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
調査の概要
状態
招待による登録
条件
研究の種類
介入
入学 (推定)
135
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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District of Columbia
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Washington D.C.、District of Columbia、アメリカ、20020
- FMCS
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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:
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研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
他の名前：
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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change from Baseline in Mean Seated Systolic and Diastolic Blood Pressure at 6 Months
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change from Baseline in Perceived Stress at 6 Months
時間枠：Baseline and 6 months
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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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月2日
一次修了 (推定)
2027年3月1日
研究の完了 (推定)
2027年4月1日
試験登録日
最初に提出
2026年5月11日
QC基準を満たした最初の提出物
2026年5月11日
最初の投稿 (実際)
2026年5月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月23日
QC基準を満たした最後の更新が送信されました
2026年6月18日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。