NightmaresNCT03974503
Understanding Trauma Nightmares Using In-Home Measurement
A study testing Exposure, Relaxation, and Rescripting Therapy and Sleep and Nightmare Management in people with Nightmares and Stress Disorders, Post-Traumatic, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nightmares, Stress Disorders, Post-Traumatic, Actigraphy
- What is being tested?
- Exposure, Relaxation, and Rescripting Therapy and Sleep and Nightmare Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2019to 7 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
About this study
Official title: Characterization of Sleep With Trauma Nightmares Using Ambulatory Sleep Measurement
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.
Read the 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.
- Conditions
- Nightmares, Stress Disorders, Post-Traumatic, Actigraphy, Respiratory Sinus Arrhythmia, Veterans
- Being tested
- Exposure, Relaxation, and Rescripting Therapy, Sleep and Nightmare Management
- Keywords
- Nightmares, Cognitive Behavioral Therapy, PTSD, Veterans
- Medical subject headings
- Stress Disorders, Post-Traumatic, Arrhythmia, Sinus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure, Relaxation, and Rescripting TherapyBehavioural
Also called ERRT
ERRT is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in trauma-exposed adults.
Sleep and Nightmare ManagementBehavioural
This is a manualized protocol developed to be of similar length but exclude the active components of standard ERRT.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sleep and Nightmare Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Baseline past week; post-5-week-treatment past week; 3-month follow-up past week
Secondary outcomes (2)
Change in Total PTSD Symptom Severity
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)
Measured: Baseline, 1-week post-5-week-treatment, 3-month follow-up
Change in Nightmare Severity
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.
Measured: Baseline past week; post-5-week-treatment past week; 3-month follow-up past week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start2 Dec 2019
- Primary completion31 Mar 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for NightmaresStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Participants will be randomly assigned to one of two cognitive-behavioral treatments for sleep and nightmares.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Katherine Elizabeth Miller, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974503
- Sponsor's protocol ID
- MHBB-018-18F
- Other IDs
- IK2CX001874
- Status last verified
- Mar 2026
- First submitted
- 30 May 2019
- Last updated
- 9 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35473648Tighe 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.
PubMed 37917476Miller 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.
PubMed 37532605Miller 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. 2026 Aug;23(3):403-410. doi: 10.1037/ser0000994. Epub 2025 Sep 15.
PubMed 40952699So 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.
PubMed 40932590Miller 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.
PubMed 39950038So 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.
PubMed 38293647Miller 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.
PubMed 37044001Brownlow 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.
PubMed 36171859Brownlow 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.
PubMed 35413357Miller KE, Ross RJ, Harb GC. Lucid Dreams in Veterans With Posttraumatic Stress Disorder Include Nightmares. Dreaming. 2021 Jun;31(2):117-127.
PubMed 37363340Polyne 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.
PubMed 33867309Brownlow 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.
PubMed 33552844Miller 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.
PubMed 31739859Miller 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.
PubMed 31541965
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Sleep With Trauma Nightmares Using Ambulatory Sleep Measurement
- ClinicalTrials.gov ID
- NCT03974503
- Acronym / sponsor ID
- MHBB-018-18F
- Conditions
- Nightmares, Stress Disorders, Post-Traumatic, Actigraphy, Respiratory Sinus Arrhythmia, Veterans
- Keywords
- Nightmares, Cognitive Behavioral Therapy, PTSD, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Posted 9 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two cognitive-behavioral treatments for sleep and nightmares.
| Arm | Type | Receives |
|---|---|---|
| Exposure, Relaxation, and Rescripting Therapy (ERRT) | Experimental | Behavioral: Exposure, Relaxation, and Rescripting TherapyExposure, 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. |
| Sleep and Nightmare Management | Active comparator | Behavioral: Sleep and Nightmare ManagementThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure, Relaxation, and Rescripting TherapyAlso: ERRTERRT is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in trauma-exposed adults. | Behavioural | Exposure, Relaxation, and Rescripting Therapy (ERRT) |
| Sleep and Nightmare ManagementThis is a manualized protocol developed to be of similar length but exclude the active components of standard ERRT. | Behavioural | Sleep and Nightmare Management |
Primary outcome
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.
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.
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).
2 secondary outcomes
Change in Total PTSD Symptom Severity
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35473648Kuhn 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.
- Background: PubMed 37917476Tighe 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.
- Background: PubMed 37532605Miller 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.
- Background: PubMed 40952699Miller 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. 2026 Aug;23(3):403-410. doi: 10.1037/ser0000994. Epub 2025 Sep 15.
- Background: PubMed 40932590So 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.
- Background: PubMed 39950038Miller 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.
- Background: PubMed 38293647So 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.
- Background: PubMed 37044001Miller 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.
- Background: PubMed 36171859Brownlow 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.
- Background: PubMed 35413357Brownlow 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.
- Background: PubMed 37363340Miller KE, Ross RJ, Harb GC. Lucid Dreams in Veterans With Posttraumatic Stress Disorder Include Nightmares. Dreaming. 2021 Jun;31(2):117-127.
- Background: PubMed 33867309Polyne 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Elizabeth Miller, PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure, Relaxation, and Rescripting Therapy and Sleep and Nightmare Management in people with Nightmares and Stress Disorders, Post-Traumatic, run by VA Office of Research and Development 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 9 Apr 2026. 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?
Yes. Results are posted in the registry (first posted 9 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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). The study lists 3 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 NCT03974503, which also lists 15 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 9 Apr 2026.