RECRUITING

Nightmare Deconstruction and Reprocessing vs. NightWare Wristband

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The overall goal of this Phase IIa randomized controlled pilot trial is to assess the potential efficacy of two emerging treatments for post-trauma nightmares and to test the feasibility of study design and methods. Symptom change will be assessed in two treatment arms: (1) Nightmare Deconstruction and Reprocessing (NDR), an exposure-based psychotherapy; and (2) NightWare (NW), a non-exposure approach using a wristband device. The investigators will also assess the feasibility of circadian-dependent blood sampling and use of another wristband to collect physiologic data. Specific aims are: (1) Compare evidence of how well participants tolerate and comply with the two treatments and test feasibility of methods and procedures; (2) Collect additional evidence of the potential efficacy of two contrasting non-pharmacologic approaches to treating posttraumatic nightmares; (3) Explore the operational stress index (OSI) as a reliable, objective measure of sleep disturbance and nightmare events.

Official Title

Pilot Trial Comparing Exposure and Nonexposure Treatments for Posttrauma Nightmares and Insomnia: Nightmare Deconstruction and Reprocessing vs. NightWare Wristband

Quick Facts

Study Start:2024-06-11
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06399874

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Active duty service members and veterans
  2. * Minimum symptom severity:
  3. * Has had at least 1 nightmare per week for the past month
  4. * Has a minimum ISI score of 8
  5. * If taking medications for PTSD, depression, anxiety, or insomnia, must be on stable dose for 8 weeks.
  1. * Serious risk of suicide
  2. * Psychosis, bipolar disorder, or alcohol or substance use disorder
  3. * Untreated moderate to severe sleep apnea
  4. * Use of synthetic glucocorticoid beta blockers, prazosin, or varenicline
  5. * Current evidence-based or experimental psychotherapy directly targeting nightmares, insomnia, or PTSD
  6. * Inability to recall nightmare content
  7. * Inability to wear wristband or sync wristband data
  8. * Inability to comply with blood draws
  9. * Refusal to consent to DNA analysis of blood samples
  10. * Refusal to consent to audio recording of study visits
  11. * REM sleep behavior disorder or narcolepsy as determined by investigator

Contacts and Locations

Study Contact

Patricia Spangler, PhD
CONTACT
240-620-4076
patricia.spangler.ctr@usuhs.edu

Principal Investigator

James C West, MD
PRINCIPAL_INVESTIGATOR
Uniformed Services University of the Health Sciences

Study Locations (Sites)

Uniformed Services University of the Health Sciences
Bethesda, Maryland, 20814
United States

Collaborators and Investigators

Sponsor: Uniformed Services University of the Health Sciences

  • James C West, MD, PRINCIPAL_INVESTIGATOR, Uniformed Services University of the Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-11
Study Completion Date2026-03

Study Record Updates

Study Start Date2024-06-11
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • Nightmares
  • Insomnia
  • PTSD
  • Heart Rate Variability
  • Electrodermal Activity
  • BDNF
  • Cortisol
  • ACTH
  • Treatment

Additional Relevant MeSH Terms

  • Nightmare