Developing a Targeted Intervention for Sleep Disturbance in Spousal Bereavement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility of recruitment
研究概览
简要总结
The purpose of this study is to develop and optimize a targeted behavioral intervention for sleep disturbance among individuals who have recently lost a spouse/long-term cohabitating partner. In the first phase of this study, patient focus groups were conducted to gather information about the unique sleep challenges experienced by spousally bereaved individuals and the kinds of support they would like to receive from a program based on Cognitive Behavior Therapy for Insomnia (CBT-I). In the second phase of the study, a two-arm randomized controlled trial will be conducted to compare changes in sleep and inflammation among participants in the targeted CBT-I intervention to those in an information-only control. Participants will be asked to attend two in-person visits (at baseline and, approx. 8 weeks later, at post-treatment) to provide a blood sample and have vital signs and basic anthropometric measurements (height, weight, waist circumference) taken. After their baseline visit, participants will be randomized into either the targeted CBT-I intervention or the information-only control. The targeted CBT-I intervention will entail 6 online sessions (approx. 50 mins. each) delivered via videoconference by a trained facilitator, once per week over the course of approx. 6 weeks. The information-only control will entail 1 online session (approx. 50 mins.) delivered via videoconference by a trained facilitator. Sleep data (collected via both actigraphy watches and patient self-report sleep diaries) and data on mood, grief, and sleep habits will be collected from participants at three timepoints (baseline, post-treatment, and then again at a 6-month 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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants will not be informed which arm they have been randomized into. Research assistants will also be blinded to randomization. Only the control and intervention session facilitators and Principal Investigator will be aware of participants' study arm.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Has experienced the loss of a spouse/long-term cohabitating partner (i.e., partner who lived with participant for at least 1 year before passing) within the past 3 months
- •Scores 5 or above on the Pittsburgh Sleep Quality Inventory (PSQI; administered by research staff during phone screening call)
- •Must have access to an internet-enabled device (e.g., smartphone, computer, tablet) to take part in the online intervention
排除标准
- •Under age 18
- •Non-English speakers
- •Those with a previously diagnosed sleep disorder (e.g., restless leg syndrome; note: individuals with obstructive sleep apnea (OSA) will be eligible as long as they use a continuous positive airway pressure (CPAP) machine at least 5 days a week for at least 5 hours per day)
- •Those who have been taking prescribed sleep medication(s) for 6 months or more
- •Those with autoimmune or inflammatory diseases (such as: acute or chronic immune system medical conditions, medications or other conditions that impact immune function (e.g., chronic fatigue syndrome [CFS], lupus, rheumatoid arthritis, Sjogren's disease, systemic lupus erythematosus [SLE], Hepatitis C, or any other immunosuppressive treatment requiring conditions, per investigator discretion).
- •Those who regularly use illegal substances.
- •Those who are on medications with major immunological consequences (e.g. steroids)
- •Women who are pregnant or nursing
- •Those who have been vaccinated in the past two weeks (note: these individuals may simply delay enrollment by two weeks if otherwise eligible)
- •Those with significant visual or auditory impairment, medical or psychiatric condition that is unstable, requires immediate treatment or is judged to interfere with study protocol (e.g., substance abuse, psychotic disorder, cognitive disorder, current suicidal ideation)
结局指标
主要结局
Feasibility of recruitment
时间窗: Approx. 18 months
Feasibility of recruitment will also be measured by the proportion of eligible participants who are enrolled (consented) and randomized.
Adherence to the intervention
时间窗: Approx. 6 months
Adherence to the intervention will be measured by the number of sessions attended by participants.
Treatment-specific retention rates
时间窗: Approx. 6 months
Treatment-specific retention will be measured by the percentage of participants who complete the post-treatment assessment in each arm.
Acceptability
时间窗: Approx. 6 months
The acceptability of the intervention will be demonstrated by ≥ 85% completion of the study protocol across the sample.
Attrition
时间窗: Approx. 6 months
Attrition will be measured at each follow-up visit (post intervention and 6-month follow-up) and will be defined by the percentage of randomized participants who did not attend the follow-up visit. Causes of attrition will be measured by analyzing reasons for participant drop-out as documented over the course of the study.
Preliminary change in sleep disturbance
时间窗: Approx. 6 months
Using the previously validated Pittsburgh Sleep Quality Index (PSQI), change in sleep disturbance will be assessed from baseline to 1. post-intervention (6-8 weeks later), and a 2. six-month follow-up. Global scores on the PSQI range from 0 to 21, with a higher score indicating more severe sleep disturbance.
Treatment-specific acceptability
时间窗: Approx. 6 months
Treatment-specific acceptability will be measured by preference ratings gathered during the post-treatment debriefing session for each arm.
次要结局
- Preliminary change in inflammation(Approx. 8 weeks)
- Preliminary change in quality of life(Approx. 6 months)
研究者
Diana Chirinos-Downie
Assistant Professor of Preventive Medicine (Epidemiology)
Northwestern University