Using Mobile Stress Management to Reduce Hypertension in African American Men
2026年6月18日 更新者：ISA Associates, Inc.
Reducing Hypertension Among African American Men: A Mobile Stress Management Intervention to Address Health Disparities
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
研究概览
地位
邀请报名
条件
研究类型
介入性
注册 (估计的)
135
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
District of Columbia
-
Washington D.C.、District of Columbia、美国、20020
- FMCS
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- African American/Black
- documented diagnosis of hypertension
- documented blood pressure recorded at systolic BP 130+ mmHg or diastolic BP 80+ mmHG
- reliable access to a smartphone capable of receiving text messages and streaming video
- patient at the study's participating clinic so that study staff can confirm blood pressure history and complete required blood pressure measurements
Exclusion Criteria:
-
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：mobile cognitive behavioral stress management intervention (m-CBSMi)
Experimental group participants will have access to the m-CBSMi
|
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.
其他名称：
|
|
有源比较器：Diploma in Stress Management course
Control group participants will have access to the Diploma in Stress Management course on the Alison.com
e-learning platform
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline in Mean Seated Systolic and Diastolic Blood Pressure at 6 Months
大体时间：Baseline and 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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from Baseline in Perceived Stress at 6 Months
大体时间：Baseline and 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.
|
Baseline and 6 months
|
|
Change from Baseline in Coping Strategies at 6 Months
大体时间：Baseline and 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
大体时间：Baseline and 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
大体时间：Baseline and 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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月2日
初级完成 (估计的)
2027年3月1日
研究完成 (估计的)
2027年4月1日
研究注册日期
首次提交
2026年5月11日
首先提交符合 QC 标准的
2026年5月11日
首次发布 (实际的)
2026年5月19日
研究记录更新
最后更新发布 (实际的)
2026年6月23日
上次提交的符合 QC 标准的更新
2026年6月18日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.