StressNCT04073524
The Wild Man Programme - a Nature-based Rehabilitation Enhancing Quality of Life for Men on Long-term Sick Leave
A study testing Nature-Body-Mind-Community and Treatment as usual in people with Stress and Anxiety, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The aim of the present study is to examine whether the nature based 'Wild man Programme' can help to increase quality of life among men on sick leave compared to treatment as usual. Additionally, the study examines which natural environments best work as supportive environments in the rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 68 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Depression
- What is being tested?
- Nature-Body-Mind-Community and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2018to 1 Jun 2021
- 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 68 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
The inclusion and exclusion criteria are similar for the two groups.
The inclusion criteria are:
- male gender
- 18 to 68 years of age
- clinical or self-reported symptoms of stress, anxiety, depression
- clinical diagnosis of cancer, cardiovascular disease, chronic obstructive pulmonary disease (COPD), diabetes or other kinds of chronic diseases
- ability to walk approximately three kilometers in nature
- ability to understand and speak Danish
The exclusion criteria are:
- psychosis or psychotic disorders, brain injuries or physical disabilities that prevent the participant from participating in the physical exercise programme or move about in nature
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Wild Man Programme. A Nature-based Rehabilitation Enhancing Quality of Life for Men on Long-term Sick Leave - a Matched Controlled Study
The aim of the present study is to examine whether the nature based 'Wild man Programme' can help to increase quality of life among men on sick leave compared to treatment as usual. Additionally, the study examines which natural environments best work as supportive environments in the rehabilitation.
Read the detailed description
Many men in Denmark have poor mental health and need help to recover. However, designing a rehabilitation intervention appealing to men is challenging. The 'Wild man Programme' is a rehabilitation programme for men on long-term sick leave and with clinical or self-reported stress due to prolonged health problems such as stress, anxiety, depression, cancer, chronic obstructive pulmonary disease (COPD), cardiovascular disease or diabetes. The programme is a nature-based rehabilitation (NBR) initiative combining nature experiences, attention training, body awareness training and supporting community spirit.
The aim of the present study is to examine whether the 'Wild man Programme' can help to increase quality of life among men on sick leave compared to treatment as usual. Additionally, the study examines which natural environments best work as supportive environments in the rehabilitation.
A matched control study comparing an intervention group (N=38) which receives a nine-week nature-based intervention to a control group (N=38) receiving case management as treatment as usual in the municipalities. Outcomes are measured at baseline (T1), post treatment (T2), and at follow-up 6 months post intervention (T3). The primary outcome is an improvement in quality of life and the secondary outcome is a decrease in stress level.
With the 'Wild man Programme' we investigate whether it is a model that can be implemented in the health system in Denmark to help men with different kinds of health problems improve their quality of life and stress levels. The programme can also deliver valuable information for future nature-based rehabilitation for women (Wild woman) and mixed gender groups. The project will also contribute with information on whether the method and the concept can be a valuable tool for health professionals in the health sector.
- Conditions
- Stress, Anxiety, Depression, Cardiac Disease, Cancer, Diabetes
- Being tested
- Nature-Body-Mind-Community, Treatment as usual
- Keywords
- Supportive Environment Theory (SET), Aesthetic Affective Theory (AAT), Attention Restoration Theory (ART), Nature-Body-Mind-Community (NBMC)
- Medical subject headings
- Anxiety Disorders, Depression, Heart Diseases, Neoplasms, Diabetes Mellitus, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature-Body-Mind-CommunityOther
The Nature-Body-Mind-Community (NBMC) approach has been developed in a pilot project over 2014-2018. The 'Wild man Programme' consists of the following main elements: 1. Nature environments and nature experiences, 2. Mind relaxation and meditation, 3. Body awareness and 4. Fire talks, storytelling and community spirit.
Treatment as usualOther
Treatment as usual consist of the rehabilitation offered by the hospital or municipality for the specific condition e.i. cancer, diabetes, COPD, anxiety, depression and stress
| Study group | Role | What they receive |
|---|---|---|
| Nature-Body-Mind-Community (NBMC) + treatment as usual | Experimental | 9 weeks of nature-based therapy (Nature-Body-Mind-Community (NBMC)) treatment as usual Receives: Other: Nature-Body-Mind-Community; Other: Treatment as usual |
| Treatment as usual | Other | Treatment as usual Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of quality of life - total score
The primary outcome is self-experienced quality of life. The World Health Organization's brief quality of life questionnaire (WHOQOL-BREF) will be used. The questionnaire examines four domains on a five-point Likert scale: Physical health, mental health, social relationships and health-related environments e.g. instant access to medical care. The global quality of life is based on the participants' scores on the four domains and they range from 0-100, with a high score indicating high quality of life.
Measured: 9 weeks
Secondary outcomes (6)
Level of quality of life - physical health
The WHOQOL-BREF will be used. The domain of physical health is measured on a five-point Likert scale with five questions.
Measured: 9 weeks
Level of quality of life - mental health
The WHOQOL-BREF will be used. The domain of mental health is measured on a five-point Likert scale with five questions.
Measured: 9 weeks
Level of quality of life - social relationships
The WHOQOL-BREF will be used. The domain of social relationships is measured on a five-point Likert scale with five questions.
Measured: 9 weeks
Level of quality of life - health related environments
The WHOQOL-BREF will be used. The domain of health related environments is measured on a five-point Likert scale with five questions.
Measured: 9 weeks
Level of self-experienced restitution
Self-experienced restitution. The Perceived Restorativeness Scale-11 (PRS-11) will be used.
Measured: 9 weeks
Level of self perceived stress
Self perceived stress. The Cohen's Perceived Stress Scale (PSS) will be used. The scale consists of 14 items measured on a five-point Likert scale.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start1 Jun 2018
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
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 StressStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study is a matched control study where the intervention group receives a nine-week nature-based intervention and is compared to a matched control group receiving case management as treatment as usual in the municipalities (see figure 1). All primary and secondary outcomes are measured at baseline (T1), post treatment (T2), and at follow-up 6 months post intervention (T3).
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark
- Responsible party
- Sponsor
- Investigators
- Simon Høegmark, Master, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073524
- Sponsor's protocol ID
- USouthernDenmarkpsychology
- Status last verified
- Nov 2020
- First submitted
- 23 Aug 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be submitted to the peer-reviewed journal BMC Public Health
Publications
Bratland-Sanda, S., Andersson, E., Best, J., Høegmark, S. & Roessler, K. K. The use of physical activity, sport and outdoor life as tools of psychosocial intervention: the Nordic perspective 2019. Sport in Society. 22, 4, s. 654-670, 2018.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Wild Man Programme. A Nature-based Rehabilitation Enhancing Quality of Life for Men on Long-term Sick Leave - a Matched Controlled Study
- ClinicalTrials.gov ID
- NCT04073524
- Acronym / sponsor ID
- USouthernDenmarkpsychology
- Conditions
- Stress, Anxiety, Depression, Cardiac Disease, Cancer, Diabetes
- Keywords
- Supportive Environment Theory (SET), Aesthetic Affective Theory (AAT), Attention Restoration Theory (ART), Nature-Body-Mind-Community (NBMC)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 29 Aug 2019 (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 the present study is to examine whether the nature based 'Wild man Programme' can help to increase quality of life among men on sick leave compared to treatment as usual. Additionally, the study examines which natural environments best work as supportive environments in the rehabilitation.
Detailed description
Many men in Denmark have poor mental health and need help to recover. However, designing a rehabilitation intervention appealing to men is challenging. The 'Wild man Programme' is a rehabilitation programme for men on long-term sick leave and with clinical or self-reported stress due to prolonged health problems such as stress, anxiety, depression, cancer, chronic obstructive pulmonary disease (COPD), cardiovascular disease or diabetes. The programme is a nature-based rehabilitation (NBR) initiative combining nature experiences, attention training, body awareness training and supporting community spirit.
The aim of the present study is to examine whether the 'Wild man Programme' can help to increase quality of life among men on sick leave compared to treatment as usual. Additionally, the study examines which natural environments best work as supportive environments in the rehabilitation.
A matched control study comparing an intervention group (N=38) which receives a nine-week nature-based intervention to a control group (N=38) receiving case management as treatment as usual in the municipalities. Outcomes are measured at baseline (T1), post treatment (T2), and at follow-up 6 months post intervention (T3). The primary outcome is an improvement in quality of life and the secondary outcome is a decrease in stress level.
With the 'Wild man Programme' we investigate whether it is a model that can be implemented in the health system in Denmark to help men with different kinds of health problems improve their quality of life and stress levels. The programme can also deliver valuable information for future nature-based rehabilitation for women (Wild woman) and mixed gender groups. The project will also contribute with information on whether the method and the concept can be a valuable tool for health professionals in the health sector.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a matched control study where the intervention group receives a nine-week nature-based intervention and is compared to a matched control group receiving case management as treatment as usual in the municipalities (see figure 1). All primary and secondary outcomes are measured at baseline (T1), post treatment (T2), and at follow-up 6 months post intervention (T3).
| Arm | Type | Receives |
|---|---|---|
| Nature-Body-Mind-Community (NBMC) + treatment as usual | Experimental | Other: Nature-Body-Mind-Community, Other: Treatment as usual9 weeks of nature-based therapy (Nature-Body-Mind-Community (NBMC)) treatment as usual |
| Treatment as usual | Other | Other: Treatment as usualTreatment as usual |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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-Body-Mind-CommunityThe Nature-Body-Mind-Community (NBMC) approach has been developed in a pilot project over 2014-2018. The 'Wild man Programme' consists of the following main elements: 1. Nature environments and nature experiences, 2. Mind relaxation and meditation, 3. Body awareness and 4. Fire talks, storytelling and community spirit. | Other | Nature-Body-Mind-Community (NBMC) + treatment as usual |
| Treatment as usualTreatment as usual consist of the rehabilitation offered by the hospital or municipality for the specific condition e.i. cancer, diabetes, COPD, anxiety, depression and stress | Other | Nature-Body-Mind-Community (NBMC) + treatment as usual, Treatment as usual |
Primary outcome
Level of quality of life - total score
Time frame: 9 weeks
The primary outcome is self-experienced quality of life. The World Health Organization's brief quality of life questionnaire (WHOQOL-BREF) will be used. The questionnaire examines four domains on a five-point Likert scale: Physical health, mental health, social relationships and health-related environments e.g. instant access to medical care. The global quality of life is based on the participants' scores on the four domains and they range from 0-100, with a high score indicating high quality of life.
6 secondary outcomes
Level of quality of life - physical health
Time frame: 9 weeks
Level of quality of life - mental health
Time frame: 9 weeks
Level of quality of life - social relationships
Time frame: 9 weeks
Level of quality of life - health related environments
Time frame: 9 weeks
Level of self-experienced restitution
Time frame: 9 weeks
Level of self perceived stress
Time frame: 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- BackgroundBratland-Sanda, S., Andersson, E., Best, J., Høegmark, S. & Roessler, K. K. The use of physical activity, sport and outdoor life as tools of psychosocial intervention: the Nordic perspective 2019. Sport in Society. 22, 4, s. 654-670, 2018.
- Individual participant dataSharing planned: Yes. The study protocol will be submitted to the peer-reviewed journal BMC Public Health
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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.
Simon Høegmark, Master principal investigator
University of Southern 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 Nature-Body-Mind-Community and Treatment as usual in people with Stress and Anxiety, run by University of Southern Denmark 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?
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 4 Nov 2020. 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?
Results are not available in the source record.
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?
Level of quality of life - total score (time frame: 9 weeks). 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 NCT04073524, 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 4 Nov 2020.