Behavioral Treatment of Narcolepsy-Related Nightmares
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Daily diary
研究概览
简要总结
The goal of this clinical trial is to test two behavioral treatments for nightmares in adults with narcolepsy. The main questions it aims to answer are:
- Is imagery rehearsal therapy (IRT) effective for narcolepsy-related nightmares?
- Does adding targeted dream control (TDC) to IRT make it more effective?
Participants will be randomized to one of two treatment groups and will be asked to:
- Complete a daily log of sleep symptoms for up to 13 weeks.
- Attend 7 sessions of treatment.
- Complete questionnaires before and after treatment.
- Go to the research lab in Evanston, IL to complete a sleep study during a daytime nap (Chicago area residents only).
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
- 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
- •(all participants):
- •Diagnosis of narcolepsy
- •Age 18 or older
- •Speak English
- •Live in the United States
- •Receiving standard medical care for narcolepsy
- •Sleep and psychiatric medications stable for at least 3 months
- •Nightmare frequency of ≥3 times per week
- •Nightmare Disorder Index score indicates probable nightmare disorder
- •Inclusion Criteria (Chicago area participants):
- •Able to attend a study appointment in Evanston, IL
- •Able and willing to not take wake-promoting medications on day of lab visit
排除标准
- •History of a neurological disorder that might alter EEG
- •Currently engaged in sleep- or trauma-focused psychotherapy
- •Previous behavioral treatment for nightmares
- •Medical, psychiatric, or cognitive condition which would interfere with ability to engage in the treatment
- •Untreated sleep apnea (AHI ≥ 5)
研究组 & 干预措施
Imagery rehearsal therapy and targeted dream control (IRT+TDC)
Participants randomized to this group will receive 7 sessions of IRT+TDC.
干预措施: Imagery rehearsal therapy (Behavioral)
Imagery rehearsal therapy and targeted dream control (IRT+TDC)
Participants randomized to this group will receive 7 sessions of IRT+TDC.
干预措施: Targeted dream control (Behavioral)
Imagery rehearsal therapy (IRT)
Participants randomized to this group will receive 7 sessions of IRT.
干预措施: Imagery rehearsal therapy (Behavioral)
结局指标
主要结局
Daily diary
时间窗: Duration of study (11-13 weeks)
Nightmare severity/frequency
Nightmare Frequency
时间窗: Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)
Frequency of nightmares as measured by daily diary
Disturbing Dream and Nightmare Severity Scale
时间窗: Baseline and posttreatment (up to 13 weeks)
Measures nightmare severity. Minimum = 0, maximum = 37. Higher scores represent a worse severity of nightmares.
次要结局
- Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale(Baseline and posttreatment (up to 13 weeks))
- Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale(Baseline and posttreatment (up to 13 weeks))
研究者
Jennifer Mundt, PhD
Professor
Northwestern University