Effects of Urban Nature on Stress and Quality of Life

October 24, 2023 updated by: Andreas Michalsen, Charite University, Berlin, Germany

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Profile of Mood States (POMS)
Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
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
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
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
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
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
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
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
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
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
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
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
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
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
Date of Inclusion (Baseline)
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
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
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)
Date of Inclusion (Baseline)
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
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
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
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
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
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
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)
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
General Self-Efficacy Short Scale-3 (GSE-3)
Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Subjective Vitality Scale (SVS-G state)
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
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Heart Rate (HR)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
24h measuring by faros 180
Date of inclusion (baseline), after 8 weeks, after 16 weeks
Heart Rate Variability (HRV)
Time Frame: Date of inclusion (baseline), after 8 weeks, after 16 weeks
24h measuring by faros 180
Date of inclusion (baseline), after 8 weeks, after 16 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Qualitative interviews in individual interviews
Time Frame: 8 weeks after inclusion
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andreas Michalsen, Prof. Dr., Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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