Clinical trial NCT04529070: Nightmare Rescripting and Rehearsal
Official title: Nightmare Rescripting and Rehearsal: Testing a 10-Minute Intervention to Treat Recurring Distressing Dreams in Primary Care.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nightmare
Sleep
Keywords: nightmare rescripting
dreams
behavioral health
sleep
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2020-08-27
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: \*\*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

Primary outcomes:
measure: Nightmare distress Questionnaire (change from nightmare distress baseline from screening at each 4 visits)
timeFrame: screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)
measure: Nightmare Frequency in the past week (change from nightmare frequency screening baseline at each 4 visits)
timeFrame: screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)
Secondary outcomes:
measure: Posttraumatic Stress Disorder Checklist (PTSD)
timeFrame: screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)
measure: Beck Depression Inventory II
timeFrame: screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)
measure: General Anxiety Disorder (anxiety)
timeFrame: screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)
measure: Insomnia Severity Index (insomnia)
timeFrame: screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)
Other outcomes:
Locations:
city: Nellis Air Force Base
country: United States
facility: Mike O'Callaghan Military Medical Center
state: Nevada
Study officials:
References:
citation: American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arlington, VA: American Psychiatric Association.
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citation: Pruiksma, K. E., Slavish, D., Wardle, S. Ojeda, A., Taylor, D., Peterson, A., Kelly, K., Maur, D., Mintz, J., Litz, B., Borah, E., Brundige, A., Young-McCaughan, S., Williamson, D. (2019). Prevalence and correlates of nightmares in Active Duty Service Members. Sleep, (42)1, A267. https://doi.org/10.1093/sleep/zsz067.667
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