Feasibility and Acceptability of Mindfulness-based Stress Reduction Program on Patients with Nocturnal Hypertension: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- rate of recruitment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
mindfulness-based stress reduction program on top of usual care
Mindfulness training will be delivered through a generic 8-week MBSR.
干预措施: mindfulness based stress reduction program (Behavioral)
结局指标
主要结局
rate of recruitment
时间窗: over 1- year
number of participants recruited per month during the recruitment period
feasibility of repeated ambulatory blood pressure monitoring
时间窗: baseline, 8 weeks
the proportion of patients finishing both ambulatory blood pressure monitoring
次要结局
- blood pressure as measured by 24-hour ambulatory blood pressure monitoring(baseline, 8 weeks)
研究者
Lee Kam Pui
clinical associate professor
Chinese University of Hong Kong