Problem Adaptation Therapy for Mild Cognitive Impairment and Depression
Phase: NA
Conditions: Cognitive Impairment, Depression
Sponsor: Weill Medical College of Cornell University

PATH-MCI STUDY OPERATIONS MANUAL 
6/30/2020 
1
Problem Adaptation Therapy for Mild Cognitive 
Impairment and Depression (PATH-MCI)
Weill Cornell Medicine 
Operations Manual 
June 2020 
Sponsored by the National Institute on Aging (NIA) 
NCT 03043573 

PATH-MCI STUDY OPERATIONS MANUAL 
6/30/2020 
 
 
2
TABLE OF CONTENTS 
 
 
1. Study Site Contact List……………………………………………………………..3 
 
2. Background 
Description……………………………………………………………….…………...6 
Study Aims…………………………………………………………………..............7 
Overview of Design………………………………………………………………….8 
 
3. Protocols  
Recruitment Protocol……………………………………………………………….9 
Study Protocol……………………………………………………………………...11 
Montefiore Medical Center Site…………………………………………………..13 
Full Sample Collection and Processing Protocol……………………………….14 
Sample Collection Visit Protocol………………………………………………….15 
Sample Collection Site Protocol………………………………………………….16 
PATH-MCI Adverse Events- Safety Report Form………………………………17 
Suicidal Ideation/Behavior Protocol………………………………………..........18 
 
4. Research Assessments……………………………………………………….…..19 
 
5. Intervention………………………………………………………………………….20 
 
6. Follow-up Assessments……………………………………………………………20 
 
7. Procedures for Treatment after Study Completion……………………………..20 
 
8. Data Management………………………………………………………………….21 
 
9. Sustainability………………………………………………………………………..21 
 
10. Conducting the Study Remotely………………………………………………….22 
 
11. Protocol for Assessing and Documenting Suicidal Ideation.………………….23 
 
 
 
 
 
 
 
 
 

PATH-MCI STUDY OPERATIONS MANUAL 
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STUDY SITE CONTACT LIST 
 
 
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 
 
Paul B. Rosenberg, MD 
John Hopkins University School of 
Medicine 
Division of Geriatric Psychiatry and 
Neuropsychiatry 
Johns Hopkins Bayview Medical Center 
5300 Alpha Commons Drive 4th floor 
Baltimore, MD 21224 
Tel: (410) 550-9883 
Fax: (410) 550-1407 
Email: prosenb9@jhmi.edu 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Mirnova E. Ceïde, MD, MSc 
Montefiore Medical Center 
Department of Psychiatry & Behavioral 
Sciences and Medicine 
111 East 210th Street 
Bronx, NY 10467 
Tel: (718) 430-2290 
Fax: (718) 920-6538 
Email: mceide@montefiore.org 
 
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 
 
Data Manager 
Brian Liles, MS 
Weill Cornell Medicine 
Department of Psychiatry 
Westchester Division 
21 Bloomingdale Road 
White Plains, NY 10605 
Fax: (914) 683-6979 
Email: bkl2001@med.cornell.edu 
 
 
 
 

PATH-MCI STUDY OPERATIONS MANUAL 
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Programmer 
Huaian Yu, MS 
Weill Cornell Medicine 
Department of Psychiatry 
Westchester Division 
21 Bloomingdale Road 
White Plains, NY 10605 
Fax: (914) 682-6979 
Email: huy4001@med.cornell.edu 
 
Research Assistants 
Danielle Abraham, BS 
Weill Cornell Medicine 
Department of Psychiatry 
Westchester Division 
21 Bloomingdale Road 
White Plains, NY 10605 
Fax: (914) 682-6979 
Email: daa4008@med.cornell.edu 
 
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 
 
 
Danielle Vaamonde, BS 
Weill Cornell Medicine 
Department of Psychiatry 
Westchester Division 
21 Bloomingdale Road 
White Plains, NY 10605 
Fax: (914) 682-6979 
dav4003@med.cornell.edu 
 
 
 
 
 
 
 

PATH-MCI STUDY OPERATIONS MANUAL 
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Social Workers 
Rebecca Bent, LMSW 
Weill Cornell Medicine 
Department of Psychiatry 
Westchester Division 
21 Bloomingdale Road 
White Plains, NY 10605  
Tel: (914) 682-9100 ext. 101-2454 
Fax: (914) 682-6979 
Email: reb3002@med.cornell.edu 
 
Juliet Faber, LCSW 
Weill Cornell Medicine 
Department of Psychiatry 
Westchester Division 
21 Bloomingdale Road 
White Plains, NY 10605 
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. 101-2454 
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 
 
 
 
 
 
 
 
 
 
 
 
 
 

PATH-MCI STUDY OPERATIONS MANUAL 
6/30/2020 
 
 
6
BACKGROUND 
 
Problem Adaptation Therapy for elders with major or minor depression and mild 
cognitive impairment (PATH-MCI) is a non-pharmacological intervention that facilitates 
problem-solving and adaptive functioning. The goals of PATH-MCI are to reduce 
patients’ depression, disability, and stress through emotion regulation.  
 
PATH-MCI aims to reduce negative emotions and promote positive emotions 
associated with depression, including depressed mood, hopelessness, helplessness, 
guilt, anxiety, and anhedonia. The tools to achieve emotion regulation are: a) a hands-
on problem-solving approach, simplified from Problem Solving Therapy (PST); b) 
compensatory strategies and environmental adaptations to bypass mild cognitive 
deficits or functional and behavioral limitations, due to depression or physical disability; 
c) careful integration of significant other involvement; and d) engagement in pleasurable 
activities. Using these tools, PATH-MCI can create an environmentally friendly 
“ecosystem” that decreases everyday stressors, empowers patients, instills hope, and 
promotes emotion regulation.  
 
A simplified problem-solving approach from PST was chosen because: a) PST has 
been found effective in cognitively-intact depressed elders and in depressed elders with 
mild executive dysfunction; b) PST creates a forum within which patients and therapists 
can collaboratively set treatment goals, and it provides the structure and the process for 
patient problem-solving pertinent to decreasing depressive symptoms and functional 
limitations; and c) problem-solving strategies can be appropriately modified, and when 
this is done, they can help remedy behavioral limitations resulting from depression and 
mild cognitive impairment. Because solutions of problems may not necessarily reduce 
depression, the focus of PATH-MCI’s problem-solving approach is to reduce negative 
emotions and promote positive emotions that are associated with the specific problem. 
To achieve emotion regulation, the PATH- MCI therapist guides the patient to find the 
best possible solution but also helps the patient adapt, if the solution is not satisfactory.  
 
Consistent with the NIMH Objective 3 for a person-centered approach using RDoC, 
PATH-MCI uses a neurobiological model to streamline and structure its interventions for 
use in primary care practices.  
 
Elders with depression and MCI may benefit from PATH-MCI. Preliminary results have 
demonstrated that PATH-MCI reduces depression and disability in elders with major or 
minor depression and mild cognitive deficits. PATH-MCI is not designed for patients 
with dementia as these patients may require additional assistance. 
 
 
 
 
 

PATH-MCI STUDY OPERATIONS MANUAL 
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STUDY AIMS 
 
The goals of the study are: 
MONTHS 1-3: 
 
1. Finalize the PATH-MCI Manual and establish feasibility of therapist training. We 
will train 4 LMSW/LCSWs: 2 will be trained in the PATH-MCI therapy, 2 will be 
trained in Supportive Psychotherapy. We will determine the success rate of 
training and number of hours needed to achieve PATH-MCI certification.  
 
MONTHS 4-60 
 
2. Assess PATH-MCI’s reach, feasibility and acceptability: We will assess across 
conditions:  
a. Reach: Number of patients screened, and those who meet inclusion 
criteria;  
b. Feasibility: Number of patients who receive PATH-MCI or ST for mental 
health care and research procedures (timely referrals, assessments);  
c. Acceptability: Patient’s treatment satisfaction at 6, 12, 24, 36 and 52 
weeks.  
 
Benchmarks of the study progress: Feasibility: At least 75% of PATH-MCI 
participants will complete PATH-MCI. Acceptability: We will obtain treatment 
satisfaction score at the end of PATH-MCI treatment.  
 
3. Preliminary Effectiveness: Over the course of 52 weeks, PATH-MCI patients, 
compared to patients receiving Supportive Psychotherapy, will have better global 
cognition and greater (effect size) and clinically significant reductions in disability 
and depression. Furthermore, better episodic memory and executive function will 
mediate the effects on cognitive outcomes 
 
 
 
 
 
 
 
 
 
 
 

PATH-MCI STUDY OPERATIONS MANUAL 
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8
OVERVIEW OF DESIGN 
Figure 1. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screen positive: age 60-85, 
have a study partner, no 
antidepressants or stable 
dose 12 weeks prior, CDR= 
0.5, WTAR and HVLT 
scores that meet criteria. 
Baseline 
Randomization 
(80 patients 
recruited from all 
sites)
PATH-MCI 
(40 patients)
ST 
(40 patients)
Follow-up assessments 
at weeks 6, 12, 24, 36 
and 52. 
Baseline 
Follow-up assessments 
at weeks 6, 12, 24, 36 
and 52.   
PATH-MCI with study 
therapist once per week over 
12 weeks and then once per 
month over 3 months. 
ST with study therapist 
once per week over 12 
weeks and then once per 
month over 3 months. 

PATH-MCI STUDY OPERATIONS MANUAL 
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9
RECRUITMENT PROTOCOL  
1. Patients are assessed and recruited from New York City Locations and 
Westchester. 
 Patients in NYC will be seen at 425 E 61st St., Penthouse Floor.  
 Patients in Westchester will be seen at 21 Bloomingdale Rd, White Plains, 
Institute of Geriatric Psychiatry. 
 Patients at Montefiore will be seen at 1515 Blondell Ave, Bronx, NY.  
 Note: There is no compensation for transportation expenses for patients. 
Any special cases must be discussed with Dr. Kiosses and Laurie Evans. 
 Patients who are not able to meet in person may be assessed by phone or 
video. 
 
2. Study staff may recruit using flyers, posters and referrals. 
 Flyers 
NYC 
- 
Flyers for the study are placed in the waiting room of doctor’s 
offices at 425 E. 61st Street, as permitted by the doctor’s office. RAs 
must talk to the front desk before leaving flyers. Preferred floors are 
the 11th and 12th floors. 
- 
Flyers also can be placed in the elevators of the main hospital 
building on 72nd Street. Permission for this has been granted. 
WP 
- 
Flyers can be placed in the waiting room of the Institute of Geriatric 
Psychiatry. 
- 
Flyers also may be distributed at events, eg. Salute to Seniors, etc.  
 Posters 
- 
A poster version of the flyer can be placed in the lobby of the 425 E 
61st Street office. 
- 
RAs must communicate at all times with the building manager, Kim 
Canazi: Kim.Canzani@colliers.com. Inform her that we will be 
placing a poster in the lobby. Confirm with her the schedule for this, 
and that the easel obtained is the correct one to use.  
- 
Order posters through Marcella Sanchez or Andrei Gangal. 
 Referrals 
- 
We obtain referrals from different doctors. I.e. Dr. Ravdin. 
- 
Make sure to follow up with the referral sources and to update 
referral sources about the patients they referred to us (meet criteria, 
did not meet, did not reach out to us, etc.). 
- 
We may also obtain referrals from sources, like the 4331 line at the 
Institute of Geriatric Psychiatry, and outside sources like JASA. 
- 
 
3. Phone screens 
 When calling a potential patient, RA makes sure to first explain the study 
(quick overview) and answer any questions. 

PATH-MCI STUDY OPERATIONS MANUAL 
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 Proceed with the phone screen, if a patient is interested in the study and 
agrees to the phone screen. Phone screens must be conducted with 
patients prior to scheduling a screening appointment 
 Phone screen form for PATH-MCI study can be found at 
I:\Cores\DMB\KIOSSES STUDIES\Phone Screens 
 RAs must conduct phone screens on days and times that therapists and 
psychologists at the Institute are available. In case of an emergency, ie. a 
patient endorses suicidal ideation, the RA must communicate this 
information immediately to the therapists and psychologists present. RA 
must follow the suicide risk protocol. (See comprehensive SRA protocol at 
end of this document.) 
 If the patient seems eligible from the phone screen (i.e. endorses some 
depression and low mood and some memory problems), schedule a 
screening session with the patient.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PATH-MCI STUDY OPERATIONS MANUAL 
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STUDY PROTOCOL 
1. RAs obtain potential patient information from various referral sources.  
2. RA contacts a potential patient to complete a phone screen about 
memory/neurological problems, mood/depressive symptoms, current involvement 
in treatment, and medical illnesses.  
3. If the individual is interested in participating in our study and does not appear to 
meet exclusion criteria, the RA will invite the individual to come to our offices in 
White Plains or NYC, or to schedule a video or phone appointment, depending 
on the circumstances.   
4. At the onset of the screening interview, the RA will conduct the informed consent 
process.  If the patient has capacity to consent, the RA will conduct the screening 
assessment.  
5. The RA will discuss the results of the assessment with Dr. Kiosses. 
6. If the patient is eligible, the RA will email the data manager with the individual’s 
information.  
7. The data manager will randomize the patient to either PATH-MCI or Supportive 
Therapy.  
8. The data manager will notify Dr. Kiosses and the supervising therapist (not 
administering the intervention) about the randomization.  
9. The supervising therapist will assign a therapist to the patient and inform the 
therapist to contact the patient to schedule first appointment (to take place 
following the baseline assessment). 
10. The RA will schedule the baseline assessment with the patient and study partner. 
The patient will receive $30, and the study partner will receive $20 for the 
baseline assessment.  
11. Team weekly meetings: 
 Review recruitment (specifically the numbers of positive screen patients)  
 Referrals 
 Tracking of all patients; we will discuss:   
- 
The status of assessments 
- 
The status of therapy sessions  
 The data manager will generate charts with recruitment progress. 
12. The RA will conduct assessments with patients and their study partners at the 
following time points: 6, 12, 24, 36, and 52 weeks after the baseline assessment. 
Patients will receive $30 (cash, check or gift card) for each set of assessments. 
Caregivers will be compensated $20 (cash, check, or gift card) for each set of 
assessments. 
 Note: Genetic testing does not have an additional compensation. 
13. If the caregiver does not come in person for assessments and they agree we can 
give their compensation to the patient, they must first sign the reimbursement 
form stating that it’s okay for the patient to receive the money on their behalf. 
(See form I:\Cores\DMB\KIOSSES STUDIES\PATH-MCI\Reimbursment 
Forms) 

PATH-MCI STUDY OPERATIONS MANUAL 
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14. If the caregiver reimbursement can’t be given to the subject, then we can do a 
payment requisition through WBG (during COVID-19), send a gift card, or send a 
money order.  If possible, for money orders, send the caregiver a reimbursement 
form and self-addressed stamped envelope, so they can sign and mail the form 
back to us. Once the form is received, send a money order for the amount of the 
reimbursement. 
15. All technology lent to patients will be returned to study staff. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PATH-MCI STUDY OPERATIONS MANUAL 
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13
Montefiore Medical Center Site 
1. Patients will be recruited from Montefiore.  When a patient is identified (by 
Montefiore) and agrees to be contacted by Cornell, a WCM RA will call the 
patient to schedule a screening appointment at the Blondell Site (1515 Blondell 
Ave, Bronx, NY). 
2. RAs will schedule Montefiore patients for Tuesdays, when there is space and Dr. 
Erica Weiss is there to supervise. There is room for one RA; if more than one RA 
needs to go, email Dr. Weiss to see if she can find more room.  Montefiore 
therapists will see study patients on Mondays and Fridays. Patients must sign 
both the Montefiore and WCM consent forms. 
3. If a Montefiore subject signs the Genetics consent form, we will pay for 
transportation to Cornell for the blood draws. Blood draws can only be done at 
Cornell (White Plains or NYC), not Montefiore. 
4. If RAs are there for the entire day, we will not pay for transportation, except for 
the cost of the parking garage. 
5. If the RA is going to both the Montefiore and White Plains offices in the same 
day, we will pay for the transportation between the two sites (mileage for those 
driving, Uber/Lyft for those without a car). 
6. RAs should bring data/work with them to Montefiore, regardless of how many 
patients they have scheduled, as there may be downtime if a patient screens out 
early. If only one patient is scheduled (am or pm), RAs should plan on being in 
White Plains the other half of the day. 
7. Scheduling Patients at Montefiore: To aid the front desk in managing the patients 
coming in, please email Dr. Weiss (and Dr. Ceide, so she can troubleshoot if Dr. 
Weiss is away) every Friday the schedule of patients you are seeing the following 
week. These can be individual emails (ie. the RA’s cases do not have be on the 
same email as the therapist’s cases).  Please use the following format:  
 
Schedule for [insert date]  
 
 
Email Sample: 
9am- [patient name]  
 
 
 
Schedule for 12/10/2019 
10 am- [patient name] 
 
 
 
10am- Erica Weiss 
11am- [patient name] 
 
 
 
2pm- Mirnova Ceide 
1pm [patient name] 
2pm [patient name] 
3pm [patient name] 
 
In addition to helping the staff know whom to expect, this will facilitate locating the RA 
when a patient calls to confirm their appointment or if they come on the wrong day. 
1 
 
 
 
1 As of June 2020, we are not recruiting patients from the Montefiore Medical Center site. 

PATH-MCI STUDY OPERATIONS MANUAL 
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14
FULL SAMPLE COLLECTION AND PROCESSING PROTOCOL 
1. All blood draws must be tracked in RedCap. 
 
2. General Guidelines 
 Blood specimens will be collected at the following time points: 
- 
baseline, week 12, and week 52.  
 Baseline 
- 
~16cc collected. 
o 10cc DNA that will be serum frozen 
o 6cc of red top tube 
 Week 12 and Week 52 
- 
~ 6cc 
- 
DNA should only be collected from individuals who consent during 
screening visit to have their bio-specimens stored for future 
research. 
 
3. Supplies 
 Lavender top tube will be collected at the baseline visit for DNA.  
- 
BD Vacutainer© K2 EDTA Plus Blood Collection Tubes (REF 
366643) 
- 
10 mL tubes 
 Red top tubes (SST) will be collected at the baseline, week 12 and 52.   
- 
BD Vacutainer© Serum Blood Collection Tubes (REF 367815) 
- 
6 mL tubes 
 BD Vacutainer Blood Collection Set  
- 
Safety-Lok 
- 
0.6 x 19mm x 305mm 
 BD Vacutainer one-use holder 
 Gloves  
 Alcohol pads 
 Large gauzes sterile 
 Medical tape sterile 
 Band-aids regular sized 
 Kimwipes 
 Waterproof thin sharpies 
 
 
 
 
 
 
 
 
 

PATH-MCI STUDY OPERATIONS MANUAL 
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SAMPLE COLLECTION VISIT PROTOCOL 
 
BASELINE VISIT: 
Specimen Collection  
1. Label one lavender tube with study name (PATH-MCI), patient #, date, visit #. 
2. Label one red tube with study name (PATH-MCI), patient #, date, visit #. 
3. Collect blood in labeled lavender tube for DNA (10mL tube). 
4. Collected blood in one labeled red tube for processing (6ml tube). 
 
Specimen Processing 
1. Gently mix lavender tube collected. 
2. Take the lavender tube to the deep freezer for immediate storage. Deep freezer 
settings -70 °C (-80 °C is also acceptable). 
3. Allow red top tube to clot for 30 minutes standing up right at room temperature. 
4. Centrifuge 4.4 RPM for 15 minutes until clot and serum are well separated. (This 
can either be chilled centrifuge or room temperature). 
5. Pipette serum into 2mL aliquot tubes -approx. 1 mL in each tube. 
6. Label the tubes with study name (PATH-MCI), patient #, date, visit #. 
7. Store aliquot tubes in the deep freezer -70 °C (-80 °C is also acceptable). 
 
WEEK 12 VISIT: 
Specimen Collection  
1. Label one red tube with study name (PATH-MCI), patient #, date, visit #. 
2. Collected blood in one labeled red tube for processing (6ml tube). 
 
Specimen Processing 
1. Allow red top tube to clot for 30 minutes standing up right at room temperature.  
2. Centrifuge 4.4 RPM for 15 minutes until clot and serum are well separated. (This 
can either be chilled centrifuge or room temperature). 
3. Pipette serum into 2mL aliquot tubes -approx. 1 mL in each tube. 
4. Label the tubes with study name (PATH-MCI), patient #, date, visit #. 
5. Store aliquot tubes in the deep freezer -70 °C (-80 °C is also acceptable). 
 
Week 52 Visit: 
Specimen Collection  
1. Label one red tube with study name (PATH-MCI), participant #, date, visit #. 
2. Collected blood in one labeled red tube for processing (6ml tube). 
 
Specimen Processing 
1. Allow red top tube to clot for 30 minutes standing up right at room temperature.  
2. Centrifuge 4.4 RPM for 15 minutes until clot and serum are well separated. (This 
can either be chilled centrifuge or room temperature). 
3. Pipette serum into 2mL aliquot tubes -approx. 1 mL in each tube. 
4. Label the tubes with study name (PATH-MCI), patient #, date, visit #. 
5. Store aliquot tubes in the deep freezer -70 °C (-80 °C is also acceptable). 
 

PATH-MCI STUDY OPERATIONS MANUAL 
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16
 
 
SAMPLE COLLECTION SITE PROTOCOL 
 
NYC 
 
1. Choose time for blood draw with the patient (Monday-Friday 9AM-5PM). 
Location: 525 E.68th St F building 2nd floor F260 
2. Email Carol Brook (clbrook@med.cornell.edu), Marc Vieux 
(mav9041@med.cornell.edu) about time slot, and cc Andrika 
(anm2134@med.cornell.edu) and Barbra (bhormann@nyp.org). 
3. In the email, send a copy of the consent form (study consent and genetics 
consent form), order form with subject name and assay form (iDrive link: 
I:\Cores\DMB\KIOSSES STUDIES\PATH-MCI\Blood Draws\Forms for CTSC 
NYC). The order form needs to be signed by Dr. Alexopoulos. 
4. In the email clarify to Carol and Marc to make sure they print the assay 
request form and include it with the sample.  
5. To fill out the assay request form, please follow the template included and 
previously completed assay request forms found on the iDrive. 
6. The CTSC will take care of processing and storing of the samples.  
*Note: Even though the CTSC is doing the processing, please make 
sure to track how many tubes, etc. they processed. Track in the WP 
about notebook. 
 
WHITE PLAINS: 
 
1. When Blood Draw is conducted by RA who is Phlebotomy-Certified, follow the 
protocol called, “PATH-MCI Blood Processing Instructions” in the following iDrive 
location: I:\Cores\DMB\KIOSSES STUDIES\PATH-MCI\Blood Draws 
2. When Blood Draw is conducted by the Health Clinic/Lab in Westchester: 
 Make sure patient has been registered. All of our PATH-MCI patients 
should have an MRN provided by the registration done in On-Core, so 
their MRN number can be found on the On-Core spreadsheet. If they do 
not have an MRN assigned for some reason, first check with Laurie, but 
you can register the patient using the registration form found on the iDrive: 
I:\Cores\DMB\KIOSSES STUDIES\PATH-MCI\Blood Draws\WP 
Registration for Venipuncture 
 Fill out a requisition form, which is located in the RA office 106. A sample 
of how this needs to be filled out is included below. 
 Once the patient has been registered, call Mary Ann at the Clinical lab 
x2259, to schedule a blood draw. Try to schedule the blood draw a day or 
two before the actual date. Phlebotomy lab hours are 8:30AM-2:30PM. 
When you call Mary Ann, give her the following information: 
- 
Remind her of the study. Let her know that we only require the 
blood draw, not the processing. 
- 
Give the patient’s first and last name 

PATH-MCI STUDY OPERATIONS MANUAL 
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- 
Patient’s date of birth 
- 
Billing Code for Reqs: 12R 
- 
WBS (account # for petty cash, etc.) 
- 
MD name (Dr. Alexopoulos) 
- 
Diagnosis code 
- 
Time and date of blood draw 
 Once a date and time have been established, send Mary Ann the 
requisition form with the date. You can fax this form to her at x6912.  
 Call to confirm appointment. 
 The day of the appointment, walk the patient to the clinic, bring a sterile 
glove with you because you will be transporting the samples back with 
you. Obtain the sample from the phlebotomist, and immediately go to the 
lab to process the samples and store. Follow the specimen processing 
steps detailed above.  
 
 
2 
 
 
 
 
 
 
 
PATH-MCI Adverse Events – Safety Report Form 
1. The Safety Report form is in RedCap.  
2. RAs will keep this form with each research assessment they do and ask the 
patient at each visit whether they’ve experienced any new health or medical 
problems since their last visit (At Baseline, the time frame is since 
screening/consent.).   
3. If the patient says yes, then complete the form (date of onset, severity, medical 
care received, etc.).  The guidelines for assessing what constitutes an AE, the 
severity level, etc. can be found in the NIA guidelines (saved on the I drive: 
(I:\Cores\DMB\KIOSSES STUDIES\PATH-MCI\Adverse Events)   
4. Therapists do not need to ask about new health problems.  If the patient 
spontaneously says something in a session, the therapist should try to get as 
much of the above information as possible and let the RA know, so that the RA 
can complete this form. 
 
 
 
 
 
2 As of June 2020, the Westchester Division no longer has a clinical laboratory.  Only a certified RA may collect 
samples at the White Plains site.  

PATH-MCI STUDY OPERATIONS MANUAL 
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18
 
 
SUICIDAL IDEATION/ BEHAVIOR PROTOCOL 
 
When a patient reports passive suicidal ideation on the MADRS Suicide Ideation item or 
the Scale for Suicide Ideation:  
 
1. Complete a Suicide Risk Assessment  
2. Reach out to the patient’s study therapist. If the therapist is not available, reach 
out to Dr. Kiosses or another attending psychologist at the Institute.  
3. The clinician will speak to the patient and assess the situation. 
 
When a patient reports active suicidal ideation or any kind of suicidal behavior (suicide 
attempt, self-injurious behaviors, interrupted or aborted attempts, preparatory acts) on 
the MADRS Suicide Ideation item or the Scale for Suicide Ideation: 
 
1. Complete a Suicide Risk Assessment. 
2. Reach out to the patient’s study therapist. RA or therapist also needs to reach 
out to Dr. Kiosses and inform him about the situation and ask him to assess the 
patient.  If Dr. Kiosses is not available, contact another attending psychologist at 
the Institute (Dr. Kiosses needs to be informed later on about the situation.)  
3. Preferably, the assessment by a clinician is done during the same phone call or 
when the patient is still in the office. 
 
*Please see comprehensive SRA protocol at the end of this document. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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RESEARCH ASSESSMENTS 
 
The RA will describe the study, ask potential patients to sign consent, and administer a 
screening assessment to evaluate eligibility. Once this is confirmed, the RA will 
administer a baseline assessment. At this assessment, the RA will explain that follow-up 
assessments will be administered at 6, 12, 24, 36 and 52 weeks after the baseline 
assessment. The RA also explains that patients will be compensated $30 for each set of 
completed assessments. Caregivers will be compensated $20 for each set of 
assessments. 
 
Inclusion Criteria:  
1. Have a study partner. 
2. Be 60-85 years old. 
3. No antidepressants or have been on a stable dose of antidepressants for 12 
weeks prior to start of study. 
4. CDR = 0.5 
5. WTAR and HVLT scores that screen the participant in (see: 
I:\Cores\DMB\KIOSSES STUDIES\PATH-MCI\HVLT and WTAR Scoring) 
6. English speaking. 
7. Capacity to consent. 
 
Exclusion Criteria: 
1. Age is less than 60 or greater than 85 years old. 
2. CDR ≠ 0.5 
3. MADRS score < 7 or > 30 
4. WTAR and HVLT z-score difference > -1.5 
5. Change in antidepressant, cholinesterase inhibitors or memantine in the last 12 
weeks prior to start of study and/or with medical recommendation to adjust 
dosage in the next 3 months (during treatment) 
6. Current involvement in psychotherapy 
7. Deemed to have a significant suicide risk 
8. Deemed too unstable medically, psychiatrically or neurologically to safely enroll 
9. Lack of English fluency 
10. No available study partner 
11. Screening incomplete 
 
 
 
 
 
 
 

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INTERVENTION 
 
PATH-MCI:  
PATH-MCI follows the process model of emotion regulation. According to this model, 
emotions such as those associated with depression, can be regulated with five broad 
strategies: situation selection (selecting the situations a person is exposed to), situation 
modification (changing potentially emotion-eliciting situations), attentional deployment 
(shifting one’s attention within a situation), cognitive change (changing how one thinks 
about a situation), and response modulation (utilizing direct efforts to alter one’s 
emotional responses). In conjunction with these strategies, PATH-MCI incorporates a 
simplified problem-solving approach, compensatory strategies, environmental 
adaptations and significant other involvement to achieve emotion regulation. At the end 
of treatment, PATH-MCI therapists provide to patients a personalized summary of 
treatment that highlights the problems that were addressed and the successful 
techniques that were used to solve them.  
 
Comparison Condition: Supportive Therapy:  
ST is a control intervention not aimed to improve emotion regulation. The ST therapist 
strives to create a positive alliance with the patient by emphasizing non-specific 
therapeutic interactions and techniques that convey to the patient, interest, concern and 
understanding. For the purposes of this study, an effort will be made to avoid all 
emotion regulation techniques that relate to PATH-MCI.  
 
FOLLOW-UP ASSESSMENTS 
Follow-up assessments are conducted by the WCM RA at 6,12, 24, 36 and 52 weeks 
after the baseline and include measures of mood, cognition and suicidal ideation. 
Patients will receive $30 (cash, check or gift card) as compensation for assessment 
completion at each time point. Study partners will receive $20 (cash, check or gift card) 
as compensation for assessment completion at each time point. 
 
 
PROCEDURES FOR TREATMENT AFTER STUDY COMPLETION  
Patients whose follow-up assessments indicate a need for continued mental health 
services will be provided with mental health referrals.  
 
 
 

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21
DATA MANAGEMENT 
Data will be collected by the study RA at baseline and at follow-up assessments. The 
RA also will be responsible for writing and presenting patient summaries to the PI. The 
social worker will complete updates on the progress of their therapy sessions. Brian 
Liles manages the PATH-MCI database and weekly reporting.  
Research records will be kept confidential to the extent permitted by law. Patients will 
be assigned ID numbers by the PATH-MCI 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 access to these files. Computers will be password-protected, and all staff 
participating in the study will be 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 two LCSWs in PATH-MCI (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 PATH-MCI sessions to 2 pilot patients 
during the first four months.  To be certified in PATH-MCI, therapists must achieve a score of 
greater than or equal to 4 (very good) out of 5 on the PATH-MCI Adherence Scale. 
 
 
 
 
 
 
 
 
 
 
 

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Conducting the Study Remotely 
Due to COVID-19, and other circumstances where a patient would not be able to be seen in 
person, the study may take place remotely.  E-consenting can take place via REDCap if the 
patient has access to Internet.  The consenting process would be the same as in-person 
consent, with a member of the study team speaking with the patient over the phone or 
videoconference to explain the consent in detail.  The consent form may also be mailed to the 
potential participant with a self-addressed stamped envelope to return to the study team.  
Research assessments and both interventions (PATH-MCI and ST-CI) can take place over the 
phone and/or videoconference.  Therapy visits will be conducted in a private room (home or 
office) and sessions will be recorded only if subjects have consented to that.   
Research assessments will also take place in a private room with no one else present; if 
patients do not have access to video, some assessments may not be able to be completed in 
full.  Please reference most recent Assessment Grid for list of assessments that can be done 
remotely and via which method (phone and/or video). 
 
If the study is being conducted remotely, the genetics blood draws cannot be done. 
 
 
 

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PROTOCOL FOR ASSESSING AND DOCUMENTING SUICIDAL IDEATION 
Emotion, Cognition, and Psychotherapy Lab 
Dr. Dimitris Kiosses 
If suicidal ideation is expressed during the assessment research assistant should: 
1. Complete Suicide Risk Assessment (SRA) or 
2. Start SRA; finish completing it based on information from clinical evaluation 
 
 
 
 
  
 
 
 
 
 
 
 
PASSIVE SUICIDAL IDEATION EXPRESSED TO RESEARCH ASSISTANT
CSSRS=1 (wish to be dead, wish to not wake up) or having thoughts that life is not worth living
PATIENT ASSESSED AS MILD SUICIDE 
RISK BY CLINICIAN 
Action Step: Clinician emails Dr. Kiosses 
with a brief summary of the situation.* 
PATIENT ASSESSED AS INTERMEDIATE OR HIGH RISK BY CLINICIAN 
 Action step 1: Clinician informs primary clinician (if they are not the 
treating clinician) 
 Action step 2: Clinician reaches out to Dr. Kiosses to evaluate the patient.* 
If Dr. Kiosses isn’t available then: 
o Clinician reaches out to attending psychologist/psychiatrist to 
evaluate whether the patient needs hospitalization, or 
o
Clinician takes the patient to evaluation center or calls 911
Action Step: Review & Finalize SRA 
The clinician evaluates the following 
and the RA or clinician include the 
appropriate language on page 6 (last 
page) of the SRA:  
“The patient has been evaluated and is 
not in imminent need of hospitalization 
at this time. Patient confirmed that if 
the intensity or frequency of thoughts 
increased, they would take appropriate 
action (ie, speak with family, call 911, 
go to the ER.) SRA completed in 
collaboration with… and reviewed by 
….” 
Amy Stern, Jody Monkovic, or Dr. 
Kiosses signs the SRA.  
Study therapists should include this in 
the clinical notes as well.   
Action Step 1: Research Assistant reaches out to clinician. 
Action Step 2: Clinician speaks with patient to evaluate them either in person or by phone. 
PATIENT ASSESSED AS 
MILD OR 
INTERMEDIATE SUICIDE 
RISK BY SUPERVISING 
CLINICIAN 
PATIENT ASSESSED AS 
HIGH SUICIDE RISK BY 
SUPERVISING 
CLINICIAN
Action Step: Hospitalization required 
In Westchester:  The clinician and/or the supervising clinician will call the 
Evaluation Center (914-997-5700) to inform them that there is a patient in 
need of immediate evaluation and to provide preliminary demographic 
and clinical information.  The clinician and/or supervising clinician will walk 
patient to EC.  If needed, clinician and/or supervisor will call Security to 
request an escort (x2424). 
In Manhattan: The clinician or supervisor clinician will call 911.  Notify the 
front desk in the building lobby (212-308-2289) so they may facilitate 
entrance of the police/EMS.  All clinical information should be provided to 
EMS by the clinician and/or supervising clinician.
Action Step: Complete SRA

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24
 
 
 
 
 
 
 
ACTIVE SUICIDAL IDEATION EXPRESSED TO RESEARCH ASSISTANT
C-SSRS ≥ 2 or reports any kind of suicidal behavior (suicide attempt, self-injurious behaviors, 
interrupted or aborted attempts, preparatory acts) 
Action Step: Hospitalization required
In Westchester:  The clinician and/or the supervising 
clinician will call the Evaluation Center (914-997-5700) to 
inform them that there is a patient in need of immediate 
evaluation and to provide preliminary demographic and 
clinical information.  The clinician and/or supervising 
clinician will walk patient to EC.  If needed, clinician 
and/or supervisor will call Security to request an escort 
(x2424). 
In Manhattan: The clinician or supervisor clinician will call 
911.  Notify the front desk in the building lobby (212-308-
2289) so they may facilitate entrance of the police/EMS.  
All clinical information should be provided to EMS by the 
clinician and/or supervising clinician. 
Action Step: Review and Finalize SRA
The clinician evaluates the following and the RA or 
clinician include the appropriate language on page 6 (last 
page) of the SRA: 
“The patient has been evaluated and is not in imminent 
need of hospitalization at this time. Patient confirmed 
that if the intensity or frequency of thoughts increased, 
they would take appropriate action (ie, speak with family, 
call 911, go to the ER.) SRA completed in collaboration 
with… and reviewed by ….” 
Amy Stern, Jody Monkovic, or Dr. Kiosses signs the SRA. 
Study therapists should include this in the clinical notes 
as well.   
Action Step: Complete SRA
If the participant is a patient of one of NYP psychiatric services (eg OPD, partial hospital, inpatient service), these
clinical team must be informed of the patient’s SI and/or hospitalization. If patient is receiving treatment at 
the PHP program, additionally notify Dr. Alexopoulos, pager:914-321-7042, gsalexop@med.cornell.edu 
* Therapist should have 
clear information re. the 
nature of the SI, any 
consideration of methods, 
suicide plan,  or intent. 
* Therapist should have 
clear information re. the 
nature of the SI, any 
consideration of methods, 
suicide plan,  or intent. 
PATIENT ASSESSED AS HIGH SUICIDE RISK BY 
CLINICIAN AND SUPERVISING CLINICIAN
Action Step 1: Research Assistant reaches out to clinician. 
Action Step 2: Clinician evaluates patient in person. 
Action Step 3: Clinician or Research Assistant contact primary clinician (if they aren’t the primary clinician) and informs 
them of the situation.  
Action Step 4: Research Assistant or clinician reaches out to Dr. Kiosses.* Dr. Kiosses evaluates the patient. If Dr. Kiosses 
isn’t available then: 
o Clinician reaches out to attending psychologist/psychiatrist to evaluate the patient; or 
o Clinician takes the patient to evaluation center or calls 911 
PATIENT ASSESSED AS INTERMEDIATE SUICIDE RISK 
BY CLINICIAN AND SUPERVISING CLINICIAN

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25
PROTOCOL FOR ASSESSING AND DOCUMENTING SUICIDAL IDEATION 
Emotion, Cognition, and Psychotherapy Lab 
Dr. Dimitris Kiosses 
If suicidal ideation is expressed during the therapy session, the therapist should: 
1. Use the SRA assessment as a guideline to evaluate the patient  
2. Start completing SRA during the evaluation or complete the SRA after the evaluation based on 
clinical notes.  
 
 
 
 
 
 
 
 
 
 
 
 
PASSIVE SUICIDAL IDEATION EXPRESSED TO STUDY THERAPIST
PATIENT ASSESSED AS MILD SUICIDE 
RISK BY CLINICIAN 
Action Step: Clinician emails Dr. Kiosses 
with a brief summary of the situation.* 
Action Step: Review and Finalize 
SRA 
The clinician evaluates the following 
and the RA or clinician include the 
appropriate language on page 6 (last 
page) of the SRA:  
“The patient has been evaluated and 
is not in imminent need of 
hospitalization at this time. Patient 
confirmed that if the intensity or 
frequency of thoughts increased, 
they would take appropriate action 
(ie, speak with family, call 911, go to 
the ER.) SRA completed in 
collaboration with… and reviewed by 
….” 
Amy Stern, Jody Monkovic, or Dr. 
Kiosses signs the SRA.  
Study therapists should include this 
in the clinical notes as well.   
PATIENT ASSESSED AS INTERMEDIATE OR HIGH RISK BY CLINICIAN 
Action step: Clinician reaches out to Dr. Kiosses to evaluate the patient, if he 
thinks necessary.* If Dr. Kiosses isn’t available then: 
o Clinician reaches out to attending psychologist/psychiatrist to 
evaluate whether the patient needs hospitalization, or 
o Clinician takes the patient to evaluation center or calls 911 
PATIENT ASSESSED AS 
MILD OR 
INTERMEDIATE SUICIDE 
RISK BY SUPERVISING 
CLINICIAN 
PATIENT ASSESSED AS 
HIGH SUICIDE RISK BY 
SUPERVISING  
CLINICIAN
Action Step: Hospitalization required 
In Westchester:  The clinician and/or the supervising clinician will call the 
Evaluation Center (914-997-5700) to inform them that there is a patient in 
need of immediate evaluation and to provide preliminary demographic and 
clinical information.  The clinician and/or supervising clinician will walk 
patient to EC.  If needed, clinician and/or supervisor will call Security to 
request an escort (x2424). 
In Manhattan: The clinician or supervising clinician will call 911.  Notify the 
front desk in the building lobby (212-308-2289) so they may facilitate 
entrance of the police/EMS.  All clinical information should be provided to 
EMS by the clinician and/or supervising clinician.
Action Step: Complete SRA
* Therapist should have 
clear information re. the 
nature of the SI, any 
consideration of methods, 
suicide plan,  or intent. 

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26
 
 
 
 
 
 
 
 
 
 
Action Step: Complete SRA
 If the participant is a patient of one of NYP psychiatric services (eg OPD, partial hospital, inpatient service), the 
clinical team must be informed of the patient’s SI and/or hospitalization.   If patient is receiving treatment 
at the PHP program, additionally notify Dr. Alexopoulos: pager: 914-321-7042, gsalexop@med.cornell.edu 
* Therapist should have 
clear information re. the 
nature of the SI, any 
consideration of methods, 
suicide plan,  or intent. 
ACTIVE SUICIDAL IDEATION EXPRESSED TO STUDY THERAPIST
Action Step: Clinician reaches out to Dr. Kiosses. Dr. Kiosses evaluates the patient, if he thinks necessary.* If Dr. 
Kiosses isn’t available then:  
o Clinician reaches out to attending psychologist/psychiatrist to evaluate the patient OR 
o Therapists takes the patient to evaluation center or calls 911 
PATIENT ASSESSED AS INTERMEDIATE SUICIDE RISK 
BY CLINICIAN AND SUPERVISING CLINICIAN 
PATIENT ASSESSED AS HIGH SUICIDE RISK BY 
CLINICIAN AND SUPERVISING CLINICIAN
Action Step: Review and Finalize SRA
The clinician evaluates the following and the RA or 
clinician include the appropriate language on page 6 
(last page) of the SRA: 
“The patient has been evaluated and is not in imminent 
need of hospitalization at this time. Patient confirmed 
that if the intensity or frequency of thoughts increased, 
they would take appropriate action (ie, speak with 
family, call 911, go to the ER). SRA completed in 
collaboration with… and reviewed by ….” 
Amy Stern, Jody Monkovic, or Dr. Kiosses signs the 
SRA.  
Study therapists should include this in the clinical notes 
as well.  
Action Step: Hospitalization required
In Westchester:  The clinician and/or the supervising 
clinician will call the Evaluation Center (914-997-5700) to 
inform them that there is a patient in need of immediate 
evaluation and to provide preliminary demographic and 
clinical information.  The clinician and/or supervising 
clinician will walk patient to EC.  If needed, clinician 
and/or supervisor will call Security to request an escort 
(x2424). 
In Manhattan: The clinician or supervising clinician will 
call 911.  Notify the front desk in the building lobby (212-
308-2289) so they may facilitate entrance of the 
police/EMS.  All clinical information should be provided 
to EMS by the clinician and/or supervising clinician. 

PATH-MCI STUDY OPERATIONS MANUAL 
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27
 
Contact Page: 
 
LCSWs: 
 
Amy Stern: 516-241-4893  
Rebecca Bent: 914-329-5097 
Jody Monkovic: 914-325-4271 
Juliet Faber: 212-203-7345 
 
Psychologists: 
 
 
Dimitris Kiosses, PhD 
Cell: 914-882-9997 
Office: 914-997-4381 
 
Victoria Wilkins, PhD 
 
 
Patricia Marino, PhD 
Cell: 845-337-2540  
 
 
Cell: 917-696-0351 
Pager: 914-321-0201 
 
 
Pager: 914-321-1029 
Office: 914-682-5411 
 
 
Office: 914-997-8691 
 
Dora Kanellopoulos, PhD  
 
Jennifer Bress, PhD 
Cell: 917-886-4779  
 
 
Cell: 617-335-4321 
Office: 914-997-5201 
 
 
Office: 914-997-8683