A Holistic Approach to the Management of Arterial Hypertension in Older Women: Evaluating the Effectiveness of a Mindfulness-Based Programme and the Forest Therapy Method
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Perceived stress
研究概览
简要总结
This pilot study, conducted by the Department of Social Medicine and Epidemiology, Faculty of Medicine, University of Rijeka, and funded by the University of Rijeka (project no. uniri-iskusni-biomed-23-181), evaluated two adjunctive non-pharmacological interventions - an eight-week Mindfulness-Based Living Course (MBLC) and a guided forest bathing (Shinrin-yoku) program - relative to a non-randomized comparison group, in older women with treated arterial hypertension. The study used a non-equivalent, pre-test/post-test quasi-experimental design; allocation was non-randomized, based on geographic catchment area and registration with community patronage nurses, with first-come, first-served enrollment until recruitment targets were met. A total of 60 women over 60 years of age were planned for enrollment: 20 in the MBLC group, 20 in the forest bathing group, and 20 in a comparison group receiving usual care. The MBLC group attended eight weekly two-hour workshops based on the Mindfulness Association (UK) curriculum, led by certified facilitators in Rijeka. The forest bathing group attended three weekly guided sessions of approximately 120-150 minutes each at a forest site near Delnice, Gorski Kotar, led by an FTHub-certified guide following the Forest Therapy Hub (FTHub) Walk Activities Sequence. The comparison group received no structured intervention. Outcomes were assessed at baseline and immediately after each group's intervention period (approximately 8 weeks for MBLC; approximately 3 weeks for forest bathing; a matched interval for the comparison group). The primary outcome was perceived stress (10-item Perceived Stress Scale). Secondary outcomes included chronic-disease self-efficacy, health-related quality of life, systolic and diastolic blood pressure, heart rate, and serum cortisol. Eligible participants were women over 60 with documented, treated arterial hypertension who gave written informed consent; exclusions included age under 60, inability to participate for the study duration, homelessness, a diagnosed psychiatric condition, cognitive impairment, and alcohol or substance dependence. The study was approved by the Ethics Committee of the University of Rijeka, Faculty of Medicine (Class: 007-08/24-01/70; 22 October 2024) and was conducted January-May 2025 in Rijeka and the Gorski Kotar region, Croatia. The study is being registered retrospectively, after data collection was complete.
详细描述
Background and rationale: Arterial hypertension (AH) is highly prevalent among older women, in whom blood pressure control is influenced by chronic psychosocial stress and often deteriorates after menopause. Despite effective antihypertensive pharmacotherapy, population-level blood pressure control remains suboptimal, creating a need for feasible, low-risk adjuncts to standard care that support self-management and well-being without replacing medication. Current European Society of Hypertension guidance acknowledges a role for stress-reduction approaches within lifestyle management. Two candidate adjunctive approaches were of interest here: mindfulness-based intervention, which targets attentional regulation, non-judgmental awareness, and self-compassion; and guided forest bathing (Shinrin-yoku), a nature-based intervention thought to act through sensory immersion, attentional restoration, and parasympathetic activation. Comparative evidence on structured mindfulness-based versus forest-based adjuncts in older women with treated hypertension, assessed across psychological, quality-of-life, and physiological outcomes together, remains limited. This pilot study was designed to generate effect-size estimates to inform a future adequately powered trial rather than to provide confirmatory tests of effectiveness.
Objectives: The general objective was to evaluate and compare the effectiveness of two adjunctive non-pharmacological interventions - an eight-week Mindfulness-Based Living Course (MBLC) and a guided forest bathing intervention - relative to a non-randomized comparison group, in improving perceived stress, chronic-disease self-management self-efficacy, health-related quality of life, and selected physiological parameters among older women with treated arterial hypertension, from baseline to follow-up. Specific research questions addressed: (1) whether MBLC or forest bathing produced a greater reduction in perceived stress than the comparison group; (2) whether either intervention produced greater improvement in chronic-disease self-efficacy; (3) whether either intervention produced greater improvement in health-related quality of life; (4) whether either intervention produced more favorable change in blood pressure, heart rate, or cortisol; and (5) whether effects differed between the two active interventions.
Design and allocation: This was a non-equivalent, pre-test/post-test quasi-experimental pilot study with three parallel groups (two intervention groups and one comparison group). Allocation was non-randomized. Randomization was not feasible because the mindfulness workshops and forest bathing sessions were each delivered as a community-based service at fixed sites linked to specific community patronage nurses and required advance scheduling and capacity planning within existing primary-care infrastructure. Participants were therefore allocated pragmatically according to their geographic catchment area and registration with a participating community patronage nurse, and were enrolled consecutively as they expressed interest, on a first-come, first-served basis, until each group's recruitment target was reached.
Setting and timeline: The study was conducted from January 2025 to May 2025. Recruitment and the mindfulness workshops took place in Rijeka, Croatia; the forest bathing sessions took place at a forest site near Delnice, in the Gorski Kotar region. Data were collected at two time points for every participant: baseline (T0) and immediately after completion of that participant's assigned intervention period (T1) - approximately 8 weeks after baseline for the MBLC group and approximately 3 weeks after baseline for the forest bathing group, with a matched elapsed interval used for the comparison group.
Interventions: The MBLC group attended one two-hour workshop per week for eight weeks (16 structured contact hours), delivered by certified mindfulness facilitators using a structured manual. MBLC is a curriculum developed by the Mindfulness Association (United Kingdom) that cultivates present-moment awareness, compassion, and self-compassion, progressing across sessions from attentional and somatic training toward emotion regulation and compassion-based practice. Participants were encouraged to complete approximately 20-30 minutes of daily home practice, supported by guided audio/video recordings and a workbook; home-practice adherence was not formally tracked. The forest bathing group attended three weekly guided sessions of approximately 120-150 minutes, scheduled within a consistent morning window to limit diurnal variation in physiological outcomes, at the same forest site and along the same predefined route (approximately 1.5-2 km) each time. Sessions were led by a guide certified by the Forest Therapy Hub (FTHub) and followed the FTHub Walk Activities Sequence (introduction/arrival, Mechanical Senses, Chemical Senses, Engage/Direct Exposure activities, Txoko sit-spot, and a closing Circle of Incorporation); no structured home practice was assigned between sessions. The comparison group continued routine general-practitioner follow-up and usual antihypertensive management, with no structured attention-control activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman older than 60 years
- •Diagnosed arterial hypertension (pharmacologically treated)
- •Signed informed consent form for participation
排除标准
- •Age under 60 years
- •Inability to participate in the study over a six-month period (e.g., persons planning extended travel or terminally ill patients)
- •Without stable housing (homeless individuals)
- •Diagnosed psychiatric disorder(s)
- •Cognitive impairment
- •Alcohol or other substance dependence
- •Unsigned consent form for participation
结局指标
主要结局
Perceived stress
时间窗: Baseline and immediately after completion of the assigned intervention period: up to 8 weeks (MBLC group), up to 3 weeks (forest bathing group), matched interval (comparison group)
The 10-item Perceived Stress Scale (PSS-10; Cohen et al., 1983) was used to assess a person's stress level based on their perception of life as unpredictable, uncontrollable, and overwhelming. The questionnaire includes 10 items rated on a Likert scale (0 = Never, 1 = Almost never, 2 = Sometimes, 3 = Quite often, 4 = Very often). The items are grouped into two factors: the first relates to perceived helplessness, and the second to perceived self-efficacy \[33\]. Higher scores indicate a higher level of perceived stress.
次要结局
- Chronic disease self-management self-efficacy(Baseline and immediately after completion of the assigned intervention period: up to 8 weeks (MBLC group), up to 3 weeks (forest bathing group), matched interval (comparison group))
- Health-related quality of life(Baseline and immediately after completion of the assigned intervention period: up to 8 weeks (MBLC group), up to 3 weeks (forest bathing group), matched interval (comparison group))
- Blood pressure (systolic and diastolic)(Baseline and immediately after completion of the assigned intervention period: up to 8 weeks (MBLC group), up to 3 weeks (forest bathing group), matched interval (comparison group))
- Cortisol(Baseline and immediately after completion of the assigned intervention period: up to 8 weeks (MBLC group), up to 3 weeks (forest bathing group), matched interval (comparison group))
- Heart rate(Baseline and immediately after completion of the assigned intervention period: up to 8 weeks (MBLC group), up to 3 weeks (forest bathing group), matched interval (comparison group))
- Self-rated health status on the day of questionnaire completion(Baseline and immediately after completion of the assigned intervention period: up to 8 weeks (MBLC group), up to 3 weeks (forest bathing group), matched interval (comparison group))
研究者
Denis Juraga
Deputy principal Investigator
University of Rijeka
