Psychosocial Adjunctive Treatment for Hypersomnia (PATH): A Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire (PHQ)
研究概览
简要总结
Current pharmacological treatments for chronic hypersomnia (narcolepsy, idiopathic hypersomnia) can effectively reduce excessive daytime sleepiness but a high proportion of patients experience depressive symptoms and poor health-related quality of life. Unfortunately, there are currently no psychosocial interventions that directly addresses this issue. Therefore, the overall goal of this project is to gather initial outcome data and work out methodological issues to determine if a future pragmatic clinical trial is warranted.
详细描述
Chronic hypersomnia (CH) is a serious and debilitating condition involving persistent excessive daytime sleepiness (EDS) and includes narcolepsy and idiopathic hypersomnia (IH). Currently, pharmacotherapy is the only empirically-validated treatment for reducing EDS in this patient population but the burden of long-term management and adverse effects of the medication lead to poor health-related quality of life (HRQoL) and elevations in depressive symptoms
Evidence-based psychosocial interventions have been developed in other areas to improve HRQoL related to chronic illnesses, such as cancer and chronic pain. These interventions typically involve a package of cognitive and behavioral techniques teaching coping skills (e.g., emotion-focused and problem-focused coping), behavioral management of the chronic illness symptoms (e.g., relaxation for pain management), and other strategies to improve psychosocial functioning (e.g., mindfulness). However, no such interventions have been developed or used for people with CH. Therefore, a major research gap exists for an empirically-validated psychosocial intervention which is aimed directly at improving emotional functioning and HRQoL for people with CH.
The purpose of this project is to develop a cognitive-behavioral treatment for hypersomnia (CBT-H) and conducting a feasibility trial of CBT-H. The specific aims for this project are to: 1) develop and refine a treatment protocol for CBT-H; 2) identify the optimal delivery format of CBT-H; and 3) gather feasibility data on recruitment, retention, and selection criteria for a future clinical trial. The overall significance of this project is to improve the quality of care for people with CH by using a psychosocial intervention with medical management of hypersomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Males and females age 18 and older.
- •Meets criteria for Narcolepsy (Type I or II) or Idiopathic Hypersomnia (IH).
- •Moderate to severe symptoms of depression.
- •Established standard care for CH at a sleep clinic.
排除标准
- •Hypersomnia not of central origin.
- •Current suicidal ideation or intent.
- •Uncontrolled medical conditions or physical limitations that require immediate medical treatment that would prevent ability to engage in the treatment protocol.
- •Inability to engage in the treatment protocol due to a psychiatric or cognitive issue.
- •Untreated moderate-to-severe sleep-related breathing disorder.
- •Unable to attend intervention sessions due to accessibility or availability.
结局指标
主要结局
Patient Health Questionnaire (PHQ)
时间窗: Change from Baseline PHQ at 6 weeks (Post-treatment)
The PHQ is a 9-item self-report scale of depressive symptoms that has been validated to assess the severity of depression in clinical practice. PHQ-9 cut scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
次要结局
- Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Scale(Baseline to post-treatment (6 weeks))
- Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale(Baseline to post-treatment (6 weeks))
- Patient Reported Outcomes Measurement Information System (PROMIS) Phyiscal Function Scale(Baseline to post-treatment (6 weeks))
- Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale(Baseline to post-treatment (6 weeks))
- Functional Outcomes of Sleep Questionaire (FOSQ)(Baseline to post-treatment (6 weeks))
- Patient Reported Outcomes Measurement Information System (PROMIS) Self Efficacy Scale(Baseline to post-treatment (6 weeks))
- Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale(Baseline to post-treatment (6 weeks))
- Epworth Sleepiness Scale (ESS)(Baseline to post-treatment (6 weeks))
- Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Scale(Baseline to post-treatment (6 weeks))
研究者
Jason Ong
Associate Professor
Northwestern University