Self-Help Video for Insomnia in College Students
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Consensus Sleep Diary
研究概览
简要总结
The purpose of this study is to test the effectiveness of a 1-session abbreviated cognitive-behavior therapy for insomnia among college students. The investigators will examine the following hypotheses in the present study: 1) Viewing the treatment video will produce an increment in sleep knowledge relative to baseline and minimum treatment control; and 2) Viewing the treatment video will result in improved sleep relative to baseline and minimum treatment control.
Students who self-identify as having insomnia will be recruited from the University of Alabama's Psychology subject pool. Students who enroll in the study will receive a link to the demographic and screening questionnaire. Individuals who have a history of other sleep disorders or who currently present with symptoms strongly suggestive of sleep disorders, such as obstructive sleep apnea or narcolepsy will be excluded. Individuals who are shift-workers and those with a history of severe mental illness will also be excluded.
Participants who meet criteria for this study will then be directed to complete a measure of sleep knowledge. Once they have completed the measure of sleep knowledge, they will be directed to complete the Consensus Sleep Diary (CSD) for 14 days as soon as possible after awakening in the morning. During the second week of completing the CSD, participants will be directed to complete the Insomnia Severity Index and the Patient-Reported Outcomes Measurement Information System Sleep Disturbance and Sleep-Related Impairments Short Forms on the last day they complete a CSD.
Participants will be randomized to a treatment group or a minimum treatment control group upon completion of these baseline measures. Those in the treatment group will be emailed the following components of the insomnia treatment: a link to the treatment video, an mp3 file with a relaxation recording, and a pdf file of a brochure reviewing the information presented in the treatment video. Participants will be asked to view the treatment video and begin practicing the relaxation technique presented in the mp3 file as soon as possible. Participants in the minimum treatment control group will receive a link to a sleep education video.
Two weeks after participants have viewed the videos, they will be asked to complete post-treatment measures in the same sequence as they did at baseline. One month after the post-treatment measures have been completed, both groups will be asked to complete the same measures again for follow-up.
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
- None
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be a student at The University of Alabama
- •Must be 18-24 years old
- •Must have a complaint of insomnia
排除标准
- •history of sleep disorder other than insomnia
- •symptoms strongly suggestive of sleep disorders other than insomnia
- •shift-work
- •history of severe mental illness (e.g., psychotic disorders, bipolar disorder, severe depression, or personality disorders)
研究组 & 干预措施
Abbreviated cognitive behavioral therapy
Arm 1 is a multi-component package including sleep hygiene, stimulus control, cognitive therapy, and passive relaxation.
干预措施: Abbreviated cognitive behavioral therapy (Behavioral)
Sleep education/sleep hygiene
Arm 2 consists of education about sleep and fatigue as well as sleep hygiene recommendations (e.g., avoiding nicotine and caffeine late in the day).
干预措施: Sleep education/sleep hygiene (Behavioral)
结局指标
主要结局
Consensus Sleep Diary
时间窗: Change in sleep diary variables at 1-month follow-up (post-treatment and 1-month follow-up)
次要结局
- Insomnia Severity Index(Change in score at 1-month follow-up (post-treatment and 1-month follow-up))
- Measure of Sleep Knowledge(Change in sleep knowledge at 1-month follow-up (post-treatment and 1-month follow-up))
- Patient-Reported Outcomes Measurement Information System Sleep Disturbance and Sleep-Related Impairments Short Forms(Change in sleep disturbance and daytime impairments at 1-month follow-up (post-treatment and 1-month follow-up))