The Wild Man Programme - a Nature-based Rehabilitation Enhancing Quality of Life for Men on Long-term Sick Leave

Depression Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04073524
• Other study ID #: USouthernDenmarkpsychology
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: November 2020
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 76
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 68 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Cancer
• Cardiac Disease
• Copd
• Depression
• Diabetes
• Heart Diseases
• Stress

Intervention

Other:
• Nature-Body-Mind-Community
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 usual
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

Locations

Country	Name	City	State
Denmark	Southern Danish University	Odense	Fyn

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 weeks
Secondary	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.	9 weeks
Secondary	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.	9 weeks
Secondary	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.	9 weeks
Secondary	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.	9 weeks
Secondary	Level of self-experienced restitution	Self-experienced restitution. The Perceived Restorativeness Scale-11 (PRS-11) will be used.	9 weeks
Secondary	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.	9 weeks