NCT01440777已完成不适用
Effectiveness and Adherence to an Online Sleep Program - A Pilot Study
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
- 101
- 试验地点
- 1
- 主要终点
- Insomnia severity
研究概览
简要总结
This research will examine the effectiveness of a 6-week online sleep program (Go! To Sleep) which provides a set of various psycho-educational materials and behavioral techniques to reduce insomnia symptoms, improve sleep, and improve quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 70 years old.
- •Currently living in the continental United States and Canada.
- •Symptoms of insomnia based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) definition of insomnia disorder:
- •Self-reported sleep difficulties (including sleep-onset latency, waking after sleep onset, early waking of more than 30 min duration) 3 or more times a week in the past 3 months.
- •Self-reported insomnia problem for more than 3 months.
- •Self-reported significant daytime impairment due to sleep difficulties.
- •Willingness to log onto the internet on a regular basis for the duration of the study (3-7 months).
- •Willingness and able to complete almost daily a sleep log to track sleep pattern for up to 2 months at a time (approximately 2-3 min daily).
- •Willingness to be in the Wait-list control group and not have access to the program for 3 months.
排除标准
- •Pregnant or planning to be pregnant in the next 6 months.
- •Lack of internet access and/or Mac computer at place of residence.
- •Currently participating or have participated in group or individual therapy for insomnia in the prior month.
- •Patient Health Questionnaire (PHQ9) depression score >
- •Recent treatment (less than 3 months) or medication for depression or anxiety.
- •Change in treatment or medication for depression or anxiety in the past month or planned change in the next 3 months.
- •Current treatment (therapy, prescription) for any other psychological or emotional conditions (including but not limited to: mania, manic-depression, psychosis, schizophrenia, adjustment disorder).
- •Diagnosed and currently suffering from a sleep disorder (including, but not limited to sleep apnea, restless leg syndrome, sleep walking, narcolepsy) which is untreated or has been treated for less than a month.
- •Suffer from physical symptoms or medical conditions that may affect sleep (including but not limited to: pain, arthritis, tinnitus, diabetes, night time cough, shortness of breath, hot flashes, frequent urination, heartburn).
- •Steroid an stimulant use (including but not limited to prednisone, methylprednisolone or Solumedrol (for inflammatory disorders), methylphenidate, or Ritalin (for Attention-Deficit Hyperactivity disorder), Provigil (for narcolepsy), Wellbutrin or Zyban (for tobacco cessation), cocaine or methylenedioxymethamphetamine (MDMA) (a.k.a. Ecstasy)).
- •Irregular workshift.
- •Having young children who may affect sleep pattern.
- •Taking over-the-counter or prescribed sleep medication 3 or more times a week.
- •Alcoholism.
- •Inability to access the internet on a consistent regular basis for the duration of the study (3-7 months).
- •Inability to complete daily sleep log to track sleep patterns for up to 2 months at a time.
- •Unwillingness to be assigned to the wait-list control group for 3 months prior to gaining access to the program.
研究组 & 干预措施
Go! to Sleep
Active Comparator
Participants access and utilize the 6-week online program that provides a set of various psycho-educational materials and behavioral techniques to treat insomnia.
干预措施: Go! to Sleep (Behavioral)
Control Group
No Intervention
No intervention provided. These participants will receive the Go! to Sleep program after the research trial has been completed (10 weeks after registration).
结局指标
主要结局
Insomnia severity
时间窗: 5 months
To assess the effectiveness of the online Go! to Sleep program in improving sleep by measuring insomnia severity using the Insomnia Severity Index (ISI).
次要结局
- Daytime Dysfunction(5 months)
- Sleep pattern(5 months)
- Program adherence(5 months)
- Insomnia symptoms(5 months)
- Stress(5 months)
研究者
Linda Libertini
Research Coordinator
The Cleveland Clinic
研究点 (1)
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