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临床试验/NCT04073524
NCT04073524Unknown不适用

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

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
76
试验地点
1
主要终点
Level of quality of life - total score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

盲法说明

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.

入排标准

年龄范围
18 Years 至 68 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •The inclusion and

排除标准

  • •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

研究组 & 干预措施

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

Experimental

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

干预措施: Nature-Body-Mind-Community (Other)

Treatment as usual

Other

Treatment as usual

干预措施: Treatment as usual (Other)

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

Experimental

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

干预措施: Treatment as usual (Other)

结局指标

主要结局

Level of quality of life - total score

时间窗: 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.

次要结局

  • Level of quality of life - social relationships(9 weeks)
  • Level of self-experienced restitution(9 weeks)
  • Level of self perceived stress(9 weeks)
  • Level of quality of life - mental health(9 weeks)
  • Level of quality of life - physical health(9 weeks)
  • Level of quality of life - health related environments(9 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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