Building Community Capacity for Disability Prevention for Minority Elders - Renewal
Phase: NA
Conditions: Depression, Anxiety, Physical Disability
Sponsor: Massachusetts General Hospital

Positive Minds Strong Bodies Implementation (PMSB-E) 
NCT04545593   
 
Principal Investigator: Margarita Alegria, PhD 
Protocol Title: Positive Minds Strong Bodies Implementation 
Funding: National Institute on Aging and the National Institute of Mental Health R01AG046149 
Grant title: Building Community Capacity for Disability Prevention for Minority Elders (Renewal) 
Version Date: 7/24/25 
 
 

Trial Protocol 
 
Note: This online supplement presents the Trial Protocol as it was written just prior to the onset of the 
recruitment process and hence many sentences are written in the future tense.  
 
Principal/Overall Investigator: Margarita Alegria, PhD 
Protocol Title: Positive Minds Strong Bodies Implementation 
Funding: National Institute on Aging and the National Institute of Mental Health R01AG046149 
Version Date: 7/24/25 
 
Background and Significance 
 
By 2030, the US population of older adults (65+) is projected to increase to 72.1 million.1 Nearly one in 
five will suffer from mental health and/or substance use conditions,2 with mood disorders being the most 
significant source of emotional distress,3 and will be at risk for mental and/or physical disability.4 Older 
adults are also becoming more diverse, with more than one-fourth of older adults expected to belong to a 
racial/ethnic minority group by 2030.5 Minority older adults are at a greater risk for severity, persistence, 
and recurrence of psychiatric disorders. Yet, minority older adults have less access to mental health care6-8 
and disability prevention than non-Hispanic Whites. Minority older adults with mental health problems 
and at risk of disability may not access clinical services due to stigma9 and self-reliance,10,11 limited 
English proficiency,12 undocumented status, and lack of recognition13 of their mood symptoms. 
Furthermore, recognition of mental health problems does not result in increased help-seeking among older 
adults.14,15 Despite the great need, 90% of older adults with mental health conditions receive no mental 
health treatment and no disability prevention services. This is in part due to workforce shortages of 
healthcare professionals,16 particularly for serving racial/ethnic and linguistic minorities in either clinical 
or community settings. This represents a missed opportunity, given that mood disorder treatment has been 
shown to reduce disability days by 40%-45% in those with severe to moderate depression.17 Furthermore, 
the prevalence of impairments and frailty in older adults can be significantly reduced after participation in 
physical activity programs. 
 
Previous pre-clinical or clinical studies leading up to and supporting the proposed research 
 
At the time of original submission of this protocol, our team was completing the Positive Minds Strong 
Bodies study, testing the effectiveness of the Positive Minds (10 sessions of individual psychoeducation 
and activities adapted from CBT) and Strong Bodies (24 sessions of exercise provided over 14 weeks) 
interventions (PMSB). PMSB was administered to minority older adults ages 60+ by a community health 
worker (Positive Minds) and an exercise trainer (Strong Bodies). The interventions have been delivered in 
English, Spanish, Mandarin, and Cantonese, yielding a unique program to address the unmet needs of 
linguistic minority older adults in geographic areas within diverse settings. Preliminary results show 
much promise. The current project incorporates critical adaptations to yield an enhanced intervention, 
PMSB-E, that improves upon therapeutic strategies, facilitates the work of CHWs, and incorporates 
ongoing group sessions in mental health and disability prevention to maintain gains. 
 
To address disparities and prevent disability among minority older adults, we proposed a renewal grant of 
our NIA/NIMH-funded project, “Building Community Capacity for Disability Prevention for Minority 
Elders” (R01AG046149), ending in April 2019. The current grant tests the effectiveness of an Enhanced 
Positive Minds-Strong Bodies intervention (PMSB-E) in preventing disability. More importantly, we hope 
to transfer what seems to be an effective intervention into a product ready for implementation in low-
resource community settings. The renewal grant tests: 1) a streamlined PMSB-E intervention, to increase 
effectiveness by augmenting adherence and enabling a stronger and lasting effect on outcomes; 2) 
implementation readiness, evaluating issues such as feasibility, planned adoption, and potential barriers to 

sustainability; and 3) a dissemination toolkit to facilitate uptake in new agencies with similar interests in 
disability prevention. 
 
We have received two research supplements to this grant and a diversity supplement. One expands the 
sample to 450 enrolled participants, 1/3 non-Latino Black, 1/3 Asian, and 1/3 Latino. The second 
addresses the COVID-19 pandemic, to assess the impact of the COVID-19 pandemic on stressors and 
responses to public health interventions (i.e. confinement, social distancing and isolation, mass 
communications, testing, intention to vaccinate and contact tracing) among ethnic/racial minority older 
adults in the new trial as well as the original trial. (We note that the supplement will also work with older 
adults from the original PMSB trial to understand whether the intervention shows a trend of reducing 
mortality in participants in the original intervention and potentially mitigates effects in reducing mental 
health symptoms. We will amend that protocol accordingly. For the purposes of publishing this protocol 
for the study’s primary outcomes, we will not include the details of the diversity supplement, which is not 
included in the main paper. 
 
I. 
Rationale behind the proposed research, and potential benefits to patients and/or society 
 
This study aims to address service disparities and prevent disability among minority older adults through 
collaborative research for the provision of evidence-based mental health and disability prevention 
interventions in community-based organizations. 
 
The combined Positive Minds-Strong Bodies (PMSB) intervention model provides an ideal opportunity to 
improve physical and mental health outcomes for minority older adults. For this renewal, we made 
important adaptations to yield an Enhanced PMSB, intended to facilitate easier adoption at the 
organizational level, mental health symptom reduction beyond 6 months, and greater adherence to 
exercise components. 
 
Few studies focus on adaptations for feasibility and sustainability of health service innovations,34,35 
resulting in an expansive literature filled with “effective” psycho-social treatments that never get adopted. 
Sorting out the factors that enhance or challenge feasibility and sustainability in CBOs and clinics can 
facilitate the adoption of health service innovations.36 We define feasibility as the degree of ease/burden 
associated with CHWs/Exercise Trainers' use, the resource requirements, and risks seen as acceptable; 
and sustainability as the continuation of an innovation within an organization or clinic.36,37 We propose to 
expand our work from the original grant to focus on capacity building for the sustainable delivery of 
disability prevention services in CBOs and clinics. 
 
Fostering clinical competency among lay personnel within CBOs and community clinics is a promising 
model for reducing service disparities. The number of mental health and rehabilitative professionals in 
communities of color is inadequate, and the availability of primary care providers is seriously limited.39,40 
The Affordable Care Act recognizes the importance of CHWs in improving health care access, outcomes, 
and quality of life.41 International data demonstrates significant decreases in depression and disability 
over one year of using CHWs to offer treatment, and U.S. evaluations of CHWs’ efficacy in providing 
mental health and disability prevention interventions remain limited but promising.42,43,44-46 Our study can 
help determine whether a CHW/trainer-administered intervention is ready for broad-scale 
implementation. In Aim 3, we propose identifying aspects to accelerate implementation and scalability if 
the PMSB-E continues to prove feasible, effective, and sustainable. We will create and test the utility of a 
multimedia toolkit approach for dissemination, which incorporates guidelines, videos, and materials for 
fast implementation of the PMSB-E. 
 
Specific Aims 
 

The current protocol only refers to Aims 1 and 2 of our grant application. We will include subsequent 
Aims of dissemination and implementation of the study if they include human subjects research per IRB 
request at a future date. 
 
Our specific aims are to: 
 
Aim 1: Evaluate the acceptability, effectiveness, and twelve-month sustainability of the Enhanced 
Positive Minds-Strong Bodies intervention offered by CHWs and Exercise Trainers in CBOs and 
community clinics. 
 
Aim 2: Assess implementation readiness of the Enhanced PMSB (PMSB-E) intervention by 
evaluating factors associated with acceptability, feasibility, adoption, and sustainability. 
 
We divide the description of the Detailed Protocol by Aim: 
 
AIM 1 
 
Subject Selection: To identify the population in need, CHWs will screen 1800 participants over years 1-
4, to enroll approximately 495 eligible participants (only 25-30% will be eligible). With attrition, we 
expect at least 450 participants to participate in the trial (225 intervention participants and 225 enhanced 
control participants), of which about 1/3 will be Latino, 1/3 non-Latino Blacks, and 1/3 Asian. 
 
Inclusion Criteria: Latino, Asian or Black (African American or Afro-Caribbean) or non-Latino White 
older adults 60+ years of age with mild, moderate, or severe depressive (PHQ-9>5 or GDS-15>5)83 or 
anxiety symptoms (GAI >8),77,84 and without any specialty mental health care in the past 3 months. We 
selected a score of PHQ-9 >5, allowing for a wide range of severity, as this preventive intervention could 
impact the avoidance of disability. Fulfilling rigorous diagnostic criteria for mood disorders is relatively 
rare in late life.85 Participants using antidepressants will be included, and medications will be recorded 
and used as a covariate. We will also include community-dwelling participants with scores between 3 and 
11 on the SPPB82 who have some mobility limitations but are not home-bound.86 We used the virtual 
SPPB (vSPPB) in 3.7% of participants who had concerns about in-person activities during the early 
months of the COVID-19 pandemic. Given the high numbers of vaccinations in older adults and the 
success of our testing of the in-person SPPB, we returned to using the in-person SPPB for eligibility for 
the majority of participants (96.3%). 
 
Exclusion Criteria: Participants will be excluded if there is evidence of: 1) current or last 3 months use 
of specialty mental health treatment, 2) evidence that patient cannot consent or is cognitively impaired;87 
and 3) current suicidal risk (‘yes’ to items 4 or 5 on the Paykel suicide scale),88 whereby participants will 
be connected to an emergency services provider or specialty provider based on CBO/clinic preferences, 
and following a study emergency protocol. Exclusion from Strong Bodies will also happen if a participant 
is physically unstable, has an acute or an exacerbation of a chronic disease, or a neuromusculoskeletal 
impairment, or cannot commit to 2 sessions weekly.  
 
During the COVID pandemic, we assessed this by: a total sum score ≥5 on the SARC-F; or an indication 
that the doctor told them not to exercise because of a medical condition or recent hospitalization. Suppose 
a participant is only ineligible because of the SARC-F and has a score on the borderline of eligibility (5 or 
6). In that case, we will request to check with their primary care provider (PCP) whether they could 
provide medical clearance for participation. We would also do this for participants scoring 2 on the 
vSPPB. This would involve asking the participant whether we can check with their PCP and sending the 
PCP a communication via Epic (if MGB) or phone or fax for non-MGH. We used a medical clearance 

form with the info explained to the PCP as requested. Participants who are only administered the SPPB in 
person would be excluded with a score of 1, 2, or 12.  
 
As of 4/2022 given the status of in-person activities during the pandemic, we are updating our exclusion 
criteria for the study. We are making efforts to conduct an in-person SPPB physical health screening for 
all potential participants. Accordingly, we would like to remove the requirement of the SARC-F as part of 
eligibility for the trial, including removing the related medical clearance. We incorporated the SARC-F 
when we could not do the in-person SPPB physical health assessment with potentially eligible 
participants. However, we will continue to administer the SARC-F. If a participant refuses to participate 
in the in-person SPPB, we will administer the SPPB via Zoom and consult with our exercise intervention 
expert on whether the case can be considered for eligibility. 
 
Study Design 
 
To test the Enhanced Positive Minds-Strong Bodies intervention with minority older adults with elevated 
mood symptoms and risk for disability, eligible participants will be randomized after baseline to either the 
enhanced intervention or an enhanced usual care group. Randomization will be stratified by site using a 
computer-generated block randomization scheme with a block size of 2 (NQuery software). Primary 
outcomes are: acceptability (>70% of participants attending >50% of their intervention sessions, reporting 
satisfaction with treatment) and effectiveness (whether the intervention [1] significantly decreases 
depressive and anxiety symptoms from baseline as measured by the Hopkins Symptom Checklist [HSCL-
25], a widely used measure of depression and anxiety in clinical monitoring and outcome assessment; [2] 
increases physical functioning objectively measured using the Short Physical Performance Battery 
[SPPB]; and [3] increases self-reported physical functioning using the function component of the Late 
Life Function and Disability Instrument [Late-Life FDI]). We will also test the moderating effects of 
sociocultural (e.g., SES, race/ethnicity, language, time in residency among immigrants) and clinical 
factors (e.g., baseline PHQ-9, functional impairment, and antidepressant use). To address concerns about 
in-person activities due to COVID-19, we temporarily used a virtual version of the SPPB (Marsh et al., 
2015), set up locally for our team. This will be used for screening and follow-up assessment evaluation. 
 
Recruitment Strategy 
 
We will conduct the PMSB-E intervention in collaboration with CBOs and clinics serving Latino, Black, 
and Asian older adults. Partner selection was based on 3 criteria: 1) community agencies and clinics that 
serve large numbers of racial/ethnic and linguistic minority older adults; 2) availability of older adults 
service programs; and 3) interest in introducing evidence-based practices in their service delivery. As the 
trial progressed we included both cede review sites and multiple sites not engaged in human subjects 
research. For confidentiality, we do not include these in the published protocol. 
 
We will include as participants in the project individuals who are not only patients or clients of the 
participating clinics or community-based organizations (CBOs), but who have been made aware of the 
project in the community or by other participants. Specifically, our collaborating clinics/CBOs have staff 
who do outreach in the community and might identify interested participants. In other cases, a participant 
might mention the study to a friend or acquaintance interested in being screened. We want to allow these 
participants to similarly be part of the trial. We took a very similar approach in our previously approved 
protocols. Similarly, we have also spoken with networks of sites that work on behalf of older adults, some 
of whom are happy to email the flyer to their networks of individuals and organizations. We do not 
consider these outreach efforts as new 'sites' but will screen potential participants who call or contact us as 
interested. We will include the distribution of flyers to older adults taking part in activities such as food 
distribution in the park. 
 

During the pandemic, the study was only conducted virtually, by phone, or via Zoom. As such, it could 
expand access to individuals who may not be directly connected to a clinic or CBO. We want individuals 
to contact study staff and self-refer if they hear about the program outside of a specific clinical or 
organizational visit. For instance, if a research team member discusses the study at a media or public 
event, and an individual hears about it and contacts the research staff, that participant could be screened. 
A participant could refer a friend, family member, or other individual to participate. We will also accept 
other potential participants who are not affiliated with a participating site or referred by a current 
participant, but who might be known to our CHWs or staff from their connections or communities. We 
would conduct screening in the same fashion as typically done. 
 
Drawing on discussions with MGH clinic medical directors and staff, we would provide access for our 
project coordinator to Epic to communicate with providers through Epic in-basket messaging. This secure 
form of communication would be helpful to providers when sending patient referrals to our team. 
 
As we have done in previous studies, at MGH clinics, we would also like to use the RPDR registry to 
identify potential participants (with identifying information) to contact and screen. We would request that 
participants who fulfill specific criteria (i.e.,≥60 years) be determined. Once we receive eligible 
participant information, we will collaborate with the Medical Director and clinicians at the site to have a 
letter co-signed by the study PI and the participant’s provider, inviting the participant to learn more about 
the study and to be screened. As we did in our previous study, we will contact participants by phone after 
sending a letter from the clinic director inviting them to participate. We would also allow community or 
clinical sites to contact their clients directly by telephone or let them know that our study team will 
contact them to introduce the study. This would be an alternative to sending the letter. This would allow 
staff to provide us with a list of participants from their site that our study staff can contact to describe the 
study, consent, and screen for participation. 
 
The COVID-19 crisis has affected the ability of trials like this one to operate in person. We are including 
our regular in-person consent and screening plans and a virtual alternative that we have successfully 
utilized in another clinical trial. 
 
We want to offer the interviews and intervention in person, in some instances where the participant and 
staff feel comfortable. We will also maintain our remote recruitment and sessions but will allow this as an 
option. Certain participants indicated that they would only feel comfortable participating in person, given 
their lack of comfort with using Zoom or other options that rely on technology. We will allow this on a 
case-by-case basis. Staff and participants should wear masks and maintain social distancing as much as 
possible. This will also provide the opportunity to offer the SPPB assessment in person as a test against 
the virtual option. Based on the test of this option, the SPPB in person is a better option in the future. It is 
done either in participants’ homes or in one of the study sites. 
 
Consent and Screening 
 
In person 
 
Clinical Research Coordinators (CRCs), Research Assistants (RAs), and/or Community Health Workers 
(CHWs) will work closely with clinical providers or community organization staff to identify potential 
participants who may be approached for a screening. Depending on clinic preferences, CRCs, RAs, and 
CHWs may approach any individual waiting in the community site or clinic. Recruitment will occur while 
the participants are at the CBO for regular programming. The research staff (i.e., CRCs, RAs, CHWs) will 
introduce themselves and explain that they would like to discuss a new study being implemented. After 
introducing themselves and briefly describing the program to the participant, the CRC/RA/CHW and 
potential participant will move to a private room for verbal consent administration. These research staff, 

hired either by MGH or the collaborating CBOs and familiar with the CBO and the clients who attend the 
CBO, will administer the informed consent form in the participant's preferred language (English, Spanish, 
Mandarin, or Cantonese). Participants’ rights and precautions for data safety and protection of 
confidential information will be clearly explained. Consent forms will be tailored to low-literacy 
participants. The CRC/RA/CHW will read the form aloud if a participant is not literate. During the 
consent process, the CRC/RA/CHW will obtain participant consent to contact emergency or primary care 
providers if the participant endorses harmful thoughts or behaviors or reports medical side effects of their 
medication that require care by the primary care physician (PCP) or emergency health services. 
Participants who are actively suicidal at the time of screening will not be included in the intervention but 
will be re-contacted 30 days after the initial screening to reassess if the participant remains ineligible for 
enrollment in the study. Suppose the potential participant is eligible as determined by the screener and 
willing to participate in the intervention/usual care. In that case, the CRC/RA/CHW will administer a 
capacity to consent form (based on Zayas et al, 2005). Participants who are eligible as determined from 
the screener, pass the Capacity to Consent, and are interested and available to participate in the study will 
then be enrolled. The CRC/RA/CHW will administer the baseline interview. For a small proportion of 
participants who are not eligible, we will administer the baseline interview and provide them with the 
incentive. This is to ensure that our screener accurately identifies positive cases.  
 
In some sites, we will collaborate with community-based organization staff or the Medical Director and 
clinicians to identify potential participants who might be interested in being screened. We will send a 
letter cosigned by the PI and community-based staff or clinical staff to invite them to participate in the 
study and to let them know we will be calling to assess interest. The study flyer will be attached to the 
letter. The CRC/RA/CHW will meet the participants in person to administer informed consent, ask them 
to review the Informed Consent Form, provide verbal consent if they are interested and available to 
participate in the study, and conduct the screening. We will not record the full consent administration; 
however, we will audio-record the participant’s study ID, and ask them to confirm verbally that they 
reviewed the informed consent form and text messaging consent form with the research staff by phone, 
and that they consent to participate in and receive text messages from the study. The CRC/RA/CHW will 
administer the Capacity to Consent form if eligible. If the potential participant passes the Capacity to 
Consent, the participant will be enrolled in the study, and the CRC/RA/CHW will then schedule the 
baseline assessment. 
 
We are including a decline form for participants who do not wish to be screened. If they allow us, we will 
ask these questions to participants in the waiting room or elsewhere who do not wish to participate. If 
they do not want to answer the demographic questions, we will only ask the reason for not participating. 
This will help us to understand how best to target the program. 
 
In-person events 
 
For older adults at Community-Based Organizations, Housing Facilities, Senior Centers, and other 
locations, in-person group events are an opportunity to present the program and engage individuals in a 
trusted group setting. Study staff will work with site leaders or collaborators at the individual study sites 
to set up group meetings, using study flyers as promotional tools. On the day of the event, research staff 
would meet with the group attending to give an overview of information related to mental health and 
disability prevention pertinent to the study. The research staff would then review with the group the 
information found in the Informed Consent (PI, Benefits, risks, Study Structure, PCP, risk, text messages, 
etc). They would pause regularly to ask questions from group members and clarify these continuously. 
After reviewing the informed consent in the group and responding to questions, they will go around to 
individuals attending to assess interest. If someone is interested, then staff will talk with them 
individually, to ask if there are any questions and review any specific areas of the informed consent they 
request to clarify or have questions about. As this study is approved for verbal consent, research staff will 

audio record the participant’s response to individual questions to provide consent. As time permits, staff 
will conduct the in-person SPPB segment of the screener and follow up by telephone for the additional 
screening pieces for participants who consent. If an individual is eligible, before enrollment and 
randomization, each participant will also be administered the capacity to consent question that we use to 
ensure they understand the consent materials. 
 
Virtual 
 
Given the current public health concern surrounding the coronavirus, we will provide the option of 
continuing our recruitment by phone. In particular, we will adjust our protocol to allow audiotaped, 
phone-based informed consent. We will work with community/clinical staff to identify potential 
participants willing to be screened. The organizational/clinic staff will talk to the participant to let them 
know that a research staff member will contact them. If a call is impossible, we will send the letter 
described above.  
 
Rather than scheduling an appointment to conduct the consent and screening in person in the clinic or 
community site with an interested patient, we will allow research staff to administer the next steps 
virtually. If the potential participant expresses interest, then the CRC/RA/CHW will proceed to review the 
full informed consent and text messaging consent with the participants by phone. We note here that if 
potential participants share their email addresses with the CRC/RA/CHW and want to review a copy of 
the informed consent, we will email them. We will not record the full consent administration; however, 
we will audio-record the participant’s study ID, and ask them to confirm verbally that they reviewed the 
informed consent form and text messaging consent form with the research staff by phone, and that they 
consent to participate in and receive text messages from the study. A CRC/RA/CHW will proceed to 
administer the screener to participants who provide verbal consent to participate in the study. A 
CRC/RA/CHW will administer the Capacity to Consent to eligible participants, as the screener 
determines. We will mail gift cards to participants who complete the screener. If the potential participant 
passes the Capacity to Consent, the participant will be enrolled in the study. 
 
We will maintain in shared folders an Excel tracking form with information about the verbal consent 
process for such participants, the date the consent was obtained verbally, and the response of the 
participant to the subsequent informed consent form questions regarding sharing info with the PCP and 
related to referrals.  
 
For participants who consent to receive text messages for the Positive Minds Strong Bodies study, we will 
invite them to receive the assessment scales via text message during the screener, baseline, and follow-up 
assessments to streamline the administration of the questionnaire sets. For participants who consent to 
receive text messages but are not interested in receiving the screener scales, the interview will proceed 
with the interviewer reading the scale for each question. 
 
For those participants who consent to receive text messages for the Positive Minds Strong Bodies 
Implementation study, we will allow them to text program staff to discuss availability and to schedule 
appointments. This will facilitate communication with participants and ensure they can communicate 
confidentially. We will inform participants during the consent process that we will only respond to text 
messages during business hours about scheduling appointments and that they should use 9-1-1 for 
emergencies. 
 
CRCs/RAs/CHWs will administer the baseline interview. Once the baseline interview is complete, the 
CRC/RA/CHW will contact the Project Director, who will then randomize the participant. The project 
director will assign participants randomized to the intervention group to a CHW at the participant’s CBO, 
and the CHW will call the participant to schedule an initial session. The project director will also inform 

the exercise trainer, who will contact the participant to schedule the first exercise session. CHWs will 
conduct a welcome session to introduce participants to the program and provide a manual with 
educational and exercise materials. Although we can perform many parts of the project via HIPAA-
compliant Zoom or telephone, we will set up safety accommodations for in-person activities. We will 
encourage intervention participants to have their first session in person, to create a relationship, and to set 
up Zoom for psychosocial and exercise components. We will also consider the need to meet in person if 
screening and assessment of the exercise component are challenging for participants to conduct remotely. 
Staff who visit participants in their homes will be equipped with PPE to make this session as safe as 
possible, given concerns of COVID-19 transmission. 
 
The CHW will use sessions adapted from CBT and motivational enhancement to engage the participant. 
Every other week, the CHW will evaluate the participant with the PROMIS and the 5-item suicide 
questionnaire for participant safety and to ensure that mental health is not deteriorating to the point where 
immediate intervention or referral is necessary (for intervention and usual care). Sessions will continue 
until 10 sessions or 6 months have passed. Participants will also be offered 24 Strong Bodies exercise 
sessions, each lasting 45-60 minutes, with 2-8 older adults per group. The project director will contact 
participants randomized to the usual care group to inform them that they have been randomized to this 
group, and that they will be contacted by phone by research staff 4 times over 6 months to assess any 
severe symptomology with PROMIS and the 5-item suicide questionnaire and to provide empathic 
support. 
 
CRCs/RAs blinded to group assignment will administer the measures at baseline, 3 months, 6 months, 
and 12 months after baseline. Our original selection of measures was based on brevity of measures, 
established usage in our previous trial to allow for comparisons, presence of domains with face validity 
for minority populations, and valid psychometric properties. These measures have been translated, 
piloted, and/or adapted for use among Spanish-speaking and Chinese-speaking populations by our team 
91 and tested in the original project, and by other investigators using state-of-the-art methods for cross-
cultural adaptation and translation.92,93 
 
The flow of the intervention enrollment and activities would thus be as follows: 
 
• 
Screening 
o If eligible, a $10 gift card for completing the screening 
o If not eligible - $10 gift card for completing the screening 
o If ineligible only due to the endorsement of active suicidality on the Paykel Suicide Risk 
Questionnaire (Item 4 and/or 5) 
▪ 
Potential participants will be contacted 30 days after the initial screening to be 
reassessed for eligibility  
• 
Baseline interview scheduled for consented participants, compensated with a $60 gift card 
o If active suicidality is not endorsed on the Paykel Suicide Risk Questionnaire (Item 4 
and/or 5) 
▪ 
A potential participant can proceed to be enrolled in the study 
o If active suicidality is endorsed on the Paykel Suicide Risk Questionnaire (Item 4 and/or 
5) 
▪ 
Potential participants will be contacted 30 days after the initial baseline interview 
to be reassessed with the Paykel Suicide Risk Questionnaire 
• 
Randomization by the project director 
• 
Intervention and Control participants contacted by CRC/RA to conduct interviews at 3 months, 6 
months, and 12 months 
 

At the patient level, we assess the acceptability of the intervention based on the percentage of participants 
attending ≥50% of their intervention sessions. We obtained information from participants during the 6 and 
12-month intervention assessment to see if they reported benefiting from the intervention (patient’s 
satisfaction). At the provider or staff level, we examine CHW implementation of the intervention, 
including fidelity (defined as 70% fidelity to the intervention based on review of a random 15% of CHW 
audio recordings, CHW fidelity checklist, and review of CHW logs). 
 
We anticipate enrolling all trial cases by the end of Year 4 and completing all assessment interviews by 
the first 6 months of Year 5. 
 
We want to send appointment reminders by text message to participants enrolled in the clinical trial. We 
would use an encrypted cellphone and ask participants to complete a text message consent. 
 
We use Zoom for video calls with participants in the intervention sessions or for assessments. This was a 
more personal alternative to phone calls. We selected Zoom because it has already been vetted and is a 
technology approved for patient use. Additionally, we request that we use Zoom to record a random 
sample of exercise sessions, given that we will need to video record sessions to evaluate fidelity to the 
Strong Bodies intervention. 
 
We will share Zoom video recordings with the exercise supervisor at UPR, who will evaluate fidelity for 
these cases. We will share videos through a HIPAA-compliant Dropbox or secure MGH server. We may 
also facilitate video sharing using these methods for other participating sites in the project. We will 
receive Zoom video recordings from other collaborating sites in the project, who will share videos by 
HIPAA-compliant Dropbox or through the secure MGH server. We discontinued video fidelity early in 
the study due to challenges with doing this remotely.  
 
We have created a video for study participants about how to use Zoom for study-related meetings. The 
video describes how to download the Zoom app and how to join Zoom meetings. We will share the 
YouTube link for this video with participants to help them set up Zoom. 
 
This is a protocol where the MGH IRB will cover other sites via cede review. Staff from different sites 
may offer screening, intervention/usual care calls, and interviews with participants recruited from other 
sites, and we will note this in the consent form.  
 
We let participants know that if there is any concern about physical symptoms during the remote exercise 
sessions, we may have to put them in touch, remotely or in person, with someone who can assess that 
they are ok, including their PCP. 
 
Other recruitment options 
 
Project coordinators and research assistants doing recruitment will have access to providers’ schedules on 
EPIC for clinics where this is possible (ie, at MGH). We will use these schedules only to know when to 
go to the clinics to recruit in person and when there is a good flow of older patients. We will not call 
patients to recruit from EPIC; we know Partners do not authorize this. Our CRCs/RAs only need access to 
the schedules and age/language data to identify potential patients. We will enroll research staff for the 
required EPIC training. 
 
We want to take advantage of the opportunity to recruit patients identified through EPIC as potential 
candidates for our study. We would work with the Epic Helpdesk to identify patients who fulfill certain 
criteria.  Once we receive eligible patient information, we would collaborate with the Medical Director, 
clinicians, and the patient’s provider, inviting the patient to learn more about the study and be screened. 

We will discuss with the clinicians the possibility of contacting the patients by phone to ask them to 
participate. 
 
The study team may also conduct outreach about the study to outside agencies, including local churches, 
outpatient geriatric providers, senior housing complexes, or other facilities utilized by older adults. 
Providers at these facilities may refer older adults to the study. CRCs/RAs will schedule screenings with 
interested older adults in that case. To screen participants from outside agencies, agency directors will be 
asked to sign a “Performance Site Not Engaged in Research Form”, which will be submitted to the IRB 
for approval. 
 
Intervention Description 
 
The PMSB-E intervention provides an integrated program to address the dual challenges of mental health 
and disability among minority older adults. It seeks to improve mood symptoms and augment clinically 
significant changes in observed and self-reported physical functioning compared to enhanced usual care 
in participants with elevated depressive (PHQ-9 >5) or anxiety (GAI>8) symptoms and moderate to 
minimal disability.76-78 
 
The Enhanced Positive Minds Intervention for Months 1-6: Positive Minds identifies and corrects 
negative distortions or cognitions, promotes behavioral activation through engaging the participant in 
pleasant activities, and encourages developing supportive relationships. All sessions are tailored to the 
participant’s needs using a collaborative approach. We have made several important adaptations to the 
Enhanced intervention to be more sensitive to cultural beliefs and presentation of therapeutic strategies. 
The enhanced version expands interpersonal components with effective communication skills, practice 
activities, additional breathing scripts and exercises, improved psychoeducation, and dedicated attention 
to nutrition and sleep problems. These additional areas were deemed central in minority older adults’ lives 
and were collaboratively arrived at. We first asked CHWs and supervisors to complete a questionnaire 
with feedback by session on the manual and participants’ workbook. Using this feedback, study staff 
engaged in two open meetings with CHWs to develop adaptations and with the Executive Research 
Committee to generate feedback. The research team then integrated changes for review and testing. In this 
final year of the PMSB project, we have selected 9 participants across sites to pilot test the PMSB-E 
intervention and determine its acceptability. CHWs have noticed positive responses from participants, 
including revisions to the psychoeducational material, which helped facilitate patients’ problem 
recognition and engagement for future sessions. CHWs noted that participants expressed deeper 
understanding of their symptomology, which translates into insight, motivation, and a readiness for 
change. Including more scenarios and role-play allowed participants who value privacy to practice 
listener-speaker techniques in fictitious situations instead of divulging personal examples. CHWs also 
noted improvements in the thought-feeling-behavior triangle integration and new breathing exercises. 
 
Enhanced Positive Minds group component for Months 6-12: We have designed a group session 
component to strengthen the Positive Minds intervention effects. After participants finish the 10 sessions 
of Positive Minds, CHWs will offer 2 weekly group sessions as a drop-in program for older adults who 
want more support and practice after completing PMSB-E. Groups will be structured using a manual that 
PMSB-E intervention supervisors developed, reinforcing the core components of the intervention and 
allowing for more group practice. It will also enable participants to meet and support each other. After 6 
months of participating in the PMSB-E trial, some participants may be offered a Maintenance 
intervention that aims to keep the benefits of the PMSB-E intervention and prevent mood and anxiety 
problems. This is also a combined intervention that involves physical exercise and psychoeducation 
sessions. The sessions are in a group and provided by CHWs and ETs using Zoom. Sessions occur 3 times 
a week (2 with the ET and 1 with the CHW), and participants can attend as many sessions as they want 
for 6 months. All participants enrolled in the intervention arm of the PMSB-E trial will be randomized to 

receive the PMSB-E Maintenance intervention or usual care. Both groups will receive two safety 
assessments to monitor symptom severity and assess the need for referral to behavioral health services. 
That means that only half of the participants in the intervention arm will be offered the PMSB-E 
Maintenance intervention. 
 
Strong Bodies: Strong Bodies consists of a series of exercises that are conducted while wearing a 
weighted vest. Resistance progresses in 2% body weight increments and will be distributed evenly within 
the vests. Exercise intensity is monitored using the Borg Scale of received exertion (RPE) with a goal of 
between 11 and 16 (moderate intensity) and stopped or resistance reduced if RPE exceeds 16 or a heart 
rate above 85% of age-predicted maximum. Resistance is increased when RPE values fall below the 
targeted range. Progression and technique are modified, and exercises are stopped if the participant 
experiences persistent physical complaints. The Exercise Trainer supervises the maintenance of safe 
positioning, posture, and form, and keeps track of participant attendance and compliance with exercise 
prescriptions. An MD provides close supervision, including bi-weekly calls with the Exercise Trainers to 
review any concerns or adjustments needed to individual exercise programs. As part of the Enhanced 
Strong Bodies program, we added scripts to make the sessions more fun, light music (not included after 
the COVID pandemic), and motivational interviewing training for the Exercise Trainers. Study 
participants assigned to receive the Strong Bodies intervention may also receive an instructional video of 
the exercises for at-home use and training for using it safely at home. The video is intended to supplement 
the in-person classes and allow participants to exercise individually once a week. Participants report video 
use to their Exercise Trainer for tracking. We provide the opportunity for participants who have finished 
their 6 months to continue to attend regular scheduled Strong Bodies sessions, to help with maintaining 
gains. In this renewal, we will additionally incorporate an ongoing group component, after the 6 months 
of the intervention have passed, in tandem with PM group sessions. The Strong Bodies intervention calls 
for participants to use several devices: 1) a weighted vest whose weights are adjusted according to 
participant weight and perceived exertion; 2) an aerobic step to build lower extremity strength, and whose 
height may be adjusted from 4 – 8 inches; 3) a balance beam (2” tall) to improve balance. 
 
Description of Enhanced Usual Care: Participants in this arm will receive an NIH booklet about anxiety 
and depression and taking care of one’s mental and physical health in Spanish, English, or 
Mandarin/Cantonese, based on a NIMH standard resource available. The research assistant will call the 
participant 4 times over 6 months to assess any severe symptomology with the PROMIS and the 5-item 
suicide questionnaire to mimic the administration in the intervention group. Based on the work of 
Gallagher-Thompson and colleagues, they will also provide empathic support if the participant expresses 
concerns.9 Such support will consist of a 15-minute call every 2 weeks, with participants receiving 4 calls 
over eight weeks. 
 
Fidelity Checks: We will standardize the Positive Minds component by strict training and certification 
(i.e., intervention administration with at least 75% fidelity in 2 pilot cases). CHWs must complete 
checklists of intervention components delivered during a session and document the time needed to 
monitor the “dose” delivered. MGH-affiliated graduate students will review a random 10% sample of 
recordings and treatment fidelity checklists. For the Strong Bodies intervention, we assess fidelity in 3 
ways: 1) a training log of elements covered per session and obstacles to completion; 2) random project 
coordinator spot checks of sessions, documenting areas for improvement; and 3) videotapes of a random 
sample of sessions, collected by Project Coordinators and reviewed by Dr. Frontera to address concerns or 
adjustments. We will hold bi-weekly coordination meetings to facilitate communication between CHWs 
and ETs. 
 
Supervision: We will conduct weekly supervision for CHWs and bi-weekly supervision for ETs. Cases 
that show no improvement or deterioration will receive more intensive monitoring from the supervising 
clinicians and, if necessary, will be referred to primary care for medication consult. The supervising 

clinicians will meet with the CHWs in weekly 1.5- 2.0-hour phone sessions to discuss participants with 
worsening depressive or anxiety symptoms or suicidal ideation over the study period. Cases overdue for 
monitoring calls, non-participation, and other cases, as requested by the CHWs, will be discussed. In an 
emergency, CHWs will have direct access (through cell phones) to the Site Leader and supervising 
clinicians at the Boston, New York, and Puerto Rico sites. Participants in intervention and enhanced usual 
care conditions who respond positively to questions #4 or #5 on the Paykel Suicide questionnaire will be 
referred for an urgent evaluation. Licensed supervising clinicians will help determine whether immediate 
referral and removal from the study are necessary. 
 
Aim 2: Assess implementation readiness of the Enhanced PMSB intervention by evaluating factors 
associated with acceptability, feasibility, adoption, and sustainability.  
 
In Aim 2, we will draw on the lessons learned from organizations and collaborators in our PMSB-E study 
to identify factors likely to facilitate the success of implementation and sustainability. Informed by the 
CFIR framework, we will assess facilitators, barriers, and process/potential moderators concerning:  
 
(a) intervention characteristics; (b) inner setting; (c) outer setting; (d) characteristics of individuals; and 
(e) implementation process. 
 
Study Design 
 
(A) Concerning characteristics of the PMSB-E intervention, we will assess satisfaction and acceptability 
of PMSB-E at the participant-level (older adults), provider-level (CHWs and primary care team 
members), and organizational-level (clinic/CBO directors) using a mixed methods approach including 
quantitative Likert measures of satisfaction and acceptability in conjunction with qualitative semi-
structured interviews at the 6 and/or 12-month intervals. (B) Concerning the inner setting, we will 
evaluate organizational (CBO/clinic) characteristics and implementation readiness. In our first year, we 
incorporated qualitative (interviews) and quantitative (organizational characteristics survey) measures to 
assess implementation readiness. We will interview site leaders and staff to reassess potential barriers and 
facilitators they anticipate when starting the PMSB-E. We will collect an organizational characteristics 
survey to ascertain baseline data on participating sites and interview site leaders and executive teams 
about barriers or facilitators to success. Organizational characteristics will be assessed using an 
organizational characteristics survey including information on organization size (# employees/clients, # 
sites, total operating budget), and type (clinics, physician led-practices, or stand-alone CBOs); scope of 
services (primary, urgent, specialty, or integrated care); population covered per 1,000; and level of CHW 
integration into the clinical/CBO team as a moderator (using SAMHSA’s measure of provider 
integration117). Organizational implementation readiness will be assessed using the Organizational 
Readiness for Implementing Change (ORIC) measure, consisting of 12 items rated on a 5-point ordinal 
scale. It is a brief, practical, and reliable measure of key domains reflecting an organization’s readiness to 
adopt and implement an evidence-based practice. The survey will also collect demographics of clients 
served annually, average caseload (age, sex, race/ethnicity, socioeconomic status), and payer mix 
(Medicare, Medicaid, private payer). As part of our original grant, we prepared site profiles including 
much of this information, so a portion of the work in year 1 will be updating these materials and seeing 
changes in the organizations from the onset. This will help us to develop the profile of organizations that 
can successfully carry out this work. 
 
As part of Aim 2, we will also create a learning community of CBOs, clinical sites, and academic partners 
to share elements that have contributed to initial success and are essential to strengthening the 
collaboration. At the onset, we will review the roles and responsibilities of our partnership and create a 
new memorandum of understanding for our joint work. The learning community will share information 
through regular calls every 2 weeks to review project progress and in one-on-one discussions between 

research staff, site leaders, CHWs/ETs, and other players, such as primary care, to assess barriers and 
facilitators to success. 
 
In Aim 2, we will work with sites to identify opportunities in the ‘outer setting’ to facilitate financial 
sustainability and put into place systems to collect data and monitor information needed to successfully 
solicit local, state, and federal funding.  We will collect data at the start of the project and yearly with the 
partners to see the utility of a resource packet and training materials to support the development of a 
toolkit used for dissemination and implementation in Aim 3. 
 
The research team will conduct interviews with Site Leaders, CHWs, ETs, and institutional and clinic 
directors to address acceptability, barriers, and facilitators of the program, as well as an understanding 
about how implementation readiness is seen across the CIFR framework.  They will also help collect 
initial information for the Organizational Characteristics Survey. We plan to program the survey into an 
easy-to-use online questionnaire using REDCap that CRCs/RAs can run through with the participant or 
that can be self-administered. 
 
We will evaluate factors associated with acceptability, feasibility, adoption, and sustainability of the 
intervention at collaborating sites and with staff. We will conduct qualitative interviews and focus groups 
with Site Leaders, CHWs, ETs, and institutional, clinic, and CBO directors and staff to address 
acceptability, barriers, facilitators, and implementation readiness. We will provide a $50 gift card for 
participation in the in-depth interview or focus group (unless participants cannot accept it due to 
organizational affiliation or set up). We include a Cede review from Columbia University for MGB so our 
collaborator can conduct this work. 
 
Biostatistical Analysis 
 
AIM 1 
 
Statistical methods: We began with descriptive analysis of all data by site, using means, standard 
deviations, skewness, quartiles, and graphical assessments of the distribution. We compared distributions 
of baseline characteristics between intervention and enhanced usual care groups in each site to assess the 
balance of the observed covariates between the randomized groups.  
We used intent-to-treat principles and included all randomized participants. We compared changes in 
outcome scores using repeated measures linear mixed-effects models with a participant-level random 
intercept for the primary (12-month), key secondary (6-month), and exploratory endpoints (3-month). 
Expressly, we entered treatment condition (EUC or PMSB-E), time (3-, 6, or 12-months), and treatment-
time interactions into repeated measures linear mixed-effects regression models to assess the impact of 
the treatment over time. All three post-randomization assessments were included in the linear mixed-
effects models, which are defined with the following hierarchical structure: 
 
𝑦𝑖𝑡= 𝛽0𝑖+ 𝛽1𝑇𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡𝑖+ 𝛽2𝑇𝑖𝑚𝑒𝑡+ 𝛽3(𝑇𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡𝑖× 𝑇𝑖𝑚𝑒𝑡) + 𝛽4𝑃𝑜𝑠𝑡𝑇𝑖𝑚𝑒𝑡
+𝛽5(𝑇𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡𝑖× 𝑃𝑜𝑠𝑡𝑇𝑖𝑚𝑒𝑡) + 𝑦𝑖0 + Β′𝑋𝑖+ 𝑢𝑖𝑡
𝐸𝑞. [1] 
 
where 𝑦𝑖𝑡 is the outcome variable of interest (HSCL-25, Late-Life FDI, SPPB, or WHODAS 2.0 scores) 
for individual 𝑖 at post-randomization time 𝑡 (3-, 6-, and 12-months). This mixed-effects model included 
two different time terms, 𝑇𝑖𝑚𝑒𝑡, to account for the slope of the outcome trajectory, and 𝑃𝑜𝑠𝑡𝑇𝑖𝑚𝑒𝑡, 
which measures time since month 6 to account for a possible change in slope between months 6 and 12 
(or to account for a possible change in slope during the group maintenance phase of the intervention). 
Together, the terms 𝑇𝑖𝑚𝑒𝑡 and 𝑃𝑜𝑠𝑡𝑇𝑖𝑚𝑒𝑡 specify a linear spline model, with two linear segments joined 
at month 6 representing, respectively, the trajectory during the one-on-one phase of the intervention 
(baseline to month 6) and the trajectory during the group maintenance phase (after month 6). To evaluate 

the impact of the intervention, we included an effect-coded variable for treatment (𝑇𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡𝑖), and two 
treatment-time interactions (𝑇𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡𝑖× 𝑇𝑖𝑚𝑒𝑡 and 𝑇𝑟𝑒𝑎𝑡𝑚𝑒𝑛𝑡𝑖× 𝑃𝑜𝑠𝑡𝑇𝑖𝑚𝑒𝑡) to allow control-
intervention differences to change over time. 𝑦𝑖0 is the outcome score at baseline. 𝑋𝑖 is a vector of 
covariates to adjust for unintended imbalance between intervention and control conditions. 𝑢𝑖𝑡 denotes the 
residual error for participant 𝑖 at time 𝑡. The intercept, 𝛽0𝑖, was estimated as a random effect that varies 
across participants. The main coefficients of interest were the treatment effects (i.e., contrasts between the 
randomized groups) at the primary (12-month), key secondary (6-month), and exploratory endpoints (3-
month), which were obtained by centering the time terms at the 12-, 6-, and 3-month endpoints, 
respectively. Expressly: 
1. The intervention effect at the primary 12-month endpoint was obtained by coding 𝑇𝑖𝑚𝑒𝑡 as (-9, -
6, and 0) at 3, 6-, and 12-months, respectively. The 𝑃𝑜𝑠𝑡𝑇𝑖𝑚𝑒𝑡 term was coded as (-6, -6, and 0) 
at 3, 6-, and 12-months, respectively. Under this coding scheme, the coefficient 𝛽1 from 𝐸𝑞. [1] 
directly represented the intervention effect at month 12. 
2. The intervention effect at the secondary 6-month endpoint was obtained by coding 𝑇𝑖𝑚𝑒𝑡 as (-3, 
0, and 6) at 3, 6-, and 12-months, respectively. The 𝑃𝑜𝑠𝑡𝑇𝑖𝑚𝑒𝑡 term was coded as (0, 0, and 6) at 
3, 6-, and 12-months, respectively. Under this coding scheme, here too the coefficient 𝛽1 from 
𝐸𝑞. [1] directly represented the intervention effect, but this time at month 6. 
3. Finally, the intervention effect at the exploratory 3-month endpoint was obtained by coding 
𝑇𝑖𝑚𝑒𝑡 as (0, 3, and 9) at 3, 6-, and 12-months, respectively. The 𝑃𝑜𝑠𝑡𝑇𝑖𝑚𝑒𝑡 term was coded as 
(0, 0, and 6) at 3, 6-, and 12-months, respectively. Under this coding scheme, here too the 
coefficient 𝛽1 from 𝐸𝑞. [1] directly represented the intervention effect, but this time at month 3. 
Because of the importance of the different racial/ethnic makeup of the sample, prespecified subgroup 
analyses were conducted by adding interaction terms between intervention and race/ethnicity and time × 
intervention × race/ethnicity interactions. The model is flexible enough to incorporate the association of 
race and ethnicity on the treatment effect. In exploratory analyses, we considered inserting two-way 
interaction terms to provide preliminary evidence of the heterogeneity of treatment effects by socio-
cultural, clinical, and medication factors. 
 
Power Analyses: Participation of a minimum of 400 participants across all sites (assuming a conservative 
20% attrition at 12-month follow-up, a total of 320 completions) allows for adequate power to detect the 
effect of the intervention on primary outcomes. We estimated the power to detect the intervention effect 
based on 𝐸𝑞. [1], assuming a two-sided type I error rate of 0.05, correlation of 0.5 among repeated 
measures, and similar standard deviations as in the previous study of the PMSB intervention. For the 
effect sizes assessed at the 12-month follow-up, we assumed that the enhanced treatment would achieve 
an effect size that was derived from the prior PMSB study results as follows: 
 
Target Effect Size = ITT Effect Size + 1/3 * (FC Effect Size – ITT Effect Size), 
 
where ITT Effect Size denotes the effect size for the intent to treat analysis, and FC Effect Size denotes 
the effect size for as-treated analysis assuming full compliance with the protocol. Given the design to 
enhance compliance in the current study, the effect size should be close to the full compliance effect size. 
However, we assumed conservatively that the enhancement only improved upon the ITT Effect Size by 
one-third of the gap between the FC Effect Size and the ITT Effect Size (Table 1). Under those 
assumptions, we estimated that the PMSB-E would have 78.5%, 86.8%, and 92.3% power to detect a 
difference in HSCL-25 (Cohen d =0.26), SPPB (d =0.29), and the function component of the Late-Life 
FDI (d =0.32) between treatment and usual care groups at the 12-month assessment, respectively. 
 
Table 1: Estimated Effect Sizes at 12-month Assessment from Prior PMSB Study  

Intent-to-treat 
Effect Sizes 
Full 
Compliance 
Effect Sizes 
Target Effect 
Sizes 
Short Physical Performance Battery 
0.26 
0.35 
0.29 
Function component of the Late Life 
Functioning and Disability Instrument 
0.28 
0.41 
0.32 
Hopkins Symptom Checklist-25  
0.23 
0.32 
0.26 
 
In prespecified subgroup analyses, with 320 participants, we also estimated 89.3% and 74.3% power to 
detect a significant interaction between race/ethnicity and treatment for SPPB and Late-Life FDI, 
respectively. We were nonetheless underpowered to detect a significant interaction for HSCL-25, unless 
(1) we included only three racial/ethnic groups (Latinos, Asians, and Blacks), or (2) we oversampled 
Blacks and Whites to have a more even distribution across race/ethnicity. We conducted additional power 
calculations to determine the needed effective sample size to have adequate power to detect a significant 
interaction between race/ethnicity and treatment for HSCL-25 under these two scenarios. If we were to 
limit the study to sample only three racial/ethnic groups (33.3% Latinos, 33.3% Asians and 33.3% 
Blacks) in equal proportions, an effective sample size of 450 participants, instead of 320, would provide 
adequate power (73.3%) to detect a significant interaction between race/ethnicity and treatment for 
HSCL-25. If the racial/ethnic composition comprises 25% Latinos, 25% Asians, 25% non-Latino Blacks, 
and 25% non-Latino Whites, an effective sample size of 600 participants (150 in each group) would 
provide 70% power to detect a significant interaction. Given budget and recruitment constraints, our final 
planned effective sample size was 450 participants in equal proportions across Latino, Asian, and Black 
racial/ethnic groups. 
 
To ensure that the significance of our findings is not an artifact of assessing multiple outcomes, we will 
conduct sensitivity analyses that estimate a single multilevel mixed model on an aggregate variable 
capturing all outcomes112. This approach accounts for the correlation between outcomes and is less 
conservative than a Bonferroni correction. Given the levels of power calculated for the overall 
intervention effect, we are confident that we will have adequate power to test treatment differences even 
after this correction for multiplicity is made. Prior experience suggests that treatment outcomes may differ 
by site, socio-cultural factors, CHW fidelity, and therapeutic alliance. We will conduct exploratory 
assessments of these treatment differences, recognizing that the sample size is unlikely to provide 
sufficient power to detect these differences. 
 
Aim 2 
 
Data collection and analysis: The research will conduct interviews with Site Leaders, CHWs, ETs, and 
institutional and clinic directors to address acceptability, barriers, and facilitators of the program, as well 
as how implementation readiness is seen across the CFIR framework. They will also help collect initial 
information for the Organizational Characteristics Survey. We plan to program the survey into an easy-to-
use online questionnaire using REDCap that RAs can administer to the participant or that can be self-
administered. Given our experience in previous work, we will corroborate information about the 
organizations or clinics with external data sources or hospital-wide data (in the case of MGH). We will 
also have data from research interviews with older participants on experiences with care, as well as 
satisfaction with the PMSB-E program. For qualitative data, RAs and Project Managers will conduct a 
first round of coding to analyze data using two simultaneous approaches: 1) coding about barriers and 
facilitators identified a priori; and 2) open coding to identify new concepts. Codes will be compared using 
the constant comparative method116,117. To ensure inter-rater reliability, coders will meet regularly to 
discuss consistency and resolve discrepancies118. Coders will use an axial coding scheme and analyze how 
themes compare across staff and participants and within/across organizations. Our statistician will analyze 
the Organizational Characteristics survey to compare key areas of similarity and difference between sites. 

We will consider how site-level factors influence outcomes. Student interns will take part in transcription 
and coding. Results will be discussed with the Executive Committee and used to optimize processes for 
implementation readiness. 
 
Expected outcomes from the qualitative and quantitative integration include: 1) acceptability of the 
PMSB-E intervention by both participants and CHWs/Exercise trainers; 2) characterization of site and 
participant-level factors; 3) identification of opportunities and plans for workforce training and ongoing 
financial sustainability of the program; and 4) an assessment of implementation readiness, that can be 
applied to toolkit development. 
 
Risks and Discomforts 
 
AIM 1 
 
We do not anticipate significant risks associated with the proposed study. Minimal risks include the 
possibility of discomfort when discussing mental health problems and receiving treatment with the CHWs 
or Exercise trainers (for the intervention arm) or during research assessments or control calls (for both 
intervention and control). Participants in the treatment condition may become upset in discussing their 
frustrations dealing with depression and anxiety, or in previously trying to obtain mental health care. 
Intervention and control participants may experience mild emotional discomfort in responding to sensitive 
questions in the interview. These inherent risks are typically assessed to be low compared to the long-term 
potential benefits from this type of research. 
 
Should participants endorse suicidality in any research assessments, CRCs/RAs will follow an emergency 
protocol tailored to each site (see end of human subjects document for an example) that involves clinics 
designated to receive emergency cases (see adequacy of protection against risks below). CHWs will 
discuss potential clinical concerns for their patients in weekly supervision meetings with licensed mental 
health professionals or on the same day with clinical supervisors. See the adequacy of protection against 
risks for more details. Participation in the Strong Bodies Exercise component is deemed safe, with 
exercise trainers attentive to any physical restrictions of participants so that they can adjust activities 
accordingly.  
 
Enrolled participants will be administered four research assessments as part of the intervention and 
control groups. Those who answer positively to questions 4 or 5 on the Paykel, suggesting acute 
suicidality, will be provided emergency care following the emergency protocol developed by the 
Disparities Research Unit. The emergency protocol involves immediate referral to emergency services for 
assessment and treatment. The participant’s PCP will also be notified, and participants will have 
consented to this as part of the study consent form. 
 
Participant Privacy: Every effort will be made to uphold participant privacy throughout this study. The 
research staff will protect information pertinent to an individual’s involvement in the study. Participants 
will be assigned participant identification (ID) numbers, which will be used on study documents 
(including the tracking logs for the gift card incentives) and communications without any identifying 
information. Links to these ID numbers will be kept in password-protected documents. All telephone 
sessions will use phone adapters with landlines that allow interviews to be recorded privately per study 
protocol. If a landline is unavailable, the speakerphone setting on cellular phones also yields adequate 
recording quality; this method would be used in private settings. Audio recordings will be saved in secure 
computer directories to assure confidentiality, then deleted from the audio recorder, once supervision, data 
cleaning, and data analyses have been completed. 
 

Adequate provisions will be made to protect the privacy of potential and current participants throughout 
all phases of the research. Staff will schedule assessment interviews in private settings. They will not 
discuss participant project information with anyone other than research staff, nor leave sensitive messages 
on voicemails. Staff will ensure that conditions under which information will be collected (e.g., telephone 
contact, mail, or email) are afforded protections against participants being overheard or inadvertently 
intercepted. Part of the training for CHWs and Exercise Trainers will include ensuring that the CHWs and 
Exercise Trainers check whether the participant is receiving the call from a confidential or secluded place 
to ensure confidentiality of the information. CHWs and Exercise Trainers will undergo a comprehensive 
training on the confidentiality of participant information. We will also inform participants how their 
information is secured, particularly emphasizing that their information will not be disclosed to anyone 
outside the research team. We will clarify how all information is presented in aggregate form so that no 
one can be identified. 
 
Suppose participants are very hard to reach or have challenges preventing them from participating in 
certain sessions/interviews at the clinic or by phone. In that case, we will offer the possibility of home 
visits. This includes conducting the CHW/Exercise Trainer sessions or research assessments in the home. 
This has been a helpful strategy in previous studies with hard-to-reach patient populations and has been 
important for reaching participants we are concerned about with serious mental health concerns. We 
would include information in our consent form to ensure this option is clear to participants. Staff 
conducting home visits will be trained in safety procedures. Before research staff conduct a home visit, 
they will alert study staff in the office, and are asked to be in contact before and after leaving the site to 
ensure that everything is fine. Staff are not mandatory reporters, but if they see anything serious 
happening in the home, like child or elder abuse, suicidality, or a risk of death, they will implement the 
emergency protocol and contact supervisors when in doubt to provide advice and jointly determine next 
steps. 
 
Suppose an older adult suffers from a physical ailment during the PMSB-E sessions that needs care. In 
that case, we will coordinate a visit through their primary care clinician, or in the event of an emergency, 
will contact the emergency room of the nearest medical center to the clinic or community-based 
organization. If hospitalization is deemed necessary for intervention participants, CHWs and Exercise 
Trainers will proceed with sessions following the participants’ discharge and coordinate with emergency 
clinicians to ensure that participants are referred for additional health services. 
 
AIM 2 
 
Risks to the Subjects  
 
Some participants may feel uncomfortable answering certain questions during in-depth interviews or 
focus groups. Before interviews commence, participants will be told that they can refuse to answer 
specific questions or terminate the interviews.  
 
Adequacy of Protection Against Risks  
 
Every precaution will be taken to maintain participants' rights and privacy protections in in-depth 
interviews and focus groups. All identifying locator data for individuals interviewed or organizations 
profiled will be stored in locked file cabinets, and data used for analysis will be de-identified and assigned 
an identification (ID) number for privacy. All research personnel will have access to the de-identified 
subject information. Only research staff will have access to identifying information for the initial data 
cleaning period. All investigators who work with the data in any capacity will sign a data release 
agreement. This agreement outlines the data access criteria, includes research use conditions, incorporates 
privacy and confidentiality standards to ensure data security, and prohibits data manipulation. 

 
II. 
Potential Benefits 
 
AIM 1 
 
Potential Benefits of the Proposed Research to the Subjects and Others  
 
Participants in the intervention may achieve decreased depressive and anxiety symptoms, better muscle 
resistance and mobility, and a reduction in disability days. Participants in the intervention arm, as 
compared to the enhanced usual care condition, may be better able to recognize and self-manage their 
mood problems, as well as increase their ability to deal effectively with structural barriers (e.g., stigma) 
that may impede them from entering and staying in mental health treatment. They may experience 
physical strengthening and improved mobility due to the exercise component of the intervention. The 
results of the study may provide evidence of how best to work with minority older adults with depressive, 
anxiety, and/or disability symptoms in community settings to prevent or decelerate disability. The study 
may also prove effective for diminishing mental health symptoms, thereby reducing disparities in care 
and disparities in disability outcomes among minority older adults. Participants randomized into the 
enhanced usual care group may benefit from support by research staff, such as coordination of 
appointments in primary care or mental health services, if they request them. Study participants will 
receive a $60 gift card incentive for each completed assessment interview: baseline, 3-month, 6-month, 
and 12-month follow-up, for $240 ($250 with the $10 screener gift card). The gift card will be tracked by 
the participant’s assigned ID number and logged in the gift card log book by the research staff. 
Participants receive no compensation for taking part in the PMSB-E sessions.  
 
To ensure sufficient time for data cleaning, analysis, and paper writing in a no-cost extension period, we 
plan to finalize clinical trial data collection at the end of October 2024. With this change, a segment of 
participants will have their final interview 6 months after baseline, rather than 12 months. For these cases, 
we will move the final qualitative questions to the 6-month rather than the 12-month interview. To ensure 
we provide the promised incentive, we will provide a $120 gift card at participants' final 6-month 
assessment (comprising the 6-month and 12-month incentive amount). We will inform participants about 
this change when we call them to schedule their 6-month interview. Clinical trial recruitment has been 
finalized, so no changes to the consent form are required. 
 
Importance of the Knowledge to be Gained  
 
We anticipate the information gained from the intervention will illustrate an important model for building 
community capacity for disability prevention and mental health service delivery. It is also a means of 
engaging and treating minority older adults with depressive or anxiety symptoms and at risk for disability 
in CBOs by Community Health Workers and Exercise Trainers. There is a tremendous need for 
sustainable and affordable solutions that use task shifting for mental health problems and disability 
prevention for ethnic/racial and linguistic minority older adults. We envision that the proposed model of 
building community capacity will be able to be delivered and sustained at relatively low costs by 
participants outside of clinics, making it a unique and much-needed intervention model with a high 
potential for feasibility, acceptability, and sustainability after the project ends. From a public health 
perspective, this type of model for problem solving and building resources in the community is beneficial 
because it could diminish disability associated with mood and mobility problems among a population that 
already suffers disproportionately in these areas. In testing this strategy using a randomized clinical trial 
and collecting data throughout the project, we will be able to determine its benefits.  
 
AIM 2  
 

Potential Benefits of the Proposed Research to the Subjects and Others  
 
The Site Leaders, CHWs, Exercise Trainers, CRCs/RAs, and other staff who consent to participate will be 
told that their participation in the study may be of no direct benefit to them. Some respondents in the 
study may find it beneficial to discuss issues of importance in their organization and community related to 
depression/anxiety among older adults and the context of their community-based organization (CBO) or 
community clinic, but these benefits will be indirect. Indirect benefits include the knowledge gained about 
organizational capacity and factors likely to facilitate the success of implementation and sustainability in 
each site.  
 
Importance of the Knowledge to be Gained  
 
This aspect of the study will contribute significantly to our understanding of implementation readiness 
and what is required to integrate the intervention at various sites successfully. Expected outcomes 
include: 1) understanding of acceptability of the PMSB-E intervention by both participants and 
CHWs/Exercise trainers; 2) characterization of site and participant-level factors; 3) identification of 
opportunities and plans for workforce training and ongoing financial sustainability of the program; and 4) 
an understanding of implementation readiness; that can be applied to toolkit development in Aim 3. It will 
also provide insight on how the intervention fits into each community clinic and organization and what 
accommodations may need to be made in each context to inform the development of resources and 
competence for delivering mental health services in ACO sites. 
 
III. 
Monitoring and Quality Assurance 
 
We will make extensive efforts to ensure study participants' safety and systematically track risks, issues, 
and outcomes across CBO sites. We will create a monitoring registry using a HIPAA-compliant, web-
based program accessible by research teams and supervisors, where we can tabulate and track any human 
subjects and systematic issues that arise with implementation across sites, as well as between intervention 
and control conditions. We will identify a core set of patient issues that will be flagged if they occur: 1) 
cases with no improvement, an increase in symptom scores, or physical pain linked to outcome; 2) no-
show for scheduled appointments; 3) staff concerns about participant’s well-being; or 4) site operational 
issues (such as space limitations for sessions, transportation challenges, resistance by site staff to any 
aspect of the study, such as the procedures for the emergency protocol etc.). These four areas will be 
programmed into the registry, with an area for notes and additional details. The Project Manager will 
maintain the registry and set it up to track patients by case ID, clinical site, and date of occurrence. We 
will create logons for CHWs/Exercise Trainers and CRC/RA interviewers at each site, who can enter 
information about their cases. We will use specialized permissions at the user level to ensure that 
CRCs/RAs remain blinded to any information about participant condition. The Project Manager will 
review data in preparation for weekly team and clinical supervisor meetings and will download the 
registry data to review with study staff and supervisors. At the project's onset, we will work with the study 
data analyst to program an algorithm to easily query the system to display cases with elevated issues in 
each of the 4 categories. This process will allow us to flag and highlight individual cases and generate 
reports on the frequency of any given issue within and across the CBO sites. Solutions will be discussed 
and determined by the research team, including the PIs at each site, and these will be reintegrated into the 
protocol by the Project Manager. We will thus systematize our monitoring of outcomes and challenges to 
view patterns and optimally address them. The registry will also inform us of our overall understanding of 
implementation challenges. 
 
Responsibility for data and safety monitoring  
 

We will put in place a Data Safety and Monitoring Board. Data safety is ultimately the responsibility of 
the Principal Investigator. She will consult with the Human Subjects Office to assess any research risks 
and work with the IRB as potential issues arise.  
 
Frequency of Data Safety Monitoring (DSM) reviews. We will plan to assemble a Data Safety and 
Monitoring Board (DSMB) to monitor the study every year. We plan to hold two annual DSMB meetings 
via teleconference software such as Zoom. The DSMB will review study progress, data quality, and 
participant safety, per the guidelines in the DSMB charter. If a serious adverse event occurs, we will 
conduct a special DSM review to ensure that protocols are assessed as needed and revisions are made. 
The event was addressed and resolved in a manner satisfactory to those involved.  
 
Content of the DSM report  
 
As part of our progress report, we will incorporate a DSM update that summarizes recruitment progress 
and retention of participants in the intervention, any safety or quality care issues that may have arisen, and 
a summary of any Adverse events that have occurred. We will also track any changes to the protocol that 
have been required because of these events. 
 
Only research staff authorized by the PI will have access to the data. The lead analyst working with the 
data is the only person on-site with network-level administrative password privileges. Offsite, only 
authorized MGH IT department technicians can access the server holding this data. The original data and 
the encrypted data will not be transported or used at any other location and the data will not be copied 
onto other computers, discs, CDs etc. We will maintain all print-outs, electronic files, personal computers 
with restricted data on the hard drives, or other physical products containing data in locked cabinets, file 
drawers or other secure locations when not in use. Printed material that includes analyses based on 
restricted data will be promptly destroyed. At the end of the project, all files that include restricted data 
will be destroyed, including copies and subsets on the MGH server or any project computers. 
 
The MGH research team staff will also work closely with the CBO Site Leader to help put together IRB 
amendments, yearly IRB continuing reviews, reporting materials as required by the funder, and budget 
and invoice materials as part of the site subcontracts. 
 
To improve the security of data collection, we will be working with the Dimagi Corporation, using 
their secure server to collect data via the CommCare HQ technology. This is installed in a series of 
secure tablets through which research assessments will be collected. Dimagi is a HIPAA compliant, 
secure, encrypted server that allows for host intrusion and intrusion monitoring system. All technology 
can only be accessed through secure and password servers. The CommCare HQ application will be 
installed on tablets and these tablets will be made available to CRCs/RAs serving as interviewers on 
the PMSB Implementation study. Our CRCs/RAs have already undergone training by Dimagi. 
 
The Dimagi CommCare HQ system is a healthcare data collection application installed on tablets 
designated solely for study use. Dimagi is bound by a confidentiality agreement and has various data 
safeguards in place including: a secure, multi-tenant system hosted in Dimagi’s Secure Private Cloud, 
based in Chicago, IL; Network Intrusion Detection System (NIDS): Web Application Firewall (WAF); 
Host Intrusion Detection System (HIDS); Server Event and Information Management (SEIM); encrypted 
hard drives; data destruction policy; and being Health Insurance Portability and Accountability Act 
(HIPAA) compliant. 
 
All data transfers to and from the Dimagi server will be conducted over industry standard transmission 
encryption (HTTPS). All access to the cloud infrastructure is protected behind a firewall 

and require unique VPN access permissions. All data is transferred through channels that are monitored 
by intrusion monitoring system. 
Data on the Dimagi server can be accessed by Partners staff through secure connections. All interactions 
with the server are saved and catalogued to report user, date, time, and location to better serve with 
regulations and auditing purposes. Monitoring system admin access: administrative access will be 
restricted solely to Dimagi and associated sub-vendors. All system level access will be fully logged for 
auditing purposes. Different Partners users can have different levels of access to the system and require 
secure authentication to access the data. The server also allows for data integrity, it does not allow for raw 
data to be altered once it’s been entered. All changes are recorded with time and data, creating records for 
quality control. 
 
All audio-recorded interviews will also be uploaded immediately to the same secure, password protected 
server maintained at MGH.  No reports will be made public using any names or identifying information. 
Our coded dataset will be stored on a secure central server. Only authorized research staff approved by the 
site Institutional Review Boards will have access to the data. PHI will be destroyed according to standard 
protocols, 7 years after the completion of the study. 
 
Outcomes monitoring:  
 
Quality Control: Collection protocols have been established to ensure accuracy and quality of the data 
obtained from all participant interviews with CRCs/RAs and treatment sessions with CHWs and ETs. 
Interviewers will have biweekly conference calls with Site Leaders at the community clinics and/or 
community-based organizations and in collaboration with the team where data quality and data analyses 
will be discussed. These calls will provide a forum for interviewers to discuss issues and concerns 
pertaining to data collection protocol as well as a time to provide feedback on completed assessments. 
CHWs and ETs will meet by conference call on a weekly or biweekly basis with supervisory 
clinicians/MD to discuss any concerns that arise regarding the weekly risk assessments with their 
participants. Supervisors and CRCs/RAs will hold a conference call every Friday to coordinate the 
research tasks, problem solve logistical or budgetary issues, and review the progress towards achieving 
milestones.  
 
For the intervention, the quality of the CHW and ET work will be monitored by the PI, Site Leaders, 
supervising clinicians, and the MD. We will conduct random (15%) adherence checks using a fidelity 
checklist that mirrors the intervention manual. This checklist documents activities covered in the training 
session, difficulties encountered, and CHWs’ observations regarding the participants’ level of 
understanding and participation in the intervention. In addition, supervisors will lead weekly 
meetings/conference calls to review the CHWs’ caseloads and assist them in following the manualized 
protocol. The investigators from all sites will participate in biweekly group supervision and review 
treatment fidelity checklists required of all CHWs to ensure standard treatment delivery within and across 
sites. For exercise trainers, fidelity will be assessed through a training log, in which the trainer records 
their ability to cover all elements of each session and notes any obstacles to keeping up with the 
prescribed activities each time they meet with a group. Additionally, project coordinators, the MD, and 
coordinators will work with Site Leaders to conduct random spot checks of the exercise sessions. They 
will keep notes of areas that might need improvement. Finally, a random sample of videotapes of random 
exercise group sessions will be collected by the Project Coordinators and reviewed by the exercise 
supervisor to evaluate fidelity to the Strong Bodies intervention. 
 
Plans for Interim Analysis of Effectiveness Data  
 
We will clean the data periodically as the protocol progresses. This will enable us to undertake interim 
assessments of the effectiveness of the intervention. We will report on any effectiveness data to date in 

the yearly progress report. We determined with the DSMB not to do an interim analysis and removed 
details of this section from the protocol. 
 
Adverse event reporting guidelines:  
 
Reporting mechanisms of AEs/SAEs  
 
As explained here, we will follow the policies and procedures for adverse event reporting. 
 
Definitions are as follows:  
 
Adverse Event (AE): Any untoward or unfavorable medical occurrence in a clinical research study 
participant, including any abnormal sign (e.g., abnormal physical exam or laboratory finding), symptom, 
or disease temporally associated with the participant’s involvement in the research, whether or not 
considered related to participation in the study.  
 
Serious Adverse Events: Any adverse event that: results in death; is life-threatening, or places the 
participant at immediate risk of death from the event as it occurred; requires or prolongs hospitalization; 
causes persistent or significant disability/incapacity; results in a congenital anomaly/congenital disability; 
or is another condition which investigators judge to represent substantial hazards. Given that we are 
working with an older population, we anticipate that there will be some possibility of serious illness, 
hospitalization, or death, due to factors not associated with the study or due to natural causes. A summary 
of these expected SAEs will be reported quarterly to the NIA PO and the DSMB. 
 
Reporting mechanisms of IRB actions  
 
We will report regular changes to the protocol to NIH at the annual progress report. If a serious adverse 
event requires immediate notification, we will report to NIH and the IRB according to the rules above.  
 
Report of changes or amendments to the protocol  
 
We will report changes to the protocol and amendments at the time of the annual progress report.  
 
Trial stopping rules  
 
Per the rules for management of an SAE, if the IRB deems that a serious adverse event suggests that the 
risks of the trial outweigh the benefits, we would temporarily stop further data collection until an alternate 
plan can be developed to ensure the safety of the trial participants.  
 
Management of SAEs or other study risks  
In collaboration with the IRB, we will assess the necessity of the following steps.  
• changes to the protocol to minimize risks to subjects;  
• changes to the consent form to accurately reflect the nature, frequency, or severity of the event;  
• Ask subjects to re-consent to participate in the study if necessary.  
• placing the study on temporary hold to new enrollment and/or discontinuing procedures if, based on the 
information available, the risk-benefit ratio appears unfavorable to the subjects.  
 
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