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| ID | Type | Description | Link |
|---|---|---|---|
| R44MD017106 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The goal of this clinical trial is to learn whether a smartphone-based stress management program can reduce blood pressure and perceived stress in Black men with hypertension. The main questions it aims to answer are:
Does a mobile cognitive-behavioral stress management intervention (m-CBSMi) reduce systolic and diastolic blood pressure more than a standard online stress management course over 6 months? Does the m-CBSMi reduce perceived stress more than a standard online stress management course over 6 months?
Researchers will compare participants assigned to the m-CBSMi - a culturally tailored program delivered via text message and video - to participants assigned to the "Diploma in Stress Management" course on Alison.com, to see if the m-CBSMi produces greater improvements in blood pressure and stress outcomes.
Participants will:
Complete a phone-based survey at baseline and again at 6 months Attend two in-person blood pressure measurement visits at the partnering clinic, one at baseline and one at 6 months Complete their assigned stress management program (m-CBSMi or the Alison.com course) over 3 months, delivered via smartphone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mobile cognitive behavioral stress management intervention (m-CBSMi) | Experimental | Experimental group participants will have access to the m-CBSMi |
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| Diploma in Stress Management course | Active Comparator | Control group participants will have access to the Diploma in Stress Management course on the Alison.com e-learning platform |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile cognitive behavioral stress management intervention | Behavioral | A culturally tailored, smartphone-delivered cognitive-behavioral stress management intervention (m-CBSMi) for Black men with hypertension. The m-CBSMi consists of 11 video-based sessions covering the stress-hypertension relationship, the impact of racial discrimination on stress, and evidence-based coping strategies. Sessions 2-11 each introduce a new relaxation technique (e.g., diaphragmatic breathing, progressive muscle relaxation, mindfulness meditation), which participants practice via audio-narrated exercises. Content is delivered through embedded video links sent via text message, along with psychoeducational and motivational texts. Participants are encouraged to complete one session per week over 3 months and to revisit relaxation techniques between sessions. The program is fully self-paced and accessible on any smartphone capable of receiving texts and streaming video. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Mean Seated Systolic and Diastolic Blood Pressure at 6 Months | Blood pressure will be assessed using a clinically validated upper-arm oscillometric device following a standardized office measurement protocol. After a 5-minute seated rest, three readings will be taken at 1-minute intervals; the average of the three readings will serve as the study value. Systolic and diastolic blood pressure will each be analyzed as separate continuous outcomes. Lower values indicate better outcomes. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Perceived Stress at 6 Months | Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10). Participants rate how often they experienced stress-related thoughts and feelings in the past month on a scale from 1 (never) to 5 (very often). The total score will be divided by the number of items to yield a mean item score, resulting in a scale range of 1 to 5, with higher scores indicating greater perceived stress. |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FMCS | Washington D.C. | District of Columbia | 20020 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Diploma in Stress Management course | Behavioral | A publicly available, online stress management course ("Diploma in Stress Management") offered by Alison.com, one of the world's largest free learning platforms. The course consists of 11 video-based modules covering causes of stress, the link between stress and physical health, the role of thoughts and emotions in stress responses, and relaxation techniques. Three modules are designated as core content for this study: Module 1 (Introduction to Stress), Module 7 (Roles of Thoughts, Beliefs, and Emotions), and Module 8 (Relaxation and Cognitive Techniques). Participants are asked to complete these three core modules within 3 months and are encouraged to complete remaining modules as time allows. Weekly text message reminders are sent throughout the program period. The course is self-paced and accessible via smartphone using study-provided login credentials. |
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| Baseline and 6 months |
| Change from Baseline in Coping Strategies at 6 Months | Coping will be assessed using a 28-item adapted version of the Brief COPE measuring the frequency of approach-oriented (e.g., active coping, seeking support, positive reframing) and avoidant (e.g., denial, behavioral disengagement, substance use) coping strategies used in the past month. Items are rated from 1 (not at all) to 4 (a lot). The total score will be divided by the number of items to yield a mean item score, resulting in a scale range of 1 to 4. Approach and avoidant coping subscales will be scored separately, with higher scores indicating greater use of each strategy type. | Baseline and 6 months |
| Change from Baseline in Coping Self-Efficacy at 6 Months | Coping self-efficacy will be assessed using a 13-item brief version of the Coping Self-Efficacy Scale. Participants rate their confidence in performing specific coping behaviors when things are not going well on a scale from 1 (not at all confident) to 5 (completely confident). The total score will be divided by the number of items to yield a mean item score, resulting in a scale range of 1 to 5, with higher scores indicating greater coping self-efficacy. | Baseline and 6 months |
| Change from Baseline in Mindfulness at 6 Months | Mindfulness will be assessed using the 10-item Cognitive and Affective Mindfulness Scale-Revised. Participants rate how often statements about attention, present-moment awareness, emotional acceptance, and non-judgmental observation of thoughts apply to them, using a scale from 1 (never/rarely) to 4 (almost always). The total score will be divided by the number of items to yield a mean item score, resulting in a scale range of 1 to 4, with higher scores indicating greater mindfulness. | Baseline and 6 months |