NCT02886052已完成不适用
Therapist Guided Internet Cognitive Behavioral Therapy (ICBT) for Insomnia for Bereaved Parents: a Randomized Controlled Trial (RCT)
Ersta Sköndal University College0 个研究点目标入组 21 人开始时间: 2016年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 主要终点
- Change (from baseline) in Insomnia Severity Index, ISI
研究概览
简要总结
The purpose of this project is to evaluate an Internet-based Cognitive Behavioral Therapy (ICBT) for bereaved parents with insomnia. Participants are randomized to either a therapist guided ICBT or to an active control who receives written information on sleep, insomnia, and sleep hygiene. The primary purpose is to evaluate changes in insomnia severity for treatment compared control, after treatment and at 9 and 18 months follow up. A secondary purpose is to evaluate changes in symptoms of complicated grief and depression.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical level of Insomnia (more than 10 on ISI)
- •Meets criteria for Insomnia according to DSM-5
- •Enough Swedish language skills
排除标准
- •Other sleep disorders that require other treatment (e.g. sleep apnea)
- •Somatic or psychiatric conditions requiring acute care
结局指标
主要结局
Change (from baseline) in Insomnia Severity Index, ISI
时间窗: 0, 9 and 18 months after treatment
7-item, self-rated questionnaire measuring change in insomnia severity.
次要结局
- Change (from baseline) in Generalised Anxiety Disorder Assessment, GAD-7(0, 9 and 18 months after treatment)
- Change (from baseline) in PTSD Checklist for DSM-5 , PCL-5(0, 9 and 18 months after treatment)
- Change (from baseline) in Montgomery Asberg Depression Rating Scale, MADRS-S(0, 9 and 18 months after treatment)
- Change (from baseline) in Prolonged Grief Disorder, PG-13(0, 9 and 18 months after treatment)
- Change (from baseline) in Utrecht Grief Rumination Scale, UGRS(0, 9 and 18 months after treatment)
研究者
Josefin Sveen
PhD
Ersta Sköndal University College
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