跳至主要内容
临床试验/NCT02410564
NCT02410564终止不适用

Testing an Accessible Cognitive Behavioral Therapy for Insomnia (CBT-I) Intervention in Newly Diagnosed Cancer Patients

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
29
试验地点
2
主要终点
To determine the efficacy of a CBT-I intervention that improves sleep and quality of life outcomes during cancer treatment.

研究概览

简要总结

To determine the efficacy of a CBT-I intervention in improving sleep and other quality of life outcomes during cancer treatment. To assess the feasibility and acceptability of a CBT-I intervention among newly diagnosed cancer patients.

详细描述

The proposed study will be a randomized controlled trial design. Participants will be randomized to either a CBTI treatment or a wait list control condition. The intervention is SHUTi, a validated web based version of CBTI, which will take place over seven weeks and will include a combination of face to face and telephone sessions, and email updates. All participants will have a face to face meeting with the doctoral student at enrollment. During the intervention period, all participants will be contacted by telephone at week 1, 3, and 6 to check in and to encourage participant engagement. However, during phone calls with control participants, no advice regarding sleep will be given and if participants ask, they will be informed that such advice can be provided in a few weeks if they choose to crossover to the treatment condition at the end of the study. Participants in SHUTi will additionally be provided the the doctoral student's phone number and will be encouraged to contact her if they have any questions during the intervention. They will also have the option of setting up appointments for face to face meetings during a clinic appointment if they desire additional therapist guidance. Pretreatment, all participants will complete a two week sleep diary and multiple self report measures. At the end of the intervention, all participants will complete a two week sleep diary and multiple self report measures again.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To determine the efficacy of a CBT-I intervention that improves sleep and quality of life outcomes during cancer treatment.

时间窗: 1 year

CBT-I is a cognitive behavioral therapy for insomnia. Pretreatment,all participants will complete a two week sleep diary and multiple self report measures. At the end of the intervention, all participants will complete a two week sleep diary and multiple self report measures again.

次要结局

  • To assess the feasibility of a CBT--I intervention among newly diagnosed cancer patients.(1 year)
  • To assess the acceptability of a CBT--I intervention among newly diagnosed cancer patients.(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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