Stress, PsychologicalNCT04780646
Effects of Urban Nature on Stress and Quality of Life
A study testing Nature therapy in urban nature and City Walk in people with Stress, Psychological, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Nature therapy in urban nature and City Walk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteGermany
- Study dates
- 29 Jun 2022to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charite University
Berlin, 14169
Miriam Rösner, +4980505682, naturheilkunde.studien@immanuel.de
Andreas Michalsen, MD
About this study
Official title: 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.
- Conditions
- Stress, Psychological
- Being tested
- Nature therapy in urban nature, City Walk
- Keywords
- Nature therapy, Stress
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature therapy in urban natureBehavioural
Nature therapy means visits in nature, actively perceiving the flora and fauna
City WalkBehavioural
City Walk means walking through urban surroundings (houses, streets, concrete..) with as little as possible contact to nature
| Study group | Role | What they receive |
|---|---|---|
| Nature therapy in urban nature | Experimental | 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. Receives: Behavioral: Nature therapy in urban nature |
| City Walk | Active comparator | 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. Receives: Behavioral: City Walk |
| Waiting List | No intervention | Subjects don't receive any therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Secondary outcomes (19)
Zerssen symptom list (B-LR and B-LR')
Assessing full scale, range 20-80, higher score meaning a better outcome
Measured: 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
Measured: 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
Measured: 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
Measured: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
General Self-Efficacy Short Scale-3 (GSE-3)
Measured: 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
Measured: 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
Measured: 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
Measured: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Hospital Anxiety and Depression Scale (HADS)
Measured: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Profile of Mood States (POMS)
Measured: 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
Measured: Date of Inclusion (Baseline)
Behavioural questions: doctor visits and health
amount of doctor visits, amount of sick leave days in the last 2 months
Measured: 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)
Measured: Date of Inclusion (Baseline)
Behavioural questions: cigarette consumption
Number of cigarettes on average per day in the last month
Measured: 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
Measured: 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
Measured: 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)
Measured: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Heart Rate (HR)
24h measuring by faros 180
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Heart Rate Variability (HRV)
24h measuring by faros 180
Measured: Date of inclusion (baseline), after 8 weeks, after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start29 Jun 2022
- Primary completion15 Oct 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof. Dr., Principal investigator, Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780646
- Sponsor's protocol ID
- Stadtnatur
- Status last verified
- Oct 2023
- First submitted
- 22 Feb 2021
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Urban Nature on Stress and Quality of Life of Subjects With Elevated Stress Levels - a Three-armed Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04780646
- Acronym / sponsor ID
- Stadtnatur
- Conditions
- Stress, Psychological
- Keywords
- Nature therapy, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nature therapy in urban nature | Experimental | Behavioral: Nature therapy in urban natureSubjects 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. |
| City Walk | Active comparator | Behavioral: City WalkSubjects 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. |
| Waiting List | No intervention | –Subjects don't receive any therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nature therapy in urban natureNature therapy means visits in nature, actively perceiving the flora and fauna | Behavioural | Nature therapy in urban nature |
| City WalkCity Walk means walking through urban surroundings (houses, streets, concrete..) with as little as possible contact to nature | Behavioural | City Walk |
Primary outcome
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.
19 secondary outcomes
Zerssen symptom list (B-LR and B-LR')
Time frame: 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
Maslach Burnout Inventory (MBI)
Time frame: 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
General Self-Efficacy Short Scale-3 (GSE-3)
Time frame: 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
Subjective Vitality Scale (SVS-G state)
Time frame: 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
Hospital Anxiety and Depression Scale (HADS)
Time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Profile of Mood States (POMS)
Time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Sociodemographic Measurements
Time frame: Date of Inclusion (Baseline)
Behavioural questions: doctor visits and health
Time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks
Expectation questions
Time frame: Date of Inclusion (Baseline)
Behavioural questions: cigarette consumption
Time frame: 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
Behavioural questions: time in nature
Time frame: 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
Heart Rate (HR)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Michalsen, Prof. Dr. principal investigator
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature therapy in urban nature and City Walk in people with Stress, Psychological, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miriam Rösner (00493080505682, m.roesner@immanuel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress questionnaire (Cohen Perceived Stress Scale, CPSS) (time frame: Date of Inclusion (Baseline), after 8 weeks and after 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.