Imagery Rehearsal Therapy for the Treatment of Nightmares in Narcolepsy: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Disturbing Dream and Nightmare Severity Index (DDNSI)
研究概览
简要总结
The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with narcolepsy. All participants will receive the treatment and will complete three assessments. Half of the participants will receive the treatment after the first assessment, and half will receive it after the second assessment. Romantic partners of participants with narcolepsy will also be eligible to enroll in the study. Partners will complete three assessments but will not participate in the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •PARTICIPANTS WITH NARCOLEPSY/NIGHTMARES
- •Inclusion Criteria:
- •Diagnosis of narcolepsy type 1 or narcolepsy type 2
- •Nightmare frequency of ≥1 times per week
- •Age 18 or older
- •Able to speak, read, and write in English
- •Live in the United States
- •Sleep and psychiatric medications stable for ≥ 1 month and willing to keep medications stable for the duration of the study
排除标准
- •Currently engaged in trauma- or sleep-related psychotherapy
- •Previous behavioral treatment for nightmares
- •Medical, psychiatric, or cognitive condition which would interfere with ability to engage in the treatment
- •Untreated moderate-severe sleep apnea
- •PARTICIPANTS WHO ARE PARTNERS OF SOMEONE WITH NARCOLEPSY
- •Inclusion Criteria:
- •Live with a romantic partner who meets the above criteria and has agreed to participate in the study
- •Age 18 or older
- •Able to speak, read, and write in English
- •Live in the United States
研究组 & 干预措施
Treatment
The Treatment arm will receive the intervention immediately following the first assessment.
干预措施: Imagery Rehearsal Therapy (IRT) (Behavioral)
Waitlist
The Waitlist arm will undergo a waiting period following the first assessment and then will receive the treatment after the second assessment.
干预措施: Imagery Rehearsal Therapy (IRT) (Behavioral)
结局指标
主要结局
Disturbing Dream and Nightmare Severity Index (DDNSI)
时间窗: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
The DDNSI is a questionnaire which measures the severity of nightmares.
Nightmare frequency (sleep diary)
时间窗: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
The number of nightmares experienced each day will be collected on daily sleep diaries completed during each assessment period.
次要结局
- PROMIS Anxiety(Completed at each of the three assessments (baseline, 10 weeks, 19 weeks))
- PROMIS Depression(Completed at each of the three assessments (baseline, 10 weeks, 19 weeks))
研究者
Jennifer Mundt
Assistant Professor
University of Utah