Clinical trial NCT04073524: The Wild Man Programme - a Nature-based Rehabilitation Enhancing Quality of Life for Men on Long-term Sick Leave
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Anxiety
Depression
Cardiac Disease
Cancer
Diabetes
Copd
Keywords: Supportive Environment Theory (SET)
Aesthetic Affective Theory (AAT)
Attention Restoration Theory (ART)
Nature-Body-Mind-Community (NBMC)
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
First posted: 2019-08-29
Enrollment: 76
Sex: MALE
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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).
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of quality of life - total score
timeFrame: 9 weeks
Secondary outcomes:
measure: Level of quality of life - physical health
timeFrame: 9 weeks
measure: Level of quality of life - mental health
timeFrame: 9 weeks
measure: Level of quality of life - social relationships
timeFrame: 9 weeks
measure: Level of quality of life - health related environments
timeFrame: 9 weeks
measure: Level of self-experienced restitution
timeFrame: 9 weeks
measure: Level of self perceived stress
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Southern Danish University
state: Fyn
Study officials:
affiliation: University of Southern Denmark
name: Simon Høegmark, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.