Nightmare Rescripting and Rehearsal
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|ClinicalTrials.gov Identifier: NCT04529070|
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : February 23, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Nightmare Sleep||Behavioral: Nightmare Rescripting and Rehearsal Behavioral: standard of care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nightmare Rescripting and Rehearsal: Testing a 10-Minute Intervention to Treat Recurring Distressing Dreams in Primary Care.|
|Actual Study Start Date :||January 21, 2021|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2022|
Experimental: Intervention + Standard of care
Nightmare Rescripting and Rehearsal: a 10 minute intervention for Primary Care plus Sleep Hygiene handout.
Behavioral: Nightmare Rescripting and Rehearsal
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.
Behavioral: standard of care
standard of care
Active Comparator: Standard of care
Standard of Care Sleep Hygiene handout alone.
Behavioral: standard of care
standard of care
- Nightmare distress Questionnaire (change from nightmare distress baseline from screening at each 4 visits) [ Time Frame: 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) [ Time Frame: 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.
- Posttraumatic Stress Disorder Checklist (PTSD) [ Time Frame: screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week) ]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.
- Beck Depression Inventory II [ Time Frame: screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week) ]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.
- General Anxiety Disorder (anxiety) [ Time Frame: screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week) ]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.
- Insomnia Severity Index (insomnia) [ Time Frame: screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week) ]ISI. Measures insomnia problems occurring in the last 2 weeks. 7 questions with added up scores. Higher score indicates greater symptom severity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529070
|Contact: Jill M Clark, MBAfirstname.lastname@example.org|
|United States, Nevada|
|Mike O'Callaghan Military Medical Center||Recruiting|
|Nellis Air Force Base, Nevada, United States, 89191|
|Contact: Amanda J Crawford, MSHS 702-653-3298 email@example.com|
|Contact: Jill M Clark, MBA/HCM 702-653-3298 firstname.lastname@example.org|