Understanding Trauma Nightmares Using In-Home Measurement
NCT ID: NCT03974503
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2019-12-02
2025-04-07
Brief Summary
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Detailed Description
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The study will include 80 trauma-exposed Veterans reporting with trauma-related nightmares. Eligible participants will monitor their sleep for a week using a multi-night mattress actigraphy implemented in their home. Mattress actigraphy, which measures movements using accelerometers embedded in a mattress topper, employs no body surface sensors. Therefore, this system represents a truly zero-burden method for obtaining intensive longitudinal sleep measurement. During the week of sleep monitoring, participants also will complete one-night of polysomnography (PSG) sleep assessment to calibrate the actigraphic sleep efficiency and to identify untreated sleep apnea. These methods will be used to investigate candidate physiological parameters associated with trauma-related nightmares. After establishing the levels of these candidate markers, this project will assess the impact of a cognitive-behavioral treatment, Exposure, Relaxation, and Rescripting Therapy (ERRT), on the subset of markers which can be measured continuously over the course of the treatment. Participants will be randomized to five weeks of active treatment (ERRT; n = 40) or to five weeks of the comparison treatment (sleep and nightmare management; n = 40). Throughout the course of treatment, participants will continue to sleep while monitored by the mattress actigraphy system. Upon completion of treatment, a post-treatment and follow-up assessment will assess subjective symptom change. Results from this study will provide important information to facilitate increased understanding of the phenomenology, pathophysiology, and treatment of nightmares in trauma-exposed Veterans.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Exposure, Relaxation, and Rescripting Therapy (ERRT)
Exposure, Relaxation, \& Rescripting Therapy (ERRT) will be conducted once a week for five consecutive weeks for approximately one hour per session. Each treatment session focuses on one of the following topics/skills: psycho-education and investment in treatment, sleep behavior modification, Progressive Muscle Relaxation, diaphragmatic breathing, exposure to the trauma-nightmare, rescription, and treatment maintenance planning.
Exposure, Relaxation, and Rescripting Therapy
ERRT is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in trauma-exposed adults.
Sleep and Nightmare Management
This treatment protocol has amounts of therapist contact, handouts, and homework between sessions equivalent to those in ERRT. The protocol contains psychoeducation about sleep disturbances and trauma-related nightmares, including their distressing nature, chronicity, and impact on sleep and daytime functioning. Additionally, basic sleep behavior modification are presented. No nightmare content or rescripting will be explicitly discussed, and the diaphragmatic breathing techniques will be omitted from this protocol.
Sleep and Nightmare Management
This is a manualized protocol developed to be of similar length but exclude the active components of standard ERRT.
Interventions
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Exposure, Relaxation, and Rescripting Therapy
ERRT is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in trauma-exposed adults.
Sleep and Nightmare Management
This is a manualized protocol developed to be of similar length but exclude the active components of standard ERRT.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have stable housing for the duration of the study period
* Have experienced any traumatic event meeting Criterion A for PTSD at least three months before the baseline assessment
* Meet criteria for a current PTSD diagnosis or subthreshold PTSD diagnosis
* Self-report experiencing trauma-related nightmares at least once per week for the past month, that are mostly-remembered and that cause awakening
* Self-report global sleep disturbance indicated by a score of 5 or greater on the Pittsburgh Sleep Quality Index (PSQI)
* Be stable on any psychoactive medications for a minimum of two weeks before the baseline assessment
Exclusion Criteria
* Medical conditions that limit ability to apply the treatment e.g., needing a health aide or caregiver to record sleep diaries, unable to get out of bed without assistance
* Current pregnancy and/or birth of a child within the previous 6 months
* Current alcohol or illicit substance use disorders or early remission (at least 3 months abstinent)
* Active suicidal or homicidal ideation
* A history of any bipolar disorder spectrum disorder or psychotic disorder
* Hospitalization for a mental health disorder in the past 2 months
* Enrolled in current PTSD-focused treatment (e.g., Cognitive Processing Therapy or Prolonged Exposure), current nightmare treatment or a history of treatment failure with a cognitive-behavioral nightmare intervention
* Veterans may also be excluded from participation if they have been identified by the local VA disruptive behavior committee to have displayed disruptive, threatening and/or violent behavior
18 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Katherine Elizabeth Miller, PhD
Role: PRINCIPAL_INVESTIGATOR
Minneapolis VA Health Care System, Minneapolis, MN
Locations
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Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States
Countries
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References
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Kuhn E, Miller KE, Puran D, Wielgosz J, YorkWilliams SL, Owen JE, Jaworski BK, Hallenbeck HW, McCaslin SE, Taylor KL. A Pilot Randomized Controlled Trial of the Insomnia Coach Mobile App to Assess Its Feasibility, Acceptability, and Potential Efficacy. Behav Ther. 2022 May;53(3):440-457. doi: 10.1016/j.beth.2021.11.003. Epub 2021 Nov 19.
Tighe CA, Berlin GS, Boland EM, Miller KE, Bramoweth AD. Identifying predictors of the amount of veteran participation in cognitive behavioral therapy for insomnia in the Veterans Affairs health care system. Psychol Serv. 2024 Aug;21(3):581-588. doi: 10.1037/ser0000818. Epub 2023 Nov 2.
Miller KE, So CJ, Brownlow JA, Woodward SH, Gehrman PR. Neighborhood disadvantage is associated with sleep disturbance in a sample of trauma-exposed Veterans. Sleep Health. 2023 Oct;9(5):634-637. doi: 10.1016/j.sleh.2023.06.006. Epub 2023 Jul 31.
Miller KE, Bolstad CJ, Carlile JA, Balliett NE, Trivedi S, Davis JL, Schubert J, Krieg C, Shah M. Providers' use and perceived benefits and barriers of delivering cognitive behavioral therapy for nightmares (CBT-N) to veterans. Psychol Serv. 2025 Sep 15:10.1037/ser0000994. doi: 10.1037/ser0000994. Online ahead of print.
So CJ, Bolstad CJ, Miller KE. Status of Imagery Rehearsal Therapy and Other Interventions for Nightmare Treatment in PTSD. Curr Psychiatry Rep. 2025 Nov;27(11):671-678. doi: 10.1007/s11920-025-01639-z. Epub 2025 Sep 11.
Miller KE, Boland EM, Barilla H, Ross RJ, Kling MA, Bhatnagar S, Gehrman PR. Ecological momentary assessment of daily affect, stress, and nightmare reports among combat-exposed Veterans. Dreaming. 2024;34(4):307-317. doi: 10.1037/drm0000281.
So CJ, Miller KE, Gehrman PR. Sleep Disturbances Associated With Posttraumatic Stress Disorder. Psychiatr Ann. 2023 Nov 1;53(11):491-495. doi: 10.3928/00485713-20231012-01.
Miller KE, Tamayo G, Arsenault N, Jamison AL, Woodward SH. Longitudinal profiles of sleep during residential PTSD treatment. Sleep Med. 2023 Jun;106:52-58. doi: 10.1016/j.sleep.2023.03.020. Epub 2023 Mar 31.
Brownlow JA, Miller KE, Ross RJ, Barilla H, Kling MA, Bhatnagar S, Mellman TA, Gehrman PR. The association of polysomnographic sleep on posttraumatic stress disorder symptom clusters in trauma-exposed civilians and veterans. Sleep Adv. 2022 Aug 11;3(1):zpac024. doi: 10.1093/sleepadvances/zpac024. eCollection 2022.
Brownlow JA, Klingaman EA, Miller KE, Gehrman PR. Trauma type as a risk factor for insomnia in a military population. J Affect Disord. 2022 Jul 1;308:65-70. doi: 10.1016/j.jad.2022.04.018. Epub 2022 Apr 9.
Miller KE, Ross RJ, Harb GC. Lucid Dreams in Veterans With Posttraumatic Stress Disorder Include Nightmares. Dreaming. 2021 Jun;31(2):117-127.
Polyne NC, Miller KE, Brownlow J, Gehrman PR. Insomnia: Sex differences and age of onset in active duty Army soldiers. Sleep Health. 2021 Aug;7(4):504-507. doi: 10.1016/j.sleh.2021.03.003. Epub 2021 Apr 15.
Brownlow JA, Miller KE, Gehrman PR. Treatment of Sleep Comorbidities in Posttraumatic Stress Disorder. Curr Treat Options Psychiatry. 2020 Sep;7(3):301-316. doi: 10.1007/s40501-020-00222-y. Epub 2020 Jun 12.
Miller KE, Babler L, Maillart T, Faerman A, Woodward SH. Sleep/Wake Detection by Behavioral Response to Haptic Stimuli. J Clin Sleep Med. 2019 Nov 15;15(11):1675-1681. doi: 10.5664/jcsm.8038.
Miller KE, Brownlow JA, Gehrman PR. Sleep in PTSD: treatment approaches and outcomes. Curr Opin Psychol. 2020 Aug;34:12-17. doi: 10.1016/j.copsyc.2019.08.017. Epub 2019 Aug 23.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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MHBB-018-18F
Identifier Type: -
Identifier Source: org_study_id
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