A Pilot Study of Delivering 'Engage' Psychotherapy Via Telemedicine Through the Tablet-based 'Prism' System to Homebound Older Adults With Depression
Phase: NA
Conditions: Depression
Sponsor: Weill Medical College of Cornell University

 
 
 
1 
 
 
 
The Feasibility of Engage Therapy With Video Support for 
Homebound Older Adults 
 
 
Clinical trials number: NCT05346055 
 
 
 
Primary investigator: 
Natalie C. Benda, PhD 
560 West 168th Street, New York, NY 10032 
Room 623 
212-305-9547 
nb3115@cumc.columbia.edu 
 
 
 
 
Sponsor: 
Weill Cornell Medical College of Cornell University  
 
 

  
Page # i 
 
TITLE:   The feasibility of Engage Therapy with Video Support for Homebound Older Adults 
 
IRB Protocol #: 20-10022828 
Version Date: 11/20/2020 
Funding Source(s): National Institute for Mental Health (Grant# 3P50MH113838-02S1, PI – G. 
Alexopoulos) 
 
Principal Investigator:  
 
Natalie C. Benda, PhD 
425 E. 61st St., Suite 301, New York, NY  
 646-962-9435 
Ncb4001@med.cornell.edu 
 
Admin contact: Krystalle Lyons 
914-997-5238 
Krl4003@med.cornell.edu 
21 Bloomingdale Road, Unit 7 South 
White Plains, New York 10605 
 
Additional investigators:   
 
Jo Anne Sirey (Co-Investigator) 
914-997-4333 
jsirey@med.cornell.edu 
21 Bloomingdale Road, Unit 7 South  
White Plains, New York 10605 
 
Sara Czaja, PhD (Co-Investigator) 
646-962-7148 
sjc7004@med.cornell.edu 
420 East 70th Street, 3rd Floor, Suite B (Office LH-311) 
New York, NY 10021 
 
 
Alexandra Woods, PhD (therapist) 
alg2040@med.cornell.edu 
21 Bloomingdale Road 
White Plains, New York 10605 
 
George Alexopoulos, MD 
(914) 997-5767 
gsalexop@med.cornell.edu 
21 Bloomingdale Road 
White Plains, New York 10605 
 
Samprit Banjeree, PhD 
646-962-8014 
sab2028@med.cornell.edu 

Protocol # 20-10022828 
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Page # ii 
 
21 Bloomingdale Road  
White Plains, New York 10605 
 
Arielle Guillod 
844-999-8746 ext 705 
aig4001@med.cornell.edu 
21 Bloomingdale Road, Unit 7 South  
White Plains, New York 10605 
  
Paula Zanotti 
(844) 999-8746 ext 700 
paz4001@med.cornell.edu 
21 Bloomingdale Road, Unit 7 South  
White Plains, New York 10605 
 
Sarah Weingast 
646-962-7161 
Medicine-Geriatrics and Palliative Medicine 
 
Gabriel Gladstone-Groth 
646 962 7152 
Medicine-Geriatrics and Palliative Medicine 
 
Marvens Dorce 
646 962 7150 
Medicine-Geriatrics and Palliative Medicine 
 
Marco Ceruso 
212 746 5454 
Medicine-Geriatrics and Palliative Medicine 
 
 
Participating Sites:  Weill Cornell Medical College 
 
 

Protocol # 20-10022828 
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Page # iii 
 
Table of Contents 
LIST OF ABBREVIATIONS................................................................................................................ VI 
1. PROTOCOL SUMMARY ........................................... ERROR! BOOKMARK NOT DEFINED. 
1.1 Study Objectives ...................................................................................................................... 1 
1.1.1 Objectives 
1 
1.1.2 Hypotheses / Research Questions 
1 
2. BACKGROUND AND SIGNIFICANCE ............................................................................................. 1 
3. STUDY DESIGN AND METHODS ................................................................................................... 2 
3.1 Overall Design .......................................................................................................................... 2 
3.2 Interviews, Focus Groups, Surveys, and/or Observations ....................................................... 2 
3.2.1 Interviews .............................................................................................................................. 2 
3.2.2 Questionnaires ...................................................................................................................... 2 
4. STUDY DESIGN ............................................................................................................................. 4 
4.1 Study Population ...................................................................................................................... 4 
4.2 Inclusion Criteria ...................................................................................................................... 4 
4.3 Exclusion Criteria ...................................................................................................................... 4 
4.4 Strategies for Recruitment and Retention ............................................................................... 6 
5. REGISTRATION PROCEDURES ...................................................................................................... 6 
5.1 
Subject Registration (WCM only) ........................................................................................ 6 
5.2 Subject Registration (Sub-sites) ............................................................................................... 6 
6. DATA REPORTING / REGULATORY CONSIDERATIONS ................................................................ 6 
6.1 Data Collection ......................................................................................................................... 6 
6.1.1 Interviews 
7 
6.1.2 Questionnaires 
7 
7.2 Regulatory Considerations ..................................................... Error! Bookmark not defined. 
7.2.1 Institutional Review Board/Ethics Committee Approval Error! Bookmark not defined. 
7.2.2 Ethical Conduct of the Study 
9 
7.2.3 Informed Consent 
9 
7.2.4 Compliance with Trial Registration and Results Posting Requirements 
9 
7.2.5 Record Retention 
9 
8. STATISTICAL CONSIDERATIONS ................................................................................................... 9 
8.1 Sample Size/Accrual Rate ......................................................................................................... 9 
9. ADVERSE EVENT REPORTING REQUIREMENTS ......................................................................... 10 
10. UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS ............................ 10 

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10.1  Definition of Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO) 10 
10.1.1 Unanticipated Problem Reporting 
10 
REFERENCES ............................................................... ERROR! BOOKMARK NOT DEFINED. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Page # v 
 
Confidentiality Statement 
 
This document is confidential and is to be distributed for review only to investigators, potential 
investigators, consultants, study staff, and applicable independent ethics committees or institutional 
review boards. The contents of this document shall not be disclosed to others without written 
authorization from WCM. 
 
 
 
 
 
 
 
 
 
Weill Cornell Medical College 
_________________________________________________________________ 
Institution Name 
 
 
 

Protocol # 20-10022828 
Version Date 11/20/2020 
 
 
Page # vi 
 
List of Abbreviations 
 
 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CTSC 
Clinical Translational Science Center  
DSMB 
Data Safety Monitoring Board 
DSMP 
Data Safety Monitoring Plan 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HRBFA 
Human Research Billing Analysis Form 
HUD 
Humanitarian Use Device  
ICF 
Informed Consent Form 
IDE 
Investigational Device Exemption  
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
PHI 
Protected Health Information 
PI 
Principal Investigator 
REDCap 
Research Electronic Data Capture 
REDS 
Reaching and Engaging Depressed Senior Center Clients 
SAE 
Serious Adverse Event 
SUSAR 
Suspected Unexpected Serious Adverse Reaction  
UIRTSO 
Unanticipated Problem Involving Risks to Subjects or Others 
WCM 
Weill Cornell Medicine 
 
 

Protocol #  
Version Date 
 
Page # 1 
 
 1. Study Objectives 
 
 
1.1. Objectives  
 
Our primary aim in this in this pilot project is to test the feasibility, acceptability and impact of a 
brief behavioral treatment for depression (Engage) combined with video social support (PRISM 
2.0) among socially isolated/lonely case management clients who endorse depressive 
symptoms. Secondarily, we will assess technology-related outcomes.  
 
We plan to recruit 50 subjects based on a proposed recruitment of at least 3 subjects per month 
(17 months).   Eligible participants will be offered the combination of Engage and Prism 2.0, 
called Engage-Prism.  
 
 
 
1.2. Hypotheses / Research Questions 
 
 
 
We hypothesize that the intervention will be acceptable by participants and that it will improve 
social connection, perceived social support, and reduce loneliness and depressive symptoms. 
 
2. Background and Significance 
 
Older adults who are homebound are socially disconnected with high rates of loneliness and depression. 
Social isolation places individuals at risk of all-cause mobility and mortality (Holt-Lunstad & Hawkley 
2016) including suicidal attempts (Calati et al., 2019). In the Health and Retirement study social 
disconnectedness is associated with 5% risk of falls, and social isolation combined with loneliness is 
associated with a 33% increase in falls (Quach & Burr, 2020). In a sample of 1,885 homebound and semi-
homebound older adults from the National Health and Aging Trends Study (NHATS) 15.62% scored 
above the suicide risk cutoff, 23.73% of homebound older adults reported a history of suicidal ideation 
or behavior, 65 adults in this sample (13.18%) indicated the possibility of attempting suicide in the 
future (Xiang & Brooks, 2017).  Social isolation and depression may be bidirectional (Santini et al, Lancet 
2020). Aging services providers are not trained to distinguish loneliness, depression and disconnection 
making links to appropriate services challenging (Choi NG, Sirey JA, Bruce ML, 2013). 
 
Brief behavioral interventions have shown an increase in social interaction, a decrease in loneliness, 
depression and disability (Choi and Bruce, 2020). Engage is a brief therapy designed to offer a 
structured, stepped approach and interventions to reduce barriers to increased engagement with 
rewarding activities to improve depression (Alexopoulos et al, 2020). The goal is to increase 
participation in meaningful activities. Recent research supports the importance of engagement in social 
interpersonal-individual predicting subsequent increases in behavioral activation and improvement of 
depression (Solomonov et al, 2019).  Homebound older adults have limited social interaction given their 
restricted mobility and medical burden. Innovative steps to improve interactions have used technology 
to link clients who are homebound. In an intervention targeting social engagement with a technology 
intervention (PRISM 2.0), participants reported increased social support, decreased loneliness, increased 
feelings of well-being, more positive attitudes about computers, and gains in computer proficiency 
(Czaja et al., 2017). These gains were maintained improvements at 12 month follow-up. 
 

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3. Study Design and Methods 
 
3.1 Overall Design 
 
The study will include the following steps: 
1. Referral from case management service, determination of eligibility, collection of informed 
consent 
2. Baseline assessment and training with the Engage-Prism technology 
3. 9 Engage sessions (1 per week) and use of the Prism platform (9 weeks total) 
4. Brief interim assessments at 3 and 6 weeks 
5. Post-therapy assessment and follow-up interview at week 9 
6. Follow-up assessment at week 12 
Details related to the questionnaires in the baseline and Week 9assessment as well as the follow-up 
interview are described in the subsequent sections. 
 
3.2 Baseline assessment/training, Engage sessions, technology use, post-study assessment and 
interview  
 
3.2.1 Baseline assessment and training 
 
Participants will be mailed the Prism technology or provided the technology in-person. 
Participants will be provided a tablet and trained in the utilization of Prism by a study team 
member and technology specialist. Trainings will occur virtually (via Zoom or telephone) or in-
person. In-person training will be conducted by research assistants and occur in the participants’ 
home as many are homebound. The determination for in-person versus virtual training will be 
based on the preference of the participant the research regulations of Weill Cornell Medicine 
pertaining to the on-going COVID-19 pandemic. Following the training, baseline questionnaire 
data will be collected with the study team member reading the questions aloud and marking the 
responses of the participant. Included questionnaires are described in the subsequent section.  
 
 
3.2.2 Questionnaires  
 
 
Questionnaires collected during the baseline and study assessments include (attached to IRB 
application): 
1. Hamilton Depression Rating Scale (HAMD) for depression severity 
2. Behavioral Activation for Depression Scale (BADS) for behavioral activation* 
3. Duke social interaction subscale – to assess social connection 
4. Duke perceived support subscale – to assess perceived social support 
5. UCLA 3-item scale – to assess loneliness  
6.  12-item World Health Organization Disability Assessment Schedule (WHODAS 2.0)- to 
assess different domains of disability** 

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7. Technology readiness questionnaire (Jay & Willis, 1992)* 
8. Mobile Device Proficiency Scale (MDPQ-16) 
9. Computer tablet opinions questionnaire (Czaja et al., 2018)* 
10. Demographics** 
11. Client Satisfaction Questionnaire 3-item for therapy satisfaction 
12. Intent to Participate – to assess intention to continue study 
*Pre and post only (i.e. not at 3, 6 or 9 weeks) 
**Pre only 
 
3.2.3. Engage therapy sessions 
 
Participants will complete 9 Engage therapy sessions. Engage is a form of personalized, stepwise 
treatment for late-life depression. The main intervention of Engage is an adapted form of 
behavioral activation tailored to older adults focused on “reward exposure,” namely 
encouraging patients to engage in (i.e., expose themselves to) rewarding activities between 
sessions to enhance activation of the reward system. At each session, patients will be guided to 
select a rewarding activity they had not engaged in recently or wanted to do more often. Then, 
the clinician will help patients develop a plan to engage in the selected activity and to cope with 
potential difficulties when exposed to such rewarding situations. If a patient does not 
successfully engage in planned rewarding activities and show clinical improvement by the third 
session, the clinician will add techniques to address barriers to reward exposure (Solmonov et al, 
2019). Weekly depression severity is tracked using the PHQ-9. Engage has previously 
demonstrated efficacy for decreasing depressive symptoms in older adults (Alexopoulos et al, 
2016).  
 
3.2.4. Prism system 
 
Throughout the 12-week study, participants will be given the Prism 2.0 system to use. 
Participants will be provided a tablet with internet access, pre-loaded with the Prism 2.0 
software. The Prism software involves a suite of programs for improving the social support and 
interaction felt by older adults. Previous studies have demonstrated that Prism system reduces 
loneliness and increases perceived social support and computer proficiency (Czaja et al., 2017).  
Prism software includes: Internet browser access (with vetted links to sites such as 
NIHSeniorHealth.Gov), an annotated resource guide, a dynamic classroom feature, a calendar, a 
photo feature, E-mail, games, and online help. Clinicians will incorporate elements of the Prism 
system into therapy as appropriate, and participants will be instructed to use the Prism system 
at their leisure or as it pertains to their chosen “reward exposure” activities.  
 
3.2.5 Post-study interviews 
 
Following completion of week 9 questionnaires, participants will discuss semi-structured 
interview questions with a study team member related to barriers and facilitators to the Engage 
therapy and use of the Prism technology platform (script attached). Interviews will be audio 
recorded with the consent of the participant. 
 

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4. Study Design  
 
4.1 Study Population 
 
The study population involves socially isolated/lonely older adult case management clients who 
endorse depressive symptoms. 
 
4.2 Inclusion Criteria 
 
Criteria Referral to study:  
1. Age at least 60 years.  
2. English speaking.  
3. Currently enrolled in case management at in 2 included agencies 
4. Major depression on the SCID and 24-item Hamilton Depression Rating Scale (HAM-D) ≥ 19 
5. Report of loneliness social isolation as determined by the UCLA 3-item scale and Duke social 
interaction subscale, respectively 
Following referral, participants must be willing and able to consent to the study procedures and 
related activities. 
 
 
4.3 Exclusion Criteria  
1. Psychotic depression by SCID-V, i.e. presence of delusions 
2. High suicide risk, i.e. intent or plan to attempt suicide in the near future 
3. Presence of any Axis I psychiatric disorder or substance abuse other than unipolar major 
depression 
4. History of psychiatric disorders, hypomania, are excluded 
5. Acute or severe medical illness, i.e. delirium, metastatic cancer, decompensated cardiac, liver, or 
kidney failure, major surgery, stroke, or myocardial infarction during the three months prior to 
entry; or drugs often causing depression, e.g. steroids, reserpine, alpha-methyl-dopa, 
tamoxiphen, vincristine 
6. Current involvement in psychotherapy 
7. Cognitive impairment (i.e. telephone administered MoCA < 11) 
8. Currently dwelling in non-community dwelling (e.g. prison, nursing home) 
9. Hearing that would not allow participants to complete sessions with the RA/therapist 
10. Vision impairment that would not allow the participant to use the study provided tablet 
11. Inability to speak English 
12. Aphasia interfering with communication 
13. Literacy – assessed by reading a paragraph designed for those at 6th grade reading level 
 
 

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INSTRUMENTS 
Administered by: 
Screening 
Baseline Wk 3 
Wk 6 
Wk 9 
Wk 12 
Screening Assessment 
 
 
 
 
 
 
 
Demographic 
Questionnaire 
Research 
Assistant (RA) 
X 
X 
 
 
 
 
Medication List 
RA 
X 
 
 
 
 
 
Health Information 
Questionnaire 
RA 
X 
 
 
 
 
 
Functional status 
(WHODAS 12-item) 
RA 
 
X 
 
 
 X 
X 
Telephone- MoCa 
RA 
X 
 
 
 
 
 
Dx, Depression Severity 
and Anhedonia  
 
 
 
 
 
 
 
Hamilton Depression 
Rating Scale (HAMD) 
 Research 
Assistant   
X 
X 
X 
X 
X 
X 
Structured Clinical 
Interview for DSM -V 
Clinician 
X 
 
 
 
 
 
SCID Score Sheet 
RA 
X 
 
 
 
 
 
PHQ-9 
Clinician 
 
Weekly during clinician sessions 
Behavioral Activation  
 
 
 
 
 
 
 
Behavioral Activation for 
Depression Scale (BADS) 
RA 
 
X 
X 
X 
X 
X 
Social Connection and 
Loneliness 
 
 
 
 
 
 
 
Duke (social interaction and 
perceived support subscales) 
RA 
 
X 
X 
X 
X 
X 
UCLA Loneliness Scale 3-
item 
RA 
 
X 
X 
X 
X 
X 
Technology 
 
 
 
 
 
 
 
Technology readiness 
questionnaire 
RA 
 
X 
 
 
X 
 
Mobile Device Proficiency 
Scale (MDPQ-16) 
RA 
 
X 
 
 
X 
X 
Computer Tablet Opinions 
Questionnaire  
RA 
 
X 
 
 
X 
 
Other 
 
 
 
 
 
 
 
Client Satisfaction 
Questionnaire 3-item 
RA 
 
 
X 
X 
X 
X 

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4.4 Strategies for Recruitment and Retention 
 
Case managers will inform the potential participants of the study and let them know that a study 
team member will contact them. Following referral by case management, eligible participants will 
be contacted by study staff via phone to provide the initial consent. Eligibility will be confirmed by 
the study personnel, and potential participants will be invited to participate in the study.  
 
Subjects participating in this study will be compensated approximately $25 for each research 
assessment ($125 total) for completion of the study. Subjects will receive $25 via check or gift card in 
the mail for remote visits.  There is no charge or compensation for the weekly psychotherapy 
sessions.  
 
If participants do not “log on” to the Prism system for 7 consecutive days, a study team member will 
call them to make sure they do not have questions, technical issues, or require re-training.  
 
5. Registration Procedures 
 
5.1 Subject Registration (WCM only) 
 
Not applicable. 
 
 
 
5.2 Subject Registration (Sub-sites) 
 
Not applicable. 
 
6. Data Reporting / Regulatory Considerations 
 
6.1. Data Collection 
 
6.1.1. Study outcomes: Feasibility and Acceptability 
 
To evaluate acceptability and feasibility we will record the number of clients who are meet 
eligibility criteria and accept the intervention (versus refuse). Acceptability will be assessed 
based on client satisfaction with the therapy and the technology. The Clients Satisfaction 
Questionnaire will be administered at weeks 9 and 12 with benchmarks will be set at >3 (out of 
4).  
 
 
Intent to Participate 
RA 
 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 

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This will be recorded by the study team member who interviews the potential study 
participants. No personal information will be stored for ineligible persons or persons who do not 
consent to participate. Only descriptives regarding whether or not the person contacted was 
eligible and consented will be recorded. This will be recorded by the study team member 
performing recruitment using an online form.  
 
 
6.1.2. Questionnaires (baseline and post-study) 
 
 
Personnel conducting the study will verbally ask questions of contained in the questionnaires 
described, and record the participants answers using pen/paper or electronic form. Study 
investigators will write the participant number on each questionnaire so questionnaires from 
the same participant can be matched. Assessments will be collected prior to the first Engage 
session and following the final Engage session. 
 
 
6.1.3. Expert assessment 
 
Weekly depression severity is tracked using the PHQ-9 by the clinician. Each session, clinicians 
will also record when a new participant initiates therapy and whether or not the patient attends 
each therapy session using an online form.   
 
Acceptability will be evaluated based on the client and therapist satisfaction participating in 
Engage-Prism using the Client Satisfaction Questionnaire (CSQ 3-item). 
 
6.1.4. Technology utilization 
 
The Prism system collects de-identified statistics regarding the frequency and duration of 
utilization of each of the Prism applications (e.g. calendar, web browser, classroom), but does 
not collect surveillance data such as message content or search history. The data is stored on a 
secure, encrypted server where only study team members will have access.  
 
As described above, if participants do not “log on” to the Prism system for 7 consecutive days, a 
study team member will call them to make sure they do not have questions, technical issues, or 
require re-training.  
 
6.1.5. Post-study Interviews  
 
 
Interviews will be audio-recorded. The team member conducting the interview will take notes to 
supplement the recording. As feasible, audio recordings will be sent to a HIPAA-compliant, CITI-
certified transcription service or transcribed by a study team member. Although participants will 
be instructed not to provide any PHI during the interview, the transcription service will omit PHI 
if it is accidentally verbalized by the participant. The transcripts and investigator notes will serve 
as the data to be analyzed related to the interviews. Audio recording and transcripts will be kept 
on a secure server that only study personnel have access to through password protected logins.  
 
6.1. Data Analysis 
 

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Baseline, interim, and post-study assessment data will be analyzed using statistical hypothesis 
testing with appropriate parametric or non-parametric tests as dictated by the nature of the 
assessment output and the distribution of the data collected.  
 
Technology utilization data will be analyzed and reported using aggregated descriptive statistics. 
Secondary analyses may involve comparing differences in time using the various applications 
included in Prism, and differences in use based on participant demographics.  
 
Qualitative data from the follow-up interviews be analyzed using inductive methods and the 
constant comparative process. Coding will be accomplished by multiple coders using consensus 
coding to elicit key themes from the data.  
 
We will conduct a comparison with a matched sample of case management clients obtained from 
our prior research project (R01 MH075900, PI - Arean; R01 MH075897, PI - Alexopoulos) .We will 
compare the Engage-Prism participants response and remission rates with the rates found in the 
CARE-D study. We expect equal response rates (33-42.5% and remission rates (31- 37.9%) 
(Alexopoulos, 2016) 
7. Regulatory Considerations 
 
7.1. Institutional Review Board/Ethics Committee Approval  
 
As required by local regulations, the Investigator will ensure all legal aspects are covered, and 
approval of the appropriate regulatory bodies obtained, before study initiation.  
Before initiation of the study at each study center, the protocol, the ICF, other written material 
given to the patients, and any other relevant study documentation will be submitted to the 
appropriate Ethics Committee. Written approval of the study and all relevant study information 
must be obtained before the study center can be initiated or the IP is released to the Investigator. 
Any necessary extensions or renewals of IEC/IRB approval must be obtained for changes to the 
study, such as amendments to the protocol, the ICF, or other study documentation. The written 
approval of the IEC/IRB together with the approved ICF must be filed in the study files.  
The Investigator will report promptly to the IEC/IRB any new information that may adversely 
affect the safety of the subjects or the conduct of the study. The Investigator will submit written 
summaries of the study status to the IEC/IRB as required. On completion of the study, the IEC/IRB 
will be notified that the study has ended.  
 
All agreed protocol amendments will be clearly recorded on a protocol amendment form and will 
be signed and dated by the original protocol approving signatories. All protocol amendments will 
be submitted to the relevant institutional IEC/IRB for approval before implementation, as 
required by local regulations. The only exception will be when the amendment is necessary to 
eliminate an immediate hazard to the trial participants. In this case, the necessary action will be 
taken first, with the relevant protocol amendment following shortly thereafter.  
Once protocol amendments or consent form modifications are implemented at the lead site, Weill 
Cornell Medicine, updated documents will be provided to participating sites. Weill Cornell 
Medicine must approve all consent form changes prior to local IRB submission.  

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Relevant study documentation will be submitted to the regulatory authorities of the participating 
countries, according to local/national requirements, for review and approval before the beginning 
of the study. On completion of the study, the regulatory authorities will be notified that the study 
has ended.  
 
7.2. Ethical Conduct of the Study  
The Investigators and all parties involved will conduct this study in adherence to the ethical 
principles based on the Declaration of Helsinki, GCP, ICH guidelines and the applicable national 
and local laws and regulatory requirements.  
 
This study will be conducted under a protocol reviewed and approved by the applicable ethics 
committees and investigations will be undertaken by scientifically and medically qualified 
persons, where the benefits of the study are in proportion to the risks. 
 
7.3 Informed Consent 
 
Patients will provide verbal informed consent (script and information sheet attached).  
 
7.2.4 Compliance with Trial Registration and Results Posting Requirements  
 
Not applicable – not a clinical trial 
 
7.2.5 Record Retention 
 
Essential documents are those documents that individually and collectively permit evaluation of 
the study and quality of the data produced. After completion of the study, all documents and 
data relating to the study will be kept in an orderly manner by the Investigator in a secure study 
file. Essential documents should be retained for 2 years after study conclusion. In addition, all 
subjects’ medical records and other source documentation will be kept for the maximum time 
permitted by the hospital, institution, or medical practice. 
 
8. Statistical Considerations 
 
8.1 Sample Size/Accrual Rate 
 
The goal of this early-stage pilot feasibility study is to assess feasibility, acceptability and impact of a 
brief behavioral treatment for depression (Engage) combined with social support (Prism). Though 
we have planned statistical hypothesis testing for a comparison with a historical sample, our goal is 
not to demonstrate definitive significant differences or establish but understand whether this is a 
feasible, acceptable, promising intervention that warrants further exploration with a larger sample 
of participants. The sample size is based on previous work by the investigators in similar feasibility 
assessments of the Engage therapy (Alexopoulos et al., 2016).  
 
 

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9. Adverse Event Reporting Requirements 
 
Not applicable, this is not a clinical intervention.  
 
10. Unanticipated Problems Involving Risks to Subjects or Others  
 
Not applicable 
 
10.1  Definition of Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO) 
 
Not applicable 
 
 
 
10.1.1 Unanticipated Problem Reporting 
 
Not applicable