Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV
Phase: NA
Conditions: HIV Infections, Health Behavior
Sponsor: University of Alabama at Birmingham

 
Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black 
Women Living With HIV 
 
Principal Investigator:  
Crystal L. Chapman Lambert 
 
Sponsor:  
NCCIH 
 
National Clinical Trial (NCT) Identified Number:  04193605 
 
Version Number:  v1.0 
31 October 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

State of Compliance  
 
The trial will be conducted in accordance with the International Conference on 
Harmonisation Good Clinical Practice (ICH GCP) and the applicable United States (US) 
Code of Federal Regulations (CFR). The Principal Investigator will monitor for 
deviations from or changes to the protocol that are not in accordance with approval from 
the Institutional Review Board (IRB), except where necessary to eliminate an immediate 
hazard(s) to the trial subjects. All personnel involved in the conduct of this study have 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all subject materials 
will be submitted to the local Institutional Review Board (IRB) for review and approval. 
The protocol and the consent form must be approved before any subject is enrolled. 
Any amendment to the protocol will require review and approval by the IRB before the 
changes are implemented in the study. All changes to the consent form will be IRB 
approved; a determination will be made regarding whether new consent must be 
obtained from subjects who provided consent using a previously approved consent 
form. 
 
Study Synopsis 
 
Title: 
Feasibility of the Mindfulness-Based Stress Reduction (MBSR) 
Intervention for Black Women Living With HIV 
Study Description: 
Black women living with HIV are at higher risk for experiencing 
stressful life events which can lead to deleterious health 
outcomes. MBSR offers a complementary and integrative 
approach for reducing stress as a mechanism for improving 
health outcomes. This is a randomized control pilot test aims to 
explore if MBSR is practical in the target population.  
Objectives: 
 
To conduct a 2-armed pilot test of the behavioral intervention 
compared to the standard of care to assess the feasibility and 
acceptability of the adapted mindfulness intervention for Black 
women living with HIV. 
Endpoints: 
Feasibility of the intervention 
Study Population: 
Black women living with HIV 
Phase: 
Stage I: Feasibility and pilot testing 
Description of 
Study Intervention: 
The intervention consists of the following: (1) a series of eight 
weekly session of 2.5 to 3 hours; (2) a silent retreat during the 
sixth week; (3) daily home assignments including formal and 
informal mindfulness practices; and (4) didactic presentations 
on stress and the consequences of stress. 
Study Duration: 
The estimated study duration of the randomized pilot study 
(e.g., from IRB approval to screening to finishing the study) is 
approximately 18 months. 
Participant 
Duration: 
The estimated participant duration (e.g., from pre-survey to 
post-survey) is approximately 3 months. 

Schedule of Activities 
 
Procedures 
Pre-
screening 
(consent)
Visit 1 
(Week 1) 
Visit 2 
(week 2 ± 7 
days)
Visit 3 
(week 3 ± 7 
days)
Visit 4 
(week 4 ± 7 
days)
Visit 5 
(week 5 ± 7 
days)
Visit 6 
(week 6 ± 7 
days)
Visit 7 
(week 7 ± 7 
days)
Visit 8 
(week 8 ± 7 
days)
Visit 9 
(week 8 ± 7 
days)
Visit 10 
(week 9 ± 7 
days) 
Visit 11 
(week 10 ± 
7 days) 
Visit 12 
(week 11 ± 
7 days) 
Eligibility via EMR review  
X 
 
 
 
 
 
 
 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Demographics survey 
 
X 
 
 
 
 
 
 
 
 
 
 
 
MBSR components 
 
 
 
 
 
 
 
 
 
 
 
 
 
Orientation  
 
 
X 
 
 
 
 
 
 
 
 
 
 
8-weekly sessions 
 
 
 
X 
X 
X 
X 
X 
X 
 
X 
X 
 
Retreat 
 
 
 
 
 
 
 
 
 
X 
 
 
 
Post-intervention interview and survey 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 

Purpose 
 
The primary purpose is to assess the feasibility and acceptability of an adapted 
mindfulness intervention for Black women living with HIV. Please note that we are not 
seeking to determine the efficacy of the study. Slight deviations from the protocol are 
allowed with the goal of assessing efficacy in a future study.  
 
Background 
 
Black/African American women remain disproportionately burdened by the HIV epidemic 
in the United States (US), accounting for 70% of new HIV diagnoses among women and 
60% of women living with HIV (WLWH). Black WLWH have mortality rates 17 times higher 
than rates observed for White WLWH [1]. Sustained HIV viral load (VL) suppression is 
vital for improving survival and quality of life (QOL). Two essential self-care behaviors for 
people living with HIV (PLWH) to achieve and sustain VL suppression and improve their 
health outcomes are adherence to antiretroviral therapy (ART) and adherence to 
scheduled medical visits [2, 3]. Medical visit adherence is suboptimal among all WLWH, 
and VL suppression rates among Black WLWH are notably lower compared to White 
WLWH, 73% compared to 91% [4], and Black WLWH are nearly 3 times more likely than 
White women not to achieve VL suppression when prescribed ART 4. VL suppression 
among Black women continues to be below the global target, which is to have 90% of 
those treated to achieve a suppressed VL [4-6]. There is an urgent need for gender-
specific and culturally tailored interventions that can help Black WLWH achieve VL 
suppression. 
 
Failure to achieve VL suppression and suboptimal ART and medical visit adherence 
among WLWH are associated with experiencing stressful and traumatic life events [7-21]. 
WLWH are more likely to report experiencing stressful and traumatic life events than both 
men living with HIV and non-infected women, [20, 22, 23] with Black women having higher 
rates of traumatic life events than White women [24]. Mindfulness-Based Stress 
Reduction (MBSR) offers a complementary and integrative approach to reducing stress 
and the potential for improving adherence to ART and medical visits, ultimately leading 
to VL suppression. MBSR, developed by Jon Kabat-Zinn [25], has demonstrated efficacy 
in improving stress management, physical and psychological symptoms [26-29], QOL 
[30], and coping [27, 31] among breast cancer survivors, female interpersonal violence 
survivors, and primarily White and non-Southern HIV patient populations. Efficacy data 
on the effects of MBSR on ART adherence are limited by high baseline adherence rates 
in published studies [26, 29]. Yet, MBSR has demonstrated efficacy in improving VL 
suppression in a primarily young male HIV patient population [31]. No studies to date 
have adapted a MBSR for Black WLWH aiming to reduce stress and improve ART and 
medical visit adherence. Thus, research is needed to culturally adapt the promising 
MSBR intervention to enhance HIV health behaviors and outcomes for Black WLWH, 
which has the potential to attenuate racial and gender disparities in HIV. 
 
 
 

Study Aim 
 
Conduct a two-arm randomized pilot test of the adapted intervention compared to usual 
care among 48 Black WLWH (24/arm) to assess the feasibility and acceptability of the 
adapted intervention. 
 
Study Design 
 
The study presented in this protocol is a pilot randomized controlled trial with two parallel 
groups and a primary endpoint of intervention feasibility. Participants will be randomized 
(1:1) allocation to either the control arm (usual care) or the experimental arm (MBSR).  
 
Study Setting 
 
Participants will be recruited from an academic ambulatory care clinic in the Southern US. 
The clinic provides comprehensive care to people living with HIV.  
 
Inclusion and Exclusion Criteria 
 
Inclusion Criteria 
1) Cisgender females  
2) HIV seropositive  
3) 18 years of age or older 
4) Able to speak English 
5) An active patient at the study site 
6) at least 1 HIV VL that is >500 copies/mL during the previous 12 months or one missed 
scheduled medical visit.  
 
Exclusion Criteria 
1) Unable to speak English  
2) Appearing temporarily impaired (e.g., intoxicated), or 
3) Unwilling to or legally able to provide informed consent. 
 
Recruitment Procedures 
 
We will use multiple methods for recruitment. Our primary method of recruitment is via a 
data query. Research staff will also run a data query of the outpatient HIV clinic EMR to 
produce a list of patients who meet the eligibility criteria.  The list will be provided in the 
form of an Excel Spreadsheet that includes the patient’s name, MRN, next scheduled 
clinic appointment, viral load and missed visit data for the previous 12 months, and phone 
number.  Study staff will create a list of patients to approach at their clinic appointment to 
discuss the study.  If the upcoming clinic appointments are not scheduled to occur soon, 
study staff will call potential participants using the recruitment script and ask if they are 
interested in participating. Once we have exhausted the list, if needed, we can then recruit 
using flyers or a data query.  Once a potential participant calls about the study, a member 
of the study team will use the screening script to ask questions as well as review the 

potential participant’s HIV clinical data (CD4 and HIV viral load). We requested a partial 
waiver of authorization for recruitment and screening. 
 
Once eligible has been determined and verbal informed consent has been given. We will 
randomize women to either the treatment condition (MBSR; n=24) or usual care condition 
(usual care; n=24). Participants will receive a phone call and or text message reminder 
1-2 days prior to the session. If participants are not present at the time of the session, 
then a member of the research team will contact the participant via phone or text message.  
 
Study Intervention  
 
We recruit and randomize women to either the treatment condition (MBSR; n=24) or usual 
care condition (usual care; n=24). Participants will be randomized to the intervention or 
control group using an excel-based randomization algorithm that matched conditions 
based on age and missed scheduled medical visits. The control group will continue to 
receive usual care per the HIV treatment guidelines in a team environment. The academic 
health center’s HIV primary care clinic has implemented a team-based model of care in 
which physicians, nurse practitioners, nurses, social workers, counselors, and 
nutritionists collaborate to provide high-quality, affordable care to each patient. We 
decided to use usual care as the control group because previous research has 
demonstrated that using a matched time and attention group may have non-study effects 
outside of the intervention that influence outcomes [32, 33]. In addition, the primary goal 
of this study is to assess the feasibility of MBSR for Black WLWH who are currently 
receiving evidence-based care. Thus, MBSR will be an addition to usual care, which 
makes usual care a valid control condition [34]. MBSR sessions received by the treatment 
group will include an orientation, about 8-weekly sessions, and a retreat. The orientation 
session will be approximately 3 hours and include an overview of MBSR and mindfulness 
practice and discussion. Sessions 1-8 will be approximately 2.5 hours and include a brief 
opening meditation practice, additional meditation practices (e.g., body scan, focused 
awareness, yoga, etc.), group discussion, and recommendations for home practice. The 
retreat will be approximately 5 hours on a mutually agreed day between regularly 
scheduled sessions, and the activities for the retreat include group mindful eating, 
reviewing previously learned meditation practices, learning new practices, and group 
discussion. All participants will complete a pre-and post-intervention survey for feasibility 
purposes, not to determine efficacy or pre/post-intervention changes. This practice is not 
allowed by NCCIH. The intervention delivery format was changed from face-to-face to 
videoconferencing because of University COVID policies, and IRB approval was 
obtained.  
 
Potential Risks Versus Benefits 
 
There are minimal risks associated with this study. We will discuss stressful life events 
and other potentially sensitive subjects such as personal history of depression and HIV. 
This may cause emotional or psychological distress, and we want you to tell us if you feel 
distressed. We can always request a break or stop the study visit, and we can get 
additional help for you from a clinic social worker, psychologist, or counselor. In addition, 

we also ask you to perform mental tests that you may find difficult, uncomfortable, or 
embarrassing; however, these tests are designed to measure your peak mental abilities. 
For many individuals, as they want to do their best, it is normal to feel anxious or worried 
about not doing well on such tests. We just ask that you do your best, but please keep in 
mind that no one scores perfectly on these tests. 
 
During the group discussions, we will ask you to refrain from using your name during the 
discussions and not discuss other participants with individuals outside the group. There 
is a risk that you may accidentally use your name during the session. A member of the 
research team will remove participants’ names from the transcripts.  
 
There are no guaranteed benefits directly to the participant. However, participants may 
notice improvements in awareness and increased knowledge of mindfulness.  
 
Participant Discontinuation/Withdrawal from the Study 
 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue or withdraw a participant from the study for the following 
reasons: 
 
• Significant study intervention non-compliance  
• If any serious adverse event (AE) or other medical condition or situation occurs 
such that continued participation in the study would not be in the best interest of 
the participant. 
 
Participants who complete the informed consent process and are randomized but do not 
receive the study intervention may be replaced.  Participants who complete the informed 
consent process, and are randomized and receive the study intervention, and 
subsequently withdraw, or are withdrawn or discontinued from the study, will not be 
replaced. 
 
Lost to Follow-up 
 
A participant will be considered lost to follow-up if she fails to return for two scheduled 
visits and cannot be contacted by the study staff.  
 
The following actions must be taken if a participant fails to be available for a required 
study visit: 
• A study staff member will attempt to contact the participant to determine the 
reason for the missed visit, counsel the participant on the importance of attending 
scheduled study sessions, and ascertain if the participant wishes to and/or 
should continue in the study. 

• Before a participant is deemed lost to follow-up, the investigator or a study staff 
member will make every effort to regain contact with the participant (where 
possible, up to 3 telephone calls).  
• Should the participant continue to be unreachable, she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
 
Adverse Events 
 
Adverse event means any untoward medical occurrence associated with the use of an 
intervention in humans, whether or not considered intervention-related (21 CFR 312.32 
(a)). 
 
An adverse event (AE) is considered “serious” if, in the view of either the investigator or 
sponsor, it results in any of the following outcomes: 
 
• Death 
• A life-threatening adverse event (of note, the term “life-threatening” refers to an 
event in which the subject was at risk of death at the time of the event, rather than 
to an event which hypothetically might have caused death if it were more severe) 
• Inpatient hospitalization or prolongation of existing hospitalization 
• A persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions 
 
There is no expectation of any adverse events or outcomes related to participation in this 
study. Participating in behavioral interventions such as mindfulness interventions is 
considered minimal risk.  All participants will be given access to contact a study team 
member and advised to report any adverse events to the study team immediately. The 
study staff members will not specifically ask about adverse events during the study visit 
or reminder calls. Study staff members will ask participants to share voluntarily the reason 
for any missed research visits. 
 
The PI or a member of the study team will record death with start dates occurring any 
time after informed consent is obtained until 30 days after the last day of study 
participation. All serious adverse events must be reported to the IRB according to 
regulatory requirements. 
 
Statistical Analysis Plan  
 
We hypothesize that the mindfulness intervention will be feasible among Black women 
with HIV.  
 
The primary endpoint for this study is feasibility, which will be measured by the feasibility 
of the intervention measure Field [35], which consists of four items measured on a 5-point 
scale ranging from “Completely disagree” (1) to “Completely agree” (5).  

 
Our sample size considerations are based on information obtained by previous studies in 
terms of sample size for pilot projects [35, 36], successful feasibility studies of medication 
adherence in HIV patients [37, 38], and successful feasibility studies of MBSR in 
populations with chronic disease  [39, 40]. Given the limited sample size and primary 
objective of this application, which is to assess the feasibility and acceptability of the 
adapted intervention in the target population, this study is not powered sufficiently to 
formally detect significant group differences. We will not use our data to estimate an effect 
size for a future larger-scale study due to the high degree of uncertainty of estimates from 
small samples and where multiple measures are examined [35]. However, we will use 
descriptive statistics to describe sample characteristics. Bivariate analysis will be 
conducted between groups using measures of effect size (e.g., Cohen’s d, d-equivalent, 
odds ratios, etc.) and 95% confidence intervals around these measures.  
 
Regulatory, Ethical, and Study Oversight Considerations 
 
Consent forms describing in detail the study intervention, study procedures, and risks are 
given to the subject, and verbal documentation of informed consent is required prior to 
conducting study randomization procedures. A separate screening consent form will not 
be used. 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to 
participate in the study and continues throughout the individual’s study participation. 
Consent forms will be Institutional Review Board (IRB)-approved, and the subject will be 
asked to read and review the document. The investigator or a member of the research 
team will explain the research study to the subject and answer any questions that may 
arise. A verbal explanation will be provided in terms suited to the subject’s comprehension 
of the purposes, procedures, and potential risks of the study and of their rights as research 
subjects.  Subjects will have the opportunity to carefully review the written consent form 
and ask questions prior to providing verbal consent. The subjects should have the 
opportunity to discuss the study with their family or surrogates or think about it prior to 
agreeing to participate. The subject will provide verbal informed consent, which will be 
witnessed and documented by a member of the study team prior to any procedures being 
done specifically for the study. Subjects must be informed that participation is voluntary 
and that they may withdraw from the study at any time, without prejudice. A copy of the 
informed consent document will be given to the subjects for their records. The rights and 
welfare of the subjects will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study. 
 
Subject confidentiality and privacy are strictly held in trust by the participating 
investigators and their staff. Therefore, the study protocol, documentation, data, and all 
other information generated will be held in strict confidence. No information concerning 
the study, or the data will be released to any unauthorized third party without prior written 
approval of the PI.  
 
All research activities will be conducted in as private a setting as possible. 

 
Representatives of the IRB may inspect all documents and records required to be 
maintained by the investigator, including but not limited to, medical records (office, clinic, 
or hospital) and pharmacy records for the subjects in this study. The clinical study site will 
permit access to such records. 
 
The study subject’s contact information will be securely stored at each clinical site for 
internal use during the study. At the end of the study, all records will continue to be kept 
in a secure location for as long a period as dictated by the reviewing IRB and/or 
Institutional policies. 
 
Study subject research data, which is for purposes of statistical analysis and scientific 
reporting, will be stored at the UAB School of Nursing. This will not include the subject’s 
contact or identifying information. Rather, individual subjects and their research data will 
be identified by a unique study identification number. The study data entry and study 
management systems used by research staff will be secured and password protected. 
 
Study documents should be retained for a minimum of 3 years after the completion of the 
study. These documents should be retained for a longer period, however, if required by 
local regulations. 
 
The independence of this study from any actual or perceived influence, such as by the 
pharmaceutical industry, is critical.  Therefore, any actual conflict of interest of persons 
who have a role in the design, conduct, analysis, publication, or any aspect of this trial 
will be disclosed and managed. Furthermore, persons who have a perceived conflict of 
interest will be required to have such conflicts managed in a way that is appropriate to 
their participation in the design and conduct of this trial.   
 
 

Bibliography  
 
1. 
Centers for Disease Control and Prevention. HIV Surveillance Report: Diagnosis 
of HIV Infection in the United States and Dependents Areas 2016. 2017; Available 
from: https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-
report-2016-vol-28.pdf. 
2. 
Mugavero, M.J., et al., Missed visits and mortality among patients establishing 
initial outpatient HIV treatment. Clin Infect Dis, 2009. 48(2): p. 248-56. 
3. 
Giordano, T.P., et al., Retention in care: a challenge to survival with HIV infection. 
Clin Infect Dis, 2007. 44(11): p. 1493-9. 
4. 
Geter, A., et al., Trends of racial and ethnic disparities in virologic suppression 
among women in the HIV Outpatient Study, USA, 2010-2015. PLoS One, 2018. 
13(1): p. e0189973. 
5. 
Joint United Nations Programme on HIV/AIDS (UNAIDS). 90-90-90: An ambitious 
treatment target to help end the AIDS epidemic. 2014; Available from: 
http://www.unaids.org/sites/default/files/media_asset/90-90-90_en.pdf. 
6. 
Nwangwu-Ike, N., et al., Racial and Ethnic Differences in Viral Suppression Among 
HIV-Positive Women in Care. J Acquir Immune Defic Syndr, 2018. 79(2): p. e56-
e68. 
7. 
Turan, B., et al., How Does Stigma Affect People Living with HIV? The Mediating 
Roles of Internalized and Anticipated HIV Stigma in the Effects of Perceived 
Community Stigma on Health and Psychosocial Outcomes. AIDS Behav, 2016. 
8. 
Boarts, J.M., et al., Relationship of race-, sexual orientation-, and HIV-related 
discrimination with adherence to HIV treatment: a pilot study. J Behav Med, 2008. 
31(5): p. 445-51. 
9. 
Turan, B., A Comparative Summary on Antioxidant-like Actions of Timolol with 
Other Antioxidants in Diabetic Cardiomyopathy. Curr Drug Deliv, 2016. 13(3): p. 
418-23. 
10. 
Bottonari, K.A., et al., A longitudinal investigation of the impact of life stress on HIV 
treatment adherence. J Behav Med, 2010. 33(6): p. 486-95. 
11. 
Moneyham, L., et al., Perceived barriers to HIV care among HIV-infected women 
in the Deep South. J Assoc Nurses AIDS Care, 2010. 21(6): p. 467-77. 
12. 
Kempf, M.C., et al., A qualitative study of the barriers and facilitators to retention-
in-care among HIV-positive women in the rural southeastern United States: 
implications for targeted interventions. AIDS Patient Care STDS, 2010. 24(8): p. 
515-20. 
13. 
Holstad, M.M., C. Diiorio, and F. McCarty, Adherence, sexual risk, and viral load in 
HIV-infected women prescribed antiretroviral therapy. AIDS Patient Care STDS, 
2011. 25(7): p. 431-8. 
14. 
McCoy, K., et al., Age, Stigma, Adherence and Clinical Indicators in HIV-Infected 
Women. HIV/AIDS Res Treat, 2015. 2015(SE3): p. S1-S8. 
15. 
Kelso, G.A., et al., Critical consciousness, racial and gender discrimination, and 
HIV disease markers in African American women with HIV. AIDS Behav, 2014. 
18(7): p. 1237-46. 

16. 
Messer, L.C., et al., Barriers and facilitators to testing, treatment entry, and 
engagement in care by HIV-positive women of color. AIDS Patient Care STDS, 
2013. 27(7): p. 398-407. 
17. 
Tyer-Viola, L.A., et al., Predictors of medication adherence among HIV-positive 
women in North America. J Obstet Gynecol Neonatal Nurs, 2014. 43(2): p. 168-78. 
18. 
Mugavero, M.J., et al., Overload: impact of incident stressful events on 
antiretroviral medication adherence and virologic failure in a longitudinal, multisite 
human immunodeficiency virus cohort study. Psychosom Med, 2009. 71(9): p. 920-
6. 
19. 
Leserman, J., et al., Stressful life events and adherence in HIV. AIDS Patient Care 
STDS, 2008. 22(5): p. 403-11. 
20. 
Reif, S., et al., Highly stressed: stressful and traumatic experiences among 
individuals with HIV/AIDS in the Deep South. AIDS Care, 2011. 23(2): p. 152-62. 
21. 
O'Donnell, J.K., et al., Stressful and traumatic life events as disruptors to 
antiretroviral therapy adherence. AIDS Care, 2017: p. 1-8. 
22. 
Robertson, K., et al., Screening for neurocognitive impairment, depression, and 
anxiety in HIV-infected patients in Western Europe and Canada. AIDS Care, 2014. 
26(12): p. 1555-61. 
23. 
Machtinger, E.L., et al., Psychological trauma and PTSD in HIV-positive women: a 
meta-analysis. AIDS Behav, 2012. 16(8): p. 2091-100. 
24. 
Brown, J.L., R.A. Littlewood, and P.A. Vanable, Social-cognitive correlates of 
antiretroviral therapy adherence among HIV-infected individuals receiving 
infectious disease care in a medium-sized northeastern US city. AIDS Care, 2013. 
25(9): p. 1149-58. 
25. 
Kabat-Zinn, J., Full-catastrophe living: Using the wisdom of your body and mind to 
face stress, pain, and illness. Revised Edition ed. 2013, New York: Bantam 
Doubleday Dell Publishing. 
26. 
Duncan, L.G., et al., Mindfulness-based stress reduction for HIV treatment side 
effects: a randomized, wait-list controlled trial. Journal of Pain and Symptom 
Management, 2012. 43(2): p. 161-71. 
27. 
Gayner, B., et al., A randomized controlled trial of mindfulness-based stress 
reduction to manage affective symptoms and improve quality of life in gay men 
living with HIV. J Behav Med, 2012. 35(3): p. 272-85. 
28. 
Kelly, A. and E.L. Garland, Trauma-Informed Mindfulness-Based Stress Reduction 
for Female Survivors of Interpersonal Violence: Results From a Stage I RCT. J Clin 
Psychol, 2016. 72(4): p. 311-28. 
29. 
Hecht, F.M., et al., A randomized, controlled trial of mindfulness-based stress 
reduction in HIV infection. Brain Behav Immun, 2018. 73: p. 331-339. 
30. 
Lengacher, C.A., et al., Randomized controlled trial of mindfulness-based stress 
reduction (MBSR) for survivors of breast cancer. Psychooncology, 2009. 18(12): p. 
1261-72. 
31. 
Webb, L., et al., Mindfulness instruction for HIV-infected youth: a randomized 
controlled trial. AIDS Care, 2018. 30(6): p. 688-695. 
32. 
Pagoto, S.L., et al., Can attention control conditions have detrimental effects on 
behavioral medicine randomized trials? Psychosom Med, 2013. 75(2): p. 137-43. 

33. 
Freedland, K.E., Demanding attention: reconsidering the role of attention control 
groups in behavioral intervention research. Psychosom Med, 2013. 75(2): p. 100-
2. 
34. 
Freedland, K.E., et al., Usual and unusual care: existing practice control groups in 
randomized controlled trials of behavioral interventions. Psychosom Med, 2011. 
73(4): p. 323-35. 
35. 
Leon, A.C., L.L. Davis, and H.C. Kraemer, The role and interpretation of pilot 
studies in clinical research. J Psychiatr Res, 2011. 45(5): p. 626-9. 
36. 
Hertzog, M.A., Considerations in determining sample size for pilot studies. Res 
Nurs Health, 2008. 31(2): p. 180-91. 
37. 
Claborn, K., et al., Adherence intervention for HIV-infected persons who use drugs: 
adaptation, open trial, and pilot randomized hybrid type 1 trial protocol. Addict Sci 
Clin Pract, 2018. 13(1): p. 12. 
38. 
Safren, S.A., et al., A randomized controlled trial of cognitive behavioral therapy 
for adherence and depression (CBT-AD) in HIV-infected individuals. Health 
Psychol, 2009. 28(1): p. 1-10. 
39. 
Lengacher, C.A., et al., A pilot study evaluating the effect of mindfulness-based 
stress reduction on psychological status, physical status, salivary cortisol, and 
interleukin-6 among advanced-stage cancer patients and their caregivers. J Holist 
Nurs, 2012. 30(3): p. 170-85. 
40. 
Lengacher, C.A., et al., Feasibility of a mindfulness-based stress reduction 
program for early-stage breast cancer survivors. J Holist Nurs, 2011. 29(2): p. 107-
17.