illness 
 
*Note: Patients on psychotropic medications, opioids or benzodiazepines will be 
included if they do not meet DSM-5 criteria for opioid, anxiolytics or other substance 
abuse disorders (Human Subjects).  
 
 
 
 
 
 
 
 
 
 
 
 

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INTERVENTION 
 
Relief: Relief utilizes a structured, yet personalized, approach. The goals of Relief are 
to shift the attention of depressed-pain patients away from pain, discomfort and 
negative feelings, increase involvement in meaningful and pleasurable activities, use 
techniques to reduce negative emotions associated with pain, modify unrealistic 
expectations and enhance communication between the patient and primary care 
physician. The Relief therapist uses the following techniques: attention-shift (e.g 
“distract and refocus” technique, shaping procedure to sustain attention), de-escalation 
(e.g. avoidance of situations that trigger negative emotions, modification of situations, 
changing perspective), reward exposure (through explicit action plans), planning (e.g., 
step by step division of task/action, preparatory steps for a task), and motivational 
techniques (e.g. use of notebooks, calendars) to achieve its goals (Manual in 
Appendix). Relief also includes techniques to address negative emotions and views 
related to the treatment process and to reduce tension between patients and family 
members. Mobile technology is used to augment the Relief intervention.  Finally, at the 
end of treatment Relief therapists provide to patients a personalized summary of 
treatment that highlights the problems that were addressed, and the successful 
techniques that had been used to solve them.  
 
Comparison Condition: UC/RMH Offered at WCMA: UC/RMH is a strong comparison 
condition because routine care for depression in WCMA practices is superior to more 
than 80% of primary care practices. The practices do not have ongoing, standardized 
fidelity procedures to mental health treatments or guidelines. Our team will not interfere 
with these procedures but record treatment of study participants (percent referred, type 
of treatment received, frequency of sessions, attendance, referral to psychiatrist, and 
psychotropic prescriptions). In addition to the regular referral services, we will offer an 
educational booklet on chronic pain and depression. 
 
 
 
 
FOLLOW UP ASSESSMENTS 
 
Follow up assessments are conducted by the WCM research assistant at 6, 9, and 12 
weeks after the baseline, and include measures of depression and anxiety symptoms, 
and pain. Subjects will receive $25 (cash, check or gift card) as compensation for 
completing each assessment. 
 
 

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WAY TO HEALTH APPLICATION 
 
In conjunction with psychotherapy sessions, participants will be asked to download, 
activate, and use a smartphone application designed by Way to Health. If participants 
do not own a smartphone or do not want to use their own phone, we will provide them 
with a free smartphone to be used for the duration of the study. To maximize the use 
and benefits of the app, the RA and/or therapist will review its use, prepare written 
personalized instructions, ask patients for feedback, and repeat the instructions in 
subsequent sessions as needed 
A smart phone and a Withings watch will be the vehicles for mobile technology 
interventions.  
Augmentation of Relief among participants in the Relief intervention group consists of: 
1) Daily ratings of mood, interest or pleasure in activities, stress, and pain. A text 
message sent by Way to Health prompts participants to rate these 4 items on a 
scale of 1 to 10. 
2) Daily reminders to pursue preparatory steps and scheduled meaningful, rewarding 
activities as well as interventions for negative emotions. 
3) Passive sensing of movement (steps) and sleep daily by the Withings watch. 
Participants are reminded to review their step count and deep and light sleep 
duration daily and receive and a weekly summary of both on Fridays. 
4) Participants receive a text message asking them whether they practiced their 
negative emotions intervention and engaged in their planned rewarding activity and 
to rate the sense of pleasure (scale 1 to 10) and the sense of satisfaction (scale 1 to 
10) they derived. 
5) At the end of each week, participants receive a text message indicating to them the 
reward level they achieved. Based on studies of non-depressed older adults by U. 
Penn investigators, we are using an incentive plan based on behavioral economics. 
 
Participants in the UC/RMH group will also receive a smart phone and Withings watch.  
They will receive text messages prompting daily ratings of mood, interest or pleasure in 
activities, stress, and pain 
 
 
 
PROCEDURES FOR TREATMENT AFTER STUDY COMPLETION  
Participants whose follow up assessments indicate a need for continued mental health 
services will be provided with mental health referrals. If participants are members of a 
senior center in the W-MH condition they will automatically receive a referral for mental 
health services. 
 
 

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DATA MANAGEMENT 
Data will be collected by the study RA at baseline and at follow-up assessments. The 
RA will also be responsible for writing and presenting patient summaries to the PI. The 
clinician will complete updates on the progress of their therapy sessions. Brian Liles 
manages the Relief database and weekly reporting.  
Research records will be kept confidential to the extent permitted by law. Subjects will 
be assigned ID numbers by the Relief study team and all identifying information will be 
removed from records that are submitted to Weill Cornell Medicine for data analysis. 
Paper research records will be kept in locked file cabinets. When necessary for 
purposes of auditing, the Cornell IRB, NIMH, and all Federal oversight agencies will be 
provided to these files. Computers will be password protected and all staff participating 
in the study are trained in protecting human subjects in research. Data will be published 
in aggregate form without unique identifiers. No analyses will be published in which it is 
possible to identify individuals based on data.  
 
SUSTAINABILITY 
 
Dr. Kiosses will train three LCSWs in Relief (or more if needed). Training will consist of 
a one-day workshop with didactics, role-play and review of previously audiotaped 
sessions. After the workshop, the therapist will administer 6 Relief sessions to 2 pilot 
participants during the first four months.  To be certified in Relief, therapists must 
achieve a score of greater than or equal to 4 (very good) out of 5 on the Relief 
Adherence Scale.