Preventing Insomnia and Depression With Nurse Coaching in Individuals With Low Socioeconomic Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Cases of DSM-5 Insomnia
研究概览
简要总结
This study is intended to assess the efficacy of preventative Cognitive Behavioral Therapy for Insomnia (pCBT-I) on reducing the severity and stopping the progression of acute insomnia and depression. We also hope to gain a deeper understanding of the sociocultural, interpersonal, and individual factors that may have a role in development of insomnia and/or engagement with treatment plans.
详细描述
Insomnia is a debilitating condition that escalates the risk of a myriad of disorders and is a source of significant economic burden. Insomnia takes an immense toll on individuals' physical and mental wellbeing and treating it before it can develop into chronic insomnia can save individuals untold time and money on treatment.
This study is intended to assess the effects of one virtual pCBT-I session with a nurse coach on reducing the severity and stopping the progression of acute insomnia and depression. The benefits of pCBT-I have been demonstrated in prior studies but have yet to be tested on larger sample populations.
Participants will be recruited from the Henry Ford Health System (HFHS) outpatient network, as well as the Medicare/Medicaid data warehouse and other community partners. Subjects will be screened to determine eligibility, and then will be randomized into one of two insomnia treatment groups (control digital sleep education and pCBT-I via telehealth coaching).
Upon completion, the proposed research will not only have validated a preventative treatment for both insomnia and depression, but we will have the tools to apply it in the most effective way possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
The principle investigator will be blind to the group assignment
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
- •Individuals with low socioeconomic position as defined by income (<35k annual household income) or education (high school diploma or less)
- •Experiencing symptoms of prodromal acute insomnia (difficulty falling asleep, difficulty staying asleep, or problems waking up too early), along with worry or distress regarding their symptoms.
排除标准
- •Under the age of 18
- •Unwilling/unable to participate
- •Conditions that could interfere with pCBT-I (including bipolar and seizure disorders)
- •Untreated sleep disorders besides insomnia (e.g., sleep apnea, narcolepsy)
- •Untreated and severe medical or psychiatric disorders
研究组 & 干预措施
Preventative Cognitive Behavioral Therapy for Insomnia
Participants in this group will complete daily sleep diary entries for one week, and then have a telehealth pCBT-I session with a nurse coach, where they will receive personalized sleep recommendations to improve sleep quality.
干预措施: pCBT-I (Behavioral)
Digital Sleep Education Control
Participants in this group will receive digital sleep education, including tips on how to improve your sleep via interactive email. These materials are selected to help prevent chronic insomnia.
结局指标
主要结局
Cases of DSM-5 Insomnia
时间窗: 6 months post-treatment
Meet all DSM-5 criteria for Chronic Insomnia
Depression Severity
时间窗: up to one year post-treatment
QIDS-SR16 Score (0-27; higher scores correspond to worse severity)
Insomnia Severity
时间窗: up to one year post-treatment
Insomnia Severity Index Score (0 to 28; higher scores correspond to worse severity)
Cases of Clinically Significant Depression
时间窗: 6-months post-treatment
QIDS-SR16 score of 11 or higher
次要结局
- Physical Environment(Through study completion, an average of 1 year)
- Sociocultural Environment(Through study completion, an average of 1 year)
研究者
Philip Cheng
Principal Investigator
Henry Ford Health System