Effects of Urban Nature on Stress and Quality of Life

• ClinicalTrials.gov Identifier: NCT04780646
• Recruitment Status: Not yet recruiting
• First Posted: March 3, 2021
• Last Update Posted: March 3, 2021
• Sponsor: Charite University, Berlin, Germany
• Information provided by (Responsible Party): Andreas Michalsen, Charite University, Berlin, Germany

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Stress, Psychological	Behavioral: Nature therapy in urban nature; Behavioral: City Walk	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Urban Nature on Stress and Quality of Life of Subjects With Elevated Stress Levels - a Three-armed Randomized Controlled Study
• Estimated Study Start Date: April 15, 2021
• Estimated Primary Completion Date: April 15, 2022
• Estimated Study Completion Date: June 15, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Stress questionnaire (Cohen Perceived Stress Scale, CPSS) [ Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks ]
   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.

Secondary Outcome Measures :

1. Zerssen symptom list (B-LR and B-LR') [ Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks ]
   Assessing full scale, range 20-80, higher score meaning a better outcome
2. International Physical Activity Questionnaire (IPAQ) [ Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks ]
   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
3. Maslach Burnout Inventory (MBI) [ Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks ]
   Assessing full scale, range 0-96, higher score meaning a better outcome
4. Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA) [ Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks ]
   Assessing full scale, range 0-56, higher score meaning a better outcome
5. Multidimensional Assessment of Interoceptive Awareness (MAIA) [ Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks ]
   Assessing full scale, range 0-160, higher score meaning a better outcome
6. Perceived Benefits of Nature Questionnaire (PBNQ) [ Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks ]
   mean score of the 11 items, range 1-7, lower score meaning a better outcome
7. Insomnia Severity Index (ISI) [ Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks ]
   Assessing full scale, range from 0-28, lower score meaning a better outcome
8. Flourishing Scale (FS) [ Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks ]
   Assessing full scale, range 8-56, higher score meaning a better outcome
9. Depression-Fear-Stress-Scale (DASS) [ Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks ]
   Assessing three subscales on depression, stress and fear; each ranging from 0-21, lower score meaning a better outcome beträgt 10, für Angst ist ein CutOff von 6, für Stress ein Wert von 10 sinnvoll
10. Awe and Gratitude (GrAw-7) [ Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks ]
    Assessing 7 items, referring them to a 100% scale (transferred scale score) - Assessing full score, the scores can be referred to a 100% level (transformed scale score), higher score meaning better outcome
11. Inner Correspondence and feelings of Peaceful Relief (ICPH) [ Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks ]
    Assessing full score, the scores can be referred to a 100% level (transformed scale score), which reflects the degree of inner congruence, higher score meaning better outcome
12. Sociodemographic Measurements [ Time Frame: Date of Inclusion (Baseline) ]
    Age, gender, marital status, number of people in household, education level, employment status, job, personal net income, household income
13. Behavioural questions: doctor visits and health [ Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks ]
    amount of doctor visits, amount of sick leave days in the last 2 months
14. Expectation questions [ Time Frame: Date of Inclusion (Baseline) ]
    for intervention 1 and 2 on a 6-point likert scale from 1 (very strong) to 6 (nothing at all)
15. Behavioural questions: cigarette consumption [ Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks ]
    Number of cigarettes on average per day in the last month
16. Behavioural questions: alcohol consumption [ Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks ]
    Number of alcoholic beverages on average per week in the last month
17. Behavioural questions: time in nature [ Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks ]
    amount of hours spent in nature per week in the last month
18. Behavioural questions: nature as priority [ Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks ]
    if spending time in nature is seen as a priority on a 6-point likert scale 1 (very strong) to 6 (nothing at all)
19. Heart Rate (HR) [ Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks ]
    24h measuring by smartwatch
20. Heart Rate Variability (HRV) [ Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks ]
    24h measuring by smartwatch
21. Interbeat Interval (IBI) [ Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks ]
    24h measuring by smartwatch
22. Number of steps [ Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks ]
    24h measuring by smartwatch

Other Outcome Measures:

1. Qualitative interviews in focus groups interviews [ Time Frame: 16 weeks after inclusion ]
   Qualitative assessment will be carried out in 45-minute focus group interviews in 20 (randomized selected) patients participating in the study. The interviews will be recorded, transcribed and analyzed with qualitative content analysis.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Miriam Rösner; 00493080505682; m.roesner@immanuel.de

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

• Principal Investigator: Andreas Michalsen, Prof. Dr.; Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

More Information

• Responsible Party: Andreas Michalsen, Prof. Dr., Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT04780646
• Other Study ID Numbers: Stadtnatur
• First Posted: March 3, 2021
• Last Update Posted: March 3, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andreas Michalsen, Charite University, Berlin, Germany:

Nature therapy; Stress

Additional relevant MeSH terms:

Stress, Psychological; Behavioral Symptoms