Developing a Resilience Intervention for Older, HIV-Infected Women
Phase: NA
Conditions: Resilience, Psychological
Sponsor: Massachusetts General Hospital

Official Title of the Study: The BRIgHT Program: Building Resilience in HIV Together 
NCT  
 
Number: NCT03673098 
 
Date of Document: September 9, 2020 
 

 
 
PROTOCOL 
 
Principal Investigator:  
Christina Psaros, Ph.D. 
 
Project Title: 
The BRIgHT Program: Building Resilience in HIV Together 
 
Version Date: 
09 September 2020 
 
 
 
TABLE OF CONTENTS 
 
1. Specific Aims ……………………………………………………………………………............2 
2. Background and Significance …………………………………….........................................2 
i. 
Figure 1: Conceptual Model …………………………………………………………….4 
3. Research Strategy ………………………………………………...........................................7 
i. 
Table 1: Overall Study Timeline …….……….…………………………………...……9 
ii. 
Table 2: Original Relaxation Response Resiliency Program Chapters & Goals ….8 
iii. 
Table 3: Skills Table…………………………………………………………….….......10 
iv. 
Table 4: Study Event Timeline…………………………………………....…...……...12 
4. References……………………………………………………………………………………...22

 
1. SPECIFIC AIMS 
 
Specific Aims. This is the second phase of a two-part study. In the first phase (MGH IRB 
Protocol #2017P000404), we adapted an existing resiliency intervention, the Relaxation 
Response Resiliency Program (3RP), to the needs of women ages 50 and over who are living 
with HIV. We conducted preliminary testing of the refined group intervention via an open pilot 
study (N=13 enrolled) across two sites, MGH and Boston Medical Center), and conducted 
individual exit interviews to solicit feedback on the intervention, including experiences with the 
assessment protocol, intervention content, and number and duration of sessions. Data from 
these interviews were used to make adaptations to the manual in an iterative fashion after each 
of the three open pilot groups, and the final product will now be tested via a small randomized 
controlled trial.  
 
Specifically, we will conduct a randomized study (N=up to 60) of the adapted 3RP intervention 
among groups of women living with HIV, ages 50 and over. Our primary aim is to test the 
feasibility and acceptability of all study procedures; we hypothesize that our protocol will be both 
feasible and acceptable. We will also examine data on the effect of the intervention on primary 
(e.g., resilience) and secondary outcomes of interest, but these analyses are purely exploratory, 
and we are most interested in how well our selected measures may be sensitive to change. 
Secondary outcomes will include changes in measures of psychosocial distress (depressive 
symptoms, anxiety, social support, and quality of life) and HIV / physical health outcomes 
(suppressed viral load, decreased symptom burden, improved cognitive and physical status). 
We hypothesize that participants in the treatment condition will experience greater 
improvements in resilience, psychosocial distress, and HIV / physical health outcomes. Data 
from this second phase of the study will inform the eventual development of a full-scale 
randomized controlled trial.  
 
2. BACKGROUND AND SIGNIFICANCE 
 
2.1. SIGNIFICANCE 
 
The number of older women living with HIV in the U.S. is growing. In many settings, people 
living with HIV/AIDS can expect to live close to a normal lifespan with ongoing medical care.1–3 
As of 2011, approximately 26% of people living with HIV/AIDS in the U.S. are over the age of 
55; many of these individuals are among the first people in the U.S. to live with HIV over long 
periods of time.4 Because new infections continue to occur among older adults (adults over 50 
comprised 18% of new HIV/AIDS diagnoses in the United States in 2013), the population of 
older adults living with HIV will continue to grow in number.4 It is estimated that approximately 
50% of the population living with HIV will be over age 50 by 2020.5  A significant percent of 
women, particularly women of color, continue to be impacted by HIV/AIDS. Twenty percent of 
new diagnoses in the United States in 2013 overall occurred in women,4 and 23% of these new 
infections occurred in women over age 45; at the end of 2009 over 50,000 women over the age 
of 50 were living with HIV.4 Overall, the proportion of women living with HIV has more than 
tripled in the past decade.6,7 Thus, a significant percentage of older adults living with HIV/AIDS 
in the United States are women.  
 
The experience of aging with HIV results in complex biopsychosocial challenges for 
women, which are experienced as stressors. The burden of managing a lifelong illness that 
is highly stigmatized creates an environment of chronic stress. Older adults living with HIV are 
at risk for additional medical illnesses that occur at disproportionate rates relative to individuals 
not living with HIV, including cardiovascular disease, diseases of bone health, various cancers, 

 
and metabolic disorders.5 The menopausal transition may also be more complicated for women 
living with HIV, as they experience more symptoms.8 Older women living with HIV in particular 
experience greater levels of chronic pain and fatigue than their male counterparts.9,10 Women 
living with HIV report lower levels of health related quality of life than men,11 and experience 
greater numbers of HIV-related health events and greater mortality than men,12 even when 
adjusting for use of antiretroviral therapy.13 These biological factors serve to create a greater 
allostatic load than just managing HIV alone.  
 
With respect to psychological and behavioral challenges, older women living with HIV 
experience high rates of anxiety and depression,14,15 challenges negotiating healthy sexuality, 
and reduced adherence to antiretroviral therapy.16,17 Fears about disclosing serostatus, 
potentially infecting sexual partners, negotiating safer sex practices, and rejection may deter 
older women living with HIV from engaging in sexual activity, which may lead to increased 
loneliness.18,19 Previous literature suggests that women who are in midlife and older who 
experience high levels of HIV-related stigma have lower self-esteem, perform more self-
silencing behaviors, and are less assertive in sexual situations.20 This discomfort in discussing 
sexual behavior transcends interpersonal relationships, and older women may also fear 
initiating open discussions with healthcare providers about sexuality, due to concerns of that 
they will face prejudice and shame for being older and sexually active.20 Many older women 
living with HIV choose celibacy to avoid rejection, but also to avoid HIV transmission.19,21  
 
Socially, older women living with HIV report significant isolation,22–24 which is often the result of 
HIV related stigma, age related stigma or both.25,26 Older women living with HIV engage in 
deliberate attempts to avoid disclosing their HIV status,25 which has been associated with 
increased social isolation and loneliness, even among women who report some level of social 
support. Fear of HIV-related stigma is heightened by age, as older women worry that it is more 
shameful to be an older woman living with HIV than a younger woman.26 Older women living 
with HIV may also experience identity shifts, such as “empty nest” issues with the transition of 
adult children outside the home and serving as a caregiver to another person with chronic 
illness and/or grandchildren27,28; they may also have fewer surviving family members to rely on 
for support.29  
 
While stress can worsen or perpetuate chronic illness,30–33 interventions that foster 
resilience have the capacity to minimize the negative impact of illness-associated 
stressors and lead to successful aging. Resiliency is a “multidimensional construct that 
refers to the ability to maintain adaptation and effective functioning under significant adversity or 
challenging life conditions”34 and has been identified as an important intervention when 
developing psychosocial treatments for older people living with HIV/AIDS,27 particularly women. 
Skills that may foster resilience include increasing social support, mastery, optimism, 
acceptance, will to live, effective self-management, and generativity.27,33 Resiliency interventions 
go beyond traditional stress management interventions by adding elements of positive 
psychology, which teach individuals not only how to manage immediate stressors, but also how 
to live purposefully, optimize health, and build “immunity” for better long term management of 
stress. Resilience, as well as hardiness, a construct closely related to resilience, has been 
associated with improved psychological and physical health, as well as overall quality of life in 
older individuals living with HIV.35,36 Our team conceptualizes resilience as the ability to: (1) 
adapt to stress by purposefully utilizing stress reduction techniques (e.g., eliciting the relaxation 
response); (2) generate adaptive thoughts in response to stress; (3) actively engage in healthy 
lifestyle behaviors, even in the face of stress; (4) experience pleasure and appreciation, again, 
even in the face of stress; and (5) engage in pleasurable and empathic behaviors.37 The 3RP 
intervention goes beyond traditional stress management interventions, by more explicitly 

 
integrating positive psychology strategies (an outline of the 3RP intervention is provided) 
interwoven among traditional relaxation-based behavioral strategies and cognitive-behavioral 
skills. For example, Cognitive Behavioral Stress Management (CBSM) protocols make use of 
tools such as cognitive restructuring, guided imagery, breathing exercises, and communication 
skills, some of which are also contained in the 3RP. However, cognitive restructuring in the 3RP 
is focused not only on modifying maladaptive cognitions, but on eliciting a positive emotion to 
guide a more adaptive response and thus drawing meaning from stressful events. While CBSM 
focuses on enhancing social relationships, this is achieved primarily through improving 
communication skills. The social focus of the 3RP intervention involves an assessment of 
available types of social support, and in the proposed modifications, problem-solving ways to 
close perceived gaps in support to enhance one’s sense of connectedness to themselves and 
others. The 3RP intervention also focuses extensively on mindful awareness skills to improve 
the experience of daily living.  
 
Few interventions have been developed for older adults with HIV; none focus on women, 
nor do existing interventions use a “strengths based” approach. A recent review of 
interventions for older adults with HIV concluded that, overall, there is a dearth of interventions 
available for this population.38 Of the six interventions reviewed, the study populations were all 
predominantly male, and none attempted to develop strengths that may affect the full spectrum 
of factors that influence healthy aging with a chronic illness. The authors conclude that 
subsequent interventions must be more “representative... of the older adult population living with 
HIV”. Thus, the scientific community is compelled to develop interventions that may meet the 
specific needs of older women living with HIV.36  
 
Figure 1: Conceptual model 
 
 
 

 
Theoretical model: The Relaxation Response Resiliency Program (3RP).  
 
The 3RP was developed by Dr. Elyse Park and colleagues at the Massachusetts General 
Hospital’s Benson-Henry Institute for Mind Body Medicine (BHI).34 It is a blending of stress 
management principles from the relaxation response,39 cognitive behavioral treatment, and 
positive psychology. The goal of the 3RP is to decrease the physiological, emotional, cognitive 
and behavioral effects of the stress response by promoting the physiological, emotional, 
cognitive and behavioral effects of the relaxation response. To achieve these goals, the 3RP 
focuses on 3 major areas: (1) eliciting the relaxation response; (2) increasing stress awareness; 
and (3) promoting adaptive strategies (Figure 1). Eliciting the relaxation response involves 
learning strategies to reduce muscle tension, breathing rate, heart rate, and blood pressure, in 
order to help regulate cellular response to stress. Decreasing stress reactivity involves 
increasing one’s awareness of being in the stress response (negative thoughts, emotions, 
physical reactions, and behaviors) and learning skills to change/alter these components (e.g., 
cognitive restructuring). Adaptive strategies focus on utilizing different techniques to promote 
positive growth and self-efficacy in response to stress and stressful life events. It is the learning 
and integration of these three core elements that enables individuals to adaptively cope with 
stressful situations and thus promote one’s resiliency. 
 
2.2 Preliminary Studies 
 
The 3RP intervention. Over the past couple of years, BHI investigators have assessed the 
feasibility and acceptability of the 3RP with pilot trials among medical patients, clinical providers, 
and community cohorts. Pilot trials have shown that the 3RP is efficacious among participants, 
with reported post-treatment improvements in mood and positive affect, stress coping, life/work 
satisfaction, and resiliency. Following treatment, patients with neurofibromatosis (n=17) showed 
significant improvement in resiliency, satisfaction with life, stress, depression, anxiety, 
mindfulness and post-traumatic growth (Cohen’s d=.73–1.33).40 In terms of providers, the 3RP 
has been conducted with palliative care clinicians and medical interpreters. A pilot 3RP group 
was conducted with 16 palliative care clinicians from MGH. Clinicians completed a 3RP group 
treatment and showed a reduction in perceived stress (p=.03; Cohen’s d=.65), an increase in 
perspective taking (p=.10; Cohen’s d=.67) and improvements in positive affect (p=.17; Cohen’s 
d=.42).41 A 3RP treatment was modified to target the needs of medical interpreters (n=28) at 
three academic medical centers in Boston. At 4 weeks post-treatment, interpreters reported 
decreased stress reactivity (Measure of Current Status (MOCS-A)); specifically, participants 
reported feeling more assertive about their needs (p=.10; Cohen’s d=.30), more able to relax at 
will (p=.10; Cohen’s d=.35) and improvements in job satisfaction (p=.02; Cohen’s d=.41).42 We 
have conducted 3RP pilot work with two community samples – members of a World Trade 
Center cohort and veterans. Members of the World Trade Center cohort (n=27) showed post-
treatment improvements in depression and PTSD symptoms (Cohen’s d=.53 and .92, 
respectively), stress management skills (Cohen’s d=1.36) and post-traumatic growth (Cohen’s 
d=.92).37 Sixteen veterans completed the 3RP treatment and showed improvements in post-
treatment depression (p=.02; Cohen’s d=.60), anxiety (p=.06; Cohen’s d=.55), perceived stress 
(p=.04; Cohen’s d=.62), and stress coping efficacy (p=.04; Cohen’s d=.62).   
 
Qualitative data to inform modification of 3RP. As part of a qualitative study funded by the 
Harvard University Center for AIDS Research, our team conducted semi-structured interviews 
with 19 purposively sampled women who were age 50 or older, had a diagnosis of HIV/AIDS, 
and were English-speaking to explore and understand how women living with HIV over 50 
experience living with HIV.19,43 Interviews began with a free-list activity whereby participants 
were asked to list the challenges faced by women over the age of 50 living with HIV. This was 

 
followed by questions exploring the issues raised by the interviewee during the free-list activity 
as well as the following topic areas, which were selected after a review of the literature to 
identify areas important to those living with HIV, older women, or both: (1) mental health 
concerns/cognitive functioning, (2) sexual functioning, (3) menopause, (4) quality of life, (5) 
social support, and (6) management of multiple health conditions/adherence to care. 
  
In addition to identifying challenges, participants were also able to articulate facilitators 
to coping well in the context of aging with HIV. With age came knowledge and understanding of 
what it means to live well and be resilient in the face of HIV. Participants often initially assumed 
that life was over at diagnosis, but the experience of growing older with HIV caused women to 
re-examine those beliefs. This often spurred a desire to begin “living” again. In order to live well 
and cope with the demands of HIV, women made their health a priority and sought ways to 
maximize well-being. This encompassed taking care of both body and mind by seeking 
emotional support from friends, family, and therapy, and making efforts to exercise and eat well. 
Women emphasized the need to eliminate “toxic” forces in their lives, such as drug abuse and 
relationships with “toxic” people. Another aspect of living well with HIV involved making meaning 
of their diagnosis; this was often accomplished by acts of service to the HIV community. Some 
women began attending support groups to offer their support to those recently diagnosed with 
HIV. Others participated in research, or educated family and friends about HIV prevention. 
These findings are consistent with recent studies that have examined aging among older people 
living with HIV/AIDS and highlight the importance of concepts such as resilience, optimism, and 
problem-focused coping to facilitate successful aging and better quality of life.27,35,44,45 We 
describe how we use these findings to inform our modifications to the 3RP intervention to better 
meet the needs of this population below.  
 
Phase I open pilot study findings.  
Recruitment and screening. Participants were recruited through community outreach, posting 
of IRB-approved flyers, and approaching patients at the Infectious Disease Clinic (BMC). At 
MGH, 19 participants were screened. 9 participants were eligible and were then 
consented/enrolled, although 3 of these participants were lost to follow up. At BMC, 20 
participants were screened and 9 were eligible. Of these 9 participants, 4 were 
consented/enrolled and 5 were not consented due to lack of availability for group sessions 
and/or difficulty reaching via phone. 1 participant was lost to follow up due to over-commitment 
in research and scheduling difficulty. 
 
Feasibility and acceptability metrics. 39 total participants were screened and 18 were found 
to be eligible (46.1%). Of these, 13 were consented/enrolled and 10 participated in the 
intervention (76.9%). The duration of the baseline assessment averaged 1.8 hours, ranging 
from 1.25 hours to 3.0 hours (N=13). Post-treatment assessments averaged 1.5 hours and 
ranged from 56 minutes to 1.57 hours (N=6). Exit interviews averaged 36.8 minutes and ranged 
from 12 minutes to 1.03 hours (N=6). Reasons for declining enrollment included work schedule, 
the number of group sessions, transportation cost and distance, medical reasons (e.g., surgical 
procedures limiting mobility), and other life circumstances. Of the 3 participants that were lost to 
follow-up, 2 noted that they were unable to participate due to medical reasons. Participants who 
have completed the intervention to date showed decreases in depressive symptoms as 
measured by the Center for Epidemiologic Studies Depression (CES-D) scale and increases in 
resiliency scores as measured by the Connor-Davidson Resilience Scale (CD-RISC). At the end 
of the intervention, participants reported being “very satisfied” with the program overall and 
stated that they would recommend it to others, although one participant noted the program was 
moderately burdensome as measured by the Perception of Study Assessments survey.  
 

 
Demographics. Of our 13 participants, the mean age was 58, with women ranging from 50-68 
years of age. 61.5% of participants were black or African American (N=8), and 30.8% had 
completed some high school (N=4), while 38.5% had completed some college (N=5). 92.3% 
(N=12) of participants reported that they were diagnosed with HIV more than 5 years ago. 
Additionally, 53.8% (N=7) of participants reported being on disability, and 69.2% (N=9) reported 
$10,000 or less as their total annual income. 
 
Protocol changes. Changes resulting from our pilot study findings include adapting and 
shortening the assessment battery to reduce participant burden, adapting the intervention 
content and length to better meet the needs of our target population, and removing the 
resilience score criterion to decrease screening and enrollment barriers. Other changes include 
providing participants the option of attending up to 3 make-up sessions to accommodate 
scheduling conflicts, which were common in Phase I, and allowing participants to call into group 
sessions by phone after having attended at least one session in-person.  
 
Exit interview data. Participants shared a desire for longer and/or more sessions, as well as an 
appreciation the overall support received. Data collection in the open pilot is still ongoing, 
though an informal review of the qualitative interviews shows that participants have reported 
substantial benefit from the program, specifically in their ability to manage and respond to stress 
adaptively. They identified the in-session breathing exercises and discussions of healthy 
sexuality, social support, and stigma as particularly helpful. Data from participant exit interviews 
indicated general satisfaction with session content, so no substantial changes were made to 
session content (i.e., adding to deleting content) following the final open pilot group.  
 
 
3. RESEARCH STRATEGY 
 
Overview. The goal of this phase of the project is to conduct a randomized pilot study (N=up to 
60) of an adapted mind-body resiliency intervention (3RP) among biologically-born women living 
with HIV, ages 50 and over. Based on exit interviews from the first phase of this study (open 
pilot), as well as qualitative work conducted previously with this population, we will conduct a 
small, randomized pilot of the intervention in groups of up to 10 women with HIV (total N=up to 
60) to assess feasibility and acceptability of study procedures. Participants will be recruited from 
Boston-area hospitals and health care settings, including, but not limited to MGH and MGH 
satellite clinics, Brigham and Women’s Hospital, Boston Medical Center, as well as community 
organizations serving individuals living with HIV. Participants will be screened for eligibility either 
by phone or in person by a study staff member. Eligible and interested participants will attend an 
individual study visit (either in person or via Zoom), during which they will sign informed consent 
(or provide verbal consent if the assessment is conducted via Zoom) and complete a baseline 
assessment. Following completion of this visit, participants will be randomized to either the 
intervention or control arm. The intervention groups will participate in the adapted 3RP 
intervention, while the control groups will participate in a supportive psychotherapy therapy 
program that is time-matched to the intervention. Participants will attend up to 10 group 
sessions (either in person or via Zoom), with opportunities to attend up to 3 make-up sessions in 
cases of scheduling conflict or missed sessions. At the end of the program, participants will 
complete a qualitative exit interview to provide feedback on the intervention (either in person or 
via Zoom). They will also complete a post-treatment assessment, and a 3-month follow-up 
assessment (either in person or via Zoom). 
 
Study setting and participants.  
 

 
Participants will be recruited from the Boston-area hospitals and health care settings, including 
but not limited to MGH and MGH satellite clinics, Brigham and Women’s Hospital, Boston 
Medical Center, as well as community organizations serving individuals living with HIV. The 
Infectious Disease clinic at MGH serves over 1,000 individuals living with HIV per year. 
Approximately 36% of female patients identify as White/Caucasian, 40% identify as 
Black/African-American, and 12% identify as Hispanic/Latina.  
 
Inclusion and exclusion criteria: 
We will recruit and enroll up to 60 individuals meeting the following criteria:  
(1) biologically born/cisgender women who endorse a female identity;  
(2) living with HIV  
(3) age 50 or over;  
(4) English speaking;  
(5) able and willing to sign informed consent.  
 
We believe that non-cisgender women may experience unique and/or additional challenges 
than cisgender women (i.e., stigma related to sexual and/or gender identity, mode of HIV 
infection, etc.); thus, we have excluded them from the study at this time. 
 
Exclusion criteria include: (1) presence of an active (i.e. untreated) and interfering psychiatric 
disorder (e.g., bipolar disorder, schizophrenia, substance abuse) that, in the opinion of the 
principal investigator or appropriate clinical staff, would compromise the individual’s ability to 
participate in and benefit from the intervention; (2) have participated in structured cognitive 
behavioral therapy and/or a comprehensive mind-body intervention (including both mindfulness 
and behavioral therapy components) in the past year, also in the opinion of the principal 
investigator or appropriate clinical staff. By sampling from an array of medical centers, small 
clinics, and community organizations, we expect to recruit a representative sample of older 
women living with HIV. 
 
If people are ineligible for the study at screening and ask for resources, we will refer them 
additional services in the community, including, but not limited to the following: 
 
(1) stress reduction groups at the Benson-Henry Institute for Mind Body Medicine at MGH; 
(2) mindfulness-based stress reduction and mindfulness-based cognitive therapy programs at 
the Center for Mindfulness at the University of Massachusetts Medical School; 
(3) “Find a Therapist” tool on the American Psychological Association website; 
(4) their primary care provider and/or their insurance company for a therapy referral 
 
Recruitment procedures.  
 
At MGH, a research assistant or other study staff member will review lists of potentially eligible 
patients, and ask providers to introduce the study, and obtain permission to be contacted by a 
study staff member. Participants may also be directed referred to the study by a health care 
provider. Flyers advertising the study will also be posted in patient waiting areas in Boston area 
hospitals (as described above) and health centers and distributed to Boston-area community 
organizations serving persons living with HIV (e.g., AIDS Action and The Living Center). Rally, 
the Partners Healthcare online recruitment platform, will also be used to aid in recruitment 
efforts. Additionally, study staff will use the MGH Research Patient Data Registry (RPDR) to 
identify patients who meet eligibility criteria and have previously indicated their interest in 
research participation, and conduct direct patient outreach via letters. The study team will attend 
meetings of the clinics from which patients are recruited to discuss the study as needed. These 

 
methods have been used successfully in other projects, including Dr. Psaros’ Harvard University 
Center for AIDS Research Scholar Award (P30 AI060354) with a similar population, and Phase I 
of this study (2017P000404).  
 
Consent procedures. 
 
After eligibility has been determined and interest in participation has been verified, participants 
will be scheduled to attend a baseline assessment (either in person or via Zoom) during which 
the informed consent document will be reviewed in a private setting.   
 
If the baseline assessment is conducted in person, a detailed consent form will be signed by 
each participant following an explanation of the study procedures. The consent form will include 
all study procedures, information about potential risks and benefits of participation, and 
information regarding who they can contact for further questions. It also will state that 
participation is voluntary, that participants can refuse to answer any question, that they can 
withdraw from the study at any time, and that study participation is in no way related to their 
health care. The participant will also be asked to provide permission to receive a reminder call 
from a study staff member before each study visit and that it is permissible to leave a message, 
or if they prefer, to receive a confirmatory email with appointment time and location. We will 
share the “Partners Required Warning Language for Email Correspondence” if they elect to 
receive email communication to ensure their full understanding of potential confidentiality risks 
associated with unencrypted emails. Participants will be given as much time as needed to 
review the consent form before signing, even if it means postponing the baseline assessment. 
 
If the baseline assessment is conducted via Zoom, study staff will email each participant a copy 
of the study fact sheet prior to their assessment, and then review the fact sheet in full with the 
participant via Zoom in order to obtain verbal consent. Verbal consent will be documented in a 
password-protected participant tracking spreadsheet, which will be saved on the Partners 
secure shared drive and accessible only to members of the study team. Participants will also be 
given the option to receive a signed copy of the study fact sheet via email or mail for their 
personal records. 
 
Study procedures and data collection.  
 
Table 1: Approximate Study Timeline for Phase II 
 
Months 
Activity 
1-16 
• 
Conduct of the randomized pilot trial groups. 
• 
Complete all recruitment activities. 
17-20 
• 
Complete all participant activities, including post-treatment assessments and 
follow-up visits. 
• 
Data analysis and write-up. 
 
An approximate timeline for Phase II of the study is provided in Table 1. We have tailored the 
existing treatment manual to more specifically meet the needs of older women living with HIV 
based on the first phase of this study, as well as our prior qualitative work with the same 
population. The original 3RP intervention consisted of eight, 90-minute weekly group sessions 
and is described in Table 2. We expanded the number of sessions from 8 to 10 to 

 
accommodate the HIV-specific elements and skills added to the original intervention content. A 
more detailed description of the intervention modules is provided below. 
 
Table 2: Original Relaxation Response Resiliency Program Chapters and Goals 
Chapter Title 
Goals 
Chapter 1 
The Relaxation 
Response Resiliency 
Program 
o Introduce the Relaxation Response Resiliency Program 
(3RP) and its 3 components  
o Discuss how to elicit the RR 
o Introduce RR-elicitation method: single pointed focus 
meditation 
o Introduce the concept of appreciation 
o Establish program and weekly goals 
o Identify individual’s sources of stress and coping 
Chapter 2 
The Relaxation 
Response 
o Introduce RR-elicitation method: breath awareness 
o Describe the relationship between the RR, health and 
wellness 
o Introduce ‘Minis’ as a method to reduce tension and anxiety 
through the day 
o Assess recuperative sleep 
Chapter 3 
The Four Components 
of Stress: Emotional 
and Behavioral 
o Introduce RR-elicitation method: autogenic training 
o Learn the four-component model of stress 
o Identify individual’s emotional and behavioral components of 
stress 
Chapter 4 
The Four Components 
of Stress: Physical and 
Cognitive 
o Introduce new RR-elicitation method: chair yoga 
o Describe cognitive and physical components of stress 
o Describe automatic, self-defeating thoughts 
o Define different types of cognitive distortions, and learn how 
to identify them 
Chapter 5 
Building a Positive 
Perspective 
o Introduce new RR-elicitation method: joyful place imagery 
o Use cognitive reappraisal as a way to build adaption 
o Identify how positivity can increase resiliency in the long term 
o Learn concepts and strategies for enhancing positivity 
Chapter 6 
Mindful Awareness and 
Acceptance 
o Introduce RR-elicitation method: mindful awareness 
o Use strategies for applying mindful awareness in daily living 
o Learn about different coping styles: problem-solving and 
acceptance-based coping 
o Explore the development of acceptance, an essential quality 
of acceptance-based coping 
Chapter 7 
Healing States of Mind 
o Introduce RR-elicitation method: loving-kindness meditation 
o Introduce and evaluate types of social support 
o Learn how to select coping strategies: problem-solving and 
acceptance 
o Practice using humor to enhance processes of appreciation 
and acceptance 
o Introduce RR-elicitation method: idealized self 

 
Chapter 8 
Staying Resilient 
o Identify how empathy can increase resiliency in the long term 
o Review 3RP strategies learned 
o Develop a plan for continuing to use program strategies 
o Set goals for the future 
 
Optimizing health can facilitate psychological resilience. Because successful management of 
HIV requires ongoing contact with the medical system and lifelong adherence to antiretroviral 
therapy, and because older women with HIV often have to navigate additional medical 
comorbidities,46,47(p) information on how to manage health in the context of HIV has been added 
to content from the “Healing States of Mind” module, in addition to information on activity and 
nutrition. We expanded upon the “Building a Positive Perspective” content to include material on 
valued action based on our finding that living a meaningful life and finding meaning from an HIV 
diagnosis is important to aging well with HIV.43 The concept of valued action is derived from 
Acceptance and Commitment Therapy48 and involves identifying values across multiple 
domains of life and assessing current satisfaction with each domain.  
 
Our prior data also suggested that capitalizing on positive social supports and minimizing 
contact with negative social supports is important.43 Thus, we expanded the content contained 
in the “Healing States of Mind” module to include an exercise that involves identifying positive 
and negative social influences, and using problem-solving skills to formulate plans to develop 
greater positive social support, and reduce the impact of negative social influences. Given the 
data on challenges with sexuality and the high levels of stigma and social isolation in this 
population, sexuality will also be directly targeted in combination with content from the “Healing 
States of Mind” module. Updated education on risks of HIV transmission (particularly in the era 
of treatment as prevention and biomedical HIV prevention)49,50 will be shared. Goals around 
sexuality will be discussed, and problem-solving skills will be used to overcome barriers to 
healthy sexuality. 
 
Throughout the program, participants will set goals for their weekly relaxation practice, in 
addition to other self-determined goals related but not limited to healthy lifestyle behaviors, HIV 
management, social support, and valued action. Progress on goals will be evaluated and new 
goals will be set over time. For example, if an individual articulates that she values service to the 
HIV community, but is not currently engaged with that community, goals may include 
researching options for involvement, contacting agencies of interest, and eventually applying to 
serve as a volunteer. 
 
As described above, some of the most common challenges for older women living with HIV are 
anxiety, depression, loneliness, managing multiple medical comorbidities, chronic pain, fatigue, 
sexuality, and stigma. In Table 3, we highlight how the skills contained in our modified 3RP 
intervention target these issues.  
 
 

 
Table 3: Skills Table 
 
Common concerns for 
older women living       
with HIV 
Current intervention skills 
Additional skills added to 
existing intervention 
Stress of managing a 
chronic long-term, life 
threatening illness; toxicities 
associated with long term 
use of ARVs; additional 
medical comorbidities 
Eliciting the relaxation response 
(e.g., meditation, chair yoga; 
imagery); optimizing 
recuperative sleep; cognitive 
reappraisal; building a positive 
perspective; acceptance based 
coping skills; physical activity 
and nutrition recommendations 
Supporting healthy lifestyle 
behaviors (e.g., how to 
manage health in the context 
of HIV); self-compassion 
Pain and fatigue 
Eliciting the relaxation response 
(e.g., meditation, chair yoga; 
imagery); cognitive reappraisal 
Supporting healthy lifestyle 
behaviors (e.g., pacing); self-
compassion 
Stigma and social isolation 
Evaluation of current social 
support; cognitive reappraisal; 
building a positive perspective; 
acceptance based coping skills 
Valued action; problem-
solving around developing 
healthy social supports; self-
compassion 
Depression and anxiety 
Eliciting the relaxation response 
(e.g., meditation, chair yoga; 
imagery); cognitive reappraisal; 
building a positive perspective; 
acceptance based coping skills; 
physical activity and nutrition 
recommendations 
Valued action; problem-
solving around developing 
healthy social supports; self-
compassion 
Sexuality concerns 
Cognitive reappraisal 
Education around HIV 
prevention; development of 
sexuality goals; problem-
solving barriers to goals; 
self-compassion 
 
In the present phase of this study, we will conduct a randomized pilot of the revised intervention 
and all assessments among groups of up to 10 participants. Prior to beginning the revised 
intervention, participants will complete a baseline assessment lasting approximately 45-60 
minutes (either in person or via Zoom). At the baseline assessment visit, participants will 
complete a series of quantitative self-report measures (described below), including 
sociodemographic information and data on resilience, antiretroviral adherence, stress reactivity, 
HIV disclosure status, anxiety, depression, social support, health-related quality of life, symptom 
distress, coping, substance use, perceptions of HIV stigma, and sexual functioning and 
communication. Participants will also complete a cognitive assessment. All questionnaires will 
be completed on either a touchscreen tablet or on paper (if the assessment is conducted in 
person) or verbally via phone or directly in REDCap (if the assessment is conducted via Zoom). 
For participants for whom questionnaires must be read aloud, response option cards will be 
provided (either in person or via email) for each instrument to serve as a visual reminder of the 
response options for scales on different questionnaires. Study staff will be available to assist in 
completion of the self-report questionnaires when needed. Participants will also be asked to 
have their blood drawn at the MGH Clinical Research Center (CRC), located in the White 

 
Building 12 on the main hospital campus. In order to minimize inconvenience, participants will 
be provided with information about the on-call MGH shuttle service that can transport them to 
the main hospital campus from One Bowdoin Square. All blood draws are optional; participants 
may opt out and still participate in the study. Note: Study blood draws will not be conducted for 
the duration of virtual conduct of study procedures (i.e., assessment visits and group sessions). 
If and when it becomes safe for participants to receive blood draws in-person, scheduling of 
study blood draw visits will resume. 
 
If participants who have completed a baseline assessment are unable to participate in the group 
(e.g., due to changes in availability), study staff will re-do the informed consent process and 
baseline assessments before participants join a subsequent group.  
 
Following completion of this initial baseline visit, participants will be randomized (1:1) to the 
intervention or control arm. Random assignment to condition will minimize the likelihood of bias 
in either condition. A study research assistant or staff member not involved in the actual therapy 
will hold the randomization scheme, which will be developed by the study biostatistician (Dr. 
Mark Vangel). Baseline characteristics for each group will be examined for significant 
differences.  
 
The control condition will be a supportive therapy program that is matched to the intervention for 
number and length of sessions. A version of this intervention has been used in a randomized 
controlled trial evaluating the efficacy of a combined depression and adherence treatment 
intervention, on which Dr. Psaros worked (R01MH084757). Basic principles of supportive 
psychotherapy will be followed 51,52, and the interventionist will facilitate discussion around what 
it is like to live with HIV as an aging woman. Sessions will be delivered by a study staff member 
(either in person or via Zoom) who will be thoroughly trained on the intervention or control 
condition material (e.g., predoctoral psychology intern, postdoctoral psychology fellow, junior 
psychologist). All group facilitators will receive supervision on a weekly or biweekly basis.  
 
Participants will be given the opportunity to attend up to 3 make-up sessions (either in person or 
via Zoom) if they are unable to attend the originally scheduled session. For the control condition, 
makeup sessions will entail individual supportive psychotherapy. We will also allow participants 
to call into up to 3 group sessions by phone after having attended at least one session in-
person. This will allow for more flexibility in scheduling and facilitate better overall attendance 
over the duration of the program. Additionally, participants in both the intervention and control 
groups will receive a schedule of all group sessions in order to minimize confusion about 
session dates and maximize efficiency of make-up scheduling.  
 
Following completion of the intervention or the control group sessions, participants will complete 
a post-treatment assessment (either in person or via Zoom). Apart from the sociodemographic 
information, participants will complete all the same quantitative self-report measures (described 
below) as in the baseline assessment. Additional measures assessed at post-treatment include 
a measure of client satisfaction and a measure of perceptions regarding study assessments. All 
questionnaires will be completed on either a touchscreen tablet or on paper as described above 
(if the assessment is conducted in person) or verbally via phone or directly in REDCap (if the 
assessment is conducted via Zoom). We will also conduct semi-structured, individual qualitative 
exit interviews (either in person or via Zoom) to evaluate participants’ perceptions of their 
experience in the study. Interviews will explore treatment content, satisfaction with group format 
(including group versus individual delivery), length of individual sessions, scheduling and 
location of sessions, adherence to the skills covered in the sessions, length of the overall group 
intervention, and perceptions of the assessment experience, including length of battery. In 

 
addition to the qualitative interviews, the randomized pilot trial will provide information relevant 
to manual revisions in the form of audio recordings of sessions, weekly progress notes, 
therapist and patient ratings of satisfaction with and helpfulness of treatment procedures, and 
participant ratings of out of session practice of skills. Audio recordings of selected sessions will 
be made available for download from a secure, password-protected, HIPAA-compliant website 
and viewed by the study team.  
 
Finally, we will conduct 3-month follow-up assessments (either in person or via Zoom), during 
which participants will complete all the same quantitative self-report measures (described 
below) as in the post-treatment assessment, apart from the sociodemographic information, 
client satisfaction measure, and measure of perceptions regarding study assessments. All 
questionnaires will be completed on either a touchscreen tablet or on paper as described above 
(if the assessment is conducted in person) or verbally via phone or directly in REDCap (if the 
assessment is conducted via Zoom). 
 
Retention. The research assistant will track participant retention, which will be reviewed weekly 
by the principal investigator. We will collect extensive locator information at baseline (that 
contains contact information for at least two individuals with whom the participant is in regular 
contact) for participants in the event that they move or discontinue HIV care at the recruitment 
site, or become lost to follow-up from study procedures. Locator form information will be 
collected either in person or via Zoom. Should the individuals listed on the locator form be 
contacted, reference to HIV will never be made. We will make concerted efforts to maintain 
contact with individuals who discontinue the intervention but are still willing to complete follow-
up assessments. To facilitate such retention, if necessary we will meet with participants at any 
confidential location that is comfortable for them for study assessment visits. Additionally, we 
have budgeted for financial incentives and public transportation costs.  
 
Fidelity: All sessions led by the group facilitators will be audio-taped. Monitoring of the 
intervention will take into account both therapist adherence as well as competence.53 We have 
developed a rating checklist for therapist adherence including whether the specific components 
of the modules of treatment were delivered, as well as a contamination checklist to measure the 
degree to which group facilitators introduced intervention content into the control sessions. This 
will be done by the PI (Psaros) or clinical supervisor. At least ten percent of the sessions will be 
reviewed.  
 
Assessment instruments: All assessments that occur post treatment will be conducted by a 
study team member who did not serve as the group facilitator to minimize the risk of bias. We 
expect the baseline assessment, post-treatment assessment, and 3-month follow-up 
assessment to each last approximately 45-60 minutes.  
 
Sociodemographic data: Data on age, race/ethnicity, relationship status, occupational status, 
and socioeconomic status will be collected at baseline, as will disclosure of HIV status and 
history of exposure to traumatic events, including interpersonal violence. Participant zip codes 
will also be recorded to account for time traveled to study visits.  
 
Feasibility: To assess feasibility, we will track the number of potential participants we screen, 
the number of potential participants who meet study inclusion criteria, the number of participants 
who meet study criteria and then enroll (and the time it takes to complete these steps), and the 
number of treatment and assessment sessions completed by all enrolled participants. We will 
also track the duration of assessments, reasons for declining enrollment and for prematurely 
leaving the trial, and make-up sessions attended. The study team will review these data and 

 
determine the degree of feasibility, though we will consider these feasibility/retention outcomes 
in the context of what other trials conducted with older individuals living with HIV have 
achieved.38 
 
Acceptability: Acceptability will be assessed at post treatment using the eight-item Client 
Satisfaction Questionnaire (CSQ-8),54 a measure of how much an individual values a treatment. 
Items assess factors such as the perceived quality of the services, how much the services met 
needs, satisfaction with the help received, and others. Items are scored from 1 (poor) to 4 
(excellent), with higher scores indicating greater satisfaction. We will also ask participants about 
their perceptions of the burden of the study assessment battery.  
 
Resilience.  
Resilience: The Connor-Davidson Resilience Scale (CD-RISC)55 is a self-report measure of 
resiliency comprised of 10 items rated on a five-point scale (0 = not true at all, 1 = rarely true, 2 
= sometimes true, 3 = often true, 4 = true nearly all the time). Items capture various aspects of 
resilience including adaptability to change, availability and use of social support, and problem-
solving style. Total scores range from 0-40; high scores indicate greater resilience. The CD-
RISC has demonstrated good psychometric properties in previous research, including among 
medical populations.55 
 
Measure of Current Status (MOCS-A): The MOCS-A is a 13-item self-report measure of stress 
reactivity and coping, which will be administered at baseline and post treatment. It was 
developed to assess one's current self-perceived status on several skills targeted by the 
intervention, including the ability to relax at will, recognize stress-inducing situations, restructure 
maladaptive thoughts, be assertive about their needs, and choose appropriate coping 
responses. Statements are rated from 0 (I cannot do this at all) to 4 (I can do this extremely 
well). Scores range from 0-52; higher scores suggest better coping skills. 
 
Secondary Outcomes: Psychosocial.  
Anxiety: Anxiety symptoms will be assessed using the State form of the State-Trait Anxiety 
Inventory (STAI).56 The STAI State form is a 20-item self-report measure that has been used 
successfully to measure state anxiety in clinical and research settings. Respondents report the 
intensity of their current anxiety on a 4-point scale (1 = not at all, 2 = somewhat, 3 = moderately 
so, 4 = very much so). Scores range from 20-80, with higher scores indicating greater anxiety. 
This measure has been widely researched and used, and previous studies have found that the 
STAI is consistently reliable and valid.57  
 
Depression: Depressive symptoms will be assessed using the Center for Epidemiologic Studies 
– Depression scale (CES-D).58 This is a 20-item self-report measure that screens for depression 
and depressive episodes. Respondents report how often they experienced symptoms 
associated with depression on a 4-point scale (0 = rarely or none of the time, 1 = some or a little 
of the time, 2 = occasionally or a moderate amount of the time, 3 = most or all of the time). 
Scores range from 0 to 60; high scores reflect greater depressive symptoms. The CES-D has 
been found reliable (Alpha >.85) in previous research among medical populations, women in 
midlife, and older adults.59–61It has also been found to have good sensitivity and specificity.61 
 
Social support: Social support will be assessed using the Medical Outcomes Study Social 
Support Survey.62 The Medical Outcomes Study Social Support Survey is a 20-item self-report 
measure of emotional/informational support, tangible support, and positive social interaction. 
Respondents rate on a 5-point scale (1 = none of the time, 2 = a little of the time, 3 = some of 
the time, 4 = most of the time, 5 = all of the time) how often each type of social support is 

 
available to them if they need it. The measure has good reliability and was found be fairly stable 
over a one-year period.63  
 
Quality of life: Health related quality of life will be assessed using the AIDS Clinical Trials Group 
quality of life assessment, the Multidimensional Health Status Assessment. This is a self-report 
measure, in which individuals report the effect of their health on their quality of their existence 
across multiple domains including physical and psychological functioning. Items on this scale 
also assess the extent to which pain and fatigue have a negative impact on quality of life. 
Previous research has consistently confirmed that the assessment is highly reliable and valid, 
and it is used extensively in HIV research.64,65 
 
HIV stigma: HIV stigma will be assessed using the HIV Stigma Scale,66 a widely used measure 
of personalized stigma, disclosure concerns, negative self-image, and concern with public 
attitudes toward people with HIV. Respondents report their experiences of stigma on a 4-point 
scale (strongly disagree to strongly agree), with a total score ranging from 0 to 75. The measure 
has been validated among adults living with HIV (alpha = 0.88).67 
 
Substance use: The Addiction Severity Index-Lite (ASI-Lite)68 will be used to assess lifetime and 
recent substance use, including severity. It also asks about route of administration and if any 
substance use is prescribed. The number of items depends on substances endorsed. It has 
good internal consistency (alpha = 0.61 – 0.89).69 
 
Coping: Coping strategies will be assessed using the Brief COPE.70 This is a 28-item measure 
rated on a 4-point scale (I haven’t been doing this at all to I’ve been doing this a lot) evaluating 
how often individuals engage in specific strategies in response to specific stressors. It consists 
of 14 subscales (self-distraction, active coping, denial, substance use, use of emotional support, 
use of instrumental support, venting, behavioral disengagement, positive reframing, planning, 
humor, acceptance, religion, self-blame). Total scores range from 28 to 112, with higher scores 
indicating greater use of the coping strategy. 
 
Sexual functioning: Sexual functioning will be assessed using the Female Sexual Function 
Index,71 a 19-item gender-specific measure that asks about sexual functioning across six 
domains (desire, arousal, lubrication, orgasm, satisfaction, pain). Total scores range from 2 to 
36, with higher scores representing higher sexual functioning. The measure was developed for 
women with female sexual arousal disorder but has also been validated in the general 
population.72 It has good internal consistency (alpha = 0.78 – 0.84).73 
 
Sexual communication: Sexual communication will be assessed using the 6-item version of the 
Dyadic Sexual Communication (DSC) Scale,74 a measure of how individuals perceive 
discussions surrounding sexual matters with their partners. Items are rated on a 6-point Likert 
scale from 1 (disagree strongly) to 6 (agree strongly), with total scores ranging from 13 to 78, 
and higher scores indicating higher quality of communication. The original measure has been 
found to have good internal consistency (alpha = 0.81).74 
 
Secondary Outcomes: HIV/Physical Health.  
The proposed content on how to manage health in the context of HIV (See Table 3) provides 
information on the importance of sustained adherence to antiretroviral therapy and continued 
engagement in HIV care, as one must adequately manage their disease to be truly resilient in 
the face of HIV infection. Individuals will generate plans and back-up plans on how to manage 
common barriers to antiretroviral adherence, as well as engagement in HIV care. Thus, we will 
assess variables related to HIV management, to measure the performance of this content. Data 

 
on time since HIV diagnosis will be assessed at baseline. The following variables will be 
assessed: current antiretroviral therapy regimen, adherence to antiretroviral therapy regimen, 
and engagement in HIV care.  
 
Engagement in HIV care: On average, persons living with HIV should meet with their HIV 
provider four times per year.75 We will ask participants when they last saw an HIV care provider.  
 
Adherence to antiretroviral therapy: Adherence will be assessed via self-report.  Data on self-
reported adherence will be collected each week using the participant “weekly adherence to 
skills” forms described below. The questions will be based on standardized questions for self-
report assessment of adherence to antiretroviral therapy.76 A list of common antiretroviral 
medications will be provided along with the adherence assessment in order to facilitate 
participant memory and enhance self-report. 
 
CD4 and viral load: CD4 count will be assessed at baseline only, while viral load will be 
assessed at baseline, post-treatment, and 3-month follow-up visits. At the baseline assessment, 
patients will have two tubes drawn by a phlebotomist at the MGH Clinical Research Center 
(CRC), located in the White Building 12 at 55 Fruit Street, Boston, MA 02114. One EDTA 
(lavender top) tube will be used for HIV viral load measurements (10 ml of blood) and another 
for CD4 (3 ml of blood). Per hospital clinic protocol, each visit will include an intake and 
measure of vital signs prior to the blood draw. At subsequent major assessment visits (post-
treatment and three-month follow-up), only one tube will be drawn. All blood samples will be 
analyzed at the MGH Core Lab, located in the Warren Building 225 at 55 Fruit Street, Boston, 
MA 02114, and results will be available within 5-7 business days for the viral load, and 24-48 
hours for the CD4 count. Recent viral load and CD4 count will be abstracted from participants' 
health records if they are patients at MGH. The purpose of this is to save participants an 
unnecessary blood draw if they have recently had these tests done during a clinical visit. Both 
MGH patient registration status and recent clinical blood draw history will be determined during 
screening process. All blood draws are optional; participants may opt out if they so choose. 
 
Symptom burden: Symptom burden will be assessed using the using the AIDS Clinical Trials 
Group Symptoms Distress Module,77 an instrument that measures distress related to HIV 
symptoms, and asks participants to rate on a 5-point scale (0 = I do not have this symptom, 1 = 
it doesn’t bother me, 2 = it bothers me a little, 3 = it bothers me, 4 = it bothers me a lot) how 
much each of 20 symptoms (e.g., fatigue, nausea, muscle aches) bothered them during the past 
four weeks. The instrument is reliable and valid, is used extensively in HIV research and has 
also demonstrated cross-cultural validity.78,79  
 
Cognitive status: Cognitive status will be assessed using the Mini-Cog.80 The Mini-Cog can 
quickly detect cognitive impairment through its three-item recall test and a clock-drawing test 
(CDT) administered by a clinician. Respondents score as positive for cognitive impairment if 
they recall no words, or recall 1 or 2 words with an abnormal CDT. Both measures have been 
used with older adults in various health care settings, and previous research has found 
consistently good reliability and validity.81,82  
 
Weekly adherence to skills: Practice notes have been developed to correspond with each 
module of the 3RP treatment. Participants will be asked to keep brief daily diaries of their out of 
session practice (e.g., completion of 15 minutes of meditation, engaged in activities to foster 
social connectedness, engaged in a desired lifestyle behavior, etc.). These diaries will be used 
to generate a rating of adherence to out of session practice guidelines. If group sessions are 
conducted virtually via Zoom, participants in the intervention group will be mailed an envelope 

 
containing weekly practice notes to be completed during the 10-week group program. 
Participants will then be asked to mail back the completed practice notes (via a pre-paid 
envelope) at the end of the program.  
 
Treatment Credibility and Expectancy: The Treatment Credibility/Expectancy Questionnaire 
(CEQ)83 is a widely used 6-item measure that assesses treatment credibility and expectancy. 
Participants are asked to rate the treatment from 1 (not at all) to 9 (very much) and from 0% (not 
at all) to 100% (very much). The percentage ratings are subjected to linear transformation with a 
minimum of 1 and a maximum of 9. We will administer the scale after the first treatment session. 
 
COVID-19-related:  Quantitative assessments and the qualitative exit interview will contain 
COVID-19-related items in order to better understand the impact of COVID-19 and 
corresponding public health restrictions on participants' lives (e.g., mental health, ability to 
adhere to HIV medications), and their experience participating in this study. 
 
Participant remuneration.  
 
Participants will receive up to $293 over the course of the study, including $25 for their time 
after each of the assessment visits (i.e., baseline, post-treatment, 3-month follow-up, and 
optional qualitative exit interview), $25 for interview questions related to COVID-19, as well as 
$12 reimbursement for attending all study visits (either in person or via Zoom).  
 
Participants may be remunerated via eCheck or Forte cards. If study visits are conducted 
virtually, Forte cards will be mailed to participants’ homes for the purposes of remuneration 
during the study.  
  
Foreseeable risks and discomforts.  
 
It is unlikely that participants will be at any risk for physical harm resulting from study 
participation. Participants may find some of the questions covered in the assessments to be 
emotionally upsetting. Participating in a counselling study (for resilience) can be difficult, 
because it may involve discussing personal matters. As with any study, there is always the risk 
of inadvertent breach of confidentiality. This is of particular importance here because 
participants are living with HIV, which may be stigmatizing. An additional discussion of how we 
minimize these risks is described below. 
 
Minimization of risks.  
 
It is unlikely that participants will be at any risk for physical harm resulting from study 
participation. In the event that any study procedures result in significant distress, the participant 
will be given the opportunity to cease study participation. All research study staff will be 
thoroughly trained in assessment procedures. If a participant is determined to be in distress or 
actively suicidal and at risk for self-harm during any study procedure, study staff will contact the 
PI (Psaros) or another trained clinician, so that appropriate clinical intervention is executed. Any 
participant who scores greater than or equal to a 23 on the CES-D will be evaluated (either in 
person or via Zoom) by a licensed psychologist or another qualified provider/clinician and 
referred for additional services as needed.84 The group facilitators will participate in regular 
supervision. We have added a DSMB that will convene at least annually to afford additional, 
external review of study procedures, participant safety, and adverse events. 
 

 
Additionally, Dr. Psaros has been involved with numerous local and national studies of persons 
with HIV and has considerable experience implementing measures to protect confidentiality. 
Some of these steps include in-service trainings on confidentiality and the assignment of study 
ID numbers. Staff at all sites who conduct participant recruitment, screening, enrollment, and 
assessments will have been trained in ethical human subjects research, screening and 
interviewing techniques, to minimize participant risk as much as possible; this includes all staff 
at non-Partners sites. All data will be kept confidential, under lock-and-key, accessible only to 
trained study staff. Participants’ data will be identified by an ID number only, and a link between 
names and ID numbers will be kept separately under lock and key. Any paper-based 
assessments will be stored under lock and key within a secure office space accessible only to 
approved study staff. The study database will be secured with password protection and 
accessible only to approved study staff. Participants will be asked to sign a confidentiality 
statement prior to the inception of group sessions (if the baseline assessment is conducted in 
person) or verbally consent to such an agreement (if the baseline assessment is conducted via 
Zoom). 
 
Expected benefits.  
 
It is possible that there will be no direct benefit to participants in the current study. However, 
participants may benefit from participation via an increased understanding of how to optimize 
well-being among older women living with HIV, and that may improve the care of this population 
in the future. Participants may also feel a sense of purpose that they are contributing to work 
that may help others. Participants are also provided financial remuneration for their participation. 
 
Equitable selection of participants.  
 
Participants will be biologically born women, living with HIV, age 50 years or older, and English 
speaking. Participants must be able to provide informed consent and agree to study procedures 
(e.g. completion of assessments and intervention program). The patient population will be 
comprised of individuals of varied racial/ethnic and socioeconomic backgrounds. All participants 
meeting inclusion criteria will be offered the opportunity to participate. We will not exclude 
participants based on minority status. 
 
Data analytic plan. 
 
Quantitative data will be entered in an on-going fashion (into REDCap data management 
system), and will be analyzed using SPSS, “R”, and QSR NVivo qualitative software, version 9, 
after being thoroughly checked and cleaned as appropriate. Dr. Psaros has the full support of a 
biostatistician (Dr. Mark Vangel) for all statistical analyses. We will compile descriptive statistics 
to examine intervention acceptability and feasibility as described above, as well as to examine 
indicators of change on measures of various psychosocial outcomes. We will compare each 
outcome between groups using mixed model regression analyses, with subject as a random 
effect. Fixed covariates will include time in study (baseline, end of treatment, 3-month follow-up) 
and time since diagnosis. Other covariates, such as education, socioeconomic status, and 
history of exposure to traumatic events will also be considered. We will consider exploratory 
mediational and moderational analyses, based on procedures outlined by Hayes.85 We will 
assess adherence in the active treatment arm, in particular to determine if adherence is related 
to change in the primary outcome. We will perform exploratory multivariate analyses among the 
outcomes, including graphical methods and the calculation and testing of correlations and 
partial correlations. We will examine patterns in missing data in order to see if missingness is 
related to measured patient characteristics. We will adjust for missing data using multiple 

 
imputation as appropriate. We will adjust for multiple comparisons using the method of Hothorn, 
Bretz and Westfall.86 Statistical analyses will be performed using “R” software.87 
 
All qualitative data resulting from exit interviews will be analyzed using standard qualitative 
methodologies described by the Office of Behavioral and Social Sciences Research at the 
National Institutes of Health. Specifically, data will be analyzed using content analysis, an 
iterative, multi-step process as described by Miles and Huberman88 and Strauss and Corbin.89 
The investigators will use NVivo software (version 10) to organize data and to facilitate 
analyses. Two study team members will independently review the transcripts in order to 
generate an overarching thematic framework for data interpretation, in which major and minor 
themes are identified. Using multiple coders also enhances the validity of the analysis.90 The 
investigators will compare their thematic frameworks for consistency, and any discrepancies will 
be discussed until there is agreement on the thematic framework. Data will be reexamined, 
messages will be extracted and highlighted, and ongoing discussion between coders will allow 
for further theorizing and making interconnections between research questions, coding 
categories, and raw data.88 
 
Mechanisms for reporting adverse events.  
 
Adverse events are defined as harmful occurrences to study participants, either study related or 
non-study related, during participation in the clinical intervention study. As a result of 
participation in the intervention or qualitative interviews, study staff may become aware of an 
adverse event, including participant distress or disclosure of violence or abuse, or suicidal 
ideation. Study staff will be trained to make appropriate referrals for clinical care in consultation 
with the PI and co-investigators. All adverse events will be reported by the PI to the IRB within 
the required reporting periods as outlined by the PHRC policy, and these will be discussed 
during team meetings. Anticipated or unrelated adverse events will be reported to the DSMB 
and the annual summary, the DSMB report will state that the board has reviewed all AE reports. 
These will be discussed on weekly calls / in-person meetings with Dr. Psaros and key study 
staff. Unexpected fatal or life-threatening AEs related to the intervention will be reported to the 
NCCIH Program Officer within 7 days. Other serious and unexpected AEs related to the 
intervention will be reported to the NCCIH Program Officer within 15 days. To ensure 
confidentiality during reporting, adverse event reports and annual summaries will not include 
identifiable information. Each report will only include the participants’ ID numbers. 
 
Data monitoring.  
 
Data collection occurs in the form of a series of quantitative assessments and qualitative 
interviews. The principal investigator (Psaros) will work closely to oversee all data management 
and analysis issues, along with the project statistical (Vangel) and the rest of the study team. 
The study staff will review all data collection forms on an ongoing basis for data completeness 
and accuracy as well as protocol compliance. Data verification will be performed weekly by a 
study research assistant who will not be involved in data collection or have any direct contact 
with study participants. All intervention sessions and exit interviews will be audiotaped 
(participant consent will be obtained). Intervention fidelity will be assessed by randomly 
selecting approximately 10% of sessions and assessing adherence to the protocol based on 
checklists and scales specifically developed for this study. The group facilitator will also 
participate in weekly supervision with Dr. Park, Dr. Traeger or a study staff psychologist, where 
audio of sessions will also be reviewed. 
 
Project organization.  

 
 
A timeline of study procedures is provided in Table 1 and a timeline of study assessments is 
provided in Table 4. Dr. Psaros, as the principal investigator and overall project director, will 
oversee all aspects of the project. She will supervise the research assistants at MGH, and 
oversee the data management and data analyses. Lastly, Dr. Psaros will serve as a liaison 
among the other investigators, and together with the co-investigators, will prepare manuscripts 
and present findings at national conferences. 
 
 
Training of study staff.  
 
All proposed staff have participated in the NIH required trainings in participation and conduct of 
studies that involve human subjects, and any future study staff will do so upon hiring. Training 
for all staff includes (but is not limited to) Human Subjects, Informed Consent, Good Clinical 
Practice, Quality Management, Confidentiality and Reporting of Adverse Events. If any study 
staff discovers any untreated condition (e.g., a metal health condition), they will refer 
participants to appropriate treatment immediately. 
 
 

 
 
STATISTICAL ANALYSIS PLAN 
 
 
 

 
Table 4: Study Event Timeline 
 
Phone 
Screening 
Evaluation 
Baseline 
Visit and 
Enrollment 
Treatment Phase - Group 
Participation 
(10, 90-minute sessions) 
Post 
Treatment 
Assessment 
3-Month 
Follow-up 
Assessment 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
10 
22 
 
 
 
Weeks 
+ 14 Days 
± 14 Days 
Sociodemographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Treatment Credibility / 
Expectancy 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Client Satisfaction 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Resilience and MOCS-A 
X 
 
 
 
 
 
 
 
 
 
 
X 
X 
Psychosocial Distress 
X 
 
 
 
 
 
 
 
 
 
 
X 
X 
HIV / Physical Health 
Outcomes 
X 
 
 
 
 
 
 
 
 
 
 
X 
X 
Adherence to 
Antiretroviral Therapy 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adherence to 
Intervention Skills 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Qualitative Exit Interview 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 

 
Statistical Plan for Analyses 
Power: PAR-14-182 states, “...the R34 should ... enhance the probability of reaching more 
definitive outcomes in a larger trial... by working out the details of the experimental protocols, 
including the assessment protocol, the...intervention protocol, as well as the comparison 
intervention protocol and randomization procedures; examining the feasibility of recruiting and 
retaining participants into the study conditions; ... collection of preliminary data regarding 
feasibility, acceptability, safety, tolerability, and target outcomes is appropriate. Given the limited 
sample sizes that can be supported under this...mechanism, proposing the use of a comparison 
group for conducting fully powered tests of outcomes (i.e., efficacy) or attempting to utilize the 
highly variable point estimate of an effect size for power calculations would not be appropriate.” 
As stated in the specific aims, we aim to test the feasibility and acceptability of all study 
procedures as a primary goal; we will not attempt to use our data to estimate an effect size. We 
are interested in the sensitivity of our selected measures to detect change. Thus, as an 
exploratory outcome, we propose to examine the intervention effect of resilience and other 
secondary outcomes. We have conducted power calculations to ensure any lack of effect would 
be unrelated to power. We also explored current funded R34 studies of similar scope that are 
currently funded by NCCIH, and our sample size is well within the range of what is documented 
in these studies (e.g., 5R34AT008423, 1R34AT007935).  
Power calculations are based on samples of older, HIV-infected women when available. When 
data from older HIV-infected women were not available, data from samples of older women, 
women, or HIV-infected populations were used. We also examined data from community 
samples. We calculated power estimates for the primary outcome (resilience as measured by 
the CD-RISC) and for two of the secondary outcomes, depressive symptoms and health related 
quality of life. With respect to resilience, from Dodding et al.,87 we estimate the standard 
deviation of change due to the intervention to be 11.8. With 30 patients per group, we will have 
80% power to detect a change in resilience of 6.2 points or greater, in absolute value, based on 
a paired t-test at the 0.05 two-tailed significance level. We estimate the population mean and 
standard deviation to be approximately 76+/-13 for community-based controls,88 and 71.7+/-12.5 
for a community-based sample of post-menopausal women with sub-clinical depression89 
(N=401). A change of 6.2 points corresponds to approximately 1/2 of a standard deviation for 
both of these populations (i.e., an effect size of 0.5). Comparing the post-pre differences 
between treatment arms, we estimate that we will have 80% power to detect an absolute 
difference of 8.7 on the CD-RISC, based on a two-sample t-test at the 0.05 two-tailed 
significance level (an effect size of 0.7, which corresponds to a medium-large effect size.90  
For depressive symptoms, Ickovics et al.91 reported that 42% of HIV seropositive women were 
depressed, based on reporting a CES-D score of >16 for 75% of more of study visits. Assuming 
that the population proportion of participants with elevated depressive symptoms in the placebo 
arm at the end of the study is 0.42, then with 30 participants per arm, we will have 80% power to 
detect that the corresponding treatment proportion is <0.12 or >0.76. For health related quality 
of life, Mrus et al.92 reported a mean for the overall health domain of HRQoL in women engaged 
in HIV treatment of 71.4, with a standard deviation of 13.8. Using this standard deviation, with 
30 participants per arm, we will have 80% power to detect if the absolute mean between-group 
difference in this quality of life measure at the end of the study is 10.2 points or greater, based 
on a two-sample t-test at the 0.05 two-tailed significance level. In summary, we are confident 
that we can achieve a medium to large effect size90 across multiple outcomes with the proposed 
N.  

 
Analyses: With respect to quantitative data, we will compare each outcome between groups 
using mixed- model regression analyses, with subject as a random effect. Fixed covariates will 
include time in study (baseline, end of treatment, 3 month follow-up) and time since diagnosis. 
Other covariates, such as education, socioeconomic status, and history of exposure to traumatic 
events will also be considered. We will consider exploratory mediational and moderational 
analyses, based on procedures outlined by Hayes.93 We will assess adherence in the active 
treatment arm, in particular to determine if adherence is related to change in the primary 
outcome. We will perform exploratory multivariate analyses among the outcomes, including 
graphical methods and the calculation and testing of correlations and partial correlations. We 
will examine patterns in missing data in order to see if missingness is related to measured 
patient characteristics. We will adjust for missing data using multiple imputation as appropriate. 
We will adjust for multiple comparisons using the method of Hothorn, Bretz and Westfall.94 
Statistical analyses will be performed using “R” software.95  
All qualitative data will be analyzed using standard qualitative methodologies described by the 
Office of Behavioral and Social Sciences Research at the National Institutes of Health. 
Specifically, data will be analyzed using content analysis, an iterative, multi-step process as 
described by Miles and Huberman96 and Strauss and Corbin.97 The investigators will use NVivo 
software (version 10) to organize data and to facilitate analyses. Two study team members will 
independently review the transcripts in order to generate an overarching thematic framework for 
data interpretation, in which major and minor themes are identified. Using multiple coders also 
enhances the validity of the analysis.98 The investigators will compare their thematic frameworks 
for consistency, and any discrepancies will be discussed until there is agreement on the 
thematic framework. Data will be reexamined, messages will be extracted and highlighted, and 
ongoing discussion between coders will allow for further theorizing and making interconnections 
between research questions, coding categories, and raw data.96  
 
 

 
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