Nightmare Rescripting and Rehearsal

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Nightmare Rescripting and Rehearsal: Testing a 10-Minute Intervention to Treat Recurring Distressing Dreams in Primary Care.

Conditions
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Nightmare, Sleep

Intervention / Treatment
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* Behavioral: Nightmare Rescripting and Rehearsal
* Behavioral: standard of care


Participation Criteria
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Eligibility Criteria
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**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study** Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention + Standard of care<br>Nightmare Rescripting and Rehearsal: a 10 minute intervention for Primary Care plus Sleep Hygiene handout. | Behavioral: Nightmare Rescripting and Rehearsal<br>* This study aims to test the efficacy of an abbreviated version of Imagery Rehearsal Therapy ('Nightmare Rescripting and Rehearsal Therapy' (NRRT)) administered by non-mental health professionals in a Primary Care setting.<br>Behavioral: standard of care<br>* standard of care<br>|
| Active Comparator: Standard of care<br>Standard of Care Sleep Hygiene handout alone. | Behavioral: standard of care<br>* standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nightmare distress Questionnaire (change from nightmare distress baseline from screening at each 4 visits) | 13 questions, 0-4. 0 indicates lower level of distress and effects as related to nightmares. | screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week) | 
| Nightmare Frequency in the past week (change from nightmare frequency screening baseline at each 4 visits) | Boxes numbered one to 31. Pt circles the number corresponding to the number of days they had a nightmare in the past month. | screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posttraumatic Stress Disorder Checklist (PTSD) | The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The questionnaire is self-report and may be completed in 5-10 minutes. Lower score indicates less severity of PTSD symptoms but is broad enough to pick up a wide base of patients with possible PTSD. Higher scores indicate greater severity and also offeres greater sensitivity. | 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 | BDI-II. This questionnaire self-report and is made up of 21 groups of statements designed to measure attitudes and symptoms of depression severity. Each question has options that are scored on a scale of 0 to 3. Higher scores equals more severity of depression symptoms. | 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) | GAD-7. Objective screening tool to use to identify severity of: (Generalized Anxiety Disorder, Panic Disorder, Social Phobia and PostTraumatic Stress Disorder). 7 questions with options 0-3 and with a higher score indicating greater symptom severity. | 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) | ISI. Measures insomnia problems occurring in the last 2 weeks. 7 questions with added up scores. Higher score indicates greater symptom severity. | screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nightmare rescripting, dreams, behavioral health, sleep