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Effects of Urban Nature on Stress and Quality of Life

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress

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.



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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780646


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

Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Andreas Michalsen, Prof. Dr. Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
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Responsible Party: Andreas Michalsen, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04780646    
Other Study ID Numbers: Stadtnatur
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021

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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:
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Stress, Psychological
Behavioral Symptoms