Clinical trial NCT06510907: MBSR on Nocturnal Hypertension
Official title: Feasibility and Acceptability of Mindfulness-based Stress Reduction Program on Patients with Nocturnal Hypertension: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension
nocturnal hypertension
mindfulness
MBSR
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: rate of recruitment
timeFrame: over 1- year
measure: feasibility of repeated ambulatory blood pressure monitoring
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: blood pressure as measured by 24-hour ambulatory blood pressure monitoring
timeFrame: baseline, 8 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of public health and primary care
Study officials:
References: