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临床试验/NCT01152086
NCT01152086已完成4 期

The Effects of Regular Mountain Hiking on Hopelessness in Chronically Suicidal Patients

Paracelsus Medical University0 个研究点目标入组 24 人开始时间: 2010年7月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
24
主要终点
Hopelessness

研究概览

简要总结

Suicide is a major public health issue with estimated 1 million deaths worldwide within the last year. Physical activity and nature recreation might be protective factors against suicidal behaviour, suicidal ideation and contributing factors like depression and hopelessness.

In this randomized controlled cross-over intervention study the investigators aim to investigate the physical and psychological effects of a 9 weeks hiking program in chronically suicidal patients. The investigators aim to enroll 24 patients suffering from chronic suicidality, defined as at least one attempted suicide and a hopelessness greater than 26 in Beck's Hopelessness Scale summary score. At baseline patients will undergo pre-tests including questionnaires to assess suicide ideation, hopelessness, depression, anxiety, quality of life and health-related physical activity, physiological investigations to assess exercise capacity and blood investigations. Randomly assigned 12 patients start with the 9 weeks supervised mountain hiking program followed by a 9-week-period without supervised exercise program. The other 12 patients start with 9 weeks without supervised exercise program followed by a 9-week-period of supervised mountain hiking program. The mountain hiking program includes 2 training sessions per week with a duration of 3 hours per session. The hiking intervention will be performed within 70-85% of heart rate reserve and gymnastics for body and nature perception, mobilisation and stretching will enrich the training program. Further investigations including questionnaire-assessments, assessment of exercise capacity and blood investigations will be scheduled 9 and 18 weeks after the study start. In addition a daily assessment of several suicide risk-factors based on a web-based questionnaire will be done over the full study period. Within this mountain hiking program the investigators hope to reduce hopelessness in chronically suicidal patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronically suicidal defined as:
  • at least one attempted suicide
  • BHS summary scale > 26

排除标准

  • Coronary heart disease defined by angina pectoris or relevant ST-changes during exercise or myocardial infarction in the last 6 months
  • not oriented in time and space
  • acute psychotic
  • cognitively impaired
  • insufficient german language skills

结局指标

主要结局

Hopelessness

时间窗: 18 weeks (3 time points)

Summary score BHS (Beck Hopelessness Scale; 20 items)

次要结局

  • Exercise capacity(18 weeks (3 time points))
  • Depression(18 weeks (3 time points))
  • Anxiety(18 weeks (3 time points))
  • Suicide ideation(18 weeks (3 time points))
  • Quality of life(18 weeks (3 time points))
  • Blood parameters of inflammation(18 weeks (3 time points))
  • suicide risk factors(18 weeks (daily))
  • health-related physical activity(18 weeks (3 time points))

研究者

发起方
Paracelsus Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Josef Niebauer M.D., Ph.D.

Prim. Prof. MD, PhD, MBA

Paracelsus Medical University

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