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临床试验/NCT01474837
NCT01474837已完成不适用

The H.E.A.L.T.H. Project: Help Enabling Active Lifestyles Toward Health in Young People With Depression.

University of Nottingham2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2011年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
2
主要终点
change in Children Depression Inventory score

研究概览

简要总结

Exercise as an adjunct to routine treatment may be useful for helping young people recover from distressing mental health problems, but they seldom get sufficient support to help them to exercise. The reasons for this may be that services cannot agree on the benefits of exercise, and the lack of reliable evidence showing the benefits of exercise in young people who use mental health services. Compliance with prescribed exercise is generally low, but the investigators think that relatively few young people will drop out of our specially designed programme. The investigators have found that young 'healthy' people may respond better if exercise is matched to their ability. The investigators are not sure if this would work with young people with mental health difficulties, so the investigators want to test it. The investigators have also found that our enabling exercise plan, with social support and motivational coaching, helps people with depression to take part, and not to drop out. The aims of our study are to see if exercise matched to their ability, with support in taking part, helps young people recover from distressing mental health difficulties. The investigators also want to ask young people how they feel about exercise as a part of their recovery. The investigators want to see if motivational coaching can help ongoing participation in exercise, and the investigators want to follow up the young people after six months to see if they are still doing exercise. The investigators believe that this study is important because it will help young people feel better about themselves, and improve their quality of life. This is an important national public health goal and should enable young people to grow into healthy adults, and maintain their health throughout adulthood. If our study is successful, the investigators believe that it has the potential to change the way in which mental health services deliver care to young people. If the investigators can help young people feel better about themselves, and improve their general health and well being through exercise, the investigators may reduce their reliance on mental health services.

Research hypotheses A tailored exercise intervention will lead to significantly improved mental health outcomes and reduced exercise attrition rates in young people with depression.

详细描述

Aims

  1. Compare mental health outcomes in depressed young people receiving a tailored exercise intervention with mental health outcomes for depressed young people in a waiting list control group.
  2. Explore young people's experiences of exercise in the treatment of their depression.
  3. Investigate the attrition rate for the tailored exercise intervention group.
  4. Investigate longevity of changes in exercise habit with a six month follow up.
  5. Conduct an economic evaluation of the tailored exercise intervention.

Research Questions

  1. Does an exercise intervention programme tailored to young people's exercise levels significantly improve mental health outcomes and exercise attritions rates in young people with depression?
  2. Are the changes in exercise habit and outcomes brought about by participation in the tailored exercise programme still evident at six months post intervention?
  3. How cost-effective is a tailored exercise intervention in young people with depression?
  4. How acceptable is a tailored exercise intervention to young people with depression?

Design: Pragmatic Randomised Controlled Trial. An experimental arm of a tailored exercise intervention and a waiting list control group.

研究设计

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

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participants whose initial presenting problem is identified as depression will be eligible for the study

排除标准

  • Young people, who at the time of the study, are unable to participate on account of any injury or physical health problem that precludes their participation, and those who are regular exercisers

结局指标

主要结局

change in Children Depression Inventory score

时间窗: Baseline, Post-intervention (at 12 weeks), six months follow-up

The CDI has 5 scales measuring negative mood, interpersonal difficulties, negative self-esteem, ineffectiveness and anhedonia. It is designed for 7-17 year olds, is sensitive to changes over the proposed timescale, quick to administer and yields an aggregate score indicating depressive illness and clinically significant depression.

次要结局

  • Compliance with exercise(post-intervention (6 weeks))
  • change in Eq-5D score(Baseline, post-intervention (6 weeks), six months follow-up)
  • Client Services Receipt Inventory(Post intervention (6 weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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