Nightmare Rescripting and Rehearsal: Testing a 10-Minute Intervention to Treat Recurring Distressing Dreams in Primary Care.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- David Moss
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Nightmare distress Questionnaire (change from nightmare distress baseline from screening at each 4 visits)
研究概览
简要总结
This study aims to test the efficacy of an abbreviated version of Imagery Rehearsal Therapy administered by non-mental health professionals in a Primary Care setting. This treatment, to be called 'Nightmare Rescripting and Rehearsal Therapy' (NRRT) would arm Primary Care medical personnel with a nonpharmacologic, ten minute intervention for treating recurring nightmares.
The study will provide sleep hygiene education to both the control and experiment groups, NRRT to the experiment group only, and compare their Nightmare Distress Questionnaire and Nightmare Frequency Tool at two (2), four (4), and six (6) week intervals.
详细描述
This is a prospective Randomized Controlled Trial to determine if a standard of care sleep hygiene handout plus a brief 10 minute intervention for recurring nightmares (Nightmare Rescripting and Rehearsal Therapy) reduces scores on the Nightmare Distress Questionnaire and Nightmare Frequency Tool, when compared to patients solely receiving a handout outlining sleep hygiene techniques. Individuals with a minimum score on the Nightmare Distress Questionnaire and Nightmare Frequency Tool of 15 out of a possible 52 who meet all other inclusion criteria will be invited to participate.
A clinically significant reduction will be considered if a decrease in Nightmare Distress and Frequency measures is greater than or equal to 25% from baseline. Secondary outcomes will include PCL-5 (PTSD), PHQ9 (Depression), GAD7 (Anxiety), ISI (Insomnia Severity Index) scores.
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
- •Active Duty members and DoD beneficiaries.
- •Aged 18 years or older
- •Recurring disturbing dreams (at least three times per month for the past one month)
- •Participants must score a 15 out of a possible 52 on the Nightmare Distress Questionnaire and Nightmare Frequency Tool in order to qualify.
排除标准
- •Aged less than 18 years old
- •Unwilling to refrain from taking an over the counter or prescription medication for the purpose of improving sleep during the course of the study.
- •Participants that score less than a 15 out of a possible 52 on the Nightmare Distress Questionnaire and Nightmare Frequency will be excluded
结局指标
主要结局
Nightmare distress Questionnaire (change from nightmare distress baseline from screening at each 4 visits)
时间窗: screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)
13 questions, 0-4. 0 indicates lower level of distress and effects as related to nightmares.
Nightmare Frequency in the past week (change from nightmare frequency screening baseline at each 4 visits)
时间窗: screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)
Boxes numbered one to 31. Pt circles the number corresponding to the number of days they had a nightmare in the past month.
次要结局
- Posttraumatic Stress Disorder Checklist (PTSD)(screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week))
- Beck Depression Inventory II(screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week))
- General Anxiety Disorder (anxiety)(screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week))
- Insomnia Severity Index (insomnia)(screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week))
研究者
David Moss
Principal Investigator
Mike O'Callaghan Military Hospital