General PopulationNCT05338372
Effects of Forest Therapy on Physical and Psychological Parameters in the General Population
A study testing Two days forest therapy and Three days forest therapy in people with General Population, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- General Population
- What is being tested?
- Two days forest therapy and Three days forest therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteGermany
- Study dates
- 2 May 2022to 4 Jun 2022
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women and men aged 18 to 90 years.
- Capacity to consent
Who cannot join
- Serious acute or chronic medical conditions
- Immobility or limitation of mobility due to orthopedic, neurological or other medical causes
- Participation in another study
- Serious mental illness
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Forest Therapy on Physical and Psychological Parameters in the General Population
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.
- Conditions
- General Population
- Being tested
- Two days forest therapy, Three days forest therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two days forest therapyBehavioural
Participants attend two days (with a break day in between) of two-hour forest therapy at the Friedrichsruh, Barntrup or Wernigerode sites, led by an INFTA-certified forest therapy guide.
Three days forest therapyBehavioural
Participants attend three days of two-hour forest therapy at the Friedrichsruh, Barntrup or Wernigerode sites, led by an INFTA-certified forest therapy guide.
| Study group | Role | What they receive |
|---|---|---|
| Two days forest therapy | Experimental | Not described Receives: Behavioral: Two days forest therapy |
| Three days forest therapy | Experimental | Not described Receives: Behavioral: Three days forest therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of Mood States (POMS)
Assessing full scale, range 1-7, lower score meaning a better outcome
Measured: Change from baseline POMS score at 3 days
Secondary outcomes (7)
Perceived Benefits of Nature Questionnaire (PBNQ)
Assessing full scale, range 1-7, lower score meaning a better outcome
Measured: Change from baseline PBNQ score at 3 days
Subjective Vitality Scale state (SVS-G state)
Assessing full scale, range 1-80, higher score meaning a better outcome
Measured: Change from baseline SVS-G score at 3 days
Complaint List (B-LR)
Assessing full scale, range 1-50, lower score meaning a better outcome
Measured: Change from baseline B-LR score at 3 days
Perceive Stress Questionaire (PSQ)
Assessing full scale, range 1-40, lower score meaning a better outcome
Measured: Change from baseline PSQ score at 3 days
State-Trait Anxiety Inventory (STAI)
Assessing state anxiety. The scale ranges from 1 to 8. Higher scores correspond to higher levels of anxiety (after recoding three inverted items).
Measured: Change from baseline STAI score at 3 days
PROMIS Scale v1.2 - Global Health
The scale ranges from 1 to 5, where 1 is the lowest level and 5 is the highest level. Higher scores reflect better functioning.
Measured: Change from baseline PROMIS score at 3 days
Allgemeine Selbstwirksamkeit Kurzskala (ASKU)
Assessing full scale, the scale ranges from 1 to 5. Higher scores correspond to better outcomes.
Measured: Change from baseline ASKU score at 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start2 May 2022
- Primary completion4 Jun 2022
- Study completion4 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General PopulationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 178 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338372
- Sponsor's protocol ID
- KWT1
- Status last verified
- Oct 2022
- First submitted
- 11 Apr 2022
- Last updated
- 13 Oct 2022
- 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 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forest Therapy on Physical and Psychological Parameters in the General Population
- ClinicalTrials.gov ID
- NCT05338372
- Acronym / sponsor ID
- KWT1
- Conditions
- General Population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 4 Jun 2022 (actual)
- Study completion
- 4 Jun 2022 (actual)
- First posted
- 21 Apr 2022 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two days forest therapy | Experimental | Behavioral: Two days forest therapy |
| Three days forest therapy | Experimental | Behavioral: Three days forest therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women and men aged 18 to 90 years.
- Capacity to consent
Key exclusion criteria (5 listed)
- Serious acute or chronic medical conditions
- Immobility or limitation of mobility due to orthopedic, neurological or other medical causes
- Participation in another study
- Serious mental illness
- Pregnancy and lactation
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 |
|---|---|---|
| Two days forest therapyParticipants attend two days (with a break day in between) of two-hour forest therapy at the Friedrichsruh, Barntrup or Wernigerode sites, led by an INFTA-certified forest therapy guide. | Behavioural | Two days forest therapy |
| Three days forest therapyParticipants attend three days of two-hour forest therapy at the Friedrichsruh, Barntrup or Wernigerode sites, led by an INFTA-certified forest therapy guide. | Behavioural | Three days forest therapy |
Primary outcome
Profile of Mood States (POMS)
Time frame: Change from baseline POMS score at 3 days
Assessing full scale, range 1-7, lower score meaning a better outcome
7 secondary outcomes
Perceived Benefits of Nature Questionnaire (PBNQ)
Time frame: Change from baseline PBNQ score at 3 days
Subjective Vitality Scale state (SVS-G state)
Time frame: Change from baseline SVS-G score at 3 days
Complaint List (B-LR)
Time frame: Change from baseline B-LR score at 3 days
Perceive Stress Questionaire (PSQ)
Time frame: Change from baseline PSQ score at 3 days
State-Trait Anxiety Inventory (STAI)
Time frame: Change from baseline STAI score at 3 days
PROMIS Scale v1.2 - Global Health
Time frame: Change from baseline PROMIS score at 3 days
Allgemeine Selbstwirksamkeit Kurzskala (ASKU)
Time frame: Change from baseline ASKU score at 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two days forest therapy and Three days forest therapy in people with General Population, 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: finished, as of the sponsor's last update on 13 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Profile of Mood States (POMS) (time frame: Change from baseline POMS score at 3 days). 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 13 Oct 2022.