Understanding Trauma Nightmares Using In-Home Measurement

NCT03974503 | Completed Results DMC

• 2 other identifiers: MHBB-018-18FIK2CX001874
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Trauma-related nightmares in Veterans are associated with poor clinical outcomes, greater substance use, and increased risk of suicide. In spite of an urgent need to reduce the burden of trauma-related nightmares, the underlying physiological changes associated with them are poorly understood, and there are no clear evidence-based recommendations for their treatment. Limitations of current assessment procedures represent a barrier to improved care. In-laboratory sleep studies rarely capture nightmares, limiting the knowledge about them and their response to treatment. This study addresses these limitations by using extended, in-home sleep monitoring to capture sleep data associated with nightmare reports in Veterans, and assessing how these features are altered throughout a cognitive-behavioral nightmare treatment. Results from this study will increase understanding of trauma-related nightmares, and advance strategies for personalizing symptom management for Veterans.

Conditions

Actigraphy; Nightmares; Stress Disorders, Post-Traumatic; Respiratory Sinus Arrhythmia; Veterans

Keywords

Nightmares; Cognitive Behavioral Therapy; PTSD; Veterans

Outcome Measures

Primary Outcomes (3)

• Actigraphy-derived Sleep Efficiency (SE) Percentage

  Sleep efficiency will be calculated per night from a mattress actigraphy system and averaged for two time-periods (the week between mattress installation and the first treatment session; the week between the last treatment session to the 1-week post-5-week treatment assessment). Sleep efficiency is defined as the ratio of the aggregate duration of quiescent sleep periods divided by the duration of the total in bed period multiplied by 100 to convert sleep efficiency to percentage points. Lower sleep efficiency indicates more disrupted sleep.

  Week from mattress installation to first treatment session; Week from last treatment session to 1-week post-5-week-treatment assessment

• Actigraphy-derived Respiratory Sinus Arrhythmia (RSA)

  Respiratory sinus arrhythmia (RSA) was computed in the 0.15-0.40 Hz band, using median values from high-quality inter-beat-intervals segments, each night. These data were averaged for two time-periods (the week between mattress installation and the first treatment session; the week between the last treatment session to the 1-week post-5-week treatment assessment). Lower RSA indicates more cardiac vagal withdrawal.

  Week from mattress installation to first treatment session; Week from last treatment session to 1-week post-5-week-treatment assessment

• Change in Nightmare Frequency

  This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares) at each assessment (baseline, one week following 5-week treatment, and three months following treatment).

  Baseline past week; post-5-week-treatment past week; 3-month follow-up past week

Secondary Outcomes (2)

• Change in Total PTSD Symptom Severity

  Baseline, 1-week post-5-week-treatment, 3-month follow-up

• Change in Nightmare Severity

  Baseline past week; post-5-week-treatment past week; 3-month follow-up past week

Other Outcomes (6)

• Home-based Overnight Polysomnography - Apnea-Hypopnea Events Per Hour of Sleep

  Baseline

• Change in Global Sleep Quality

  Baseline; 1-week post-5-week-treatment; 3-month follow-up

• Change in Self-report Depression Symptoms

  Baseline, 1-week post-5-week-treatment, 3-month follow-up

Study Arms (2)

Exposure, Relaxation, and Rescripting Therapy (ERRT)

EXPERIMENTAL

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.

Behavioral: Exposure, Relaxation, and Rescripting Therapy

Sleep and Nightmare Management

ACTIVE COMPARATOR

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.

Behavioral: Sleep and Nightmare Management

Interventions

Exposure, Relaxation, and Rescripting Therapy BEHAVIORAL

ERRT is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in trauma-exposed adults.

Also known as: ERRT

Exposure, Relaxation, and Rescripting Therapy (ERRT)

Sleep and Nightmare Management BEHAVIORAL

This is a manualized protocol developed to be of similar length but exclude the active components of standard ERRT.

Sleep and Nightmare Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be a Veteran enrolled to receive VA medical care at the Minneapolis VA Health Care System
• 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

You may not qualify if:

• Inability to provide fully-informed written consent to participate and/or a bed partner does not agree to mattress recording during the in-home portion of the study
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

Related Publications (15)

• 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.

  PMID: 35473648 BACKGROUND

• 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.

  PMID: 37917476 BACKGROUND

• 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.

  PMID: 37532605 BACKGROUND

• 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.

  PMID: 40952699 BACKGROUND

• 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.

  PMID: 40932590 BACKGROUND

• 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.

  PMID: 39950038 BACKGROUND

• 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.

  PMID: 38293647 BACKGROUND

• 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.

  PMID: 37044001 BACKGROUND

• 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.

  PMID: 36171859 BACKGROUND

• 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.

  PMID: 35413357 BACKGROUND

• Miller KE, Ross RJ, Harb GC. Lucid Dreams in Veterans With Posttraumatic Stress Disorder Include Nightmares. Dreaming. 2021 Jun;31(2):117-127.

  PMID: 37363340 BACKGROUND

• 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.

  PMID: 33867309 BACKGROUND

• 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.

  PMID: 33552844 BACKGROUND

• 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.

  PMID: 31739859 BACKGROUND

• 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.

  PMID: 31541965 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Arrhythmia, Sinus

Interventions

Sleep

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Due to recruitment and administrative delays related to the COVID-19 pandemic and transfer of the study site, the investigators were unable to enroll the full sample originally planned. As a result, the study may have been underpowered to detect between-group differences, particularly for smaller effect sizes.

Results Point of Contact

• Title: Katherine Miller, PhD
• Organization: Minneapolis VA Health Care System

katherine.miller13@va.gov

612-467-3894

Study Officials

• Katherine Elizabeth Miller, PhD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors at the post-treatment and follow-up assessment will not be aware of what treatment the participants received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two cognitive-behavioral treatments for sleep and nightmares.

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 5, 2019
• Study Start: December 2, 2019
• Primary Completion: March 31, 2025
• Study Completion: April 7, 2025
• Last Updated: April 9, 2026
• Results First Posted: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)