Background
Among adults with high blood pressure, depression is an independent risk factor for uncontrolled hypertension, adverse cardiac outcomes, and greater health care costs [1], [2], [3], [4]. In the United States, Black/African American (B/AA) adults are >50% more likely to have co-occurring depression and hypertension compared to non-Hispanic white adults [5], [6], which exacerbates the disparity in hypertension rates between B/AA and white adults (42.7% vs. 29.6%) [7].
Small studies in clinical settings have shown that treating depression can improve blood pressure control among adults with hypertension [8], [9], [10]. Yet, intervening on depressive symptoms to promote blood pressure control is not widely practiced in routine clinical care.
B/AA adults are less likely to participate in clinic-based mental health services than white adults [11], [12], [13]. Underlying contributing contextual factors are persistent barriers to B/AA adults accessing, engaging in, and benefiting from mental health services [14], including mental health stigma [15]; economic factors [16], [17]; and neighborhood characteristics (e.g., density) [18], [19]. A recent scientific statement from the American Heart Association called for extending cardiovascular disease prevention beyond clinic settings and conducting rigorous studies of evidence-based practices in community settings to reach those populations who are excluded by the health care system [20].
Previous research has leveraged B/AA churches and faith-based organizations for both mental health service delivery and cardiovascular health promotion programs because they are regular gathering places (e.g., weekly services, bible study), a trusted community, and aligned with many principles of mental health treatments (e.g., confession, vulnerability) [20], [21], [22], [23]. A systematic review of church-based mental health programs for B/AA adults [24] found that this setting is underutilized as a mental health resource, despite church-based programs’ success in reducing racial disparities for medical conditions. Other proposed community-based approaches include libraries, community health workers, and digital interventions [25], [26], [27], [28].
Another factor that may increase reach of and access to mental health interventions among B/AA populations is cultural adaptation. Culturally adapted interventions have been shown to increase treatment engagement and improve depression outcomes among B/AA adults [29], [30], Latino adults, and other racial/ethnic minority groups [31], [32], [33], [34], [35]. Further, there have been calls for use of “alternative mental health approaches” for racial/ethnic minorities in the United States, such as mindfulness-based therapies [36].
Scoping reviews of mindfulness-based interventions have shown that even surface-level cultural adaptations (e.g., modifications to language or format of the intervention) effectively improved stress, depression, or anxiety among participants [36], [37], [38], [39]. Prior literature suggests that terms and imagery of mindfulness should match the cultural groups’ norms and be translated further to promote the accessibility of the intervention [40]. Still, few studies have tested culturally adapted mindfulness interventions for B/AA adults.
Current study
The goal of this study is to test the implementation of an evidence-based depression intervention that has been adapted for the population (B/AA adults with depression and hypertension) and the context (faith-based communities in the South Side of Chicago) that will be acceptable, feasible, and effective. We will conduct this trial as a type 1 hybrid effectiveness-implementation study [41]. Primary effectiveness outcomes will be changes in depressive symptoms and blood pressure from baseline to 8 weeks, with a secondary effectiveness outcome of medication adherence.
The primary implementation outcomes will be implementation acceptability, appropriateness, and feasibility, and secondary implementation outcomes will be fidelity and sustainability.
Community-academic partnership
This study builds on a longstanding partnership between Northwestern University and Total Resource Community Development Organization (TRCDO). TRCDO is a faith-based community outreach hub and 501(c)3 entity to assist at-risk families in need of immediate wraparound support services, such as housing counseling, utility assistance, food pantry, and mentoring programs. In 2013, TRCDO developed the faith-based engagement organization, Pastors4PCOR [42], [43], a hub for faith-based communities interested in research engagement with a mission “to inform, inspire and engage congregations in research through partnership.” Examples of projects carried out by this partnership include developing novel community-based patient recruitment strategies [44], engaging community members to prepare to implement evidence-based cardiovascular health interventions [45], [46], [47], and active implementation of evidence-based programs to reduce cardiovascular disease risk in Chicago's South Side [48].
The PI's involvement with TRCDO came out of a study focused on hypertension (since 2018) leading to a partnership development grant (awarded in 2021) to explore mental health services in the community. The aims of this research are well-aligned with community priorities in the areas of mental health and hypertension [49], [50].
Preliminary work
Preparatory activities for the present study included community-engaged intervention selection and adaptation procedures, which are detailed in a separate, forthcoming manuscript. Briefly, we engaged a community advisory board (CAB) for community mental health in Chicago's South Side. The work was carried out in three phases between November 2021 and September 2024, with each phase lasting roughly 1 year.
These phases included [1]: partnership development (e.g., semi-structured discussions about mental health, understanding lived experiences, identifying contextual factors affecting implementation of mental health interventions [51]) [2] preparation for research, (e.g., education about clinical trials, literature review, selecting and adapting the intervention); and [3] capacity-building (e.g., education with human subjects research, recruitment material developments, focus groups [52]). Collectively, this work laid the foundation for the intervention and implementation protocol described herein.
The selection and adaptation of the planned intervention began with a systematic review of culturally adapted interventions for treating depression in B/AA adults. We identified 13 studies, of which 3 were selected by the CAB leaders as they most closely reflected the study population. CAB discussions resulted in selecting the M-Body intervention [53], [54], [55] as the preferred base for the intervention.
The M-Body study, a culturally adapted intervention grounded in Mindfulness-Based Stress Reduction (MBSR), tested an 8-week group-based intervention for delivery to B/AA women (n = 74) with depressive symptoms in a Federally Qualified Health Center in Chicago. Depressive symptoms improved among participants in groups led by both novice (d = 0.83, p < .001) and experienced instructors (d = 0.84, p = .042). Thus, the intervention for the present study includes the core content from traditional MBSR, culturally adapted components of the M-Body intervention (e.g., photos, poems), and adaptations for the present study's setting (e.g., faith-based organizations) and patient population (e.g., adults with hypertension).
Specifically, the curriculum has a greater focus on 1) spirituality (e.g., prayer as meditation), 2) breath and movement (e.g., variety of breathing exercises), and 3) heart health (e.g., mindfulness for blood pressure control).
Methods
Study overview
This study is a single-arm, proof-of-concept trial of an evidence-based, community-informed, group-treated mindfulness-based intervention for B/AA adults with comorbid depression and hypertension. The trial is conceptualized as a Type 1 hybrid effectiveness-implementation study, wherein we will focus on the effectiveness of the intervention for improving depression and blood pressure control while also assessing implementation acceptability, appropriateness, feasibility, fidelity, and sustainability [41]. This study will be conducted in partnership with TRCDO in Chicago's South Side neighborhood in Chicago, IL, USA.
All study procedures will be performed in accordance with the Declaration of Helsinki and are approved by the Northwestern University IRB. All participants will provide informed consent. The trial was pre-registered on ClinicalTrials.gov (NCT06987799).
Participant eligibility and recruitment
Intervention Participants: We aim to enroll 60 participants. We will recruit 10-15 participants per CALM-Chicago group, as the optimal size for group therapy is 8-12 participants. Eligible participants will be adults (≥18 years old) who live, work, or spend much of their time in the South Side of Chicago neighborhood, self-report diagnosis of hypertension/high blood pressure by a clinician, endorse elevated depressive symptoms (Patient Health Questionnaire-9 (PHQ-9) scores ≥10), are not taking antidepressant medication or are stable on antidepressant medication for ≥6 months, and can complete study activities in English.
We did not further specify the criterion of “live, work, or spend much of their time in the South Side of Chicago neighborhood” as there are various geographic boundaries that are recognized as the South Side of Chicago, and the requirement for in-person visits will ensure that participants are local. Exclusion criteria will include a suicide attempt in the past 6 months, current suicidal ideation as reported on the PHQ-9 (item 9), or self-reported diagnosis of severe mental illness (e.g., bipolar disorder, psychotic disorder). In the case of a recent suicide attempt or current suicidal ideation, study staff will call the study PI, a licensed clinical psychologist, for assessment and a plan of action (e.g., emergency department visit) and provide the individual with a list of local resources and services.
We will recruit participants via community-based organizations (e.g., tabling, distributing recruitment materials via listservs), social media (e.g., Facebook, Meta advertising), and other research outlets (e.g., ResearchMatch). Potential participants can scan a QR code or share their contact information with study staff to complete an online questionnaire to assess initial eligibility. Those who are initially eligible will be contacted via email or telephone by a member of the research team to provide information about the study, answer questions, and conduct a thorough eligibility screen.
Community Advisory Board (CAB): We will recruit up to 10 community partners to serve on the CAB. We will reach out to former CAB members (n = 6) and invite new partners to fill vacancies and gain novel perspectives. For new members, we will leverage TRCDO's network to recruit community leaders (e.g., church pastors, elders) and community members with lived experience of depression/hypertension.
Eligible CAB members will be adults (≥18 years of age), live, work, or spend much of their time in the South Side of Chicago, and able to complete study activities in English.
Study procedures
Community-based Approach to Lowering stress through Mindfulness (CALM-Chicago) Intervention. The CALM-Chicago intervention comprises 8 weekly 90-min group sessions led by a trained group leader (see below). The first and eighth sessions will take place in-person; sessions 2-7 will take place virtually via Zoom.
The hybrid delivery approach was selected based on the recommendation of the CAB, the success of the M-Body study delivered virtually in the midst of the COVID-19 pandemic [56], and prior work indicating that MBSR can be effective when delivered remotely [57]. The CALM-Chicago curriculum includes the core content from mindfulness-based stress reduction (MBSR) [58], cultural adaptations from the M-Body curriculum [53], [54], [55], and CAB-informed adaptations for heart health (e.g., greater focus on the breath and mind-heart connection) and community-based implementation [52]. Each session includes an opening practice, review of homework, didactics and dialogue, skill practice, assignment of homework, and a closing activity; each session's theme is provided in Table 1 and a breakdown of the session activities by session is presented in Supplemental Material.
Participants will be asked to engage in formal home practice and informal mindfulness practices “as much as they can.” Formal practices include meditation, body scan, and yoga. Informal practices include cultivating mindfulness in everyday activities such as eating, walking, and communicating, noticing pleasant and unpleasant events, and practicing STOP (Stop, Take Stock, Observe, Proceed) and RAIN (Recognize, Allow, Investigate, Nurture) processes. Participants will record their weekly formal and informal practice on worksheets, review their practice with the group leader, and submit their worksheets at the end of the study.Table 1Overview of participant study activities, mode, duration, and compensation.Study WeekCALM-Chicago Session ThemeResearch ActivitiesModeTime (minutes)1n/aStudy overviewInformed consentBaseline SurveysVirtual9021.
Simple Awareness: Introduction to MindfulnessBlood pressure readingsIn-person90 +30 (research activities)32. Attention, Perception, and Spirituality: Introduction to breathing and mindful attitudesnoneVirtual9043. Honoring the Mind-Body Connection: HeartfulnessnoneVirtual9054.
Understanding Stress and Trauma: Impact on Your Heart and BodyMid-Point SurveysVirtual90 +15 (surveys)65. Resilience in the Face of Difficult Emotions and Sensations: Minding Your HeartnoneVirtual9076. Mindful Relationships: Communicating with PurposenoneVirtual9087.
Compassion for Yourself and Others: Bringing mindfulness to every daynoneVirtual9098. Keeping Mindfulness Alive: Sustaining Helpful PracticesBlood pressure readingsEnd-of-Treatment SurveysIn-person90 +30 (research activities)10n/aFocus group (OPTIONAL)Virtual60
CALM-Chicago Group Leader Training. We will identify at least two community members to serve as the CALM-Chicago group leaders. Training community members as group leaders is cost-effective for producing competent therapists, a good cultural match with the participant population, increases patient engagement, and builds community capacity [53], [59], [60], [61].
The group leaders will undergo MBSR training via a formalized, 8-week intervention with an experienced teacher, MBSR teacher training, supervision, and evaluation using the Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI-TAC) with an expert consultant during the intervention period (weekly supervision for at least two groups, then as needed once the group leaders and consultant are comfortable and confident in their approach), and research study training with the PI.
CALM-Chicago Intervention Procedures. An overview of the CALM-Chicago sessions and research activities are provided in Table 1. As participants are recruited, they will be placed in groups of 10-15.
Participants will first take part in a baseline orientation session via Zoom with trained research staff wherein participants will be provided an overview of the study, complete the informed consent process, and complete the baseline assessments. CALM-Chicago sessions 1 and 8 will take place in-person at the Salvation Army Ray and Joan Kroc Corps Community Center Chicago, which offers event spaces for rent, free parking, and childcare options. The remaining CALM-Chicago sessions (2 through 7) will take place via Zoom.
Participants will be encouraged to attend as many intervention sessions as possible, but will not be penalized for missing sessions. All CALM-Chicago sessions will be recorded via Zoom and stored on secure servers hosted by Northwestern University, transcribed, and analyzed for group leader fidelity to the CALM-Chicago protocol. Participants who miss sessions will not have access to session records to encourage synchronous participation and to respect the privacy of the participants who were present for the session.
Participants have a CALM-Chicago workbook with each session's education and exercises, and they have access to recordings of the mindfulness exercises (e.g., body scan). We anticipate running 6-8 sequential groups of 8-12 participants each over 2-3 years.
Study participant assessments (see Table 1)
Blood Pressure: In-person blood pressure readings will take place during the in-person sessions at study week 2 (CALM-Chicago session 1) and study week 9 (CALM-Chicago session 8). Blood pressure readings will be taken before and then after the CALM-Chicago session; this will allow us to evaluate both the short- and long-term effects of mindfulness on blood pressure. Blood pressure will be measured with an automated cuff by a trained member of the research team; two readings will be taken and averaged.
If a participant has an exceptionally high reading (≥180/≥110 mmHg), they will undergo a third reading. In the case of a hypertensive crisis (i.e., average BP ≥ 180/≥110 mmHg), study staff will call the study physician for assessment and a plan of action (e.g., urgent care/emergency department visit).
Participant Surveys: Participants will complete online surveys via REDCap at study week 1 (baseline), study week 5 (midpoint), and study week 9 (end of treatment); if desired, participants may request study staff help them to complete the surveys over the phone. The full list of constructs, survey measures, and timepoints are listed in Table 2. The primary effectiveness outcomes are depressive symptoms and systolic blood pressure.
Depressive symptoms will be measured using two self-report measures. First, the 9-item Patient Health Questionnaire (PHQ-9) [62] will serve as a clinically meaningful indicator of improvement in depressive symptoms (50% decrease in PHQ-9 score and/or PHQ-9 score <10). Second, the 20-item Centers for Epidemiologic Studies Depression Scale (CES-D) [63], which is often used in clinical trials and has shown to have less racial bias [64], will be used as a measure of effect of the intervention as change in depressive symptoms.
Blood pressure outcomes will be assessed in two ways. First, blood pressure control, defined as <130/<80 mmHg [65], will serve as a clinically meaningful indicator of improvement in blood pressure. Second, change in systolic blood pressure from pre-to post-intervention will serve as a measure of effect of the intervention.
The secondary effectiveness outcome of medication adherence will be assessed using the 14-item Hill-Bone Compliance to High Blood Pressure Therapy Scale [66], with subscales to assess adherence to sodium intake, appointment keeping, and medication taking.Table 2Participant surveys and study measures.Variable/construct(s) measuredInstrument/metric (reference)ScoringStudy weeka administeredNo. itemsScore rangeInterpretation159Participant characteristicsDemographicsStudy-designed measure12N/AN/AXMedical historyStudy-designed measure5N/AN/AXHealth-related social needsHIV cost and services utilization study baseline questionnaire (mental health providers, usual source of medical care, utilization of care), modified (Shapiro et al., 1999)Up to 29N/AN/AXHealth-related social needsSocial deprivation index (SDI) (Butler et al., 2012)N/A1-100Higher values = greater deprivation; ≥85 = severe deprivationXMental healthDepressionPatient Health Questionnaire (PHQ-9) (Kroenke et al., 2001)90–270–4 = Minimal symptoms5–9 = Mild symptoms10–14 = Moderate symptoms15–19 = Moderately severe symptoms20–27 = Severe symptoms0–9 = No or minimal symptoms10–15 = Mild symptoms16–24 = Moderate symptoms25 or higher = Severe symptomsXXXXXXCenters for Epidemiologic Studies Depression Scale (CES-D) (Radloff, 1977)200-60AnxietyGeneralized Anxiety Disorder (GAD-7) (Spitzer et al., 2006)70–280-4 = No symptoms5-9 = Mild symptoms10-14 = Moderate symptoms15-28 = Severe symptomsXXXQuality of lifeShort Form 12 (SF-12) (Ware et al., 1996)12N/AN/AXXXEmotion regulationDifficulties in emotional regulation scale (Kaufman et al., 2016)1818–90Higher scores = poorer emotional regulationXXXCognitive emotional regulation questionnaire (Garnefski et al., 2001)1818–90Higher scores = greater use of cognitive strategyXXXMindfulnessFive facet mindfulness questionnaire (Baer et al., 2006)3939-195Higher scores = greater mindfulnessXXXCardiovascular healthBlood pressureAutomated blood pressure cuff readingN/AN/ABlood pressure control = <130/<80 mmHGXXMedication adherenceHill-Bone Compliance to High Blood Pressure Therapy Scale (subscales: sodium intake, appointment keeping, and medication taking)Kim et al., 20001414-56Higher scores = greater adherenceXXCultural factorsReligiosityDuke University Religion Index (DUREL) (Koenig et al., 1997)55-27Higher scores = greater religiosityXSpiritualitySpirituality scale (Delaney, 2003)2323–138Higher scores = greater spiritualityXBlack/African American identityEthnic Identity Scale (subscales: exploration, resolution, negative ethnoracial affect) (Umaña-Taylor et al., 2004)177-68Higher scores = greater exploration, resolution, negative ethnoracial affectXSocial connectednessThe Campaign to End Loneliness Measurement Tool (Campaign to End Loneliness, 2019)30-12Higher scores = greater lonelinessXXPerceived Community Scale (PCOM) (based on work from Heidrich and Ryff (1993))1010-60Higher scores = greater sense of belongingXXIntervention implementationIntervention acceptability, appropriateness, and feasibilityAcceptability of Intervention Measure, Intervention Appropriateness Measure, Feasibility of Intervention Measure (Weiner et al., 2017)124-12Higher scores = greater acceptability, appropriateness, feasibility of the interventionXXTreatment fidelity/engagementNumber of sessions attendedMinutes of formal and informal practiceN/AN/A≥6 sessions = treatment adherentMore minutes = greater engagementXaStudy week: 1 = baseline (pre-intervention), 5 = mid-intervention, and 9 = end-of-treatment.
Treatment engagement and fidelity. We will track the number of sessions each participant attends and reasons for nonattendance. Participants who attend six or more sessions will be considered adherent.
We will collect the number of minutes of formal and informal practice they record each week from their worksheets. De-identified transcripts of CALM-Chicago sessions will be analyzed for group leader fidelity to the CALM-Chicago protocol, based on the Mindfulness-Based Interventions-Teaching Assessment Criteria (MBI:TAC) [67].
Focus Group. In study week 10, after participants have completed the CALM-Chicago intervention and final assessments, they will join a 60-min focus group (on Zoom). Using a semi-structured interview guide, participants will be invited to share their experience in the CALM-Chicago intervention, most and least favorite activities, recommendations for increasing reach and sustainability of the intervention, and experience of participating in a research study.
The focus group will be audio- and video-recorded and transcribed and deidentified for analysis.
Compensation. Participants will be compensated for: 1) blood pressure measurements ($15 at baseline, $15 at end of treatment), 2) surveys ($25 at baseline, $15 at midpoint, $25 at end of treatment), and 3) focus group ($25). In total, study participants will earn up to $120 for the study.
Participants will not be compensated for completing the CALM-Chicago sessions consistent with prior behavioral research, wherein the behavioral treatment is viewed as a service the participants are receiving free of charge. Participants who discontinue the intervention will be invited to continue completing the assessments, and they will receive compensation accordingly. Participants will be compensated using Amazon digital gift cards; other payment methods may be available upon request.
Community partner procedures and assessments
Community Advisory Board (CAB) Meetings. CAB meetings and community partner interviews will take place virtually via Zoom and will be audio- and video-recorded. At the first CAB meeting, community partners will complete the informed consent process and electronically sign the consent form.
CAB meetings will occur approximately 3 times per year for 90 min each. The agenda of each CAB meeting will include: ice breaker exercise, study progress, challenges encountered, next steps in the trial, and group discussion. Community partners will be encouraged to ask questions and provide input throughout.
As in our prior work, community partners who cannot attend the group meetings will be encouraged to watch or listen to the recordings and provide written or verbal comments and feedback. Although the CAB meetings will be recorded, they will not be analyzed for thematic content; rather, the feedback will be incorporated into the trial design and field notes will be integrated into the mixed methods analysis.
Individual Interviews. Community partners, group leaders, and TRCDO leaders will be invited to participate in 30-min individual interviews annually, approximately 12 and 24 months after the start of the trial. The purpose of these interviews will be to assess the implementation (i.e., acceptability, appropriateness, feasibility, fidelity, sustainability) of the CALM-Chicago program, identify additional potential strategies that may be needed to improve and sustain implementation, and plan for sustainment.
The individual interviews will be audio- and video-recorded and transcribed and deidentified for analysis.
Community Partner Surveys. Alongside the interviews, community partners, group leaders, and TRCDO leaders will be asked to complete brief surveys to assess implementation acceptability (Acceptability of Intervention Measure (AIM)), appropriateness (Intervention Appropriateness Measure (IAM)), and feasibility (Feasibility of Intervention Measure (FIM)) for both the intervention and its implementation [68]. They will also complete the brief Program Sustainability Assessment Tool (PSAT) [69].
Compensation. CAB members only will be compensated $100 for each meeting and $50 for each interview; group leaders and TRCDO leaders will complete these activities as part of their role in the project. In total, community partners may earn approximately $700 for participating in the study.
Community partners will be compensated using Amazon digital gift cards; other payment methods may be available upon request.
Evaluation
Power analysis. As with most pilots, this trial will not be sufficiently powered to detect significant group differences most appropriate to testing in a full trial; however, with 60 subjects it will be sufficiently large to obtain precise mean and variance estimates of primary outcomes and to compute appropriate sample sizes for a full-scale trial. Sixty intervention participants will give us the power to detect a pre-post effect size ≥0.4.
As the intervention will be conducted in a group setting, we will need to account for non-independence after assignment; with a typical intraclass correlation of 0.02, this would require approximately an increase in effect size to 0.5.
Analysis of effectiveness outcomes. The primary effectiveness outcomes of depressive symptoms (PHQ-9 score change, CES-D score change) and blood pressure (blood pressure control <130/<80 mmHg, systolic blood pressure changes) will be evaluated using linear and logistic regression models. All participants will be included in final analysis in an intention-to-treat (ITT) approach.
Because this is a proof-of-concept trial, the focus will be on determining effect sizes to inform a power analysis for a future trial. We will determine effect sizes (Cohen's d) of these clinical outcomes using variance estimates and clinical knowledge to calculate the power needed to detect group differences. If sample size allows, we will also conduct sex/gender-based analysis, which is especially important for this study as most culturally adapted interventions for depression in B/AA adults are tested among women.
Analysis of implementation outcomes. We will use descriptive analyses for the AIM, IAM, and FIM (benchmarked against means obtained by Weiner et al. [68]) and the PSAT. We will use Rapid Qualitative Analysis [70] to assess the interviews with community partner's perspectives of the implementation and potential for sustainability of the CALM-Chicago intervention.
We will merge the quantitative and qualitative data using joint display analysis [71] from the community partners and, where appropriate, from the CALM-Chicago participants for complementarity [72]. The results will provide well-rounded information about the acceptability, appropriateness, and feasibility of intervention and its implementation and potential for sustainability.
To prepare for a future implementation trial, a secondary outcome of Reach will be benchmarked against the study results of other adapted depression interventions (e.g., Ref. [73]). Reach will be tracked through intervention engagement cascade (e.g., referral, enrollment, attendance, and completion rates) as in other behavioral health trials [74].
Assessment of community benefit. In addition to traditional qualitative and quantitative analyses, we will apply the Translational Science Benefits Model (TSBM) [75] to this study. The TSBM includes 40 potential benefits across four primary areas: Clinical and Medical Benefits, Community and Public Health Benefits, Economic Benefits, and Policy and Legislative Benefits.
In advance of the trial, a collaborative assessment was conducted among the PI and Total Resource Community Development Organization representatives to identify the potential benefits of this study, including 2 clinical benefits, 9 community benefits, 2 economic benefits, and 2 policy benefits [75]. At the conclusion of the trial, we will review these potential benefits to assess whether any of these benefits were achieved.
Dissemination
Throughout the study, monthly newsletters will be disseminated to research partners, community partners, and community members who express interest in the study to provide updates on study activities, advertise upcoming study-related activities (e.g., recruitment at local events), and share mindfulness and mental health resources. A standing, publicly available webpage provides mindfulness resources (e.g., recordings of meditations). Study findings will be disseminated via newsletters, scientific publications, and both community and academic presentations.
Trial status
This trial is ongoing and began recruiting participants on 8/6/2025. As of 10/8/2026, 17 participants have completed the baseline assessments and enrolled in one of four CALM-Chicago groups.
Discussion
This single-arm, proof-of-concept trial, a hybrid type 1 effectiveness-implementation study, will test an adapted community-based approach to treating comorbid depression and hypertension among B/AA adults on the South Side of Chicago, a population with a higher-than-average risk for cardiovascular disease. We will assess both clinical effects on depressive symptoms, blood pressure, and medication adherence as well as antecedents of implementation (i.e., acceptability, appropriateness, feasibility), fidelity, and sustainability. The results of this study will inform a larger trial to increase reach and improve scalability of community-based mindfulness programs.
In addition to the limited interpretation offered by a single-arm, proof-of-concept trial, limitations should be acknowledged. First, the adapted intervention curriculum and implementation protocol for the South Side of Chicago community may not be replicable for other community-academic partnerships or community organizations. We hope that by sharing our procedures (in another publication), others can conduct a similar process if desired.
Second, this study is focused on patients with hypertension rather than more broadly on cardiovascular health. We chose to focus on hypertension because 1) there is a strong association between depression and blood pressure, 2) mindfulness has been shown to have a blood pressure-lowering effect [76], [77], and 3) to minimize participant burden of study procedures and sample collection.
Community-based mental health interventions hold great potential to reach at-risk, community-based, B/AA adults who are less likely to access or utilize traditional health care services. Moreover, partnering with community members and organizations to develop a community-informed approach will more effectively inform the implementation and sustainment of these interventions. Successful completion of this trial may provide evidence for the effectiveness of mindfulness for improving depression and blood pressure as well as an implementation plan for mindfulness-based interventions in communities such as the South Side of Chicago.
CRediT authorship contribution statement
Allison J. Carroll: Writing – review & editing, Writing – original draft, Methodology, Investigation, Funding acquisition, Conceptualization. Paris Davis: Writing – review & editing, Methodology.
Larissa R. Reed: Writing – review & editing, Investigation. Asia Ellis: Writing – review & editing, Project administration, Investigation.
Namratha R. Kandula: Writing – review & editing, Supervision, Methodology. Abel N.
Kho: Writing – review & editing, Methodology. Quentin R. Youmans: Writing – review & editing, Investigation.
Carly M. Maletich: Writing – review & editing, Supervision. Mark D.
Huffman: Writing – review & editing, Supervision. Justin D. Smith: Writing – review & editing, Supervision, Methodology, Conceptualization.
Inger E. Burnett-Zeigler: Writing – review & editing, Supervision, Methodology, Conceptualization.
Ethics declaration
Written informed consent to take part in the study and to publish the article has been obtained from all participants or their legal representatives. The privacy rights of participants have been observed.
This study was performed in compliance with relevant laws, regulatory frameworks and guidelines where the research took place. This study was conducted in accordance with All study procedures will be performed in accordance with the Declaration of Helsinki. This study was approved by the Northwestern University.
(Approval No. STU00215977)
The results of this clinical trial and any associated work have been posted in a registry. This clinical trial was registered with number NCT06987799 (ClinicalTrials.gov).
Ethics approval and consent to participate
This study will be performed in accordance with the Declaration of Helsinki. initial approval for the clinical trial study procedures was granted by the Northwestern University Institutional Review Board (STU00215977) on 5/9/2025. Any protocol modifications will first be submitted for approval to the Northwestern University Institutional Review Board. All study participants and Community Advisory Board (CAB) members have or will provide electronic informed consent.
Consent for publication
Not applicable.
Availability of data and materials
Data sharing is not applicable to this article as no datasets have yet been generated or analyzed. All datasets that can be shared will be deposited in openICPSR.
Funding
Funding for this work was provided by the 10.13039/100000050National Heart, Lung, and Blood Institute (K23HL168234; PI: Carroll and K24HL155897; PI: Kandula). The preparation of this article was supported in part by the 10.13039/100016793Implementation Research Institute (IRI), at the Brown School of Social Work, 10.13039/100007268Washington University in St. Louis, through an award from the 10.13039/100000025National Institute of Mental Health (R25MH080916).
The content is solely the responsibility of the authors and does not necessarily represent the official views of the 10.13039/100000002National Institutes of Health/Department of Health and Human Services.
Declaration of competing interest
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Allison Carroll reports financial support was provided by National Heart Lung and Blood Institute. Namratha Kandula reports financial support was provided by National Heart Lung and Blood Institute. Allison Carroll reports financial support was provided by National Institute of Mental Health.
Quentin Youmans is on the speakers bureau for Bayer and Astrazeneca. The other authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.