Peer Enhanced Depression Care: Using Peer Mentors to Provide Self Care Support to Low Income and Minority Older Adults
Phase: NA
Conditions: Depression
Sponsor: Massachusetts General Hospital

 
 
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Peer Enhanced Depression Care: Using Peer Mentors to Provide Self-Care 
Support to Low Income and Minority Older Adults 
 
Principal Investigator:  
Jin hui Joo, M.D., M.A. 
Massachusetts General Hospital, Harvard Medical School 
Supported by: 
The National Institute of Mental Health 
R01MH123165 
NCT04319094 
 
Version Date: 
May 20th, 2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Date: May 20, 2020___________________    
Principal Investigator: __Jin Hui Joo_______________ 
 
 
 
Study Protocol 
 
 
 
 
************************************************************************************** 
 
1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the research hypothesis, 
and the importance of the research. 
 
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) Minority populations face greater risk for depression due to greater 
burden of medical comorbidity and low socioeconomic status but up to 70% of minority older adults with clinical 
need do not use mental health services.(1) Peer support involves connecting a person who has a health problem to 
another person (a peer) who has experienced a similar health condition, someone who ‘has been there’ and ‘lived it’. 
(3, 4) 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.(5, 6) 
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.(7) Peer support has been recognized as 
useful for depression self-management, (7-9) particularly, among low-income, minority groups, for whom 
experiential learning through peers rather than teaching from professionals may be preferred.(10) Despite the promise 
of peer support, the evidence is lacking regarding the use of peer support for low-income and minority older adults 
with depression.(7, 11-18) We will partner with a committed community organization and employ a rigorous 
research design to evaluate a novel model of peer support, with the goal of maximizing effectiveness on outcomes 
and gathering information on implementation to position the program for future sustainability. In this proposal, we 
will conduct a hybrid effectiveness-implementation study. In the first phase, we will conduct a randomized controlled 
trial of a peer support program for older adults who are recruited from the community. We hypothesize that 
participation in the peer program compared to an enhanced usual care program will report decreased depressive 
symptoms. The community-based peer program, referred to as the peer support program called “PEERS”, which is a 
manualized depression care intervention, guided by theories of peer support, social support and social learning,(3, 19, 
20) tailored to a resource-poor, low-income, minority older adult population. In the second phase, we will conduct a 
mediation analysis. Many promising interventions are never implemented and disseminated on a wide scale due to 
lack of knowledge about implementation outcomes (eg. acceptability, program fit, fidelity) and core components of 
the intervention (eg. intervention staff selection, training, coaching and performance assessment, staff evaluation as 
well as systems level factors such as leadership). (21-23),(24) In the third phase, we will evaluate the implementation of 
the Peer Program by assessing program fit, barriers and facilitators and fidelity of the implementation. New 
approaches are needed that leverage existing community resources (e.g. peers) to improve depression care for a 
highly vulnerable group that often does not access traditional mental health services. 
 
2. 
Objectives (include all primary and secondary objectives) 
 
The specific aims of this proposal are as follows: 
(1) To measure the effect of a peer mentoring program on mild to moderate depression compared to social interaction 
control among minority and low-income adults aged 50+ years recruited from primary care clinics;  
H1: Older adults randomized to the Peer Program (vs. control) will report decreased depression (PHQ-9 score 
decrease > 5) at 8 weeks, 3, 6, 9 and 12 months.  
 
We will conduct a randomized controlled trial by enrolling 160 low-income and minority adults and measure the 
effect of the Peer Enhanced Depression Care Program on mild to moderate depressive symptoms compared to Social 
Interaction Control. We will recruit a total of 10 peer mentors. The supervised peer mentors who are based in the 
community will provide social support by telephone with depressed older adults recruited from primary care and the 

 
 
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community for 8 weeks with initial training and ongoing supervision by a clinical social worker. The core 
components of the Peer Program 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. In Aim 2, we will conduct a quantitative mediation analysis, specifically measuring increase in self-
efficacy as the mediating factor. In Aim 3, we will use post-study key informant interviews from a diverse group of 
stakeholders representing individuals, the community and the primary care clinic to assess implementation process, 
and we will use checklists to evaluate the fidelity of the intervention.  
 
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with procedures, drug or 
device, and any other relevant information to justify the research) 
 
We conducted a study that showed ethnic disparity in use of psychotherapy offered in primary care for 
African American older adults with depression. We capitalized on depression screening and clinical diagnostic 
assessments that occurred in PROSPECT.(25, 26) We focused on the 582 persons with complete data assessed at 
baseline.(27) Compared to White older adults, persons who self-identified as African-American were less likely to 
have received Interpersonal Psychotherapy if they had minor depression even after adjusting for potentially 
influential covariates (AOR)=0.22, 95% confidence interval (CI)=0.06-0.80). African Americans were less likely to 
receive psychotherapy than Whites among persons who met criteria for major depression as well. While the 
intervention “raised all boats,” the ethnic disparity persisted even in the intervention practices. Focus on the clinical 
setting may improve health but not health disparities. A model that is accessible in the community and linked to 
clinics may be more effective in mitigating health disparities over clinical approaches alone.  
We developed a peer intervention and evaluated the feasibility and acceptability of peer mentors for older 
adults and examined client and peer experiences of the program. We found that engagement was high (90% percent 
of older adults attended all 8 meetings with the peer). The majority was African American older adults (74%) and 
85% had decrease in PHQ-9 scores [Mean 7.1 (SD 7.1) p-value < 0.001].(28) 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). Older adults 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 older adults 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 older adults) 
seeking to obtain greater experience with a larger sample of peers and older adults 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 older adults 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 older adults. We conducted an analysis using data from 57 older adults 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.  
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.(29) We used the Roter Interaction Analysis System, a quantitative method to analyze health 
communication between peers and older adults in the pilot study. We looked at a variety of communication behaviors 
similar to other studies on communication behaviors in mental health. (30, 31) We found that peers used a variety of 
skills learned in training. This included client-centered talk, positive rapport building, emotional responsiveness, and 
education and counseling (see Table 1). Specific communication behaviors such as emotionally responsive talk and 
education about psychosocial topics were associated with decreased depression (all p<.001). We concluded that 
trained peer mentors can use skilled communication behaviors that is client-centered to provide depression care 
services to older adults. 
 
4. 
Study Procedures 

 
 
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a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
 
Study flow 
 
• 
Screen by telephone 
• 
If eligible, conduct clinical evaluation by telephone to assess eligibility for the study 
• 
If not eligible, participant will be given information and a list of community and clinical resources  
• 
If eligible, patient will undergo a baseline assessment  
• 
Participant will be asked if willing to take part in 8 peer meetings, and 6 assessments, or Social 
interaction/health education visits and assessments by phone.  
• 
If yes, we will proceed to obtain oral consent and enrollment. 
• 
Randomization occurs 
• 
If intervention condition -- contacted by Peer mentor -- begin 8 meetings by phone 
• 
If control condition -- contacted by Study staff and social interaction visits 
• 
Data collected and flagged for urgent referral if needed 
• 
Intervention and Control conditions contacted by Study coordinator to conduct interviews by telephone, post-
intervention after 8 visits and at 3 months, 6 months, 9 months and 12 months 
 
We will collaborate with Baltimore CONNECT that was formed as a research partnership in 2013 between Johns 
Hopkins University and 20+ community-based social organizations. They provide a range of services from peer 
counseling to workforce development and nutrition support, and is now a designated non-profit. We are guided by 
community-engaged principles of research emphasizing a partnership approach that is equitable and includes diverse 
research partners.(32) The Advisory Board of Baltimore Connect will assist with recruitment of peers and help 
connect older adults to social services they offer. The Advisory Board will give input regarding issues of ethnicity 
and community culture. Preliminary findings of quantitative and qualitative analyses will be presented at quarterly 
meetings of the Advisory Board for feedback and interpretation, and will be integrated into the final results.  
 
Study participants  
Identification of peer mentors. Participants will be recruited for the intervention trial as follows. Potential peer 
mentors will be recruited with the help of our community collaborators and through word of mouth referral. We will 
also advertise in CBO newsletters. Study staff will call potential peer candidates and schedule an interview. If they 
are chosen based on their interview (eg. interpersonal skills, time in recovery, volunteering experience), study staff 
will schedule a telephone meeting where consent will be obtained, and they will be invited to participate in the peer 
training. We will recruit 10 peer mentors, aiming for a balance of men and women. Interested candidates will be 
interviewed by Dr. Joo and study staff and screened for eligibility criteria. Eligible peers will be consented by Dr. Joo 
and invited to participate in training. We will measure their depressive symptoms pre and post as well as conduct 
interviews with them upon completion of the study. Peers who are not chosen for continued participation in the study 
after training will be referred to other peer mentoring opportunities. 
 
Training for peer mentors. We developed a training program that was used in our pilot study. Study staff will 
conduct 5 sessions totaling 20 hours of training using videoconference that will serve as an introduction to the peer 
mentor role with continued training and skills development occurring during the supervision meetings. Training will 
include taking a client-centered approach, using effective communication skills, including appropriate self-
disclosure, client and peer safety and client confidentiality, expression of empathy, active listening, goal-setting, 
sharing coping skills and other depression self-care skills. Establishing relationship boundaries is critical to ensuring 
that clients benefit from peer support. Training on this issue will be provided initially and continually reinforced in 
supervision meetings. Training will also include experiential learning, role-play, and discussion of client cases. The 
peers will receive training in appropriate use of audio-recordings during the meetings with participants, the 
submission of the audio-recordings to the clinical supervisor on a weekly basis and the handling of the recordings 
overall. After completion of training, study staff will assess peer mentors for suitability to be matched, taking into 
consideration attendance, active participation, commitment and demonstration of interpersonal and communication 
skills. Those peers who exhibit core peer skills and commitment will be matched with clients. Peer mentors will be 
paid for meetings with the depressed older adults and supervision meetings with the social worker.  
 

 
 
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Identification of depressed older adults. We will recruit older adults from the community with the assistance of our 
community partners. We will make presentations at community-based organizations, attend health-fairs and 
community-based research events and also disseminate flyers. We will target 5-7 older adults for enrollment and 
randomization monthly. We anticipate peer mentors will be able to manage 2-4 clients at one time from our 
experience in the pilot study. The research coordinator will screen clients by telephone for depressive symptoms 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.(33, 34) Eligible clients will include those with depressive symptoms (defined as a PHQ-9 score of 5 or 
greater) who have been experiencing depressive symptoms for at least two weeks. Eligible clients will be scheduled 
for a clinical assessment with a mental health clinician to be done by telephone.  
 
We will also recruit depressed older adults from primary care clinics. Study staff will make presentations of the study 
at the primary care clinics to clinic staff and ask for patient referrals. Study staff will place flyers in the waiting 
rooms for patients to take so patients can contact the study directly. Referred patients will be contacted by study staff 
and screened by telephone and patients who self-refer will be contacted and screened for study eligibility. Those who 
are eligible for the study will be scheduled for a mental health evaluation by a mental health clinician to be done by 
telephone.  
 
Clinical staff at Beacham clinic at Bayview will refer patients using EPIC in basket. Study staff will obtain the 
patient contact information, (name, address and telephone number) from Epic and send a letter describing the study 
to the patient to opt in to the study. The letter will contain a number to call and a card to mail if they want to receive 
any communications from the study. If they want more details, we will provide it. We will ask if they would like to 
undergo a phone screening. If they agree, study staff will do a phone screen. The patient’s name, address and 
telephone number will be entered into a database that will be stored in a secure Massachusetts General Hospital 
server. Any PHI of participants who do not contact us will be destroyed within 6 months. PHI of patients who call us 
will be saved per protocol. We add another method of referral because we have not gotten enough referrals with 
flyers and PCPs say they would like to refer but their busy clinic schedule is a significant barrier. PCPs say that 
ability to refer through EPIC will facilitate referrals.. 
 
Clinical assessment. A clinical social worker will perform the clinical assessment by telephone. She will repeat the 
PHQ-9 and conduct an assessment for Major Depression, manic episodes, alcohol abuse, substance abuse and 
psychotic disorders using the MINI (Mini-International Neuropsychiatric Interview). The clinical assessment will 
ensure that the participants are appropriate for a peer program in terms of depression severity and acute psychiatric 
symptoms. The clinical assessment will include history of present illness, psychiatric and medical history as well as 
psychosocial assessment for use by the social worker to provide relevant guidance to peer mentors during weekly 
supervision meetings. If the older adult is eligible after the clinical assessment, oral consent for participation in the 
study will be obtained and oral consent form will be mailed to the participant. After oral consent is obtained, the 
participants will undergo a baseline assessment. The assessment will consist of questions to obtain demographic 
information, medical use and depression care history as well as questionnaires to measure primary and secondary 
outcomes and mediators. Then the participants will be randomized to intervention or Social Interaction Control. The 
clinical and baseline data will be stored in a secure online Massachusetts General Hospital server that only study staff 
will be able to access.  
 
Randomization procedures. After a clinical and with informed consent, eligible clients will be randomized in a 1:1 
ratio, to receive either: (1) the Peer Enhanced Depression Care Program or (2) Social Interaction Control. We will 
use MS Excel VBA-based software developed by the study statistician to allocate participants using dynamic urn 
minimization to balance study arms by sex.(35) These procedures will maintain allocation concealment throughout 
the trial, consistent with the CONSORT recommendations.69 At the time of randomization, primary care physicians 
will be informed of the client’s assignment with consent of the participant.  
 
The intervention: PEERS. In our program trained and supervised older peer mentors with experiential knowledge 
of depression and self-care skills deliver depression care to low-income and minority older adults. The primary role 
of the peer mentors is to build relationship, provide emotional support, facilitate simple goal setting, share coping 
skills and depression self-care skills and connect to clinical and community resources for depression upon completion 
of the program. The program is relationship-based and takes an empowerment strategy to increase self-efficacy in 
depression self-care.(36) We use strategies to enhance cultural appropriateness of our program for minority and low-
income older adults such as avoiding stigmatizing clinical language about mental health, respecting non-medical self-

 
 
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care methods such as religious coping, taking a non-judgmental attitude, accommodating client preferences, being 
aware of the impact of hierarchy and power relations.(37) The peer mentor will be supervised by a licensed clinical 
social worker. 
 
Matching and scheduling of visits. Once the randomization has been completed, the older adults will be informed 
of their assignments. The social worker will call the peer mentors to provide contact information and brief summary 
of the older adult with whom they are matched. Then the peer mentors will contact the older adult and set a time and 
place for the meeting. Peer mentors will meet with older adults for 8 meetings weekly for 45 minutes to an hour each. 
Each meeting will be audio-recorded. Meetings will be by telephone. 
 
Supervisory role of the social worker. Supervision is important to sustain the quality of the program and to support 
peer mentors.(38, 39) For quality assurance, the social worker will contact the client by telephone after the 1st 
meeting with the peer mentor to assess any problems with the peer mentor or the content of the meetings during a 10-
minute call, document the content of the call and provide feedback to the peer mentor during supervision meetings. 
Peer mentors will meet by videoconference in groups of 2 on a weekly basis concurrent with meetings with clients 
for supervision, provided by two licensed clinical social workers with experience in mental health. During meetings, 
the social worker will elicit insights from peer mentors, discuss progress and problem-solve challenges e.g., lack of 
engagement and motivation. The supervision meetings will also allow the social worker to monitor the well-being of 
the peer mentor. The social worker will document the activities of supervisory meetings, maintain logs of peer 
meetings with clients, collect audio-recordings and questionnaires. A geriatric psychiatrist will be available for 
consultation to the social worker to problem–solve difficult situations. Peer mentors will have access to the social 
worker by telephone as needed outside of supervision meetings.  
 
Linkage to community-based resources. Study staff will develop a list of community-based organizations with 
relevant resources that the peer will give and encourage the older adult to use at the 8th meeting. For low-income 
older adults, access to social and material resources such as food pantries, senior centers and community clinics may 
be as important to address as the depression itself and ability to access such services may be an important part of self-
care for depression.(40) 
 
Referral to clinical care. The older adult 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 the older adult’s depression becomes severe (PHQ-9 > 15), the social worker will refer 
client to specialty mental health care services. If the client desires to continue to participate in the study, they will be 
allowed to do so. 
 
Inclusion/exclusion criteria for peers: Inclusion criteria: (1) 50 years and older, (2) history of depression, (3) at 
least 5 years in recovery, and (4) received basic training in behavioral health or have volunteer experience in mental 
health. Exclusion criteria: (1) meet current diagnostic criteria for Major Depressive Disorder; (2) meet current 
diagnostic criteria for a manic episode or a psychotic disorder; (3) meet current diagnostic criteria for substance 
abuse disorder.  
 
Inclusion/exclusion criteria for depressed older adults: Inclusion criteria are: (1) 50 years and older; (2) 
depressive symptoms with PHQ-9 scores > 5; (3) belong to an underserved population, defined as annual income less 
than 200% of the federal poverty level ($24,120) or self-identified ethnic minority; (5) able to communicate in 
English; and (6) 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, (6) a score on the Mini-Mental State Examination (MMSE) < 24.(41, 42) The 
Mini-Mental State Exam is a short standardized mental status examination that has been widely employed for clinical 
and research purposes for global assessment of cognitive functioning.(41) Clients who meet diagnostic criteria for 
severe depression, cognitive impairment, mania, hypomania, a psychotic disorder, or substance abuse or dependence 
will require clinical treatment. The research coordinator will also provide referrals for psychiatric care and list of 
community-based resources to the client. Eligible older adults will be scheduled for a clinical assessment. 
 
Comparison condition. This group will receive 8 weekly visits and phone calls by study staff that will consist of 
social interaction. The staff member will receive training and receive supervision from the PI. The purpose is to 
provide social interaction that does not focus on peer support for depression, goal-setting nor self-care skills. Study 

 
 
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staff will monitor for worsening depressive symptoms and the client will be referred to mental health services as 
appropriate. The telephone visits will be audio-recorded and feedback given during weekly team meetings where 
study processes and problems will be discussed.  
 
Implementation evaluation. Upon completion of the trial, we will collect implementation data of the Peer Program 
by conducting semi-structured interviews with diverse stakeholders representing multilevel perspectives upon 
completion of the trial. The purpose is to ensure that if the intervention is found to be efficacious, it can be 
successfully implemented in other non-research settings. Specifically, we will assess program fit, facilitators and 
barriers to implementation, and fidelity.  
 
Program fit & facilitators and barriers to implementation and scale-up: We will ask Advisory board members 
and our Baltimore Connect collaborators to refer organization staff whom we can interview by telephone. When 
referred, study staff will contact them and if interested in being interviewed, scheduling will take place. Prior to the 
interview, oral consent will be obtained. For stakeholders involved in healthcare, the PI who works in primary care 
clinics works with primary care providers, medical directors and administrators whom she will identify. Study staff 
will reach out by email or telephone and ask if they would be interested in being interviewed for our study. If 
interested an interview will be scheduled by telephone. Oral consent will be obtained prior the interview.  
 
We will identify and interview 1) older adult participants who complete the either the 8-week intervention or social 
interaction calls and 2) intervention staff e.g. peer mentors and social workers who participate in the study. The PI 
and trained team members will conduct semi-structured interviews lasting 30-45 minutes by telephone to obtain 
perspectives on topics described in Table 4 below. We will continue to conduct interviews until no new themes are 
presented. We will also conduct semi-structured interviews by telephone with community-based organization staff; 
Johns Hopkins Community Physicians (JHCP) providers and administrators to obtain feedback on intervention 
implementation and dissemination. Guided by the Consolidated Framework for Implementation Research (CFIR), 
they will be asked about the intervention on complexity, adaptability to local needs, relative advantage versus another 
type of intervention, and potential for sustainability. They will review the intervention and training materials to 
ensure that they can be readily implemented and sustained in their organization. Their insights will ensure that we 
develop a program that is beneficial to the target population as we prepare the intervention for future replication.  
 
Qualitative analytic strategy. The audio recordings of semi-structured interviews conducted with multiple 
stakeholders will be transcribed professionally. The transcripts will be analyzed using thematic analysis which is a 
flexible and commonly used approach in qualitative analysis. 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. To 
ensure trustworthiness, the PI and two 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. We will 
use 80% agreement as a benchmark for acceptable inter-rater reliability. Because we anticipate 10-15 different codes, 
we do not think it necessary to use a Kappa statistic to correct for chance agreement. The coding scheme will be 
revised to reflect their feedback prior to coding of the remainder of the transcripts. 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. Our advisory board will review and provide 
feedback on the coding scheme and study results. Qualitative data analytic software, NVIVO11, (QSR Intl, Durham 
UK) will be used. 
 
b. Study duration and number of study visits required of research participants. 
 
The study will be 18 months in duration. Research participants in the intervention will have a baseline, 8 meetings 
with the peer mentor, a post-study assessment and assessments at 3, 6, 9 and 12 months, for a total of 14 study visits. 
Participants in the control condition will have the same number of study visits. 
 
c. Blinding, including justification for blinding or not blinding the trial, if applicable. 
 
The person conducting the post-study assessment will be blinded. No other blinding is possible given the nature of 
the intervention.  
 

 
 
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d. Justification of why participants will not receive routine care or will have current therapy stopped. 
 
Patient will be free to obtain depression care outside of the study, as desired. 
 
e. Justification for inclusion of a placebo or non-treatment group. 
 
We will not use a placebo group. The control condition will consist of visits and phones by study staff to provide 
social interaction.   
 
f. Definition of treatment failure or participant removal criteria. 
 
If any participant experiences worsening of depression symptoms (eg. expression of suicidal ideation, worsening 
PHQ-9 scores that indicate severe depression) then the participant will be referred to professional mental health 
treatment. Typically, appointments with mental health providers are difficult to obtain immediately. If there is no 
objection from the participant, the peer will continue the weekly meetings with the participants while he/she waits for 
the appointment until they complete the 8 meetings.   
 
g. Description of what happens to participants receiving therapy when study ends or if a participant’s 
participation in the study ends prematurely. 
 
The peer mentor will be guided to anticipate the needs of the participant when the study ends. The peer and the 
participant will discuss community-based resources and study staff will also assist in linking the participant to both 
professional depression treatment/services. The same will occur if the participants ends the study prematurely. 
 
5. 
Drugs/ Substances/ Devices - NA 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
b. Justification and safety information if FDA approved drugs will be administered for non-FDA approved 
indications or if doses or routes of administration or participant populations are changed. 
c. Justification and safety information if non-FDA approved drugs without an IND will be administered.  
 

 
 
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Date: _May 20, 2020___________________    
Principal Investigator: __Jin Hui Joo_______________ 
 
 
6. 
Study Statistics 
a. Primary outcome variables 
 
Primary outcome: The primary outcome will be depression, measured by the Patient Health Questionnaire (PHQ-
9). A change of 5 points on the 0 to 27 point PHQ-9 scale corresponds to the minimal clinically important change for 
an individual.(34) Therefore, an improvement of 5 or more points on the PHQ-9 will be defined as response to the 
Peer Program. Studies with repeated PHQ-9 measures have shown that practice effects did not result in inability to 
detect changes in depressive symptoms even when depression was measured on a daily basis. (43, 44)  
 
b. Secondary outcome variables. 
 
Secondary outcomes will be engagement, coping, health service use, emotional, social and physical function. 
Engagement will be defined in two ways: 1) as attendance of 80% of meetings as reported by peer mentors (45) and 
2) score on the Working Alliance Inventory-SR, 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.(46, 47) Studies of working alliance typology has shown the sensitivity of this instrument in repeated 
assessments.(48) Service use will be measured with the Cornell Service Index, a questionnaire that includes use of 
both clinical and informal community-based health services and used in depression care studies among older 
adults.(49) Physical, social and emotional functioning will be assessed using the Medical Outcomes Short Form (SF-
36).(50, 51) Self-efficacy will be measured with the General Self Efficacy Scale, a 10-item scale validated for use in 
multicultural populations. (52) Loneliness will be measured with the R-UCLA loneliness scale, a commonly used, 
20-item, self-report questionnaire.(53) 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.(54)  
 
Covariates. We will obtain sociodemographic factors by self-report that will include age, education level, marital 
status, ethnicity, medical comorbidity, past and current depression treatment. We will use the Life Events 
Questionnaire to measures changes occurring in the past year and the impact of the event on a 4-point scale.(55, 56) 
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.(57) New uptake of depression care services such as professional 
counseling and antidepressant medications will be obtained by self-report at each meeting by the peer mentor to 
assess for service use during the intervention. These variables will be used to describe the sample, compare 
intervention and control groups and used as covariates in analyses. Health-related social determinants consisting of 5 
core components such as housing, food, transportation, utility needs, and safety will be measured with the 
Accountable Health Communities Core Health-Related Social Needs Screening Questions. (58) 
 
Primary analyses will be intention-to-treat. Descriptive statistics (e.g. frequencies, means, standard deviations, 
medians, interquartile ranges) and graphic displays will be generated for all study variables to  
ensure that distributional and other assumptions of the planned analyses are met. We will minimize missing data 
using our team’s documented retention strategies that have resulted in only 14% attrition.37 All primary analyses will 
be adjusted for sex, demographic factors, life events, medical comorbidity, and use of mental health services. 
Hypothesis tests will be two-sided with alpha=0.05.  
 

 
 
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c. Statistical plan including sample size justification and interim data analysis. 
 
Our primary study aim is to test the effects of the Peer Enhanced Depression Care Program for reducing 
depressive symptoms compared to Enhanced Usual Care. H1: Older adults randomized to the Peer Program (vs. 
control) will report decreased depression (PHQ-9 score decrease > 5) at 8 weeks, 3, 6, 9 and 12 months. To assess the 
immediate effects of treatment, we will fit a mixed effects model(59) with nested random effects for counselor and 
participant such that E[yij]=β0+β1tx+β2week+β3tx*week, adjusted for sex and other covariates (see 7.a.), where yij is 
the PHQ9 score for the ith individual at intervention week j, β2 is the rate of change in PHQ-9 for individuals 
randomized to EUC, and β3, the coefficient of interest, is the difference in rates of change in PHQ-9 between the Peer 
Program and Enhanced Usual Care study arms. To assess durability of the intervention effects, we will model PHQ-9 
at each post-intervention follow-up (months 3,6,9 and 12) using a time-averaged model, which adjusts for PHQ-9 at 
week 8 and models PHQ-9 scores at later time points as a function of treatment assignment. 
 
Sample size and power  
We calculated power to detect a difference in rate of PHQ-9 decline over the 8-week intervention period via 
simulation. Assuming 20% attrition, design effect of 1.2 (to account for clustering within peers (62) based on ICCs 
from pilot data), and regression parameters from our preliminary data (SD of random intercept: 2.83; SD of random 
errors:  0.11), with N=160, we would have 99% power to detect a difference in slope of 0.625, which corresponds to 
a between-group difference of 5 points on the PHQ-9 at 8 weeks. Similarly, we calculated power to detect a sustained 
post-intervention between-group difference. We will have 99% power to detect a sustained 5-point difference in 
PHQ-9 during that period.  
 
Data and safety monitoring plan  
We will have a Data and Safety Monitoring Board (DSMB) to monitor the study with an attendant monitoring plan 
that will involve interim analysis. We will provide descriptive data for the first 6 months after the first participant has 
enrolled in the study to review both the non-serious and serious adverse event rates. We will meet every 6 months 
and also meet on an ad hoc basis if the real time serious adverse events warrant meeting, in their judgment.  
 
d. Early stopping rules. 
 
At any time during the study, based on the findings of interim data analysis, the DSMB can put the study on either 
temporary hold or stop the study entirely after notifying the Principal Investigator and the IRB. In the unlikely case 
that results show that the intervention worsens depression, the study will be stopped. 
 
Table 3. Assessment schedule 
Variable 
Measure 
Timing of assessments 
 
 
0 
wk 
1 
wk 
2  
wk 
3 
wk 
4  
wk 
5  
wk 
6  
wk 
7 
wk 
8  
wk 
3 
mth 
6 
mth 
9 
mth 
12 
mth 
Sociodemographic factors 
Self-report 
x 
 
 
 
 
 
 
 
 
 
 
 
 
Depression (self-report) 
PHQ-9 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Depression (assessed by 
clinician) 
Mini-International Neuropsychiatric 
Interview (MINI) 
x 
 
 
 
 
 
 
 
x 
x 
x 
x 
x 
Client engagement 
At least 80% attendance of meetings, 
peer logs of meetings 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
 
 
Client engagement 
Working Alliance Inventory-SR 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
 
 
Physical, social and  
emotional function 
Medical Outcomes Study Short Form 36  
x 
 
 
 
 
 
 
 
x 
x 
x 
x 
x 
Self-efficacy 
General Self Efficacy Scale 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
x 
 
x 
Loneliness 
R-UCLA Loneliness Scale 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
x 
 
x 
Coping skills 
Brief Cope 
x 
 
 
 
 
 
 
 
x 
x 
x 
x 
x 
Medical comorbidity 
WHO WMH CIDI 
x 
 
 
 
 
 
 
 
x 
x 
x 
x 
x 
Clinical and community health 
service use 
Cornell Service Index 
x 
 
 
 
 
 
 
 
x 
x 
x 
x 
x 
New uptake of counseling  
and antidepressant 
Self-report  
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
 
 
Social determinants of Health 
Accountable Health Communities Core 
Health-Related Social Needs Screening 
Questions 
x 
 
 
 
 
 
 
 
x 
x 
x 
x 
x 

 
 
Page 11 of 16 
 
7. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency.  
 
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). The Principal Investigator’s experience as a researcher and 
psychiatrist has shown that when asking delicate questions and providing feedback on sensitive topics, the vast 
majority of participants have sufficient coping strategies to avert the extremes of behavior that put them at risk. 
Additionally, peer mentors are trained to be emotionally responsive with older adult participants to alleviate distress 
rather than increase distress. It is expected that older adults will feel relieved to meet with peer mentors who listen 
actively without being directive as has been our experience in the pilot study. We expect that the proposed study will 
provide older adult participants with benefits such as the discussion of psychological issues with the peer mentor that 
may offset the inconveniences or other consequences of participation.  
 
 
Expression of suicidal ideation is always a risk when working with depressed participants. We will have a protocol in 
place to evaluate and manage patients who express suicidal ideation. We believe the risk that patients will experience 
due to this intervention is very low and are further minimized by the procedures we put in place, such as initial 
clinical evaluation prior to being matched with a peer and regular monitoring for depressive symptoms. The peer 
mentor will receive supervision by a clinical social worker and consultation by a geriatric psychiatrist as needed and 
available at all times by telephone or pager. In the case that suicidal ideation is identified, a clinical intervention (see 
below).  
 
 
For peer mentors who have a history of depression (an inclusion criteria for the proposed pilot RCT), the risk of 
worsening mental health problems is possible because the peer role requires regular interaction with depressed older 
adults, which can be emotionally difficult. Peer mentors may become overwhelmed in their meetings with these 
clients. We have designed the study to minimize the risk to peer mentors (described below).  
 
b. Steps taken to minimize the risks. 
 
Undue emotional distress. Regarding undue emotional stress, peer mentors will be trained to recognize and provide 
support to manage undue emotional distress. Peer mentors will be trained to contact the social worker who will be 
available by telephone when emotional distress is extreme. A geriatric psychiatrist will be available in the case that 
the social worker is unable to manage the older adult’s distress. Multiple strategies will be used to prevent adverse 
events: 1) rigorous screening of the patient’s appropriateness for a peer mentoring program 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 social worker who 
will then speak with the older adult regarding the problem. In our experience, peers were able to detect signs in the 
older adult of escalating distress and they were able to follow the established protocol without adverse events.  
 
Suicidal ideation. When conducting studies with depressed patients, expression of suicidal ideation is a risk. We 
address this risk in multiple ways. We will conduct a clinical evaluation prior to matching to assess the older adult’s 
appropriateness for peer mentoring. 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 working with clients who express suicidal ideation and will be rigorously trained in the protocol to ensure 
the safety of the older adults. Peers will conduct the PHQ-9 with clients weekly. This questionnaires includes a 
question about presence of suicidal ideation. If the client expresses suicidal ideation during a meeting, the peer 
mentor will call the social worker who will manage the client.  
 
Assessment by the clinical social worker 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? Older adults may also be identified as a high risk for suicide if the older adult reports a specific plan to commit 
suicide, or if the older adult 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, 

 
 
Page 12 of 16 
 
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 social worker will ensure and facilitate urgent referral, 
transfer, or escort of high risk patients to the Emergency Department near their home where an evaluation to assess 
need for treatment will be 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 older adult) did arise, 
the trained peer mentor contacted the PI who spoke with the client and managed the situation without adverse events. 
 
Support for peer mentors. We also will take precautions to decrease risk of emotional distress for peer mentors. 
These precautions include the following: 1) enroll peer mentors who have 5 or more years in recovery, 2) provide 
regular weekly supervision and monitor the health of the peers, and 3) encourage mutual support among peer mentors 
in the study. We will aim to recruit peer mentors who are at low risk of relapse, which we will be determined by 
length of time in recovery and level of function, such as ability to volunteer, engage in community activities or paid 
employment. Training will reinforce that peer mentors are not clinicians, are not expected to be clinically responsible 
for depressed older adults, and that their role is one of informal psychosocial support. The social worker who is the 
supervising mental health professional will regularly monitor the peer mentor’s emotional well-being and address 
any signs of distress. If any peer mentor expresses emotional distress or the social worker detects signs during 
supervisory meetings such as irregular attendance and role performance, the social worker will discuss and provide 
support to the peer mentor. If the peer mentor experiences depression that rises to the level of clinical depression, the 
social worker will ensure that the peer is receiving clinical care, will discuss with the peer whether continued 
participation in the study is feasible and may conclude that a peer’s participation in the study should be suspended 
until the peer’s depression is no longer clinically significant.  
 
The approach of the supervising professional will be to accommodate the needs of peer mentors in their role, e.g. 
Non-clinical, psychosocial support role. Supervisory meetings will also encourage mutual support among peer 
mentors in the study. Finally, qualitative studies of peers suggest that peers benefit positively from being in a helping 
role, despite concerns about increased vulnerability. We interviewed peer mentors in our preliminary work (pilot 
study) in which they interacted with depressed older adults, and peer mentors stated that working in a role to help 
others who are struggling with depression gave their lives purpose, gave them opportunities for continued learning, 
and contributed to sustaining their own recovery. Our experience is based on a small number of peer mentors but is 
supported by studies that have shown the benefits of being in helping roles. Peer mentors will be trained to report any 
expression of self-harm immediately to the Program Coordinator who will enlist the Social Worker and Geriatric 
Psychiatrist as needed. 
 
c. Plan for reporting unanticipated problems or study deviations. 
 
Although we are not studying experimental drugs, the intervention is experimental with the attendant risks. To 
address this, we will have a Data and Safety Monitoring Board (DSMB) to monitor the study with an attendant 
monitoring plan. The role of the DSMB will be to ensure that no unexpected, untoward consequences of the 
experimental intervention occur, and if they do, to implement safeguards to decrease or eliminate future risks. 
Although the risk is low, the Peer Program could induce emotional distress associated with discussion of past trauma 
or current stressors. We will include as serious adverse events acts of suicide or attempted suicide and threats of 
violence or violence toward the research team, providers or outside personal contacts. Any adverse events related to 
behavior will be provided to the DSMB in real time. These adverse events include, but are not limited to, suicidality, 
homicidality, or inappropriate or threatening behavior with the research or clinical staff. Less serious adverse events 
related to the treatment of depression will be compiled and summarized for the DSMB at their scheduled meetings. 
All other severe adverse events in participants will be monitored by the Principal Investigator, the Study Coordinator, 
and the Social Workers and will be reported to the DSMB regardless of a priori expectation or investigator 
assessment of likelihood of the study being the cause of the adverse event.  
 
The DSMB will also have the power to request further data (e.g. depression outcome data) from the Principal 
Investigator based on any concerns that may be raised in the ongoing investigation in the scientific community. 
Interim analyses will be performed and compiled for review by the DSMB. At any time during the study, based on its 
findings, the DSMB can put the study on either temporary hold or stop the study entirely after notifying the Principal 
Investigator and the IRB. In the rare case in which they have to do so, the DSMB will generate a formal report to the 
Principal Investigator, the sponsor (NIMH), and the IRB. This report would then be modified for a lay reader, a 

 
 
Page 13 of 16 
 
version for past participants and current participants would be produced, and the letter would be sent to all past and 
current study participants and their referring providers. 
 
The DSMB will first meet 6 months after the first participant is enrolled to review both the non-serious and serious 
adverse event rates. They will meet annually and also meet on an ad hoc basis if the real time serious adverse events 
warrant meeting, in their judgment. The format of the meeting will include a presentation of the summarized data by 
the Principal Investigator and the Biostatistician. The absolute rates of adverse events as well as the rate compared 
between the intervention and control groups will be presented. After presentation by the study team, the DSMB will 
be left to confer alone. If deemed to be warranted, as described above, the DSMB can request a temporary hold be 
placed on the study until further data are reviewed.  
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
 
For older adult 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 will 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) Older adult participants will be informed that absolute confidentiality 
cannot be guaranteed but study staff will put rigorous procedures in place. In our experience, there were no known 
breaches of confidentiality in our pilot study, older adults 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 locked files that only staff associated with the study can access. These 
records will be protected by the confidentiality system of Massachusetts General Hospital and will not be disclosed 
except as required by law. Audio recordings will be saved in Massachusetts General Hospital OneDrive. 
 
e. Financial risks to the participants. 
 
There are no costs to the participant associated with the study and we do not foresee financial risks to them.  
 
8. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
 
The proposed study may benefit the older adult participants in terms of psychoeducation and self-care skills 
associated with depression, monitoring of symptoms and services delivered by a peer mentor who is under a mental 
health professional’s supervision. The peer may benefit from increased sense of self-efficacy in helping another 
person and will 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 older adults will be established. The risks to the patient for participating in this project are minimal and the 
possibility of improving depression care is substantial. 
 
A.4. Importance of knowledge to be gained 
This research will inform the development of peer programs whose aim is to improve access and engagement of 
depression care among minority and low-income populations. Given that minority older adults receive inadequate or 
no mental health care and are less likely to access traditional mental health services, developing new methods of 
delivering depression care is important.  
 
9. 
Payment and Remuneration 
a. 
Detail compensation for participants including possible total compensation, proposed bonus, and any 
proposed reductions or penalties for not completing the protocol. 
 
Peer mentors - Each peer will participate in 20 hours of training conducted by the PI and also meet weekly for 
supervision with the social worker for each contact hour with the client. Peer mentors will be paid $100 for attending 
20 hours of training. They will be only be paid if training is completed and they are successfully matched with at 

 
 
Page 14 of 16 
 
least 1 depressed older adult participant. Peer mentors will be also paid a total of $50 for 1 meeting with a client and 
1 supervision meeting. For each older adult who will receive 8 meetings with the peer, peer mentors will receive 
$400. They will receive an additional $20 for a post-study interview.  
 
Older adult incentives - Participants will be given a token of appreciation of $30 with for one (1) baseline assessment 
meeting, 8 week assessment, 3, 6, 9 and 12 month follow up assessments for total of 6 assessments for a total $180. 
 
Participant incentives for interviews: Each participant will be given $50 per interview. We will conduct individual 
interviews with approximately 20 older adults, 2 social workers, 10 peer mentors, 20 community organization staff, 
20 primary care staff and 10 health system administrators.  
 
10. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify who will 
pay for them. NA 
 
 
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