NCT04529070

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 21, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

4.9 years

First QC Date

August 21, 2020

Last Update Submit

December 10, 2025

Conditions

Keywords

nightmare rescriptingdreamsbehavioral healthsleep

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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)

Study Arms (2)

Intervention + Standard of care

EXPERIMENTAL

Nightmare Rescripting and Rehearsal: a 10 minute intervention for Primary Care plus Sleep Hygiene handout.

Behavioral: Nightmare Rescripting and RehearsalBehavioral: standard of care

Standard of care

ACTIVE COMPARATOR

Standard of Care Sleep Hygiene handout alone.

Behavioral: standard of care

Interventions

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.

Intervention + Standard of care

standard of care

Intervention + Standard of careStandard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

Related Publications (12)

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

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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 29458710BACKGROUND
  • 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.

    PMID: 29510796BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

    PMID: 8077451BACKGROUND
  • 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.

    PMID: 11109233BACKGROUND
  • 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.

    PMID: 17469988BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 25325592BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2020

First Posted

August 27, 2020

Study Start

January 21, 2021

Primary Completion

December 9, 2025

Study Completion

December 9, 2025

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

We do not plan on sharing data.

Locations