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Completed

NCT Number: NCT06510907

MBSR on Nocturnal Hypertension

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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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of public health and primary care

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. rate of recruitment

    Time frame: over 1- year

    number of participants recruited per month during the recruitment period

  2. feasibility of repeated ambulatory blood pressure monitoring

    Time frame: baseline, 8 weeks

    the proportion of patients finishing both ambulatory blood pressure monitoring

Secondary outcomes

  1. blood pressure as measured by 24-hour ambulatory blood pressure monitoring

    Time frame: baseline, 8 weeks

    daytime, nighttime and overall 24-hour blood pressure

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Feasibility and Acceptability of Mindfulness-based Stress Reduction Program on Patients with Nocturnal Hypertension: a Pilot Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2024
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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