- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05562128
Effects of Forest Therapy on Physical and Psychological Parameters in the General Population - a Randomized Controlled Trial
October 24, 2023 updated by: Andreas Michalsen, Charite University, Berlin, Germany
In recent years, nature and forest therapy has increasingly become the focus of medical research.
Recent scientific findings indicate overall positive effects of nature and forest therapy on physical and mental health.
In Asia and Australia, it has already been implemented as a public health concept of prevention and health promotion.
The aim of the project is to replicate the experience gained in Asia over the last three decades on the physical and psychological effects of nature/forest therapy in the context of the German forest and to investigate it further scientifically.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- 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 Locations
-
-
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Berlin, Germany, 14109
- Recruiting
- Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
-
Contact:
- Miriam Rösner, Study nurse
- Phone Number: 00493080505682
- Email: m.roesner@immanuel.de
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-
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
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Ability to Consent
Exclusion Criteria:
- Serious acute or chronic illness
- Immobility or limitation of mobility due to orthopedic, neurologic, or other medical causes
- Participation in another study
- Serious mental illness
- Pregnancy and lactation.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Waiting list
|
|
Experimental: Active forest therapy
|
Participants take part in a two-hour active clinical forest therapy in Berlin-Wannsee on two days (with a break day in between).
In this setting, a trained clinical forest therapist teaches exercises on the perception of nature and the connection between nature and health.
|
Active Comparator: Passive forest therapy
|
Participants take part in a two-hour passive clinical forest therapy in Berlin-Wannsee over two days (with a break day in between).
In this setting, a trained clinical forest therapist will guide participants to various locations in the forest where participants can stay and let nature have its effect on them.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Profile of Mood States (POMS)
Time Frame: Change from baseline POMS score at 3 months
|
Change from baseline POMS score at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Profile of Mood States (POMS)
Time Frame: Baseline, day 1, day 3, 1 week, 3 months
|
Baseline, day 1, day 3, 1 week, 3 months
|
|
Perceived Benefits of Nature Questionnaire (PBNQ)
Time Frame: Baseline, 1 week, 3 months
|
Baseline, 1 week, 3 months
|
|
Subjective Vitality Scale state (SVS-G state)
Time Frame: Baseline, day 1, day 3, 1 week, 3 months
|
Baseline, day 1, day 3, 1 week, 3 months
|
|
Complaint List (B-LR)
Time Frame: Baseline, 1 week, 3 months
|
Baseline, 1 week, 3 months
|
|
Perceive Stress Questionaire (PSQ)
Time Frame: Baseline, day 1, day 3, 1 week, 3 months
|
Baseline, day 1, day 3, 1 week, 3 months
|
|
Freiburger Fragebogen zur Achtsamkeit (FFA)
Time Frame: Baseline, 1 week, 3 months
|
Baseline, 1 week, 3 months
|
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline, 1 week, 3 months
|
The scale ranges from 0 to 3. Higher scores correspond to higher levels of anxiety and/or depression.
|
Baseline, 1 week, 3 months
|
Perceived Stress Scale (PSS)
Time Frame: Baseline, 1 week, 3 months
|
The scale ranges from 0 to 4. Higher scores correspond to higher levels of perceived stress.
|
Baseline, 1 week, 3 months
|
Allgemeine Selbstwirksamkeit Kurzskala (ASKU)
Time Frame: Baseline, 1 week, 3 months
|
The scale ranges from 1 to 5. Higher scores correspond to better outcomes.
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Baseline, 1 week, 3 months
|
State-Trait Anxiety Inventory (STAI)
Time Frame: Baseline, day 1, day 3, 1 week, 3 months
|
The scale ranges from 1 to 8. Higher scores correspond to higher levels of anxiety (after recoding three inverted items).
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Baseline, day 1, day 3, 1 week, 3 months
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PROMIS Scale v1.2 - Global Health
Time Frame: Baseline, 1 week, 3 months
|
The scale ranges from 1 to 5, where 1 is the lowest level and 5 is the highest level.
Higher scores reflect better functioning.
|
Baseline, 1 week, 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate Variability (HRV)
Time Frame: Baseline, 1 week
|
24h measuring by Faros 180
|
Baseline, 1 week
|
Qualitative interviews
Time Frame: 1 week and 8 weeks after inclusion
|
Qualitative assessment will be carried out in qualitative interviews in 20 patients participating in the study.
The interviews will be recorded, transcribed and analyzed with qualitative content analysis.
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1 week and 8 weeks after inclusion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 10, 2022
Primary Completion (Estimated)
October 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
September 28, 2022
First Submitted That Met QC Criteria
September 28, 2022
First Posted (Actual)
September 30, 2022
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
Other Study ID Numbers
- KWT2
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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