MBSR on Nocturnal Hypertension

NCT ID: NCT06510907

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-12-31

Brief 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).

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

mindfulness-based stress reduction program on top of usual care

Mindfulness training will be delivered through a generic 8-week MBSR.

Group Type: EXPERIMENTAL

mindfulness based stress reduction program

Intervention Type: 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

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mindfulness based stress reduction program

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Lee Kam Pui

clinical associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of public health and primary care

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

2022.593

Identifier Type: -

Identifier Source: org_study_id