Enhancing Pulmonary Rehabilitation in Veterans With Chronic Obstructive Pulmonary Disease Through Internet-based Cognitive-behavioral Treatment for Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- St. George's Respiratory Questionnaire
研究概览
简要总结
This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in Veterans with chronic obstructive pulmonary disease (COPD) and insomnia receiving an Internet-based behavioral treatment for insomnia versus online insomnia patient education. Participants will undergo a sleep and health assessment that will be performed at baseline, post-treatment, and 3-months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia or online insomnia patient education.
详细描述
Veterans with chronic obstructive pulmonary disease (COPD) are a vulnerable group for developing insomnia. Insomnia has been found to be associated with limitations in activities of daily living (ADL), lower physical activity levels, poor quality of life, greater COPD symptom severity, and reduced exercise performance. Cognitive-behavioral therapy for insomnia (CBT-I) is an efficacious and durable non-pharmacological treatment for insomnia that provides guidance on changing unhealthy sleep-related beliefs and behaviors across a variety of illnesses. CBT-I not only improves sleep-specific symptoms of insomnia but also improves quality of life and daytime function, reduces ADL limitations, and improves condition-specific symptoms.
This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in Veterans with chronic obstructive pulmonary disease (COPD) and insomnia receiving an Internet-based behavioral treatment for insomnia versus online insomnia patient education. Veterans 40 years and older, who received care from the VA Pittsburgh Healthcare System, and who have COPD and insomnia will be recruited for this study. Participants will undergo a sleep and health assessment that will be performed at baseline, post-treatment, and 3-months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia or online insomnia patient education. Both the insomnia treatment and patient education will be provided remotely.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessor will be blinded to group assignment.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 years and older
- •Primary diagnosis of COPD defined by GOLD
- •Meets criteria for Insomnia Disorder
- •At least moderate insomnia severity based on Insomnia Severity Index score >7
- •Stable psychiatric and medical conditions
- •Must have telephone, email, and reliable Internet access via computer, smartphone, or tablet
排除标准
- •Untreated current major depression
- •Serious suicidal risk
- •Substance abuse disorder within past 3 months
- •History of bipolar or psychosis
- •Untreated restless legs syndrome, delayed sleep phase syndrome, irregular sleep schedules
- •Very severe untreated obstructive sleep apnea
- •Severe excessive daytime sleepiness based on Epworth Sleepiness Scale score > 16
- •Restrictive lung disease (FEV1/FVC 70 and FEV1 < 80% predicted) or asthma
- •Plans to move during the following 6 months
- •Non-English speaking or sensory deficits
研究组 & 干预措施
Internet-based behavioral treatment for insomnia
Internet version of cognitive-behavioral treatment for insomnia
干预措施: Internet-based behavioral treatment for insomnia (Behavioral)
Online insomnia patient education
Online insomnia patient education
干预措施: Online insomnia patient education (Behavioral)
结局指标
主要结局
St. George's Respiratory Questionnaire
时间窗: 6-months post-pulmonary rehabilitation
The SGRQ is a 50-item measure assessing disease-specific quality of life. The total SGRQ score, which reflects the overall impact of the disease on quality of life, ranges from 0 to 100, with higher scores indicating greater impairment.
Insomnia Severity Index
时间窗: Baseline to post-treatment and 3-months post-treatment
The Insomnia Severity Index is a 7-item self-report questionnaire assessing nature, severity and impact of insomnia symptoms. The total score ranges from 0 to 28, with higher scores indicating worse insomnia severity.
Insomnia Severity Index (ISI)
时间窗: Baseline to 3-months post-treatment
The ISI is a 7-item self-report questionnaire assessing nature, severity and impact of insomnia symptoms. The total score ranges from 0 to 28, with higher scores indicating worse insomnia severity.
St. George's Respiratory Questionnaire (SGRQ)
时间窗: Baseline to 3-months post-treatment
The SGRQ is a 50-item measure assessing disease-specific quality of life. The total SGRQ score, which reflects the overall impact of the disease on quality of life, ranges from 0 to 100, with higher scores indicating greater impairment.
次要结局
未报告次要终点