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Objectives: To examine the feasibility and acceptability of treating nocturnal hypertension by mindfulness-based stress reduction program (MBSR). This will provide data essential for the main trial, which will also examine the definite effectiveness of MBSR to reduce nocturnal blood pressure (BP).
Hypothesis to be tested: MBSR and the current trial are acceptable and safe to patients with nocturnal hypertension; and future main trial is feasible in terms of recruitment, dropout rate and adherence to MBSR/BP measurements.
Design and subjects: This pilot randomized-controlled trial will recruit 76 patients with nocturnal HT (night-time Systolic BP (SBP) during sleep 120 mmHg) and stage I hypertension (awake SBP = 135-159mmHg), as detected by ambulatory blood pressure monitoring (ABPM). Participants will be allocated in 1:1 ratio by stratified block randomization (by age and presence of mood disorder) to receive MBSR (intervention group) or usual care (control group) respectively.
Instruments: ABPM/HBPM/MBSR patients' diary. Interventions: The generic 8-week MBSR will be taught by a certified MBSR teacher. Participants in MBSR arm will be asked to meditate 40 minutes every day during the interventional period.
Main outcome measures: rate of recruitment/dropout/adherence to MBSR/BP measurements Data analysis and expected results: The rate of recruitment/dropout/adherence to MBSR/BP measurements will be presented.
The acceptability of MBSR and the trial will also be assessed by patients' interviews. A high level of rate of recruitment, adherence to both MBSR and BP measurements and acceptability to MBSR are expected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mindfulness-based stress reduction program on top of usual care | Experimental | Mindfulness training will be delivered through a generic 8-week MBSR. |
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| Usual Care | No Intervention | Since all participants have sub-optimal daytime BP control (grade I HT), they will be given an information sheet about lifestyle treatment for HT and be advised to adhere to these lifestyle changes at recruitment by the research assistant or research nurse (to participants in both arms). For grade I HT, it is the standard clinical practice to advise non-pharmacological treatment for a few months before increasing the doses of medications. (2) There is no additional intervention provided to the standard care group. The case doctors and the patients in the standard care arm will be informed not to amend drug treatment before the ABPM at the 8-week end-point (primary end-point in future definitive RCT). In Hong Kong, patients have unlimited access to publicly-funded primary care clinics and emergency departments for any health problem. This is not limited to participants in the trial. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mindfulness based stress reduction program | Behavioral | Mindfulness training will be delivered through a generic 8-week MBSR. The MBSR will consist of weekly 2-hour classes, in which the techniques to various meditations (e.g., body scan, mindful awareness of breathing, body, sounds, thoughts, emotions, and mindful movements) will be taught and discussed. Participants will be asked to meditate for ≥40 minutes every day during the 8-week program as "homework". Besides cultivating attention control and a non-judgemental stance to experience, psychoeducation about psychological stress and stress response will also be discussed during the MBSR classes. The MBSR teacher will discuss any difficulties encountered during homework meditations in every class to enhance adherence. Each MBSR class can have up to 25 participants. The 8-week program will be taught by a qualified MBSR teacher |
| Measure | Description | Time Frame |
|---|---|---|
| rate of recruitment | number of participants recruited per month during the recruitment period | over 1- year |
| feasibility of repeated ambulatory blood pressure monitoring | the proportion of patients finishing both ambulatory blood pressure monitoring | baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure as measured by 24-hour ambulatory blood pressure monitoring | daytime, nighttime and overall 24-hour blood pressure | baseline, 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of public health and primary care | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42422470 | Derived | Wang S, Ng SN, Sit RWS, Ying CCT, Leung SY, Han J, Choi YK, Chow KF, Chung WH, Yip BHK, McManus RJ, Wong SYS, Lee EKP. Feasibility and preliminary effectiveness of mindfulness-based stress reduction program on patients with nocturnal hypertension: a pilot randomized controlled trial. Clin Hypertens. 2026 Jul 1;32:e34. doi: 10.5646/ch.2026.32.e34. eCollection 2026. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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