RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Cognitive Behavioral Therapy for Insomnia for Insomnia

The goal of this randomly assigned 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. Test the acceptability, feasibility, and satisfaction of sleep-focused CBT delivered early after trauma 2.

Official registry: https://clinicaltrials.gov/study/NCT07121270 · Henry Ford Health System · enrollment listed as 80

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Cognitive Behavioral Therapy for Insomnia, Cognitive Behavioral Therapy for Insomnia and Nightmares, or Sleep Education. The registry lists allocation as randomized. The goal of this randomly assigned 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.

They plan to enroll about 80 people at Detroit. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

Restorative Early Sleep Treatment After the Emergency Department

Interventions: Cognitive Behavioral Therapy for Insomnia, Cognitive Behavioral Therapy for Insomnia and Nightmares, Sleep Education, Sleep Education enhanced with Nightmare Education

Primary outcome (registry wording): Session Attendance

Who it is for (from inclusion criteria)

Ages 18 Years to any
Michigan residents treated at Henry Ford Hospital
Age 18 years or older
i.e., assault with a weapon, physical assault, or sexual assault
Qualifying trauma occurred within the past \~72hr
Hospital Mental Health Risk Screen score ≥ 10 (indicating at-risk for developing mental health problems)
Patient is not in any other cognitive behavioral treatment with a master's level clinician or above
Patient is appropriate for outpatient treatment and level of acuity does not require inpatient treatment

Who the registry excludes

Presenting to ED for non-interpersonal trauma
Defined as any experience that does not involve being intentionally and directly harmed by another individual
i.e., falls, motor vehicle collisions, self-injury or suicide attempt
Current or past history of schizophrenia or other psychoses based on EMR data
Current or past PTSD based on EMR data
Unmanaged mania or bipolar disorder based on EMR data
Active, untreated substance use disorder based on EMR data other than alcohol use disorder, cannabis use disorder, nicotine use disorder, or tobacco use disorder

Public study contact (from the registry)

Anthony Reffi, PhD

3138053080

areffi1@hfhs.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Henry Ford Hospital System — Detroit, Michigan (recruiting)

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FAQ about this NCT record

Is NCT07121270 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07121270?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07121270?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary