N/A
N=48
Understanding Trauma Nightmares Using In-Home Measurement
Nightmares · Stress Disorders, Post-Traumatic · Actigraphy · Respiratory Sinus Arrhythmia · Veterans
Bottom Line
View on ClinicalTrials.gov: NCT03974503 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Actigraphy-derived Sleep Efficiency (SE) Percentage — 74.89; 69.47; 66.67; 71.04 % of time asleep in bed/night
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exposure, Relaxation, and Rescripting Therapy (Behavioral); Sleep and Nightmare Management (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Actigraphy-derived Sleep Efficiency (SE) Percentage |
74.89; 69.47; 66.67; 71.04 | — |
| PRIMARY Actigraphy-derived Respiratory Sinus Arrhythmia (RSA) |
3.85; 2.96; 3.46; 3.15 | — |
| PRIMARY Change in Nightmare Frequency |
3.2; 3.5; 2.9; 2.7; 2.3; 2.5 | — |
| SECONDARY Change in Total PTSD Symptom Severity |
34; 34.4; 26.4; 29.7; 24.6; 28.6 | — |
| SECONDARY Change in Nightmare Severity |
2.4; 2.9; 2.0; 2.3; 2.0; 2.3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03974503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.