Nightmare Deconstruction and Reprocessing Pilot

NCT ID: NCT06904950

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-27
• Study Completion Date: 2022-11-30

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.

Conditions

Nightmare

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nightmare Deconstruction and Reprocessing (NDR)

Eight-session exposure-based treatment for posttraumatic nightmares and insomnia.

Group Type: EXPERIMENTAL

Nightmare Deconstruction and Reprocessing

Intervention Type: BEHAVIORAL

Eight-sessions that include 1 session of psychoeducation and treatment orientation and 7 sessions of NDR. NDR consists of three stages: (1) nightmare image deconstruction, (2) meaning making and reprocessing of cognition and emotions related to images, (3) rescripting new dream images and rehearsal of new images.

Interventions

Nightmare Deconstruction and Reprocessing

Eight-sessions that include 1 session of psychoeducation and treatment orientation and 7 sessions of NDR. NDR consists of three stages: (1) nightmare image deconstruction, (2) meaning making and reprocessing of cognition and emotions related to images, (3) rescripting new dream images and rehearsal of new images.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Walter Reed National Military Medical Center

FED

Sponsor Role: collaborator

United States Naval Medical Center, San Diego

FED

Sponsor Role: collaborator

Uniformed Services University of the Health Sciences

FED

Sponsor Role: lead

Responsible Party

Patricia Spangler

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia T Spangler, PhD

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University and Henry M Jackson Foundation

Locations

Naval Medical Center San Diego

San Diego, California, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Countries

United States

Related Links

https://www.cstsonline.org/research/active-research-studies

Description of study

https://redcap.hjf.org/surveys/?s=YEYHM97M4C

Study recruitment survey

https://www.facebook.com/NDRforPTSD

Study Facebook page

Other Identifiers

PSY-88-9157

Identifier Type: -

Identifier Source: org_study_id