Feasibility of Internet-Delivered Group Cognitive Behavioral Therapy for Insomnia in Gynecologic Oncology Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Attendance
研究概览
简要总结
The goal of this study is to evaluate the feasibility and acceptability of delivering cognitive behavioral therapy for insomnia (CBT-I) to gynecologic cancer patients in an internet-based small-group setting.
Secondary objectives:
- To compare insomnia symptoms before and after intervention.
- To evaluate any changes in quality of life symptoms while undergoing the intervention.
- To evaluate the duration of symptoms improvement after the intervention is complete.
详细描述
This is a pilot feasibility study looking at delivering CBT-I to gynecologic cancer patients. This study will be completed via a novel internet based small group platform. Twelve eligible participants will meet weekly for 6 weeks while undergoing the CBT-I program.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •English-speaking women greater than 18 years old who present to UC Davis Comprehensive Cancer Center for treatment or surveillance of gynecologic cancer
- •Must have access to internet
- •Be able to connect via secure web-based platform
- •Be able to complete online questionnaires
- •Moderate or severe insomnia
- •Have access to a mobile device or computer
排除标准
- •Participants without ability to connect with both audio and visual through secure web-based platform
- •Participant is currently taking sleep medication prescribed by their provider for sleep disturbance or insomnia - Patients taking over the counter medications or supplements are eligible
- •Participants with remote history of insomnia, but not currently having symptoms of insomnia
- •Have other reasons for poor sleep
结局指标
主要结局
Attendance
时间窗: 6 weeks
Main feasibility metric, recorded as number of sessions successfully attended. Participants would need to attend at least 4 sessions of the CBT-I sessions. Therefore, attendance among all participants must be 67% or greater to be considered feasible. A session must be attended for at least 50% of the time or will be counted as missed.
Acceptability
时间窗: 24 weeks
A three-question survey at the end of each session. Question 1 is yes/no, questions 2 and 3 are write in. At the end of the program, a longer acceptability survey will be conducted. If a participant's response to question 1 indicates acceptability for a given session, that session will be deemed 'acceptable'. If 50% or more of participants rated the session as acceptable, then that session will be rated as acceptable.
次要结局
- Changes in quality of life symptoms(24 weeks)
- Sleep Quality(24 weeks)
- Insomnia symptoms(24 weeks)