HypertensionNCT06510907
MBSR on Nocturnal Hypertension
A study testing mindfulness based stress reduction program in people with Hypertension, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- mindfulness based stress reduction program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed hypertension (HT) from clinical records (with or without anti-hypertensive medications)
- nocturnal HT (night-time systolic blood pressure [SBP] during sleep ≥120 mmHg) and stage I hypertension (daytime SBP = 135-159 mmHg), as detected by 24-hour ambulatory blood pressure monitoring (ABPM)
- no change of dose and type of anti-hypertensive(s) in the prior 2 months
Who cannot join
- patients with atrial fibrillation (these patients have greater blood pressure variability)
- daytime office systolic blood pressure (BP) ≥180 mmHg or diastolic BP ≥120 mmHg (regardless of nocturnal BP)
- patients with known obstructive sleep apnoea
- history of dementia or psychotic illnesses
- patients with end-stage malignancies
- nocturnal worker, because they will have a reverse BP pattern to other participants
Show all 11Show fewer
- patients receiving ≥3 BP medications at maximal tolerated doses
- previous participation in structured mindfulness program(s) of ≥8 weeks or regular daily meditation practices
- reported sleep time of <4 hours per day
- patients who do not agree to keep the same dose of anti-HT medications during the trial period
- patients receiving anti-coagulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of Mindfulness-based Stress Reduction Program on Patients with Nocturnal Hypertension: a Pilot Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Hypertension
- Being tested
- mindfulness based stress reduction program
- Keywords
- hypertension, nocturnal hypertension, mindfulness, MBSR
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness based stress reduction programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| mindfulness-based stress reduction program on top of usual care | Experimental | Mindfulness training will be delivered through a generic 8-week MBSR. Receives: Behavioral: mindfulness based stress reduction program |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of recruitment
number of participants recruited per month during the recruitment period
Measured: over 1- year
feasibility of repeated ambulatory blood pressure monitoring
the proportion of patients finishing both ambulatory blood pressure monitoring
Measured: baseline, 8 weeks
Secondary outcomes (1)
blood pressure as measured by 24-hour ambulatory blood pressure monitoring
daytime, nighttime and overall 24-hour blood pressure
Measured: baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Nov 2023
- Primary completion30 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Kam Pui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510907
- Sponsor's protocol ID
- 2022.593
- Status last verified
- Feb 2025
- First submitted
- 15 Jul 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 42422470
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Mindfulness-based Stress Reduction Program on Patients with Nocturnal Hypertension: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06510907
- Acronym / sponsor ID
- 2022.593
- Conditions
- Hypertension
- Keywords
- hypertension, nocturnal hypertension, mindfulness, MBSR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mindfulness-based stress reduction program on top of usual care | Experimental | Behavioral: mindfulness based stress reduction programMindfulness training will be delivered through a generic 8-week MBSR. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed hypertension (HT) from clinical records (with or without anti-hypertensive medications)
- nocturnal HT (night-time systolic blood pressure [SBP] during sleep ≥120 mmHg) and stage I hypertension (daytime SBP = 135-159 mmHg), as detected by 24-hour ambulatory blood pressure monitoring (ABPM)
- no change of dose and type of anti-hypertensive(s) in the prior 2 months
Key exclusion criteria (11 listed)
- patients with atrial fibrillation (these patients have greater blood pressure variability)
- daytime office systolic blood pressure (BP) ≥180 mmHg or diastolic BP ≥120 mmHg (regardless of nocturnal BP)
- patients with known obstructive sleep apnoea
- history of dementia or psychotic illnesses
- patients with end-stage malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mindfulness based stress reduction programMindfulness 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 | Behavioural | mindfulness-based stress reduction program on top of usual care |
Primary outcome
rate of recruitment
Time frame: over 1- year
number of participants recruited per month during the recruitment period
feasibility of repeated ambulatory blood pressure monitoring
Time frame: baseline, 8 weeks
the proportion of patients finishing both ambulatory blood pressure monitoring
1 secondary outcome
blood pressure as measured by 24-hour ambulatory blood pressure monitoring
Time frame: baseline, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Derived from this study: PubMed 42422470Wang 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mindfulness based stress reduction program in people with Hypertension, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of recruitment (time frame: over 1- year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06510907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.