Feasibility of Cognitive Behavioral Therapy vs. Bright Light Therapy to Treat Insomnia and Fatigue: an RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Retention Rate
研究概览
简要总结
Cognitive behavioral therapy (CBT-I) is a common treatment for insomnia that does not use medications. While CBT-I is effective for insomnia, it does not tend to improve the waking symptom of fatigue. Another treatment, Bright Light Therapy, is used for treating seasonal depression and sleep disorders, and may improve fatigue and physical activity in individuals with PAH. The purpose of this study to assess the effects of Bright Light Therapy compared to CBT-I to treat insomnia and fatigue in patients with PAH.
详细描述
In a single site, 3-arm (Cognitive Behavioral Therapy [CBT-I] group; Bright Light Therapy group; Standard of Care group), parallel, randomized controlled trial we will enroll 36 subjects (n=12 per group) to assess the feasibility of Bright Light Therapy compared to CBT-I in subjects with pulmonary arterial hypertension (PAH) to treat insomnia (difficulty initiating sleep or maintaining sleep) and fatigue.
- To assess the recruitment and retention rates of CBT-I and Bright Light Therapy.
- To compare the effects of CBT-I and Bright Light Therapy to Standard of Care on (insomnia and fatigue severity) and secondary (wake after sleep onset and sleep onset latency) outcomes.
- To test the effects of CBT-I and Bright Light Therapy to Standard of Care on the secondary outcome physical activity.
- To test the effects of CBT-I and Bright Light Therapy to Standard of Care on the secondary outcomes: depression, dyspnea and QOL.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PAH diagnosis
排除标准
- •Untreated obstructive sleep apnea
- •Subjects with left-sided valvular disease
- •Hospitalized or acutely ill
- •Any eye disease such as, but not limited to, cataracts, glaucoma, retinal disorders (e.g. macular degeneration), or previous eye surgery
- •Subjects with photosensitivity (e.g. epilepsy)
- •Manic-depressive psychosis or Bipolar Disorder
研究组 & 干预措施
Cognitive Behavioral Therapy-Insomnia (CBT-I)
CBT-I treatment will receive 1 session every week, for 8 weeks (8 total sessions). The CBT-I sessions will be provided by a pool of clinical PhD psychology students by a trained professional. Each visit will be conducted via telehealth. Sessions will include discussions regarding such topics as sleep restriction, stimulus control and sleep hygiene. Review of sleep diaries will occur during the sessions.
干预措施: CBT-I (Behavioral)
Bright Light Therapy
Bright Light treatment will consist of 8 weeks of daily use of the Re-timer device. The Re-timer is worn like a pair of glasses and contains light emitting diodes mounted on the lower portion of the frame. The Re-timer emits blue-green 500 nm light with an intensity of ~500 lux lm/m2. Subjects will be instructed to use the device for 30 minutes within two hours of waking, in the morning on the full brightness setting.
干预措施: Bright Light Therapy (Device)
Standard Care
Subjects will continue the care they routinely receive.
结局指标
主要结局
Retention Rate
时间窗: 8 weeks
Number of participants who completed all study procedures.
次要结局
未报告次要终点