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临床试验/NCT03556878
NCT03556878已完成不适用

Implementing and Sustaining a Transdiagnostic Sleep and Circadian Treatment

University of California, Berkeley1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年7月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
The acceptability of the intervention to providers will be assessed by the 'Acceptability of Intervention Measure' (AIM)

研究概览

简要总结

The goal is to collect pilot data on an adapted version of the Transdiagnostic Sleep and Circadian intervention (TranS-C), referred to as 'Fitted TranS-C'.

详细描述

Mental illness is often severe, chronic and difficult to treat. The sleep disturbance commonly experienced by individuals with a severe mental illness reduces capacity to function and contributes to key symptoms. This study seeks to collect pilot data on an adapted version of the Transdiagnostic Sleep and Circadian intervention (TranS-C). The adapted version will be referred to as 'Fitted TranS-C' as it is designed to improve the fit to delivery within community mental health centers. 'Fitted' treatments are needed because the context for implementation (community setting) typically differs from the original testing context (university setting) causing a lack of 'fit' between the setting and evidence based treatments.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Can understand treatment in English
  • •Is not currently at risk for suicide or homicide
  • •Has not worked the night shift more than 2 nights per week in the past 3 months
  • •Is not pregnant or nursing
  • •Has a guaranteed bed to sleep in for the next month, which is not a shelter.

排除标准

  • •At risk for suicide or homicide
  • •Has worked the night shift more than 2 nights per week in the past 3 months
  • •Is pregnant or nursing
  • •Does not have a guaranteed bed to sleep in for the next month

研究组 & 干预措施

Fitted TranS-C

Experimental

Fitted TranS-C involves 4 x 20-30 minute sessions. It involves selected cross-cutting, core and optional modules from Standard TranS-C.

干预措施: Fitted Transdiagnostic Sleep and Circadian intervention (Behavioral)

结局指标

主要结局

The acceptability of the intervention to providers will be assessed by the 'Acceptability of Intervention Measure' (AIM)

时间窗: 4 weeks (i.e. post-treatment assessment)

The AIM is a measure of the extent to which the intervention is acceptable to providers. The AIM is comprised of 4 questions rated on a 1 'completely disagree' to 5 'completely agree' scale. The responses to all four qus will be reported along with the summed total score.

PROMIS--Sleep Disturbance (PROMIS = Patient-Reported Outcomes Information System)

时间窗: Pre-treatment and 4 weeks later (i.e. post-treatment assessment)

Assesses sleep disturbance experienced by patients

CEQ (Treatment Evaluation Questionnaire)

时间窗: 4 weeks (i.e. post-treatment assessment)

Assesses patients' expectations of the treatment.

次要结局

  • Process evaluation/qualitative interview(4 weeks (i.e. post-treatment assessment))
  • MINI(Baseline only)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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