NCT06510907

MBSR on Nocturnal Hypertension

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-10-30
• Completion: 2024-12-31
• First posted: 2024-07-19
• Last updated: 2025-02-13

Locations

1 site across 1 country: Hong Kong