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RECRUITING NA

Restorative Early Sleep Treatment After the Emergency Department

NCT07121270 · View on ClinicalTrials.gov ↗

Study Summary

The goal of this randomized controlled trial is to pilot the virtual delivery of cognitive behavioral therapy for insomnia (CBT-I) and nightmares (CBT-I\&N) via telehealth as an early intervention for treating posttraumatic sleep disturbance in acute trauma patients exposed to interpersonal violence. The main aims are to: 1. Test the acceptability, feasibility, and satisfaction of sleep-focused CBT delivered early after trauma 2. Evaluate the impact of sleep-focused CBT delivered early after trauma on sleep disturbance 3. Evaluate the impact of sleep-focused CBT delivered early after trauma on PTSD symptoms The investigators will compare CBT-I and CBT-I\&N to sleep education control. Participants will meet with a provider for 6 weekly sessions via telehealth and complete surveys on the participants' symptoms.

Interventions

  • BEHAVIORAL Cognitive Behavioral Therapy for Insomnia
  • BEHAVIORAL Cognitive Behavioral Therapy for Insomnia and Nightmares
  • BEHAVIORAL Sleep Education
  • BEHAVIORAL Sleep Education enhanced with Nightmare Education

Study Locations (1)

Michigan

  • Henry Ford Hospital System — Detroit

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2025-03-17
Est. Completion 2027-08
Phase NA

Sponsor

Henry Ford Health System

171 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07121270

The ClinicalTrials.gov registry entry for NCT07121270 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Henry Ford Health System, which has 171 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Insomnia appearing as the primary indexed condition, and to 4 interventions — of which Cognitive Behavioral Therapy for Insomnia is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07121270 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07121270 about?

NCT07121270 is a clinical study titled "Restorative Early Sleep Treatment After the Emergency Department". The goal of this randomized controlled trial is to pilot the virtual delivery of cognitive behavioral therapy for insomnia (CBT-I) and nightmares (CBT-I\&N) via telehealth as an early intervention for treating posttraumatic sleep disturbance in acute trauma patients exposed to interpersonal violence...

What is the current status of trial NCT07121270?

This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2025-03-17. Estimated completion is 2027-08.

What conditions does trial NCT07121270 study?

This clinical trial studies the following conditions: Insomnia, PTSD - Post Traumatic Stress Disorder, Nightmares, Nightmares Associated With Trauma and Stress. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07121270?

The interventions under investigation include: Cognitive Behavioral Therapy for Insomnia (BEHAVIORAL), Cognitive Behavioral Therapy for Insomnia and Nightmares (BEHAVIORAL), Sleep Education (BEHAVIORAL), Sleep Education enhanced with Nightmare Education (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07121270?

This trial is sponsored by Henry Ford Health System, which has 171 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07121270 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial