- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03974503
Understanding Trauma Nightmares Using In-Home Measurement
Characterization of Sleep With Trauma Nightmares Using Ambulatory Sleep Measurement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There is a critical need for continued research to better understand trauma-related nightmares with the goal of developing personalized treatment plans. Limitations of current assessment procedures present a significant barrier to improved care. In-laboratory sleep studies rarely capture nightmares and cannot assess change over time, reducing the knowledge of phenotypic markers of nightmares to guide treatment. Therefore, there is a need to assess sleep over multiple nights in the home environment, where nightmares occur. This study aims to significantly enrich knowledge about trauma-related nightmares by using a zero-burden, multi-night, objective sleep measurement method within Veterans' usual sleeping environment prior to and during an evidence-based cognitive-behavioral intervention for nightmares. This study has two primary aims: 1) to identify, with greater precision than previously possible, objective features of sleep associated with trauma-related nightmare occurrences; and 2) to use the treatment for nightmares as interventional probes to determine whether and how changes in sleep physiological parameters identified in Aim 1 covary with changes in subjective nightmare frequency and severity.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55417-2309
- Minneapolis VA Health Care System, Minneapolis, MN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
ERRT is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in trauma-exposed adults.
Other Names:
|
|
Active Comparator: 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.
|
This is a manualized protocol developed to be of similar length but exclude the active components of standard ERRT.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Actigraphy-derived Sleep Efficiency (SE) Percentage
Time Frame: Week from mattress installation to first treatment session; Week from last treatment session to 1-week post-5-week-treatment assessment
|
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)
Time Frame: Week from mattress installation to first treatment session; Week from last treatment session to 1-week post-5-week-treatment assessment
|
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
Time Frame: Baseline past week; post-5-week-treatment past week; 3-month follow-up past week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Total PTSD Symptom Severity
Time Frame: Baseline, 1-week post-5-week-treatment, 3-month follow-up
|
Change in PTSD Symptoms will be assessed using the Clinician-Administered PTSD Scale DSM 5 (CAPS-5).
The items on the CAPS-5 are on a 5-point scale (0 - 4), (possible range: 0-80, with higher scores indicating more severe symptoms).
A symptom is considered present if the severity is rated 2 or higher.
Total scores are comprised of four symptom clusters (reexperiencing/intrusions, avoidance, cognitive/emotional and hyperarousal)
|
Baseline, 1-week post-5-week-treatment, 3-month follow-up
|
|
Change in Nightmare Severity
Time Frame: Baseline past week; post-5-week-treatment past week; 3-month follow-up past week
|
The variable from the Trauma-Related Nightmare Survey assesses the severity of the nightmares experienced in the past week (range = 0 - 4) at each assessment (baseline, one week following 5-week treatment, and three months following treatment).
Higher scores indicate greater nightmare-related severity.
|
Baseline past week; post-5-week-treatment past week; 3-month follow-up past week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Home-based Overnight Polysomnography - Apnea-Hypopnea Events Per Hour of Sleep
Time Frame: Baseline
|
Nox A1 portable polysomnography system (Nox Medical, Reykjavik, Iceland) used to record sleep stage measures and patterns of arousals, to calibrate sleep efficiency derived from the mattress system, and to detect sleep apnea.
|
Baseline
|
|
Change in Global Sleep Quality
Time Frame: Baseline; 1-week post-5-week-treatment; 3-month follow-up
|
Change in sleep Quality will be assessed using the Pittsburgh Sleep Quality Index, a 19-item self-report measure assessing qualities and problems associated with sleep in the past month.
A global sleep quality score is obtained by summing seven component scores.
Higher scores reflect poorer sleep quality.
The global score ranges from 0 to 21, with a cut-off score of 5 as distinguishing "good" sleepers from "poor" sleepers.
|
Baseline; 1-week post-5-week-treatment; 3-month follow-up
|
|
Change in Self-report Depression Symptoms
Time Frame: Baseline, 1-week post-5-week-treatment, 3-month follow-up
|
The patient health questionnaire (PHQ-9), is a 9-item self-report instrument used to assess depression severity.
Items are scored 0 to 3, with the total score being the sum of the 9 items (Total scores range from 0 to 27).
Higher scores indicate greater depression severity, with a score of 10 or greater considered major depression, and scores of 20 or more is severe major depression.
|
Baseline, 1-week post-5-week-treatment, 3-month follow-up
|
|
Change in Nightmare Effects
Time Frame: Baseline, 1-week post-5-week-treatment, 3-month follow-up
|
Change in the impact of nightmares will be assessed using the change in Nightmare Effects Survey, an 11 item Likert-type questionnaire designed to assess the impact of nightmares on 11 areas of life including work, social, and leisure activities.
Total scores range from 0 to 44, with higher scores indicating greater level of nightmare-related impairment.
|
Baseline, 1-week post-5-week-treatment, 3-month follow-up
|
|
Change in Fear of Sleep
Time Frame: Baseline, 1-week post-5-week-treatment, 3-month follow-up
|
Change in fear of sleep will be assessed using the Fear of Sleep Inventory- Short Form, a 13-item self-report measure that assesses trauma-related thoughts and activities associated with sleep and the occurrence of traumas associated with the bedroom or sleep.
Total scores range from 0 to 52, with higher scores indicating greater fear of sleep.
|
Baseline, 1-week post-5-week-treatment, 3-month follow-up
|
|
Change in Suicidal Ideation
Time Frame: Baseline, 1-week post-5-week-treatment, 3-month follow-up
|
Change in suicidal ideation will be assessed using the Depressive Symptom Index: Suicidality Subscale (DSI-SS).
The four items of the DSI-SS are scored on a 0-3 scale, with total possible sum scores ranging from 0-12; higher scores indicate greater severity of suicidal ideation.
|
Baseline, 1-week post-5-week-treatment, 3-month follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Katherine Elizabeth Miller, PhD, Minneapolis VA Health Care System, Minneapolis, MN
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Trauma and Stressor Related Disorders
- Cardiovascular Diseases
- Mental Disorders
- Pathologic Processes
- Heart Diseases
- Arrhythmias, Cardiac
- Stress Disorders, Traumatic
- Pathological Conditions, Signs and Symptoms
- Stress Disorders, Post-Traumatic
- Arrhythmia, Sinus
- Musculoskeletal and Neural Physiological Phenomena
- Nervous System Physiological Phenomena
- Sleep
Other Study ID Numbers
- MHBB-018-18F
- IK2CX001874 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress Disorders, Post-Traumatic
-
Acacia ClinicsElectroCore INC; Vagus Nerve SocietyRecruitingPTSD | Post Traumatic Stress Disorder | Post Traumatic Stress Disorders | Post-traumatic Stress Disorder (PTSD) | Post Traumatic Stress Disorder PTSD | PTSD - Post Traumatic Stress Disorder | Post-Traumatic Stress Disorder, PTSDUnited States
-
University of LuxembourgQuresta, Inc.; National Psychological Association of Ukraine; Veteran Mental...RecruitingPost Traumatic Stress Disorder | Post Traumatic Stress Disorder PTSD | Post-Traumatic Stress Disorder, PTSDUkraine
-
IWK Health CentreRecruitingPost-Traumatic Stress Disorder in Adolescence | Post-Traumatic Stress Disorder, PTSD | Post-Traumatic Stress Disorder in YouthCanada
-
Istanbul UniversityRecruitingComplex Post-Traumatic Stress Disorder (CPTSD) | Post-traumatic Stress Disorder (PTSD)Turkey
-
Istanbul UniversityRecruitingComplex Post-Traumatic Stress Disorder (CPTSD) | Post-traumatic Stress Disorder (PTSD)Turkey
-
University of California, Los AngelesDefense Advanced Research Projects Agency; Defense Group, Inc.CompletedPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder, ChronicUnited States
-
University of California, Los AngelesWithdrawnPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder in ChildrenUnited States
-
Weill Medical College of Cornell UniversityCompletedPost-traumatic Stress Disorder | Complex Post-Traumatic Stress DisorderUnited States
-
University Hospital, ToulouseCompletedPost-traumatic StressFrance
-
Soul Medicine InstituteRecruitingPost-Traumatic Stress DisordersUnited States
Clinical Trials on Exposure, Relaxation, and Rescripting Therapy
-
University of MontanaCompletedTraumatic Stress | Post Trauma NightmaresUnited States
-
University of TulsaCompletedNightmares Associated With Trauma and StressUnited States
-
University of TulsaRecruitingFrequent Trauma-related NightmaresUnited States
-
University of TulsaCompletedInsomnia | Trauma | NightmareUnited States
-
University of TulsaCompleted
-
The University of Texas Health Science Center at...American Academy of Sleep MedicineCompletedNightmaresUnited States
-
VA Eastern KansasTerminated
-
Modum BadUniversity of OsloCompletedPosttraumatic Stress DisorderNorway
-
University of WaterlooUniversity of Toronto; Hebrew University of Jerusalem; BaycrestCompleted
-
University of TulsaCompleted