An interventional study of mindfulness based stress reduction program in Hypertension, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 76 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Chinese University of Hong Kong is the lead sponsor of 1,446 studies on the registry; 467 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Mindfulness training will be delivered through a generic 8-week MBSR.
Behavioral: mindfulness based stress reduction program
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.
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
rate of recruitment
number of participants recruited per month during the recruitment period
Time frame: over 1- year
feasibility of repeated ambulatory blood pressure monitoring
the proportion of patients finishing both ambulatory blood pressure monitoring
Time frame: baseline, 8 weeks
blood pressure as measured by 24-hour ambulatory blood pressure monitoring
daytime, nighttime and overall 24-hour blood pressure
Time frame: baseline, 8 weeks
Ran from Nov 2023 to primary completion in Oct 2024, 11 months.
Of 1,339 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's 11 months is below that.
Counting every sponsor, half of 1,433 studies reached it within 23 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong →