AnxietyNCT06981000
A Feasibility Study of Nature-based Health Interventions for People With Mild to Moderate Anxiety, Depression and Stress
A study testing Locally adapted nature-based health intervention in people with Anxiety and Anxiety Disorders, run by University of Copenhagen at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Anxiety Disorders, Depression - Major Depressive Disorder
- What is being tested?
- Locally adapted nature-based health intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2025to 1 May 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Geosciences and Natural Resource Management, University of Copenhagen, Denmark
Copenhagen, Denmark
About this study
Official title: 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.
- Conditions
- Anxiety, Anxiety Disorders, Depression - Major Depressive Disorder, Depressive Disorder, Stress, Psychologic
- Being tested
- Locally adapted nature-based health intervention
- Keywords
- Nature-based health intervention, Mental health, Anxiety, Depression, Stress-related disorders
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Stress, Psychological, Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locally adapted nature-based health interventionBehavioural
The locally adapted 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 group
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).
| Study group | Role | What they receive |
|---|---|---|
| Nature-based health intervention | Other | This is a single-arm feasibility study of locally adapted NBHIs Receives: Behavioral: Locally adapted nature-based health intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to enroll participants who meet the inclusion criteria within the target time frame
Number of participants recruited
Measured: From enrollment to the end of the treatment at 10 weeks
Population composition
The composition of participants with symptoms of anxiety, depression and stress, respectively, reported in the questionnaire data
Measured: From enrollment to the end of the treatment at 10 weeks
Non-participation
Registration by the health care team of reasons for declining to participate in the nature-based health intervention
Measured: From enrollment to the end of the treatment at 10 weeks
Participant adherence to the intervention
How many times out of 10 sessions do the participants participate, reported in the questionnaire data
Measured: From enrollment to the end of the treatment at 10 weeks
Which adaptions are conducted during the program
Registrations by the health care team
Measured: From enrollment to the end of the treatment at 10 weeks
Which components from the generic logic model come into play
Qualitatively data through participant observation and focus group interviews with the health care team
Measured: 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
Qualitatively data through participant observation and focus group interviews with the health care team
Measured: From enrollment to the end of the treatment at 10 weeks
What was the participants' perception of the intervention?
Qualitatively data through focus group interviews with the participants
Measured: Week 11, one week after the completion of the intervention
What was the health care teams' perception of the intervention?
Qualitatively data through focus group interviews with the health care team
Measured: From enrollment to the end of the treatment at 10 weeks
Secondary outcomes (4)
Mental well-being
WHO-5 Well-being Index. Five item scale answered on a Likert scale 0-5, with a lower score indicating worse outcome
Measured: Baseline, post program (after 10 weeks)
Symptoms of anxiety, depression and/or stress
Depression, Anxiety and Stress Scale (DASS-21). 21 item scale answered on a Likert scale 0-3, with a higher score indicating worse outcome
Measured: Baseline, post program (after 10 weeks)
Life quality
Satisfaction with Life Scale. Five item scale answered on a Likert scale 1-7, with a lower score indicating worse outcome
Measured: Baseline, post program (after 10 weeks)
Nature relatedness
Environmental Identity Scale. 14 item scale answered on a Likert scale 1-7, with a lower score indicating lower nature relatedness
Measured: Baseline, post program (after 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Feb 2025
- Primary completion30 Apr 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Dorthe V Poulsen, Ass professor, Study director, Department of Geosciences and Natural Resource Management, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981000
- Sponsor's protocol ID
- 514-0614/25-5000
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jensen-Smidt SS, Madsen LS, Oestergaard LG, Poulsen DV, Ryom K, Jessen NH. The 'Nature Impact' feasibility study protocol: a mixed methods feasibility study of a group- and nature-based health intervention for adults experiencing mild to moderate anxiety, depression and/or stress. Pilot Feasibility Stud. 2026 Jun 22. doi: 10.1186/s40814-026-01875-x. Online ahead of print.
PubMed 42324479
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Locally Adapted Nature-based Health Interventions for People With Mild to Moderate Anxiety, Depression and Stress
- ClinicalTrials.gov ID
- NCT06981000
- Acronym / sponsor ID
- 514-0614/25-5000
- Conditions
- Anxiety, Anxiety Disorders, Depression - Major Depressive Disorder, Depressive Disorder, Stress, Psychologic
- Keywords
- Nature-based health intervention, Mental health, Anxiety, Depression, Stress-related disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 20 May 2025 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nature-based health intervention | Other | Behavioral: Locally adapted nature-based health interventionThis is a single-arm feasibility study of locally adapted NBHIs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Locally adapted nature-based health interventionThe locally adapted 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 group 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). | Behavioural | Nature-based health intervention |
Primary outcome
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
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
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
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
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
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
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
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
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
4 secondary outcomes
Mental well-being
Time frame: Baseline, post program (after 10 weeks)
Symptoms of anxiety, depression and/or stress
Time frame: Baseline, post program (after 10 weeks)
Life quality
Time frame: Baseline, post program (after 10 weeks)
Nature relatedness
Time frame: Baseline, post program (after 10 weeks)
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 22 May 2026.
- Derived from this study: PubMed 42324479Jensen-Smidt SS, Madsen LS, Oestergaard LG, Poulsen DV, Ryom K, Jessen NH. The 'Nature Impact' feasibility study protocol: a mixed methods feasibility study of a group- and nature-based health intervention for adults experiencing mild to moderate anxiety, depression and/or stress. Pilot Feasibility Stud. 2026 Jun 22. doi: 10.1186/s40814-026-01875-x. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
Dorthe V Poulsen, Ass professor study director
Department of Geosciences and Natural Resource Management, University of Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locally adapted nature-based health intervention in people with Anxiety and Anxiety Disorders, run by University of Copenhagen at 1 site in Denmark.
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 4 inclusion and 4 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 22 May 2026. 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 Denmark. 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?
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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06981000, which also lists 1 linked publication.
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 22 May 2026.