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

November 3, 2020 updated by: University of Southern Denmark

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

76

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
    • Fyn
      • Odense, Fyn, Denmark, 5230
        • Southern Danish University

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

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nature-Body-Mind-Community (NBMC) + treatment as usual
9 weeks of nature-based therapy (Nature-Body-Mind-Community (NBMC)) treatment as usual
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.
Other: 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
Other: Treatment as usual
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of quality of life - physical health
Time Frame: 9 weeks
The WHOQOL-BREF will be used. The domain of physical health is measured on a five-point Likert scale with five questions.
9 weeks
Level of quality of life - mental health
Time Frame: 9 weeks
The WHOQOL-BREF will be used. The domain of mental health is measured on a five-point Likert scale with five questions.
9 weeks
Level of quality of life - social relationships
Time Frame: 9 weeks
The WHOQOL-BREF will be used. The domain of social relationships is measured on a five-point Likert scale with five questions.
9 weeks
Level of quality of life - health related environments
Time Frame: 9 weeks
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
Level of self-experienced restitution
Time Frame: 9 weeks
Self-experienced restitution. The Perceived Restorativeness Scale-11 (PRS-11) will be used.
9 weeks
Level of self perceived stress
Time Frame: 9 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

TrygFonden, Denmark

Investigators

  • Principal Investigator: Simon Høegmark, Master, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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 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)

June 1, 2018

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

August 23, 2019

First Submitted That Met QC Criteria

August 28, 2019

First Posted (Actual)

August 29, 2019

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USouthernDenmarkpsychology

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study protocol will be submitted to the peer-reviewed journal BMC Public Health

IPD Sharing Time Frame

The protocol paper will be submitted to BMC Public Health, June 2019. A a paper on the narratives of the participating men in the 'Wild man programme' will be submitted to Qualitative Health Research in June 2020. Finally, a paper on spontaneous attention in outdoor environments and change in quality of life will be submitted to Clinical Psychology in December 2020.

IPD Sharing Access Criteria

Access to data is restricted due to the European laws. Please contact the Principal Investigator for more information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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