ACTRN12623001272684尚未招募Unknown
A randomised-control trial evaluating the effectiveness of a novel, multi-component model of care for youth with Bipolar Disorder I or II.
Orygen0 个研究点目标入组 125 人开始时间: 2023年12月7日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 125
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
- 15 Years 至 25 Years(—)
- 性别
- All
入选标准
- •1. Age 15 to 25 years.
- •2. Diagnosis of BD I or II.
- •3. Ability to provide informed consent and/or have a parent or guardian provide consent on their behalf.
- •4. Ability and willingness to nominate an emergency contact person, such as a close family member.
排除标准
- •1. Has previously received 6-months of tertiary care through a mental health service or multi-disciplinary team for bipolar disorder or psychosis.
- •2. Currently requiring more than weekly clinical contact (for 4 weeks or more) or likely to require at least weekly clinical contact (for 4 weeks or more) in the next 6-months, due to high level of severity, complexity, or risk.
- •3. Experiencing psychosis or manic episode*
- •4. Intellectual disability that interferes with the likelihood of the participant receiving benefit from participation as judged by the treating clinician.
- •5. Inability to converse in or read English. English does not have to be the young person’s primary language.
- •6. Does not have access to the internet and an internet-enabled device.
- •7. High degree of hostility and impulsivity, as judged by the treating clinician, resulting in the clinician believing that inclusion in the research project may result in harm to the young person or other users (i.e., through interactions in the social network).
- •8. Has a schizophrenia spectrum diagnosis or a significant primary mental disorder that requires a different model of care, as determined by the clinical team.
- •*Those experiencing a (hypo)manic episode will be offered treatment, and upon remission, can be admitted to the study if they meet other eligibility criteria.
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