- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06981000
- Original Trial
A Feasibility Study of Nature-based Health Interventions for People With Mild to Moderate Anxiety, Depression and Stress
May 18, 2026 updated by: University of Copenhagen
A Feasibility Study of Locally Adapted Nature-based Health Interventions for People With Mild to Moderate Anxiety, Depression and Stress
Background and aimThe increased burden on mental health both globally and nationally is a serious challenge that requires attention and action from healthcare professionals, politicians, and decision-makers.
According to the report "The National Health Profile 2021" from the Danish Health Authority, the number of adult Danes (over 16 years) with a low mental health score has increased by seven percentage points from 2010-2021 and now stands at 17.4%.
A significant proportion of these individuals suffer from anxiety, depression, and/or stress.
This increase in people with reduced mental health has consequences both for the individual's quality of life and for society as a whole.
Thus, more than 13% of the Danish population is prescribed medication for the treatment of mental illnesses, and only 28% of them are able to work while experiencing their illness.There is a growing recognition that the challenges associated with mental health cannot be solved solely through clinical treatment or medication.
In order to offer citizens and patients the best possible support, it is important to look for sustainable solutions to promote mental health and ensure access to effective treatment options.
Despite a significant increase in the number of published research studies on the positive impact of nature on mental health, there has not previously been developed a theoretical foundation and a comprehensive evidence base for nature-based health interventions in a Danish context, and there has been a lack of a structured and systematically developed understanding of the mechanisms of change in nature-based health interventions (NBHIs), so they can be implemented in a way that aligns with the best available knowledge in the field.In phase 1 of the project, a systematic review of the literature has been conducted.
Hereby followed an extensive co-creation process, including the development of a logic model and an underlying program theory, and established collaboration with three relevant implementation partners.In phase 2 of the project, the aim was to test the feasibility of three locally adapted NBHIs in a feasibility study with up to 120 participants (40 participants per partner) at three different partners.
MethodsThe locally adapted NBHIs will be tested at the Psychiatric Center Glostrup and at the Kolding and Silkeborg municipal health centers from March to November 2025.
The intervention will be carried out as an interdisciplinary initiative facilitated by two healthcare professionals employed at the respective partners, who already have experience in delivering NBHIs to the target group.The NBHIs are organized according to the following structure:• Duration of the program: Minimum 10 weeks, once a week, 1.5-2.5 hours per session• Group composition: Across conditions: mild to moderate anxiety, depression, and/or stress• Group size: 8-12 participants in a closed groupIn the locally adapted programs, activities in nature are based on three main mechanisms of change (nature interaction and sensory experiences, social communities, and physical activity and movement), identified in phase 1 of the project.
The healthcare professionals responsible for the programs will tailor the activities individually.
All activities are designed based on a generic logic model, developed through a co-creation process.Safety plays a central role in the nature-based health interventions.
All activities are planned with a focus on the participants' physical and mental well-being.
Potential risks are assessed and minimized through the selection of suitable natural environments, appropriate equipment, and thorough instruction.
The healthcare professionals ensure a safe environment where participants can feel comfortable, both physically and psychologically.
Additionally, accessibility and any individual needs are considered, so all participants can safely engage in the activities.
With this study, the results of a new treatment or examination will not be conduced (and none of the participants will receive a worse treatment offer than what currently exists).
It is about investigating the feasibility of locally adapted NBHIs at three different partners who already have nature-based programs.Both quantitative and qualitative data will be collected.
These will include questionnaire data, data from registration of participation by the partner, participant observation, focus group interviews with participants from the NBHIs, as well as focus group interviews with the healthcare professionals who are carrying out the NBHIs.
As part of the qualitative research, experiences with and perceptions of the process, including the feasibility of the NBHI and how the participants respond to the intervention will be examended.
Written consent will be obtained from the participants and healthcare professionals prior to this.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
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
-
-
Denmark
-
Copenhagen, Denmark, Denmark
- Department of Geosciences and Natural Resource Management, University of Copenhagen, Denmark
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18 years or above
- Diagnosed with or symptoms of mild to moderate anxiety, depression, and/or experiencing symptoms of stress, and as a result is the primary cause of reduced functionality
- Contact through health center in the municipality, general practitioner, job center, self-referral, or via outpatient psychiatric rehabilitation plan
- Sick leave is not a requirement
Exclusion Criteria:
- Age less than 18 years
- Serious psychiatric disorders like schizophrenia, bipolar disorder, severe anxiety or depression, posttraumatic stress disorder (PTSD)
- Suicidal risk
- Alcohol or substance abuse
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Nature-based health intervention
This is a single-arm feasibility study of locally adapted NBHIs
|
The locally adapted NBHIs are organized according to the following structure:
In the locally adapted programs, activities in nature are based on three main mechanisms of change (nature interaction and sensory experiences, social communities, and physical activity and movement). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ability to enroll participants who meet the inclusion criteria within the target time frame
Time Frame: From enrollment to the end of the treatment at 10 weeks
|
Number of participants recruited
|
From enrollment to the end of the treatment at 10 weeks
|
|
Population composition
Time Frame: From enrollment to the end of the treatment at 10 weeks
|
The composition of participants with symptoms of anxiety, depression and stress, respectively, reported in the questionnaire data
|
From enrollment to the end of the treatment at 10 weeks
|
|
Non-participation
Time Frame: From enrollment to the end of the treatment at 10 weeks
|
Registration by the health care team of reasons for declining to participate in the nature-based health intervention
|
From enrollment to the end of the treatment at 10 weeks
|
|
Participant adherence to the intervention
Time Frame: From enrollment to the end of the treatment at 10 weeks
|
How many times out of 10 sessions do the participants participate, reported in the questionnaire data
|
From enrollment to the end of the treatment at 10 weeks
|
|
Which adaptions are conducted during the program
Time Frame: From enrollment to the end of the treatment at 10 weeks
|
Registrations by the health care team
|
From enrollment to the end of the treatment at 10 weeks
|
|
Which components from the generic logic model come into play
Time Frame: From enrollment to the end of the treatment at 10 weeks
|
Qualitatively data through participant observation and focus group interviews with the health care team
|
From enrollment to the end of the treatment at 10 weeks
|
|
Are the right mechanisms of change from the logic model identified and incorporated in the intervention
Time Frame: From enrollment to the end of the treatment at 10 weeks
|
Qualitatively data through participant observation and focus group interviews with the health care team
|
From enrollment to the end of the treatment at 10 weeks
|
|
What was the participants' perception of the intervention?
Time Frame: Week 11, one week after the completion of the intervention
|
Qualitatively data through focus group interviews with the participants
|
Week 11, one week after the completion of the intervention
|
|
What was the health care teams' perception of the intervention?
Time Frame: From enrollment to the end of the treatment at 10 weeks
|
Qualitatively data through focus group interviews with the health care team
|
From enrollment to the end of the treatment at 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mental well-being
Time Frame: Baseline, post program (after 10 weeks)
|
WHO-5 Well-being Index.
Five item scale answered on a Likert scale 0-5, with a lower score indicating worse outcome
|
Baseline, post program (after 10 weeks)
|
|
Symptoms of anxiety, depression and/or stress
Time Frame: Baseline, post program (after 10 weeks)
|
Depression, Anxiety and Stress Scale (DASS-21).
21 item scale answered on a Likert scale 0-3, with a higher score indicating worse outcome
|
Baseline, post program (after 10 weeks)
|
|
Life quality
Time Frame: Baseline, post program (after 10 weeks)
|
Satisfaction with Life Scale.
Five item scale answered on a Likert scale 1-7, with a lower score indicating worse outcome
|
Baseline, post program (after 10 weeks)
|
|
Nature relatedness
Time Frame: Baseline, post program (after 10 weeks)
|
Environmental Identity Scale.
14 item scale answered on a Likert scale 1-7, with a lower score indicating lower nature relatedness
|
Baseline, post program (after 10 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Dorthe V Poulsen, Ass professor, Department of Geosciences and Natural Resource Management, University of Copenhagen, Denmark
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)
February 1, 2025
Primary Completion (Actual)
April 30, 2026
Study Completion (Actual)
May 1, 2026
Study Registration Dates
First Submitted
March 14, 2025
First Submitted That Met QC Criteria
May 12, 2025
First Posted (Actual)
May 20, 2025
Study Record Updates
Last Update Posted (Actual)
May 22, 2026
Last Update Submitted That Met QC Criteria
May 18, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 514-0614/25-5000
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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