NCT04073524

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

3 years

First QC Date

August 23, 2019

Last Update Submit

November 3, 2020

Conditions

StressAnxietyDepressionCardiac DiseaseCancerDiabetesCopd

Keywords

Supportive Environment Theory (SET)Aesthetic Affective Theory (AAT)Attention Restoration Theory (ART)Nature-Body-Mind-Community (NBMC)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Level of quality of life - physical health

    9 weeks

  • Level of quality of life - mental health

    9 weeks

  • Level of quality of life - social relationships

    9 weeks

  • Level of quality of life - health related environments

    9 weeks

  • Level of self-experienced restitution

    9 weeks

  • +1 more secondary outcomes

Study Arms (2)

Nature-Body-Mind-Community (NBMC) + treatment as usual

EXPERIMENTAL

9 weeks of nature-based therapy (Nature-Body-Mind-Community (NBMC)) treatment as usual

Other: Nature-Body-Mind-CommunityOther: Treatment as usual

Treatment as usual

OTHER

Treatment as usual

Other: Treatment as usual

Interventions

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.

Nature-Body-Mind-Community (NBMC) + treatment as usual
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

Nature-Body-Mind-Community (NBMC) + treatment as usualTreatment as usual

Eligibility Criteria

Age18 Years - 68 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • male gender
  • 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
  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Danish University

Odense, Fyn, 5230, Denmark

Location

Related 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.

    BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepressionHeart DiseasesNeoplasmsDiabetes MellitusPulmonary Disease, Chronic Obstructive

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Simon Høegmark, Master

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
The municipality of Svendborg has the superior responsibility for the 'Wild man programme'. Participation in the intervention as well as participation in the study is voluntary. All information collected in the study will be treated confidentially, and participation requires a signed consent form.
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 29, 2019

Study Start

June 1, 2018

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
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.
Access Criteria
Access to data is restricted due to the European laws. Please contact the Principal Investigator for more information.

Locations

DK(1)