Effects of Urban Nature on Stress and Quality of Life

Effects of Urban Nature on Stress and Quality of Life of Subjects With Elevated Stress Levels - a Three-armed Randomized Controlled Study

The aim of this study is to investigate the effects of regular nature therapy in urban nature with guidance of a licensed nature therapist on stress, quality of life and physical symptoms of subjects with elevated stress levels.

Study Overview

• Status: Recruiting
• Conditions: Stress, Psychological
• Intervention / Treatment: Behavioral: Nature therapy in urban nature; Behavioral: City Walk

• Study Type: Interventional
• Enrollment (Estimated): 93
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miriam Rösner; Phone Number: 00493080505682; Email: m.roesner@immanuel.de

Study Locations

• Germany
  • Berlin, Germany, 14169
    • Recruiting
    • Charité University
    • Contact: Miriam Rösner; Phone Number: +4980505682; Email: naturheilkunde.studien@immanuel.de
    • Principal Investigator: Andreas Michalsen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• stress with at least 4 of 10 points on the Numeric Analogue Scale (NAS) at least 1 month
• at least 3 of the following 8 stress-associated symptoms: sleep disturbances, inappetence or increased appetite, shoulder neck tension/back pain, tension headache, concentration disturbances, exhaustion, nervousness/irritability, stress-associated digestive complaints.

Exclusion Criteria:

• serious acute or chronic diseases
• pregnancy or lactation
• known serious mental illness
• immobility or restriction for gymnastics exercises due to orthopaedic, neurological or other medical cause
• participation in another study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nature therapy in urban nature; Subjects receive a 90-minute nature therapy session once per week for 8 weeks with a licensed nature therapist, who explains exercises on perceiving nature and the connection between nature and health.	Behavioral: Nature therapy in urban nature; Nature therapy means visits in nature, actively perceiving the flora and fauna
Active Comparator: City Walk; Subjects receive a 90-minute city walk through urban sourroundings once per week for 8 weeks with a city guide, who talks about city architecture and gives information about the history of the surroundings.	Behavioral: City Walk; City Walk means walking through urban surroundings (houses, streets, concrete..) with as little as possible contact to nature
No Intervention: Waiting List; Subjects don't receive any therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress questionnaire (Cohen Perceived Stress Scale, CPSS)	Change from Baseline in the CPSS, range from 0 to 4 in each item. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the positively stated items and then summing across all scale items while higher values meaning a higher grade of perceived stress.	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Profile of Mood States (POMS)		Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Zerssen symptom list (B-LR and B-LR')	Assessing full scale, range 20-80, higher score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
International Physical Activity Questionnaire (IPAQ)	MET minutes represent the amount of energy expended carrying out physical activity. To get a continuous variable score from the IPAQ (MET minutes a week) we will consider walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS; higher score meaning better outcome; range 0 to around 3000 MET minutes a week	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Maslach Burnout Inventory (MBI)	Assessing full scale, range 0-96, higher score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA)	Assessing full scale, range 0-56, higher score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Perceived Benefits of Nature Questionnaire (PBNQ)	mean score of the 11 items, range 1-7, lower score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Flourishing Scale (FS)	Assessing full scale, range 8-56, higher score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Sociodemographic Measurements	Age, gender, marital status, number of people in household, education level, employment status, job, personal net income, household income	Date of Inclusion (Baseline)
Behavioural questions: doctor visits and health	amount of doctor visits, amount of sick leave days in the last 2 months	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Expectation questions	for intervention 1 and 2 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all)	Date of Inclusion (Baseline)
Behavioural questions: cigarette consumption	Number of cigarettes on average per day in the last month	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Behavioural questions: alcohol consumption	Number of alcoholic beverages on average per week in the last month	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Behavioural questions: time in nature	amount of hours spent in nature per week in the last month	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Behavioural questions: nature as priority	if spending time in nature is seen as a priority on a 6-point likert scale 1 (very strong) to 6 (nothing at all)	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
General Self-Efficacy Short Scale-3 (GSE-3)		Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Subjective Vitality Scale (SVS-G state)	Assessing full scale, range from 0-28, lower score meaning a better outcome	Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Hospital Anxiety and Depression Scale (HADS)		Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Heart Rate (HR)	24h measuring by faros 180	Date of inclusion (baseline), after 8 weeks, after 16 weeks
Heart Rate Variability (HRV)	24h measuring by faros 180	Date of inclusion (baseline), after 8 weeks, after 16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative interviews in individual interviews	Qualitative assessment will be carried out in 45-minute individual interviews in 20 (randomized selected) patients participating in the study. The interviews will be recorded, transcribed and analyzed with qualitative content analysis.	8 weeks after inclusion

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Andreas Michalsen, Prof. Dr., Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Estimated): October 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 28, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Stress; Nature therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: Stadtnatur

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No