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NightmareNCT04529070

Nightmare Rescripting and Rehearsal

A study testing Nightmare Rescripting and Rehearsal in people with Nightmare and Sleep, run by David Moss at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nightmare, Sleep
What is being tested?
Nightmare Rescripting and Rehearsal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteUnited States
Study dates
21 Jan 2021to 9 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mike O'Callaghan Military Medical Center

    Nellis Air Force Base, Nevada, 89191

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Nightmare, Sleep
Being tested
Nightmare Rescripting and Rehearsal, standard of care
Keywords
nightmare rescripting, dreams, behavioral health, sleep

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nightmare Rescripting and RehearsalBehavioural

    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 careBehavioural

    standard of care

Study groups in NCT04529070
Study groupRoleWhat they receive
Intervention + Standard of careExperimentalNightmare Rescripting and Rehearsal: a 10 minute intervention for Primary Care plus Sleep Hygiene handout.
Receives: Behavioral: Nightmare Rescripting and Rehearsal; Behavioral: standard of care
Standard of careActive comparatorStandard of Care Sleep Hygiene handout alone.
Receives: Behavioral: standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)

  2. 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.

    Measured: 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)
  1. 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.

    Measured: screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)

  2. 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.

    Measured: screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)

  3. 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.

    Measured: screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)

  4. 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.

    Measured: screening, visit 1 (week 0), visit 2 (week 2 +/- 1 week), visit 3 (week 4 +/- 1 week), visit 4 (week 6 +/- 1 week)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2020
  2. Study start21 Jan 2021
  3. Primary completion9 Dec 2025
  4. Study completion9 Dec 2025

Why it stopped: Lack of Funding and PI separated from the Air Force

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04529070
Sponsor's protocol ID
FWH20200116H
Status last verified
Dec 2025
First submitted
21 Aug 2020
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We do not plan on sharing data.

Publications

  • 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.

    PubMed 29458710
  • 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.

    PubMed 29510796
  • 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, 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.

    PubMed 8077451
  • 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.

    PubMed 11109233
  • 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.

    PubMed 17469988
  • 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.

    PubMed 25325592

Questions about this trial

What is this clinical trial studying?

A study testing Nightmare Rescripting and Rehearsal in people with Nightmare and Sleep, run by David Moss at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Lack of Funding and PI separated from the Air Force). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04529070, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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