18 and older, any sex, with Nightmares or Stress Disorders, Post-Traumatic. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Actigraphy-derived Sleep Efficiency (SE) PercentagePrimary· 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
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
74.89
± 16.34
Sleep and Nightmare Management
69.47
± 19.77
Week from last treatment session to 1 week post-5-week-treatment assessment
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
66.67
± 25.14
Sleep and Nightmare Management
71.04
± 19.1
Actigraphy-derived Respiratory Sinus Arrhythmia (RSA)Primary· 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
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
3.85
± 2.12
Sleep and Nightmare Management
2.96
± 1.53
Week from last treatment session to 1-week post-5-week-treatment assessment
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
3.46
± 2.05
Sleep and Nightmare Management
3.15
± 1.52
Change in Nightmare FrequencyPrimary· 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
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
3.2
2.2 – 4.6
Sleep and Nightmare Management
3.5
2.4 – 5.0
Post-5-week-treatment past week
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
2.9
1.9 – 4.3
Sleep and Nightmare Management
2.7
1.8 – 4.0
3-month follow-up past week
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
2.3
1.5 – 3.6
Sleep and Nightmare Management
2.5
1.7 – 3.8
Change in Total PTSD Symptom SeveritySecondary· 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
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
34
29 – 38.9
Sleep and Nightmare Management
34.4
29.7 – 39.2
1-week post-5-week-treatment
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
26.4
20.5 – 32.3
Sleep and Nightmare Management
29.7
24.3 – 35.2
3 Month Follow-up
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
24.6
17.5 – 31.6
Sleep and Nightmare Management
28.6
22.2 – 34.9
Change in Nightmare SeveritySecondary· 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
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
2.4
2.0 – 2.8
Sleep and Nightmare Management
2.9
2.5 – 3.3
Post-5-week-treatment past week
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
2.0
1.5 – 2.5
Sleep and Nightmare Management
2.3
1.8 – 2.8
3-month follow-up past week
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
2.0
1.3 – 2.6
Sleep and Nightmare Management
2.3
1.7 – 2.9
Home-based Overnight Polysomnography - Apnea-Hypopnea Events Per Hour of SleepSecondary· 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.
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
5.4
± 4.66
Sleep and Nightmare Management
9.06
± 13.4
Change in Global Sleep QualitySecondary· 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
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
13.9
12.3 – 15.5
Sleep and Nightmare Management
14.6
13.1 – 16.1
1-week post-5-week-treatment
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
10.9
8.9 – 12.8
Sleep and Nightmare Management
11.3
8.8 – 13.7
3 Month Follow-up
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
11.3
8.8 – 13.7
Sleep and Nightmare Management
12.3
10.1 – 14.6
Change in Self-report Depression SymptomsSecondary· 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
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
12.3
10 – 14.7
Sleep and Nightmare Management
15.5
13.2 – 17.7
1-week post-5-week-treatment
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
8.3
5.7 – 10.8
Sleep and Nightmare Management
10.7
8.3 – 13.2
3 Month follow-up
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
9.1
5.7 – 10.8
Sleep and Nightmare Management
10.1
7.1 – 13.0
Change in Nightmare EffectsSecondary· 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
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
23.4
19.7 – 27.1
Sleep and Nightmare Management
28.1
24.3 – 31.9
1-week post-5-week-treatment
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
19.7
15.4 – 23.9
Sleep and Nightmare Management
23.2
19.1 – 27.3
3 Month Follow-up
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
16.8
11.2 – 22.3
Sleep and Nightmare Management
22.7
17.6 – 27.8
Change in Fear of SleepSecondary· 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
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
17.0
12.0 – 22.1
Sleep and Nightmare Management
22.1
17.1 – 27.1
1-week post-5-week-treatment
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
11.5
6.4 – 16.7
Sleep and Nightmare Management
19.1
14.2 – 24.1
3 Month Follow-up
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
12.7
6.8 – 18.6
Sleep and Nightmare Management
16.9
11.4 – 22.4
Change in Suicidal IdeationSecondary· 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
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
0.09
± 0.29
Sleep and Nightmare Management
1.05
± 2.11
1-week post-5-week-treatment
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
0
± 0
Sleep and Nightmare Management
0.78
± 2.05
3 month Follow-up
Group
Value
95% CI
Exposure, Relaxation, and Rescripting Therapy (ERRT)
0.07
± 0.27
Sleep and Nightmare Management
0.59
± 1.8
Adverse events — posted to ClinicalTrials.gov
Time frame: From enrollment until the 3 month follow-up.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Exposure, Relaxation, and Rescripting Therapy (ERRT)
Serious: 0/23 (0%)
Deaths: 0/23
Sleep and Nightmare Management
Serious: 0/25 (0%)
Deaths: 0/25
Other adverse events (1 terms — click to expand)
Reaction
System
Exposure, Relaxation, and …
Sleep and Nightmare Manage…
Complaint about the in-home mattress system (odor or electrical issue)
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 9 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03974503.