Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 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 Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD). People with RBD will be enrolled in the study along with their family members (a partner or other family member residing in the same home). All participants will receive the treatment via videoconference and will complete 2 assessments. Participants with RBD will attend 7 sessions, and their family members will attend 2 of those sessions with them.
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
- •Diagnosis of isolated RBD or RBD secondary to neurodegenerative disease
- •Age 18 or older
- •Speak, read, and write English
- •Live in the United States
- •Nightmare frequency ≥3 times per week
- •Disturbing Dream and Nightmare Severity Index score indicative of nightmare disorder
- •Sleep, neurological, and psychiatric medications stable for at least 1 month and willing to keep medications stable through the course of the study
- •Live with a family member who is willing to participate in the study
排除标准
- •Possible dementia
- •Narcolepsy
- •Posttraumatic stress disorder
- •Previous behavioral treatment for nightmares
- •Currently engaged in sleep- or trauma-focused psychotherapy
- •Taking a medication that could cause RBD, if the medication was started prior to onset of RBD symptoms
- •Inclusion Criteria (Family Members):
- •Live with a family member who meets all of the above criteria
- •Age 18 or older
- •Speak, read, and write English
- •Live in the United States
研究组 & 干预措施
2-week baseline
Participants will receive treatment after a 2-week baseline assessment period
干预措施: Cognitive Behavioral Therapy for Nightmares (Behavioral)
4-week baseline
Participants will receive treatment after a 4-week baseline assessment period
干预措施: Cognitive Behavioral Therapy for Nightmares (Behavioral)
结局指标
主要结局
Disturbing Dream and Nightmare Severity Index (DDNSI)
时间窗: Baseline and posttreatment
The DDNSI is a questionnaire which measures the severity of nightmares.
Nightmare frequency (sleep diary)
时间窗: Baseline and posttreatment
The number of nightmares experienced each day will be collected on daily sleep diaries completed during each assessment period.
次要结局
未报告次要终点