DepressionCALM-ChicagoNCT06987799
Community-based Approach to Lowering Stress Through Mindfulness
A study testing Mindfulness-Based Stress Reduction (MBSR; CALM-Chicago Study) in people with Depression and Hypertension, run by Northwestern University at 1 site in United States.
Trial summary
The goal of this clinical trial is to test a culturally adapted mindfulness-based stress reduction intervention in a community setting for African American adults with high blood pressure (hypertension) and depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Hypertension
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR; CALM-Chicago Study)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2025to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old
- Lives, works, or spends much of their time in the South Side of Chicago neighborhood
- Self-reports diagnosis of hypertension or high blood pressure by a clinician
- Endorses elevated depressive symptoms as Patient Health Questionnaire (PHQ)-9 scores ≥10
- Not taking antidepressant medication or stable on antidepressant medication for ≥6 months as self-reported
Who cannot join
- <18 years old
- Severe mental illness (e.g., bipolar disorder, psychosis)
- Current suicidal ideation (PHQ-9 item 9) or recent (past 6 months) suicide attempt
- Unable to provide informed consent or complete study activities in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Salvation Army Ray and Joan Kroc Corps Community Center Chicago
Chicago, Illinois, 60643
Asia Ellis, BA, 312-503-2781, calmchicagostudy@northwestern.edu
Larissa Reed, MA, lreedtrcdo@gmail.com
About this study
Official title: Addressing Depression for African American Adults With Hypertension: Applying Community-Engaged Implementation Science
The goal of this clinical trial is to test a culturally adapted mindfulness-based stress reduction intervention in a community setting for African American adults with high blood pressure (hypertension) and depression. The main questions it aims to answer are:
- Does participation in a culturally adapted mindfulness-based intervention improve depressive symptoms?
- Does participation in a culturally adapted mindfulness-based intervention improve blood pressure control?
- Is the intervention acceptable, appropriate, and feasible as delivered in a community setting?
Read more
Participants will:
- Participate in an 8-week group-based mindfulness intervention (CALM-Chicago). During intervention sessions, participants will learn about mindfulness and stress management and complete mindfulness-based activities, such as guided deep breathing and meditation.
- Complete surveys online
- Have their blood pressure measured with a non-invasive blood pressure cuff
- Attend 1 focus group (optional)
- Conditions
- Depression, Hypertension
- Being tested
- Mindfulness-Based Stress Reduction (MBSR; CALM-Chicago Study)
- Keywords
- culturally adapted, african american, depression, high blood pressure, hypertension
- Medical subject headings
- Depression, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MBSR; CALM-Chicago Study)Behavioural
Also called CALM-Chicago, M-Body
This clinical trial will evaluate the effectiveness of the culturally adapted intervention, CALM-Chicago, in a community setting. CALM-Chicago has been previously used in a clinical setting.
| Study group | Role | What they receive |
|---|---|---|
| Culturally adapted mindfulness-based stress reduction intervention | Experimental | This arm will participate in the CALM-Chicago intervention, a culturally adapted mindfulness-based stress reduction intervention that has been further adapted for implementation in faith-based communities on the South Side of Chicago. The intervention includes 8 weekly group sessions in which participants receive education about mindfulness, stress reduction, and blood pressure management; practice mindfulness activities and meditation; and develop a personal mindfulness practice. Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR; CALM-Chicago Study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: Depressive Symptom Response
Depressive symptoms are defined as signs and feeling that indicate that a person may be experiencing depression, such as sadness, fatigue, loss of interest or pleasure, and change in appetite. As a clinically sensitive measures of depressive symptom response, participants will complete the Centers for Epidemiologic Studies Depression Scale (CES-D). The CES-D consists of twenty items rated on a four-point Likert scale from 1 (Rarely or None of the time) to 4 (Most or All of the time). Total scores range from 0 to 60, with higher scores indicating a greater burden of depressive symptoms.
The CES-D is often used in clinical trials and will be used as a measure of effect of the intervention as change in depressive symptoms and has been validated in diverse populations.
Measured: From enrollment to the end of treatment at 8 weeks
Effectiveness: Systolic Blood Pressure Response
Blood pressure (BP) will be measured with an automated BP cuff. Participants will be instructed to rest quietly for 5 minutes, sit upright with feet on the floor, and keep their arm on a flat surface at heart level. Two readings will be taken and averaged. A clinically meaningful change in systolic BP, as defined as a decrease of ≥5 mmHg, would be indicative of a clinical effect of the intervention.
Measured: From enrollment to the end of treatment at 8 weeks
Implementation: Acceptability
One of the primary implementation outcomes will be acceptability of the intervention and its implementation from the perspectives of participants, community members, and organizational leadership. Acceptability will be measured using the Acceptability of Intervention Measure (AIM). The AIM is a 4-item measure with each item scored using a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). AIM scores range from 4 to 20, with higher scores indicating greater acceptability.
Measured: Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years
Implementation: Appropriateness
One of the primary implementation outcomes will be appropriateness of the intervention and its implementation from the perspectives of participants, community members, and organizational leadership. Appropriateness will be measured using the Intervention Appropriateness Measure (IAM). The IAM is a 4-item measure with each item scored using a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). IAM scores range from 4 to 20, with higher scores indicating greater appropriateness.
Measured: Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years
Implementation: Feasibility
One of the primary implementation outcomes will be feasibility of the intervention and its implementation from the perspectives of participants, community members, and organizational leadership. Feasibility will be measured using the Feasibility of Intervention Measure (FIM). The FIM is a 4-item measure with each item scored using a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). FIM scores range from 4 to 20, with higher scores indicating greater feasibility.
Measured: Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years
Secondary outcomes (4)
Effectiveness: Depressive Symptom Remission
Depressive symptoms are defined as signs and feeling that indicate that a person may be experiencing depression, such as sadness, fatigue, loss of interest or pleasure, or change in appetite. As a measure of depression that is commonly used in medical care, participants will complete the Patient Health Questionnaire 9-item scale (PHQ-9). The PHQ-9 consists of 9 items that are rated on a four-point Likert scale from 0 (Not at all) to 3 (Nearly every day). Total scores range from 0 to 27, where higher score indicate greater burden of depressive symptoms. Scores ≥10 on the PHQ-9 are suggestive of a depressive episode.
The PHQ-9 is consistent with measurement of depressive symptoms in medical/clinical settings and will serve as a clinically meaningful indicator of improvement in depressive symptoms (50% decrease in PHQ-9 score and/or PHQ-9 score <10).
Measured: From enrollment to the end of treatment at 8 weeks
Effectiveness: Blood Pressure Control
Blood pressure control is defined as maintaining blood pressure within a healthy range (i.e., <120/<80 mmHg for healthy adults; <130/<80 mmHg for adults with hypertension). Blood pressure will be measured with an automated BP cuff. Participants will be instructed to rest quietly for 5 minutes, sit upright with feet on the floor, and keep their arm on a flat surface at heart level. Two readings will be taken and averaged.
Blood pressure control (clinically meaningful indicator) will be defined as <130/<80 mmHg, per American Heart Association guidelines of blood pressure control among individuals diagnosed with hypertension.
Measured: From enrollment to the end of treatment at 8 weeks
Effectiveness: Medication Adherence
Medication adherence is defined as whether a person takes a medication as prescribed (e.g., twice daily). Medication adherence will be measured using the Hill-Bone Compliance to High Blood Pressure Therapy Scale. The Hill-Bone Compliance Scale is a 14-item scale with each item scored using a 4-point Likert scale ranging from 1 (All of the time) to 4 (None of the time). One item is reverse coded. Total scores range from 14 to 56, where higher scores indicate poorer medication adherence.
Measured: From enrollment to the end of treatment at 8 weeks
Implementation: Fidelity
Fidelity will be assessed by how well the interventionists, community members, organizational leaders, and researchers adhere to the intervention and implementation protocols. Specifically fidelity to the intervention protocol will be measured using the Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC). Ratings will be completed by the group leaders (self-ratings) and by trained research team members. The MBI:TAC summary sheet evaluates instructor competency across 6 domains, each comprising 3 to 5 key features. Items are scored using a 6-point Likert scale ranging from 1 (Incompetent) to 6 (Advanced). Total scores range from 27 to 162, with higher scores indicating greater competency in delivering the intervention and, therefore, greater intervention fidelity.
Measured: Assessed after each intervention group during the clinical trial enrollment and follow-up for up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start10 Sep 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Total Resource Community Development Organization (TRCDO)
- Responsible party
- Principal investigator, Allison Carroll, Northwestern University
- Investigators
- Allison J Carroll, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987799
- Sponsor's protocol ID
- STU00215977
- Other IDs
- K23HL168234
- Acronym
- CALM-Chicago
- Status last verified
- Apr 2026
- First submitted
- 5 May 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All datasets that can be shared will be deposited in openICPSR, a repository for social, behavioral, and health sciences research data. The participant dataset will include self-reported demographics, psychological metrics, clinical data. The community partners dataset will include coded qualitative responses. The investigators will share de-identified individual-participant level (IPD) data. Item-level data will be shared openly, along with example quantifications and transformations from initial raw data. Final files used to generate specific analyses to answer the Specific Aims and related results will also be shared. Appropriate measures such as removing or recoding identifiers (per Section 164.514(a) of the HIPAA Privacy Rule) will be used for data de-identification and sharing. To facilitate interpretation of the data, data dictionaries, statistical analysis plans, and data collection instruments will be shared and associated with the relevant datasets.
Publications
Burnett-Zeigler I, Zhou E, Martinez JH, Zumpf K, Lartey L, Moskowitz JT, Wisner KL, McDade T, Brown CH, Gollan J, Ciolino JD, Schauer JM, Petito LC. Comparative effectiveness of a mindfulness-based intervention (M-Body) on depressive symptoms: study protocol of a randomized controlled trial in a Federally Qualified Health Center (FQHC). Trials. 2023 Feb 17;24(1):115. doi: 10.1186/s13063-022-07012-2.
PubMed 36803835
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Depression for African American Adults With Hypertension: Applying Community-Engaged Implementation Science
- ClinicalTrials.gov ID
- NCT06987799
- Acronym / sponsor ID
- CALM-Chicago / STU00215977
- Conditions
- Depression, Hypertension
- Keywords
- culturally adapted, african american, depression, high blood pressure, hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Total Resource Community Development Organization (TRCDO)
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test a culturally adapted mindfulness-based stress reduction intervention in a community setting for African American adults with high blood pressure (hypertension) and depression. The main questions it aims to answer are:
- Does participation in a culturally adapted mindfulness-based intervention improve depressive symptoms?
- Does participation in a culturally adapted mindfulness-based intervention improve blood pressure control?
- Is the intervention acceptable, appropriate, and feasible as delivered in a community setting?
Participants will:
- Participate in an 8-week group-based mindfulness intervention (CALM-Chicago). During intervention sessions, participants will learn about mindfulness and stress management and complete mindfulness-based activities, such as guided deep breathing and meditation.
- Complete surveys online
- Have their blood pressure measured with a non-invasive blood pressure cuff
- Attend 1 focus group (optional)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Culturally adapted mindfulness-based stress reduction intervention | Experimental | Behavioral: Mindfulness-Based Stress Reduction (MBSR; CALM-Chicago Study)This arm will participate in the CALM-Chicago intervention, a culturally adapted mindfulness-based stress reduction intervention that has been further adapted for implementation in faith-based communities on the South Side of Chicago. The intervention includes 8 weekly group sessions in which participants receive education about mindfulness, stress reduction, and blood pressure management; practice mindfulness activities and meditation; and develop a personal mindfulness practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years old
- Lives, works, or spends much of their time in the South Side of Chicago neighborhood
- Self-reports diagnosis of hypertension or high blood pressure by a clinician
- Endorses elevated depressive symptoms as Patient Health Questionnaire (PHQ)-9 scores ≥10
- Not taking antidepressant medication or stable on antidepressant medication for ≥6 months as self-reported
Key exclusion criteria (4 listed)
- <18 years old
- Severe mental illness (e.g., bipolar disorder, psychosis)
- Current suicidal ideation (PHQ-9 item 9) or recent (past 6 months) suicide attempt
- Unable to provide informed consent or complete study activities in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR; CALM-Chicago Study)Also: CALM-Chicago, M-BodyThis clinical trial will evaluate the effectiveness of the culturally adapted intervention, CALM-Chicago, in a community setting. CALM-Chicago has been previously used in a clinical setting. | Behavioural | Culturally adapted mindfulness-based stress reduction intervention |
Primary outcome
Effectiveness: Depressive Symptom Response
Time frame: From enrollment to the end of treatment at 8 weeks
Depressive symptoms are defined as signs and feeling that indicate that a person may be experiencing depression, such as sadness, fatigue, loss of interest or pleasure, and change in appetite. As a clinically sensitive measures of depressive symptom response, participants will complete the Centers for Epidemiologic Studies Depression Scale (CES-D). The CES-D consists of twenty items rated on a four-point Likert scale from 1 (Rarely or None of the time) to 4 (Most or All of the time). Total scores range from 0 to 60, with higher scores indicating a greater burden of depressive symptoms. The CES-D is often used in clinical trials and will be used as a measure of effect of the intervention as change in depressive symptoms and has been validated in diverse populations.
Effectiveness: Systolic Blood Pressure Response
Time frame: From enrollment to the end of treatment at 8 weeks
Blood pressure (BP) will be measured with an automated BP cuff. Participants will be instructed to rest quietly for 5 minutes, sit upright with feet on the floor, and keep their arm on a flat surface at heart level. Two readings will be taken and averaged. A clinically meaningful change in systolic BP, as defined as a decrease of ≥5 mmHg, would be indicative of a clinical effect of the intervention.
Implementation: Acceptability
Time frame: Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years
One of the primary implementation outcomes will be acceptability of the intervention and its implementation from the perspectives of participants, community members, and organizational leadership. Acceptability will be measured using the Acceptability of Intervention Measure (AIM). The AIM is a 4-item measure with each item scored using a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). AIM scores range from 4 to 20, with higher scores indicating greater acceptability.
Implementation: Appropriateness
Time frame: Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years
One of the primary implementation outcomes will be appropriateness of the intervention and its implementation from the perspectives of participants, community members, and organizational leadership. Appropriateness will be measured using the Intervention Appropriateness Measure (IAM). The IAM is a 4-item measure with each item scored using a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). IAM scores range from 4 to 20, with higher scores indicating greater appropriateness.
Implementation: Feasibility
Time frame: Assessed every 6 during the clinical trial enrollment and follow-up for up to 3 years
One of the primary implementation outcomes will be feasibility of the intervention and its implementation from the perspectives of participants, community members, and organizational leadership. Feasibility will be measured using the Feasibility of Intervention Measure (FIM). The FIM is a 4-item measure with each item scored using a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). FIM scores range from 4 to 20, with higher scores indicating greater feasibility.
4 secondary outcomes
Effectiveness: Depressive Symptom Remission
Time frame: From enrollment to the end of treatment at 8 weeks
Effectiveness: Blood Pressure Control
Time frame: From enrollment to the end of treatment at 8 weeks
Effectiveness: Medication Adherence
Time frame: From enrollment to the end of treatment at 8 weeks
Implementation: Fidelity
Time frame: Assessed after each intervention group during the clinical trial enrollment and follow-up for up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 36803835Burnett-Zeigler I, Zhou E, Martinez JH, Zumpf K, Lartey L, Moskowitz JT, Wisner KL, McDade T, Brown CH, Gollan J, Ciolino JD, Schauer JM, Petito LC. Comparative effectiveness of a mindfulness-based intervention (M-Body) on depressive symptoms: study protocol of a randomized controlled trial in a Federally Qualified Health Center (FQHC). Trials. 2023 Feb 17;24(1):115. doi: 10.1186/s13063-022-07012-2.
- Individual participant dataSharing planned: Yes. All datasets that can be shared will be deposited in openICPSR, a repository for social, behavioral, and health sciences research data. The participant dataset will include self-reported demographics, psychological metrics, clinical data. The community partners dataset will include coded qualitative responses. The investigators will share de-identified individual-participant level (IPD) data. Item-level data will be shared openly, along with example quantifications and transformations from initial raw data. Final files used to generate specific analyses to answer the Specific Aims and related results will also be shared. Appropriate measures such as removing or recoding identifiers (per Section 164.514(a) of the HIPAA Privacy Rule) will be used for data de-identification and sharing. To facilitate interpretation of the data, data dictionaries, statistical analysis plans, and data collection instruments will be shared and associated with the relevant datasets.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allison J Carroll, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction (MBSR; CALM-Chicago Study) in people with Depression and Hypertension, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asia Ellis, BA (13125033569, asia.ellis@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness: Depressive Symptom Response (time frame: From enrollment to the end of treatment at 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06987799, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.