Clinical trial NCT06904950: Nightmare Deconstruction and Reprocessing Pilot
Official title: Pilot Trial of Nightmare Deconstruction and Reprocessing, a Novel Treatment for PTSD-Related Nightmares and Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nightmare
Keywords: Nightmares
Sleep disturbance
Posttraumatic
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
Collaborators: name: Walter Reed National Military Medical Center
name: United States Naval Medical Center, San Diego
First posted: 2025-04-01
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Single-arm pilot trial
Primary purpose: TREATMENT

Brief summary: This is a single-arm, multisite (2 sites) pilot trial that is evaluating Nightmare Deconstruction and Reprocessing (NDR) for treating posttraumatic nightmares and insomnia in up to 30 military service members and veterans. Study aims are to test NDR's plausibility and tolerability and to test methodologic feasibility of collecting heart rate variability (HRV), electrodermal activity (EDA), and actigraphy data via a wristband device and peripheral blood samples within a pre-specified circadian window. Treatment consists of 8 sessions over 8 weeks. Participants are assessed at study visits 0, 1, and 7 and 1-month follow-up. Psychometric assessments include the Disturbing Dreams and Nightmare Severity Index, Pittsburgh Sleep Quality Index, and Clinician-Administered PTSD Scale for DSM-5.

Detailed description: The current study is testing NDR, a three-stage treatment that integrates exposure, reprocessing, and rescripting of nightmare images to alleviate nightmare and insomnia severity. Study aims are to test NDR's plausibility and tolerability and to test the methodologic feasibility of collecting daily HRV, EDA, and actigraphy data via the E4 wristband as well as peripheral blood samples for assay at three time points. Participants are active duty military or veterans (N = 30) ages 18 to 64 with posttraumatic nightmares and insomnia. Participants undergo 8 NDR treatment visits over 8 weeks and complete a 1-month follow-up. Psychometric measures of nightmare (Disturbing Dreams and Nightmare Severity Index) and insomnia (Pittsburgh Sleep Quality Index) are administered at each visit. Objective measurement of sleep disturbance is done via the Empatica E4 wristband. In-session distress is measured using the 1-item Subjective Units of Distress Scale (SUDS), and E4 HRV and EDA data during exposure to nightmare images. BDNF, IL-2, IL-6, and TNF alpha are being assayed from blood samples taken immediately after Visit 0 (baseline), Visit 1 (first in-session exposure to nightmare images), and Visit 7 (final in-session exposure to nightmares). To control for circadian factors regulating the expression of BDNF and inflammatory cytokines, all blood samples are collected between 0900 and 1200.

Eligibility criteria: Inclusion Criteria:

* Active duty servicemembers and DEERS-eligible veterans
* DDNSI score ≥ 10
* PSQI score \> 5

Exclusion Criteria:

* Current imminent risk of suicide
* Psychotic or bipolar disorders
* Untreated moderate to severe sleep apnea/hypopnea, circadian rhythm disorders, or narcolepsy
* Current use of prazosin for nightmares
* Self-reported alcohol use \> 4x/ week and \> 3 drinks per occasion
* Concurrent evidence-based or experimental treatment directly targeting nightmares, insomnia, or PTSD
* Initiation of or change in psychotropic medications for PTSD, nightmares, insomnia, depression, or anxiety in the past 8 weeks
* Inability to recall nightmare content
* Inability to comply with requirement to wear E4 wristband and upload daily

Primary outcomes:
measure: Disturbing Dream and Nightmare Severity Index (DDNSI)
timeFrame: Up to16 weeks, starting with screening, then weekly through the treatment period (8 weeks), and at follow-up (1 month)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Up to16 weeks, starting with screening, then weekly through the treatment period (8 weeks), and at follow-up (1 month)
Secondary outcomes:
measure: Clinician-Administered PSTD Scale for DSM-5 (CAPS-5)
timeFrame: Up to16 weeks, starting with screening, then at the end of the treatment period (8 weeks), and at follow-up (1 month).
Other outcomes:
measure: In-Session Heart Rate (HR)
timeFrame: Approximately 10 weeks, data collected continuously (23 hours per day) during the treatment period (8 weeks) and 2 weeks into the follow-up period.
measure: In-session Electrodermal Activity (EDA)
timeFrame: Approximately 10 weeks, data collected continuously (23 hours per day) during the treatment period (8 weeks) and 2 weeks into the follow-up period.
measure: Brain-derived neurotropic factor (BDNF)
timeFrame: 8 weeks: blood samples taken immediately after Visit 0 and Visit 1 (week 1) and immediately after Visit 7 (week 8)
measure: Inflammatory cytokines
timeFrame: 8 weeks: blood samples taken immediately after Visit 0 and Visit 1 (week 1) and immediately after Visit 7 (week 8)
measure: Sleep Actigraphy Data
timeFrame: Approximately 10 weeks, data collected continuously (23 hours per day) during the treatment period (8 weeks) and 2 weeks into the follow-up period.
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Uniformed Services University and Henry M Jackson Foundation
name: Patricia T Spangler, PhD
role: PRINCIPAL_INVESTIGATOR
References: