Using Mobile Stress Management to Reduce Hypertension in African American Men
18 juin 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Inscription sur invitation
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
135
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
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District of Columbia
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Washington D.C., District of Columbia, États-Unis, 20020
- FMCS
-
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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:
-
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: mobile cognitive behavioral stress management intervention (m-CBSMi)
Experimental group participants will have access to the m-CBSMi
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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.
Autres noms:
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Comparateur actif: 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
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from Baseline in Mean Seated Systolic and Diastolic Blood Pressure at 6 Months
Délai: Baseline and 6 months
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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.
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Baseline and 6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from Baseline in Perceived Stress at 6 Months
Délai: 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.
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Baseline and 6 months
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Change from Baseline in Coping Strategies at 6 Months
Délai: Baseline and 6 months
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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.
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Baseline and 6 months
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Change from Baseline in Coping Self-Efficacy at 6 Months
Délai: Baseline and 6 months
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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.
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Baseline and 6 months
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Change from Baseline in Mindfulness at 6 Months
Délai: Baseline and 6 months
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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.
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Baseline and 6 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
2 juin 2026
Achèvement primaire (Estimé)
1 mars 2027
Achèvement de l'étude (Estimé)
1 avril 2027
Dates d'inscription aux études
Première soumission
11 mai 2026
Première soumission répondant aux critères de contrôle qualité
11 mai 2026
Première publication (Réel)
19 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
23 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R44MD017106 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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