Nightmare Rescripting and Rehearsal

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04529070
• Other study ID #: FWH20200116H
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Mike O'Callaghan Military Hospital
• Contact: Jill M Clark, MBA
• Phone: 7026533298
• Email: jill.m.clark15.ctr[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 156
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

**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

Related Conditions & MeSH terms

• Nightmare
• Sleep

Intervention

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.
• standard of care
standard of care

Locations

Country	Name	City	State
United States	Mike O'Callaghan Military Medical Center	Nellis Air Force Base	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
David Moss

Country where clinical trial is conducted

United States, 

References & Publications (12)

American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arlington, VA: American Psychiatric Association.

Belicki K. (1992). The relationship of nightmare frequency to nightmare suffering with implications for treatment and research. Dreaming 2 143-148. 10.1037/h0094355

Böckermann, M., Gieselmann, A., & Pietrowsky, R. (2014). What does nightmare distress mean? Factorial structure and psychometric properties of the Nightmare Distress Questionnaire (NDQ). Dreaming, 24(4), 279-289. https://doi.org/10.1037/a0037749

Collen JF, Williams SG, Lettieri CJ. Doomed to Repeat History: The Burden of Trauma-Related Nightmares in Military Personnel. J Clin Sleep Med. 2018 Mar 15;14(3):303-305. doi: 10.5664/jcsm.6964. No abstract available. — View Citation

Creamer JL, Brock MS, Matsangas P, Motamedi V, Mysliwiec V. Nightmares in United States Military Personnel With Sleep Disturbances. J Clin Sleep Med. 2018 Mar 15;14(3):419-426. doi: 10.5664/jcsm.6990. — View Citation

Harb, G. C., Forbes, D., Phelps, A., Gehrman, P. R., Cook, J. M., Gamble, G. & Ross, R. J. (2010). Treatment Manual for Imagery Rehearsal + cCBT for Insomnia.

Köthe, M. & Pietrowsky, R. (2001). Behavioral effects of nightmares and their correlations to personality patterns. Dreaming, 11, 43-52.

Krakow B, Hollifield M, Schrader R, Koss M, Tandberg D, Lauriello J, McBride L, Warner TD, Cheng D, Edmond T, Kellner R. A controlled study of imagery rehearsal for chronic nightmares in sexual assault survivors with PTSD: a preliminary report. J Trauma Stress. 2000 Oct;13(4):589-609. doi: 10.1023/A:1007854015481. — View Citation

Krakow B, Kellner R, Neidhardt J, Pathak D, Lambert L. Imagery rehearsal treatment of chronic nightmares: with a thirty month follow-up. J Behav Ther Exp Psychiatry. 1993 Dec;24(4):325-30. doi: 10.1016/0005-7916(93)90057-4. — View Citation

Levin R, Nielsen TA. Disturbed dreaming, posttraumatic stress disorder, and affect distress: a review and neurocognitive model. Psychol Bull. 2007 May;133(3):482-528. doi: 10.1037/0033-2909.133.3.482. — View 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

Seda G, Sanchez-Ortuno MM, Welsh CH, Halbower AC, Edinger JD. Comparative meta-analysis of prazosin and imagery rehearsal therapy for nightmare frequency, sleep quality, and posttraumatic stress. J Clin Sleep Med. 2015 Jan 15;11(1):11-22. doi: 10.5664/jcsm.4354. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)