Feasibility and Preliminary Efficacy of Acceptance and Commitment Therapy (ACT) for Sleep Disturbances in Adults With Sickle Cell Disease (SCD): A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Acceptability
研究概览
简要总结
Research Type: Clinical Trial
Background:
People with sickle cell disease (SCD) have many health challenges. Also, they often have trouble sleeping. Acceptance and commitment therapy (ACT) might help people with SCD to improve their sleep problems.
Objective:
To see how well ACT works in people with SCD and sleep problems and to find out how they feel about it.
Eligibility:
People between the ages of 18 and 55 with SCD and trouble sleeping.
Design:
The study is remote. Participants will not have to come to the NIH at all. They will need a device that has Bluetooth and can connect to the internet.
Some participants will be in the study for 12 weeks. Others will participate for 20 weeks.
Participants will video chat with an ACT coach once a week for 8 weeks. The coach will guide participants through mindfulness exercises and teach ACT ideas. Each session lasts about 45 minutes.
Participants will be loaned an actigraph, a device worn on the wrist like a watch that measures and records movement. They will download a free app to upload data from the actigraph for the researchers.
Participants will wear the actigraph on their nondominant wrist day and night for either 4 or 6 designated weeks. During these weeks, participants will complete a sleep diary each morning when they wake up. This takes about 2 minutes.
Participants will be sent other surveys to complete from home during the study. They will answer questions about their physical and emotional health. These take 20-25 minutes.
The last survey will be 4 weeks after participants finish the ACT treatment. They will answer questions about how helpful they thought ACT was and how easy or hard it was to wear the actigraph.
详细描述
Background:
- Individuals with sickle cell disease (SCD) are faced with numerous challenges associated with their condition including sleep disturbance.
- Actigraphy is a wearable data collection device using accelerometry to track real-time body movements and is able to document several important aspects of sleep.
- Acceptance and Commitment Therapy (ACT) has been found effective in improving several aspects of health and wellbeing in individuals with chronic illness and pain, including sleep disturbance.
- To our knowledge, ACT for sleep disturbance has not been investigated yet among individuals with SCD.
Objective:
To assess the feasibility and acceptability of an ACT for Sleep intervention in adults with SCD.
Eligibility:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Acceptability
时间窗: 4 Weeks post intervention
Patient responses on the Acceptability questionnaire; a mean score \>3.0 on items 1-4 will be deemed to reflect adequate satisfaction.
Feasibility
时间窗: Weeks 4, 8, and 12
(i) Treatment specific retention rate among all randomized participants, with a target retention rate of 70% over the 8-week intervention period (excluding those who are taken off study due to extended/frequent hospitalizations or disease complications). (ii) Compliance with at-home ACT practices per sleep diary, with a target of 4 days per week on average as assessed by a daily question during weeks 4, 8, and 12.
次要结局
- Relationship between objective and subjective measures of sleep in SCD.(Baseline, Weeks 4, 8, and 12)
- Relationships among sleep, pain, and quality of life at baseline.(Baseline)