NCT07709962

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2025

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 1, 2026

Last Update Submit

July 14, 2026

Conditions

Keywords

hypertensionagedwomen's healthmindfulnessforest bathingstresspsychologicalself-efficacyself-managementquality of life

Outcome Measures

Primary Outcomes (1)

  • Perceived stress

    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.

    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)

Secondary Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Study Arms (3)

Mindfulness group

EXPERIMENTAL

The mindfulness group attended the Mindfulness-Based Living Course (MBLC), a structured program developed by the Mindfulness Association of the United Kingdom for acquiring the knowledge and skills to practice mindfulness. Workshops were held once weekly for two hours over eight weeks. The eight sessions progressed from an introductory workshop and training the mind and body for one's own well-being, through healthy habits, healthy thinking, healthy nutrition, healthy physical activity (including SMART goal-setting), and healthy relationships, to a final session on living healthily despite a chronic condition, encouraging participants to take an active role in managing their own health and to focus on their own resources rather than on disease symptoms. The workshops were led by a certified MBLC educator at the Department of Social Medicine and Epidemiology, Faculty of Medicine, University of Rijeka.

Behavioral: Mindfulness-Based Living Course (MBLC)

Forest therapy group

EXPERIMENTAL

The forest therapy group took part in a guided forest bathing (Shinrin-yoku) program comprising three organized visits to a forest environment, each lasting for up to three hours, led by a certified forest therapy guide. Sessions took the form of guided immersion walks in forests in the vicinity of Rijeka, delivered as three organized, guided, single-day forest visits. Sessions were led by a certified Forest Bathing guide accredited 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; closing Circle of Incorporation). The program involved active participation in guided immersion in the forest environment, intended to allow participants to experience first-hand the benefits of the method, which has been associated internationally with reductions in blood pressure and in stress-hormone levels in blood, saliva, and urine.

Behavioral: Forest therapy

Control group

NO INTERVENTION

The control group did not took part in the intervention pathways and was part of their usual care during the study.

Interventions

Forest therapyBEHAVIORAL

The forest therapy group took part in a guided forest bathing (Shinrin-yoku) program comprising three organized visits to a forest environment, each lasting for up to three hours, led by a certified forest therapy guide. Sessions took the form of guided immersion walks in forests in the vicinity of Rijeka, delivered as three organized, guided, single-day forest visits. Sessions were led by a certified Forest Bathing guide accredited 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; closing Circle of Incorporation). The program involved active participation in guided immersion in the forest environment, intended to allow participants to experience first-hand the benefits of the method, which has been associated internationally with reductions in blood pressure and in stress-hormone levels in blood, saliva, and urine.

Forest therapy group

The mindfulness group attended the Mindfulness-Based Living Course (MBLC), a structured program developed by the Mindfulness Association of the United Kingdom for acquiring the knowledge and skills to practice mindfulness. Workshops were held once weekly for two hours over eight weeks. The eight sessions progressed from an introductory workshop and training the mind and body for one's own well-being, through healthy habits, healthy thinking, healthy nutrition, healthy physical activity (including SMART goal-setting), and healthy relationships, to a final session on living healthily despite a chronic condition, encouraging participants to take an active role in managing their own health and to focus on their own resources rather than on disease symptoms. The workshops were led by a certified MBLC educator at the Department of Social Medicine and Epidemiology, Faculty of Medicine, University of Rijeka.

Mindfulness group

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman older than 60 years
  • Diagnosed arterial hypertension (pharmacologically treated)
  • Signed informed consent form for participation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rijeka, Faculty of Medicine

Rijeka, Croatia

Location

MeSH Terms

Conditions

Hypertension

Interventions

Forest Therapy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Relaxation TherapyMind-Body TherapiesComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy principal Investigator

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 17, 2026

Study Start

February 3, 2025

Primary Completion

May 3, 2025

Study Completion

May 30, 2025

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations