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临床试验/NCT06215235
NCT06215235招募中不适用

Alleviation of Depressive Symptoms in People With Intellectual Disabilities

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2023年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
105
试验地点
1
主要终点
acceptability

研究概览

简要总结

Many adults with intellectual disabilities (ID) have depressive symptoms, which negatively impact their quality of life. A lot of of the non-medicinal forms of treatment are not or hardly suitable for people with ID. Bright light therapy (BLT) seems to be a good option. Earlier research has shown that BLT is applicable in this group and seems promising in terms of reducing depressive symptoms, without serious side effects.

In part 1 of this project we investigate the implementation of BLT at Amarant. We will take the lessons learned into part 2 of this project: the implementation of BLT at Abrona. We will evaluate this process and the outcomes.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

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

  • Involved in the implementation of BLT (staff) OR
  • Involved in the prescription or application of BLT (staff/relatives) OR
  • receiving BLT for their depressive symptoms (patients with ID)
  • 18 years or older
  • informed consent

排除标准

  • 未提供

结局指标

主要结局

acceptability

时间窗: three times during study, 3-4 months in between

Acceptability (Proctor et al., 2011) is the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. This will be measured by interviews.

appropriateness

时间窗: three times during study, 3-4 months in between

Appropriateness (Proctor et al., 2011) is the perceived fit, relevance, or compatibility of the innovation or evidence based practice for a given practice setting, provider, or consumer; and/or perceived fit of the innovation to address a particular issue or problem. This will be measured by interviews.

Determinants

时间窗: three times during study, 3-4 months in between

Barriers and facilitators to BLT, measured by interviews using the Consolidated Framework for Implementation Research (CFIR, Damschroder et al., 2009)

feasibility of the intervention

时间窗: three times during study, 3-4 months in between

Feasibility (Proctor et al., 2011) is defined as the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. This will be measured by interviews.

fidelity

时间窗: three times during study, 3-4 months in between

Fidelity (Proctor et al., 2011) is defined as the degree to which an intervention was implemented as it was prescribed in the original protocol or as it was intended by the program developers. This will be measured by interviews and by case report study.

strategies

时间窗: three times during study, 3-4 months in between

Implementation strategies are methods to enhance the adoption, implementation and sustainability of a policy or intervention. This will be studied with interview data and logs.

次要结局

  • Depressive symptoms(1 year)
  • Behaviour(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Margreet Vlastuin

Research Coordinator Quality

Erasmus Medical Center

研究点 (1)

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