ACTRN12614000282684招募中未知
A randomised controlled trial of a brief physical activity intervention in addition to standard clinical care for young people with depression
Orygen Youth Health Research Centre, The University of Melbourne0 个研究点目标入组 120 人开始时间: 2014年3月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 12 Years 至 25 Years(—)
- 性别
- All
入选标准
- •As this is a pragmatically oriented effectiveness trial, selection into the study will be based on ‘real-world’ characteristics of young people with depression: a) meeting the requirements for a Mental Health Treatment Plan (MHTP) to access psychological treatment under the Medicare Benefits Scheme Better Access program with likely diagnoses of major depressive disorder, rather than by a formal diagnostic research interview; OR b) endorsing items 7 to 10 (minimum of 3 out of the 4 items) on the Kessler Psychological Distress Scale(K10) with a score of 3 or more, indicating that depression symptoms have been experienced at least some of the time over the past 4 weeks. The K10 is part of the standardised intake assessment into headspace centres.
排除标准
- •Exclusion and withdrawal criteria: presence of psychotic symptoms during the intake assessment upon first presentation to the headspace centre; current physical activity meeting the Australian Government Guidelines (under 18 years: 60 mins/day moderate-vigorous activity; over 18 years: 30 mins moderate physical activity, most or all days); eating disorder symptoms reported at intake assessment, with the standardised assessment used when entering the service, conducted by Access Team clinicians; organic mental disorder; physical illness that contra-indicates participation in physical activity; intellectual disability/cognitive impairment that precludes providing informed consent.
- •Any young person reporting a prior history of physical illness will be required to receive medical clearance from a GP in order to partake in the trial.
- •Withdrawal from the study can be at the request of the participant or if any changes in the participant’s presentation warrants a referral to a specialist/tertiary service. Once withdrawn, the young person will be reviewed using the headspace centre’s standard clinical review procedure and either maintained in the headspace centre or referred to tertiary services as necessary. These young people will be withdrawn from treatment but will remain involved in the post-treatment assessment.
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