PEERS Plus - mHealth Enhanced Peer Support to Reduce Depression Among Low-income and Ethnic Minority Older Adults
Phase: NA
Conditions: Depression in Old Age
Sponsor: Massachusetts General Hospital

 
 
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PEERS Plus - mHealth Enhanced Peer Support to Reduce Depression Among Low-
income and Ethnic Minority Older Adults 
Study Protocol 
NCT05611996 
August 7th, 2022 
 

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Institutional Review Board 
Intervention/Interaction Detailed Protocol 
 
 
Principal Investigator: 
Jin hui Joo, MD MA 
 
Project Title: 
Peer plus: depression self-care support for older adults 
 
Version Date: 
8/7/22 
 
 
Version Name/Number: 
3 
 
 
 
1. 
 Background and Significance 
 
Depression affects up to 15% of older adults, is the leading cause of disability worldwide and 
decreases quality of life and increases mortality.1,2 For many ethnic minority participants, 
traditional mental health services fail to meet their depression care needs. Minority persons 
disproportionately experience risk factors for depression, such as low socioeconomic status and 
education, may have greater distrust of medical professionals and negative experiences with 
the mental health system.3,4 Despite greater risk of poorer health, up to 70% of older ethnic 
minority participants with mood disorders do not receive depression care.1,5,6 In primary care 
where majority of older adults gets mental health care, and patients who are referred to 
specialty mental health care often do not follow up, even when given transportation to 
appointments that are free of charge.7 This problem may be due in part to a misalignment of 
what patients want and what is offered. Minority persons may prefer psychosocial treatments 
for depression compared to antidepressants, have non-biomedical explanations of their illness, 
and desire relationship-based care.8-11 Given these challenges, the use of peer mentors for 
hard-to reach populations has the potential to provide depression care to those who do not 
engage in traditional depression treatment and serve as bridges to clinical care and community-
based resources.12  
 
Peer support involves connecting a person who has a health problem to another person who 
has experienced a similar health condition. 13,14 Persons who have overcome adversity can offer 
useful encouragement, hope and mentorship, including self-care skills to others facing similar 
situations and insight that can complement professional health care.15,16 Depression is a chronic 
illness that requires self-management skills to maintain emotion-wellbeing on a daily basis and 
peer support can be useful for patients who struggle with depression.17 Peer support has been 
recognized as useful for depression self-management, 17-19 particularly, among low-income, 
minority groups, for whom experiential learning through peers rather than teaching from 

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professionals may be preferred.20 Despite the potential of peer support, the evidence is lacking 
regarding the use of peer support for minority participants with depression.17,21-28 
The evidence for peer support has been established for diverse populations and multiple 
conditions such as persons with severe mental illness and substance abuse as well as diabetes 
care. The evidence is lacking regarding the use of peer support among minority participants 
with depression.17,21-28 Two meta-analyses have shown that peer approaches can decrease 
depressive symptoms with moderate effect sizes; however, 29,30 these studies included non-
randomized studies. Additionally, the majority of studies used a peer support group format 
rather than one-to-one peer support, and few studies focus on participants. Furthermore, peer 
models of care for depression are limited, although delineation of roles and training are 
important given the diversity of what peers do in different contexts.15,31 Development of a one-
to-one peer support program anchored in a conceptual framework with clearly defined peer 
roles and rigorously tested in a randomized controlled trial has the potential to increase access 
for minority participants, to bridge them to clinical treatment and have an impact on mental 
health disparities.   
 
The COVID-19 pandemic has irreversibly changed the way in which healthcare services are 
delivered, especially for older adults. Peer support is no exception. The use of telehealth and 
video conferencing has increased the reach and access for patients and the use of technology-
enhanced peer support interventions has followed. 32,33  A majority of older adults participants 
report positive attitudes towards technology 6,7 8 9 and are willing to use technology to help 
them remain independent and maintain their health and wellness.10 Over 50% of participants 
use technology and studies suggest a combination of in-person contact and technology may be 
more effective rather than technology alone.34 Evidence regarding technology enhanced peer 
interventions is emerging in depression research but has not been well studied among ethnic 
older adults. 35,36  
    
We are conducting a clinical trial of Peer Enhanced Depression Care (IRB# 2022P001675) to test 
the effectiveness of peer support on depression among low-income and minority older adults. 
We hypothesize that the participants who are randomized to the peer intervention will 
experience greater reduction in depressive symptoms compared to those randomized to an 
active control condition. The core components of the manualized Peers intervention are: (1) 
relationship building, active listening, emotionally responsive and patient-centered 
communication, (2) sharing of experiential knowledge by peer mentors, sharing of coping skills, 
modeling, and communication of positive health messages regarding self-care (3) linkage to 
community and clinical mental health resources. To date, we have recruited 149 older adult 
participants who have completed the intervention phase and continue to conduct follow up 
assessments. Preliminary analysis of post study qualitative interviews of participants who 
completed the Peers intervention suggest positive experiences of the intervention with a 
variety of benefits. They expressed comfort being able to speak to someone regarding their 
emotional distress, described adoption of coping skills and being helped with resources. In 
Peers plus, we propose to integrate technology such as video chats and texting in the 
manualized Peers intervention to enhance the ability of a lay workforce such as peer mentors 

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to meet mental health service needs of participants with depression and link them to 
professional care as needed.  
 
Preliminary studies 
 
1.Feasibility and acceptability of a peer support intervention for depression. We developed a 
peer support intervention and evaluated the feasibility and acceptability of peer support for 
participants. We examined participant and peer experiences of the program. We found that 
engagement was high (90% percent of participants attended all 8 meetings with the peer). The 
majority was African American participants (74%) and 85% had decrease in PHQ-9 scores [Mean 
7.1 (SD 7.1) p-value < 0.001].37 Loneliness decreased (pre-study mean 36.7 ± 5.4; post-study 
mean 31.4 ± 16.7, p-value 0.03) and coping skills increased (pre-study mean 65.6 ± 13.2, post-
study mean 69.9 ± 10.4, p-value 0.006). Participants emphasized the importance of a trusting 
relationship, credibility of the peer and usefulness of professional supervision in the program. 
Participants described benefits such as hope, changes in attitude, behavior, and insight. The 
program also successfully connected participants to community and clinical resources during 
and after the study. We successfully contacted 85% of patients at 12 months and assessed 
depression with the PHQ-9 by telephone. Sixty-eight percent of patients had PHQ-9 scores that 
remained below baseline scores by 5 points or more.  After completion of the feasibility study, 
we recruited 27 additional participants (total of 57 participants) seeking to obtain greater 
experience with a larger sample of peers and participants to refine the peer program. We tried 
telephone delivery of the program for two participants. Although peers found the telephone 
convenient, relationship building was more difficult, and two participants missed telephone 
calls more frequently but attended in-person meetings regularly. Given the importance of 
problems of loneliness among our study participants, we continued with in-person meetings 
and used telephone calls infrequently when peers were unable to meet in person due to 
weather. We concluded that use of supervised peer mentors is a promising model of 
depression care delivery for participants. We conducted an analysis using data from 57 
participants in the pilot study to assess whether self-efficacy predicted change in depression. 
We found that improvement in self-efficacy was associated with a decline in depression. 
Relevance: Intervention manual and protocol were developed. Feasibility and acceptability 
were demonstrated. 
2.Communication analysis to assess peer mentor training. We studied peer mentor 
communication that would inform peer training and role development. Our aim was to describe 
and associate communication behaviors used by supervised peer mentors with working alliance 
and depression.38 We used the Roter Interaction Analysis System, a quantitative method to 
analyze health communication between peers and participants in the pilot study. We looked at 
a variety of communication behaviors similar to other studies on communication behaviors in 
mental health. 39,40 We found that peers used a variety of skills learned in training. This included 
participant-centered talk, positive rapport building, emotional responsiveness, and education 
and counseling. Specific communication behaviors such as emotionally responsive talk and 

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education about psychosocial topics were associated with decreased depression. We concluded 
that trained peer mentors can use skilled communication behaviors that is participant-centered 
to provide depression care services to participants. Relevance: Specific communication 
behaviors in peer mentors training was shown to impact depression. 
2. 
Specific Aims and Objectives  
 
1. To design and test components, such as video chats and supportive texts, for a 
technology-enhanced peer support intervention for depression among community-
dwelling minority older adults 50 years of age and older called Peers plus; 
2. To determine the feasibility and acceptability of Peers plus to reduce depression among 
community-dwelling and ethnic minority adults 50 years of age and older. 
3. 
General Description of Study Design 
 
We propose a two-step study: (1) a usability study to design and assess the user experience of 
Peers plus; and (2) a 
pilot study to assess the 
intervention feasibility 
and acceptability. In the 
usability study, we will 
test Peers plus in two 
iterations of five dyads 
(participants and peer 
mentors, see Table 1). 
The RA will use zoom to 
conduct the usability 
survey and semi-
structured interview at 
2 weeks and upon 
completion of the peer 
support meetings. 
Analytics (e.g. duration 
of the video chat, 
content of the texts) will 
provide data regarding 
the intervention 
components during a 4 
week period. 
 
We will use the 
knowledge gained from 
the usability study to 
Table 1. Study flow for usability (Phase 1) and feasibility study (Phase 2). The 
studies are sequential. Recruitment and enrollment procedures are identical. 
Intervention duration and data collection procedures of the studies differ and 
are described in this table. 
Aim 1. Usability study 
Recruitment and enrollment (two cohorts of 5 dyads) 
• 
RA receives referrals, conducts telephone screen 
• 
Clinician conducts clinical assessment (zoom) and obtains verbal informed 
consent 
• 
RA conducts baseline assessment (Redcap)  
• 
RA conducts technology training as needed (e.g. access texting on zoom) 
• 
Eligible participant is matched with a peer mentor who schedules a video 
chat 
User experience assessment of Peers plus  
• 
PM conducts weekly 4 video chats and sends daily texts to the participant 
over 4 weeks. 
• 
RA conducts usability survey and brief semi-structured interview at 2 
weeks [midpoint] and at 4 weeks with the participant and the peer 
mentor. 
Aim 2: Feasibility study (20 older adult participants) 
• 
Recruitment and enrollment procedures are identical to the usability 
study 
Peers plus Intervention 
• 
PM conducts 8 weekly video chats and sends daily texts to the participant 
over 8 weeks. 
Assessments 
• 
RA conducts baseline assessment, post-study assessment and semi-
structured interview at 8 weeks with the participant. RA conducts semi-
structured interview at 8 weeks with PMs. 

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revise our intervention procedures and contents as needed. In the feasibility study, we will use 
identical recruitment and enrollment procedures to recruit depressed older adults to 
participate in a prototype of the 8-week, zoom-delivered Peers plus intervention. It will consist 
of peer support delivered through video chats (45-60 min duration) and daily texts: 1) peer 
mentors (PM) will video chat with participants and provide emotional support and encourage 
use of self-care strategies for depression, linking to community and clinical resources as 
needed, and 2) the PMs will provide one-way supportive texting by SMS to encourage and 
reinforce use of self-care strategies and exchange community and clinical resource information.  
 
Participants with depression will be recruited from the community with the assistance of 
community-based organizations that will help study staff disseminate study flyers to their 
members. This will enable older adults in the community to self-refer. The research assistant 
will screen the older adults and provide study information by telephone. Then, eligible older 
adults will be scheduled for a clinical assessment to be conducted by a mental health 
professional (MHP such as a clinical social worker or a clinical psychologist) by zoom. The MHP 
will gather depression history and psychosocial information as well as assess for inclusion and 
exclusion criteria. Eligible and interested older adults will be consented verbally by the mental 
health professional. Upon completion of the clinical assessment, the RA will conduct a baseline 
assessment by zoom. The RA will obtain verbal consent that participants are comfortable 
accepting one-way SMS texts during the study. Upon completion of the baseline assessment, 
the RA will call the PM to inform the older adult participant of the match with the PM. Then the 
PM will contact the participant by phone and schedule weekly video chats and send daily texts 
that are developed with supervision. PMs will not engage in exchange of texts with the 
participant.  
 
4. 
Subject Selection 
 
Eligibility criteria  
Identification of peer mentors. Peer mentors who have been trained in the study, Peer 
Enhanced Depression Care, (IRB #2022P001675) and who are interested in the Peers plus will 
be interviewed. These peer mentors (PM) were recruited with the help of our community 
collaborators. They were chosen based on interviews with study staff who evaluated them on 
factors such as prior experience with depressive illness, communication and relationship 
building skills, time in recovery from depression, volunteering and mental health experience. 
Those PMs who exhibit core peer skills and commitment and meet eligibility criteria will be 
invited to enroll in the study. The verbal consent form will be emailed to the candidate to 
facilitate the verbal consent process prior to the process of obtaining consent for participation 
in the study. Verbal consent will be obtained by the Mental Health Professional.  
 
Inclusion/exclusion criteria for Peer Mentors (PM): Inclusion criteria: (1) 50 years and older, (2) 
history of depression, (3) at least 5 years in recovery, (4) received basic training in behavioral 
health or have volunteer experience in mental health, (5) access to personal computer and (6) 
can provide informed consent. Exclusion criteria: (1) meet current diagnostic criteria for Major 

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Depressive Disorder; (2) meet current diagnostic criteria for a manic episode or a psychotic 
disorder; (3) meet current diagnostic criteria for substance abuse disorder; (4) will be 
comfortable using a personal device or a device provided by to use for video chats and texting 
for the study. 
 
Peer mentor training 
The Research Assistant and the PI will conduct ten hours of training remotely that will be a 
review of prior training. We developed a peer training program 41 that includes use of effective 
communication skills, including appropriate self-disclosure, participant and peer safety and 
confidentiality, expression of empathy, active listening, goal-setting, sharing coping skills and 
other depression self-care skills. Training on establishing relationship boundaries is critical to 
ensuring that participants benefit from peer support and will be provided. Training will include 
didactics, discussion, experiential learning, and role-play. In addition, PMs will receive training 
in use of zoom for video chats, making audio recordings and sending texts, confidentiality, and 
ethics. Zoom interactions will occur using the MGB Enterprise Zoom platform. After completion 
of training, study staff will review peer mentors for suitability to be matched, taking into 
consideration attendance, active participation, commitment and demonstration of 
interpersonal and communication skills and mastery of technology skills.  
 
Participant participants 
Inclusion criteria are: (1) 50 years and older; (2) depressive symptoms with PHQ-9 scores 
greater 10 or greater (2) self-identify as belonging to an ethnic minority group, (3) willing to 
give informed consent. Exclusion criteria are: (1) meet diagnostic criteria for mania or 
hypomania; (2) meet diagnostic criteria for psychotic syndrome; (3) meet diagnostic criteria for 
substance abuse or dependence; (4) acutely suicidal; and (5) those without technology will 
accept and use a device to use for video chats and texting for the study. Participants who meet 
diagnostic criteria for severe depression, cognitive impairment, mania, hypomania, a psychotic 
disorder, or substance abuse or dependence will require clinical treatment.  
 
Recruitment 
We will establish relationships with community organizations that serve older adults e.g. BDS 
Health Aging Network. This is a network of minority older adults that provides information 
about social and government services and support groups locally and nationally. We will 
conduct webinars and provide information about the study and distribute IRB approved study 
flyers to their members so that interested older adults can contact the study staff. We will track 
recruitment methods and their results by community organization that includes number 
referred, eligible, enrolled and retained. The research assistant will make 3 calls to the referred 
participant and track the number of screening attempts and the result of those attempts. 
 
5. 
Subject Enrollment 
 
For all referred older adults, the research assistant will screen them by telephone for eligibility. 
We will ask about demographic information, such as age and gender, depressive symptoms 

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with the PHQ-9, a self-report instrument that is keyed to DSM-IV-R criteria for Major 
Depression and widely used in primary care,42,43 access to technology. Upon completion of 
screening, eligible participants will be asked if they would like to proceed with a clinical 
assessment and those who are interested will be scheduled with a mental health professional 
and the verbal consent form will be emailed or mailed to the participant to facilitate the verbal 
consent process. The clinical assessment will be conducted by zoom. Any participants who are 
not interested in participation will be given information about mental health resources or clinic 
information.  
 
Brief clinical assessment. A mental health professional (MHP) will perform the clinical 
assessment by zoom. She will assess for exclusion criteria, i.e. suicidal ideation, manic episodes, 
alcohol abuse, substance abuse and psychotic disorders using the MINI (Mini-International 
Neuropsychiatric Interview),44 a yes/no instrument that derives DSM-IV-R diagnoses on the 
basis of respondent’s reports of their symptoms The clinical assessment will include history of 
present illness, psychiatric and medical history as well as a psychosocial assessment that will 
ensure that the participants are appropriate for the study. If the participant expresses suicidal 
ideation, the MHP will assess further, ensure the safety of the participant while ensuring receipt 
of appropriate clinical services. The clinical assessment will be documented and saved on a 
secure server, MGH OneDrive. If the participant meets eligibility criteria, verbal consent will be 
obtained. The MHP will explain that participation is completely voluntary and that they can 
have as much time as they need to make their decision to participate or not. We will ask them 
to call the study team when they have decided. They will be given up to 48 hours to make a 
decision. If the older adult agrees to participate, they will be scheduled for a baseline 
assessment.  
 
6. 
STUDY PROCEDURES 
 
Upon enrollment of the older adult participant, the RA will arrange delivery of devices by 
courier to those who do not have personal devices and provide any technology training that is 
needed to participants and PMs. Those participants will be given a WIFI enabled device to be 
returned when the study is completed. Baseline assessment. The RA will schedule and conduct 
the baseline assessment that lasts about 1 hour by zoom. The assessment will consist of 
questions regarding demographic information, medication use, depression care history, 
technology, and questionnaires to measure depression and function. Data will be entered 
directly into REDCAP MGH. All study documents will be in electronic form and stored on MGH 
OneDrive. Matching and scheduling of visits. After delivery and training in technology and the 
baseline assessment have been conducted, the PM will contact the participant to schedule 
weekly video chats. The weekly video chats will last for 45 – 60 minutes. Each video chat will be 
recorded. The peer mentor will be supervised by a mental health professional who will also 
review the audio recordings for quality assurance, on a weekly basis.  
 
AIM1: Usability study to design and test Peers plus components 
 

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The usability study will assess user experience so that the intervention manual (currently being 
tested in a clinical trial called Peer Enhanced Depression Care) can be adapted in an iterative 
process of trial and revision. Peers plus will consist of peer support delivered through two 
technology components: 1) PMs will video chat with participants and they will provide 
emotional support and encourage use of self-care strategies for depression and linkage to 
community and clinical resources, 2) PMs will provide supportive texting (one-way, SMS) to 
encourage and reinforce use of self-care strategies, and exchange community and clinical 
resource information to reduce depression. We will test Peers plus in 10 older adults (see Table 
2 below).  
 
Sample size considerations. Determination of sample size for Aim 1 design procedures is based 
on recommendations within the user-centered design literature.48,49 Previous research suggests 
that a sample size of 5 users detects, on average, 85% of the usability errors of a system. 
Recommendations also include additional iterations of usability testing rather than large 
samples of users. Based on these suggestions, our approach to conducting two iterations of 
usability testing with 5 participants in two cohorts (N=10) is likely to provide sufficient feedback 
to identify a substantial amount of design errors in our Peers plus intervention. 
 
Component 1: Video chats. During the video chats, peer mentors will serve as persons who 
have experienced depression, serve as models of recovery, possess self-care skills learned from 
life experience, and know how to use and navigate community and clinical services – all 
valuable for someone with depression who may not otherwise access mental health resources. 
Studies have shown the participants will engage more easily with technology when support is 
provided, so peers will be trained to support participants in technology use. Peer mentors, in 
their role, will identify goals with each participant during their video chats and share self-care 
strategies that are relevant to the participants (see Table 2 below). The video chats will be 
audio recorded on zoom for quality assurance and reviewed by the mental health professional. 
The recordings will be stored in MGH OneDrive to which only the study team who have 
completed IRB training will have access.  
 
Component 2: Supportive texting. In each dyad, the participant will receive one-way tailored 
text SMS messages delivered by the peer mentor daily during the 4 weeks of video chats. 
Supportive texts will be developed and conceptualized as “micro-interventions” informed by 
Motivational Interviewing that uses affirmations to motivate behavior change, e.g. use self-care 
skills for depression. To ensure that the texts are helpful, the peer mentor and the participant 
will discuss relevant self-care strategies during the video chats first. Based on discussion during 
the video chats, the peer mentors will send motivational and educational texts that are 
personalized, consisting of relevant affirmations (e.g. “you are taking great care of your loved 
one”), coping skills and community-based resources (e.g. “take time out for yourself” , “do 
something you enjoy”, “connect with a mental health professional”) daily to participants. Texts 
will serve to reinforce the trusting relationship, express empathy, encouragement, and self-care 
skills discussed during the video chats. The idea is that such texts encourage and support use of 
self-care behaviors that are related to depressive symptoms identified by the participant. The 

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texts will be declarative and posed as questions so that the effect is not to direct behavior but 
to stimulate thinking in the participant who then decides. All text messages will be co-
developed by the mental health professional and the peer mentor before it is sent. The PM will 
keep a log of texts specifying the day and time when it was sent and will review this process 
with the MHP during supervision meetings. 
 
Content of PM-Participant meetings. In the usability phase, Peers plus will be 4 weeks in 
duration. This is abbreviated from 8 weeks (the original duration of the Peer Enhanced 
Depression Care intervention) because the focus is on the usability of technological 
components. The primary role of the peer mentors is to build relationship, provide social 
support (emotional, appraisal, informational support) facilitate simple goal setting, share coping 
skills and depression self-care skills, and connect to clinical and community resources for 
depression. The program is relationship-based and takes an empowerment strategy to increase 
self-efficacy in depression self-care.45 We will use strategies to enhance cultural 
appropriateness of our program for minority participants such as avoiding stigmatizing clinical 
language about mental health, respecting non-medical self-care methods such as religious 
coping, taking a non-judgmental attitude, accommodating participant preferences.46 The peer 
mentor will be supervised by a mental health professional that will consist of weekly meetings 
by zoom.  
 
 
Supervisory role of the mental health professional such as a social worker or a clinical 
psychologist (MHP). Supervision is important to sustain the quality of the program and to 
support peer mentors. Peer mentors will meet in groups of 2 on a weekly basis concurrent with 
meetings with participants for supervision. During meetings, the MHP will elicit insights from 
PMs, discuss progress and problem-solve challenges e.g., lack of engagement and motivation. 
The MHP will document the activities of supervisory meetings, maintain logs of peer meetings 
with participants and review audio-recordings of meetings. The PI, who is a geriatric 
Table 2. Peers plus intervention content for usability study 
Phase  
Process and Content 
Introductory phase: Meetings 1 (1 
hour) 
Orient participant to the program and build trust  
Share personal story of depression recovery.  
Discuss participant goals for the meetings and logistics of meetings. 
 
Middle phase: Meetings 2-3 (1 
hour) 
 
Listen actively, support emotionally and motivate for self-care  
Focus on depressive symptoms and participant goals 
Active listening, empathy, emotional and appraisal support regarding 
psychosocial stressors 
Discussion, modeling and encouragement of self-care skills, e.g. positive 
affirmations, pursuing activities they enjoy, journaling, joining social 
activities.  
Coming to a close: Meetings 4 (1 
hour) 
 
Review, reinforce skills learned and plan for the future  
Provide information regarding clinical and community-based services as 
requested 

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psychiatrist, will be available for consultation to the MHP to problem–solve difficult situations 
as appropriate. PMs will have access to the MHP by telephone as needed outside of supervision 
meetings.  
 
Standard of Care/Referral to clinical care. The participant will be asked if they want referral to 
specialty mental health care if not engaged in professional care at initial clinical evaluation, 
during the meetings with the peer mentor and upon completion of the study. If at any time the 
participant asks for referral to professional care, the participant will receive information about 
specialty mental health care services so they can make an appointment.  
 
AIM 2. Feasibility study of Peer plus  
 
Knowledge gained from the usability study will be used to revise the Peers plus intervention 
manual and we will conduct a feasibility study with 20 ethnic minority, community-dwelling 
older adults with depression. In this study, recruitment, and enrollment procedures as well as 
eligibility criteria will be identical to the usability study in Aim 1. For the feasibility study, the 
duration of the Peers plus intervention will be 8 weeks with identical intervention content and 
process. Data collection procedures will consist of assessment at baseline assessment, post-
study assessment and a 3 month follow-up. We will conduct a post-study semi-structured 
interview.  
 
Data collection 
 
Quantitative data 
Listed in Table 3 is the timeline of study measures for the usability and feasibility studies. Data 
obtained from participants recruited for this protocol will include sociodemographic 
information (e.g., age, race, ethnicity, etc.), attitudes toward technology and technology use, 
self-reported clinical information (past history of depression services, current mental health 
service use), self-reported psychosocial measures (physical, social and emotional function, 
depression, self-efficacy, coping and loneliness) and social determinants of health. We will 
measure engagement defined in two ways: 1) as attendance of 80% of meetings as reported by 
peer mentors 47 and 2) score on the Working Alliance Inventory-SR.  
 
Aim 1 Usability study 
 
Quantitative data A baseline assessment will be conducted by the RA with participants 
recruited for this protocol. Baseline assessments will include demographic information (e.g. 
age, ethnicity, gender, education). We will use self-report measures to collect information on 
depression, medical comorbidity, social determinants of health, self-efficacy, loneliness, coping 
skills, social, physical, and emotional functioning, attitudes toward technology and technology 
use. Assessments at 2 and 4 weeks. With both the peer mentor and participant at 2 and 4 
weeks, we will collect measures of usability with a widely used self-report scale (i.e. System 
Usability Scale (SUS),50,51 an objective measure of user engagement with the texting and video 

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chatting system (i.e. background analytics of supportive texting). This measure is a simple, ten-
item Likert scale with five response options that measures the perception of usability by users. 
Background analytical information on various factors will also be collected, including frequency 
and duration of platform use, number of messages sent, word count in messages, number of 
video calls, and time spent on video calls.  
 
Qualitative data We will conduct a semi-structured interview with the peer mentors and 
participants at 2 weeks and 4 weeks. The study staff will assess peer and participants’ 
experiences with sending and receiving texts, the content and wording, the timing and 
frequency of the text messages received and engagement with the texting system. We will 
gather information about satisfaction with the interactions with the peer using the video chat. 
Consistent with the user-centered design principle of ideation, qualitative and quantitative data 
collected will be used to revise the intervention. The interviews will be audio recorded, 
professionally transcribed and themes extracted regarding user experience.  
 
Aim 2. Feasibility study  
 
Quantitative assessments The RA will conduct a baseline assessment that includes demographic 
information (e.g. age, ethnicity, gender, education), self-report measures on depression, 
medical comorbidity, social determinants of health, self-efficacy, loneliness, coping skills, social, 
physical, and emotional functioning, technology use and attitudes (see Table 3 below). The peer 
mentor will fill out a Working Alliance Inventory on a weekly basis to assess the quality of the 
bond, agreement on tasks and goals. Background analytical information on various factors will 
be collected, including frequency and duration of zoom use, number of messages sent, number 
of video calls, and time spent on video calls.  
 
Qualitative data We will conduct a semi-structured interview lasting approximately 45 minutes 
with the peer mentors and participants upon completion of the intervention at 8 weeks by 
zoom. We will gather information about satisfaction with the interactions with the peer using 
the video chat. The purpose will be to understand peer and participant experience in the 
intervention. The interviews will be audio recorded, professionally transcribed and themes 
extracted using a thematic analytic framework.  
Table 3. Assessments  
 
Variable 
Measure 
 
 
Demographic information 
Age, gender, ethnicity, education, marital status, mental health history 
 
Depression (self-report) 
PHQ-9 37  a widely used, self-report instrument that is keyed to DSM-IV-R criteria for Major Depression  
Physical, social and  
emotional function 
Medical Outcomes Study Short Form 36 48 10 item measure of overall health, composed of sub-sections 
that assess emotional, physical and social functioning, 
Medical comorbidity 
Medical comorbidity will be measured with the WHO WMH CIDI that has been established for use 
among older adults and has proven validity and reliability.49 

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Only trained study staff will have access to these data. Participants’ data will be identified by an 
ID number only, and a link between names and ID numbers will be kept separately under lock 
and key. Staff will have a password-protected account for downloading the data. All PM-
participant meetings will be audio-recorded to ensure fidelity. The MHP will review the 
recordings and provide feedback during weekly supervision (e.g., problem solve challenging 
cases). All study staff will have up-to-date Collaborative Institutional Training Initiative (CITI) 
certifications. All data will be collected by telephone and zoom. To protect participants’ 
confidentiality, we will not use participants’ names during supervision meetings of peer 
mentors. 
 
Standard of care 
Participants will be informed during the clinical assessment and reminded throughout the study 
that professional mental health care is the standard of care for depression. PMs are persons 
who have had positive experiences in depression treatment and are trained to encourage 
professional mental health care use in study participants. At any point, if the participants 
express desire for information or referral to professional mental health care, the study will 
provide that. 
 
Premature termination 
Participants may drop out at any point in the study. We will terminate participants who are not 
able to conform to study expectations such as meeting regularly and undergoing the 
assessments.  If they are unable to engage in study activities per protocol, study staff will have a 
discussion with the participant to explain requirements of the study and reasons for inability to 
complete study requirements. Information or clinical information will be offered to those who 
are terminated or decide to drop out.  
 
Remuneration  
Usability study: Participants will receive $30 for each assessment(4) and meeting(4) with the 
peer mentor. Assessments will include baseline, 2 weeks, post-study assessment and semi-
structured interview for a total $240. Peer mentors will receive $50 for each meeting and 
supervision (4) and $20 post study semi-structured interview. Total provided for completing all 
study activities will be $220. 
Coping skills 
The Brief Cope is widely used in depression studies which assesses trait and state coping developed 
from the COPE inventory which assesses different coping dimensions.50 
Self-efficacy 
General Self-efficacy Scale 51 10-item measure that has been used among participants and found to be 
sensitive to changes in psychosocial interventions for depression. 
Loneliness 
R-UCLA Loneliness Scale 52 a commonly used, 20-item, self-report questionnaire.53 
Technology use and attitudes 
on technology  
Questions adapted from a validated survey assessing technology and media usage and attitudes 54 55   
Working alliance  
Working Alliance Inventory-Short Revised -a short 7-item questionnaire that measures affective bond, 
agreement on tasks and goals, and has been used to measure working alliance in non-professional 
relationships in mental health. 56 
User experience (in usability 
study only) 
System Usability Testing57 10 item survey for measuring assessments of systems usability.  

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Feasibility study: Participants will receive $30 for each assessment and interview (4). 
Assessments will include baseline, post-study assessment, 3 month follow-up and semi-
structured interview for a total $120. Peer mentors will receive $50 for each meeting with the 
participant and supervision (8) and $20 post study semi-structured interview. Total payment 
provided for completing activities with one participant will be $420. 
1. 
Risks and Discomforts 
 
Psychosocial risks 
We recognize that older individuals, especially those with chronic illness, can easily feel 
overwhelmed or fatigued by what would be minimally demanding tasks for others, and, 
therefore, we include this discomfort in the potential risks. A minority of participants may 
respond to certain interview questions with feelings of sadness and grief (e.g., upon being 
reminded of interpersonal problems and social isolation). To address undue emotional stress, 
multiple strategies was used to prevent adverse events: 1) rigorous screening of the older 
adult’s appropriateness for a peer mentor intervention, performed by a mental health 
professional prior to matching, 2) rigorous training and continuous supervision of the peer to 
prevent escalating emotional distress, and 3) availability of professional staff to address peer 
mentor’s concerns by phone at all times. In the event that the peer mentor needs assistance, 
the peer will contact the supervising MHP (with geriatric psychiatrist backup) who will speak 
with the participant regarding the problem. In our experience, peers have been able to detect 
signs in the participant of escalating distress and able to follow the established protocol without 
adverse events. Peer mentors will be trained to recognize and provide support to manage 
undue emotional distress. In the case that a participant is distressed, the peer mentor will listen 
actively, provide empathy and ask if they would like to speak with a mental health professional 
on the study team. If the participant answers in the affirmative, the PM will inform the MHP 
and the MHP will call the participant and conduct a clinical assessment with appropriate triage 
to connect with community or clinical resources. If the participant declines speaking with the 
MHP, the PM will inform the MHP during weekly supervision and also follow up with the 
participant at the next meeting. The MHP will be available by telephone during the week 9-5pm 
and a geriatric psychiatrist will be available in the case that the MHP is unable to manage the 
participant’s distress.  
 
Suicidal ideation 
When conducting studies with depressed patients, expression of suicidal ideation is a risk. We 
will address this risk in multiple ways. We will conduct a clinical evaluation prior to matching to 
assess the participant’s appropriateness for the study in terms of depression severity and risk 
for suicidal ideation. In our previous work, expressions of suicidal ideation were rare because 
we assessed for depression severity and appropriateness for peer services during the initial 
clinical evaluation and such persons were excluded and referred for appropriate care. Also, 
peer mentors recruited for this study will receive training in a protocol for those participants 
who express suicidal ideation, to ensure the safety of the participants. If the participant 

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expresses suicidal ideation during a meeting, the peer mentor will immediately call the MHP 
who will call the participant and manage the situation. Assessment by the MHP may involve the 
following questions: (1) Do you have a desire to hurt yourself that you think you might act on? 
(2) Do you have a plan for hurting yourself and intend to carry the plan out? Participants may 
also be identified as a high risk for suicide if the participant reports a specific plan to commit 
suicide, or if the participant has risk factors for suicide. Risk factors may include multiple suicide 
attempts, moderate to severe depression, a high level of hopelessness, immediate access to a 
lethal method, a lack of reasons for living, psychosis or mania, poor social support or a recent 
stressful life event. Additional probing may be necessary to identify any other risk factors (e.g., 
access to a firearm). The MHP will ensure and facilitate urgent referral of high risk patients to 
the Emergency Department near their home where an evaluation to assess need for treatment 
is done. A geriatric psychiatrist (Dr. Joo) will be available for consultation in situations where 
the social worker needs assistance. In our experience, one instance of suicidal ideation (1 
participant) did arise, the trained peer mentor contacted the PI who spoke with the participant 
and managed the situation without adverse events. 
 
Confidentiality and privacy 
For participant participants, risks regarding breach of confidentiality and disclosure of clinical 
information exist and may be heightened due to use of non-professional peer mentors in the 
proposed study. Should confidentiality safeguards fail, there is potential harm in the form of 
social risks and disclosure of private information. However, the risks of participation should be 
no more than minimal, with effective confidentiality safeguards. The safeguards include the 
following: 1) Peer mentors sign a contract of confidentiality agreement before participating in 
the project, receive confidentiality training and the importance of confidentiality will be 
stressed throughout training and supervision sessions on a weekly basis. 2) Participant 
participants will be informed that absolute confidentiality cannot be guaranteed but study staff 
put rigorous procedures in place. In our experience, there were no known breaches of 
confidentiality in our pilot study or in our clinical trial, participants did not express concern 
about this during the consent process, and none dropped out of the study for this reason. All 
information collected will be coded with a study identification number and will be stored in 
secure servers that only IRB approved staff associated with the study can access. These records 
will be protected by the confidentiality system of MGH and are not disclosed except as required 
by law. Audio recordings are saved on a secure server, MGH OneDrive. 
 
2. 
Benefits 
 
The proposed study could benefit the participant participants in terms of psychoeducation and 
self-care skills associated with depression, services delivered by a PM who is under a mental 
health professional’s supervision. The peer may benefit from increased sense of self-efficacy in 
helping another person and have an increased knowledge base from the mental health training 
provided by the study. Benefits to society may include new knowledge regarding the provision 
of mental health services in the community. If the peer program is successful, new ways to 
provide depression care services in the community setting to low-income minority participants 

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are established. The risks to the patient for participating in this project are minimal and the 
possibility of improving depression care is substantial. 
 
This research intends to inform the development of peer programs whose aim is to improve 
access and engagement of depression care among minority populations. Given that minority 
participants receive inadequate or no mental health care and are less likely to access traditional 
mental health services, developing novel methods of delivering depression services is 
important.  
 
3. 
Statistical and Qualitative Analysis 
 
Statistical analysis We will screen data for quality and integrity. We will obtain descriptive 
statistics to characterize study participants. Percentage of session attended and engagement 
will be reported as percentages. Inferential analysis of depressive symptoms over time will be 
conducted using longitudinal linear regression taking into account clustering (via multi-level 
modeling) since peer mentors will meet with several patients. The quantitative data will identify 
measured factors that are related to engagement and depression reduction so that the 
mHealth components for peer delivery can be refined.  
 
Qualitative data analysis All audio recordings will be professionally transcribed. The transcripts 
will be analyzed using thematic analysis which is a flexible and commonly used approach in 
qualitative analysis.58 The study team members will proceed through 4 phases: 1) immersion in 
the data by reading and re-reading the data, 2) generation of initial codes, 3) sorting of codes 
into themes, and 4) review and refinement of themes based on coded extracts and relevance to 
the entire dataset. The PI and members of the study team have conducted and published 
numerous qualitative studies and are experienced in qualitative methods.9,38,59 To ensure 
trustworthiness, the PI and trained study team members will code a subset of transcripts 
independently, compare their agreement on segments of coded data and resolve 
disagreements through in-depth discussion. The PI and study team members will meet on a 
weekly basis during the data analysis period to discuss in depth the rationale for coding and 
theme generation, and will resolve disagreements by negotiated agreement. Qualitative data 
analytic software, NVIVO11, (QSR Intl, Durham UK) will be used. The manual of the intervention 
will be revised based on review and analysis of the qualitative and quantitative data. 
4. 
  Monitoring and Quality Assurance 
Research-Related Risks Dr. Joo will lead weekly meetings to review study operations and 
compliance (e.g., data collection and management), to discuss any emerging concerns, to 
identify any training needs, and to address any human subjects issues. Dr. Joo and the study 
team will work to ensure compliance with study procedures.  
• 
Preparation: An existing intervention manual (created for Peer Enhanced Depression 
Care) will be adapted for Peers plus, an intervention that integrates technology to 
deliver peer support. Any changes during the implementation is noted and noted, 

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• 
Ongoing monitoring: After each intervention meeting, PM activities will be reviewed by 
the mental health professional during weekly supervision meetings. All meetings will be 
audio-recorded. Protocol Fidelity and Investigator Compliance. The PI and team will 
record and report all protocol violations.  
Participant Confidentiality All study materials will identify participants only by study ID, visit 
number, and visit date. The study research assistant will be trained in procedures to protect 
study participant confidentiality. Recordings of each PM-participant meeting will be 
immediately de-identified (e.g., only ID, visit number and date) and stored on a password 
protected computer; the recording will be made on zoom and stored on MGH dropbox. The 
research team will report to the IRB any instances of participant confidentiality breach and 
corresponding plans for corrective action.  
Data Validity and Security. The research team will develop standard operating procedures for 
data collection, data management, and quality control. Dr. Joo will oversee all procedures 
related to secure data collection and management. Data activities will be conducted using 
(Research Electronic Data Capture (REDCap), a software and workflow tool for research data 
collection and management, with assistance from Partners HealthCare Research Computing, 
Enterprise Research Infrastructure & Services (ERIS) group. REDCap will provide secure web-
based applications with an intuitive user interface data and real time validation rules. 
Privacy and Confidentiality 
 
☒ Study procedures will be conducted in a private setting 
☒ Only data and/or specimens necessary for the conduct of the study will be collected 
☒ Data collected (paper and/or electronic) will be maintained in a secure location with appropriate 
protections such as password protection, encryption, physical security measures (locked 
files/areas) 
☐ Specimens collected will be maintained in a secure location with appropriate protections (e.g. 
locked storage spaces, laboratory areas) 
☒ Data and specimens will only be shared with individuals who are members of the IRB-approved 
research team or approved for sharing as described in this IRB protocol 
☒  Data and/or specimens requiring transportation from one location or electronic space to 
another will be transported only in a secure manner (e.g. encrypted files, password protection, 
using chain-of-custody procedures, etc.) 
☒   All electronic communication with participants will comply with Mass General Brigham secure 
communication policies 
☒ Identifiers will be coded or removed as soon as feasible and access to files linking identifiers 
with coded data or specimens will be limited to the minimal necessary members of the research 
team required to conduct the research 
☒ All staff are trained on and will follow the Mass General Brigham policies and procedures for 
maintaining appropriate confidentiality of research data and specimens 

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☒ The PI will ensure that all staff implement and follow any Research Information Service Office 
(RISO) requirements for this research 
☒ Additional privacy and/or confidentiality protections 
 
 
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APPENDIX A 
 
Data Monitoring Committee / Data and Safety Monitoring Board 
Appendix 
 
 
A Data Monitoring Committee (DMC) or Data and Safety Monitoring Board (DSMB) will be convened for 
safety monitoring of this research study.  The following characteristics describe the DMC/DSMB 
convened for this study (Check all that apply): 
 
☐ The DMC/DSMB is independent from the study team and study sponsor. 
 
☐ A process has been implemented to ensure absence of conflicts of interest by DMC/DSMB 
members. 
 
☐ The DMC/DSMB has the authority to intervene on study progress in the event of safety 
concerns, e.g., to suspend or terminate a study if new safety concerns have been identified or 
need to be investigated.   
 
☐ Describe number and types of (i.e., qualifications of) members: 
5 members 
1.Geriatric psychiatrist and researcher with experience of clinical trials of depression care 
interventions, NIH funded 
2.Geriatrician and researcher in mental health and use of paraprofessionals in medical care 
3.Social worker, PhD, health services research with expertise in peer support 
4.Statistician, PhD, with experience in NIH studies in geriatric mental health 
5.Study statistician, PhD, with experience in NIH studies in geriatric mental health 
 
☐  Describe planned frequency of meetings 
DSMB meetings are held every 12 months. 
 
☐ DMC/DSMB reports with no findings (i.e., “continue without modifications”) will be submitted 
to the IRB at the time of Continuing Review. 
 
☐ DMC/DSMB reports with findings/modifications required will be submitted promptly (within 5 
business days/7 calendar days of becoming aware) to the IRB as an Other Event.