NCT07121270

Brief 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. 1.Test the acceptability, feasibility, and satisfaction of sleep-focused CBT delivered early after trauma
  2. 2.Evaluate the impact of sleep-focused CBT delivered early after trauma on sleep disturbance
  3. 3.Evaluate the impact of sleep-focused CBT delivered early after trauma on PTSD symptoms

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Mar 2025Aug 2027

Study Start

First participant enrolled

March 17, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

2.4 years

First QC Date

July 21, 2025

Last Update Submit

August 7, 2025

Conditions

InsomniaNightmares Associated With Trauma and StressNightmaresPTSD - Post Traumatic Stress Disorder

Keywords

CBT-INightmaresInsomniaTraumaSleep EducationPTSDCBT-I&NAcute TraumaRCTEarly interventionBehavioral sleep medicinePosttraumatic stressTrauma-induced insomniaCognitive behavioral therapyPrevention

Outcome Measures

Primary Outcomes (4)

  • Session Attendance

    Session attendance (# visits attended/# of total visits) ≥ 65% indicates feasibility

    1-Week Post-Treatment

  • Retention Rate

    Retention rate (# CBT patients who completed ≥ 4 sessions/ # randomized to CBT) ≥ 65% indicates acceptability

    1-Week Post-Treatment

  • Patient Satisfaction

    Patient satisfaction with the CBT treatments will be assessed using the Client Satisfaction Questionnaire. Each item is rated on a 1-4 scale, with higher scores indicating greater satisfaction. Mean scores ≥ 3 indicate satisfaction.

    1-Week Post-Treatment

  • Change in Insomnia Symptoms (Insomnia Severity Index)

    The Insomnia Severity Index (ISI) is a commonly used self-report measure of insomnia symptoms. Scores on the ISI range from 0-28, with a higher score indicating greater insomnia severity.

    From Pre-Treatment to 1-Week Post-Treatment, 1-Month Post-Treatment, and 3-Months Post-Treatment

Secondary Outcomes (2)

  • Change in Nightmare Symptoms (Nightmare Disorder Index)

    From Pre-Treatment to 1-Week Post-Treatment, 1-Month Post-Treatment, and 3-Months Post-Treatment

  • Change in PTSD Symptoms (PTSD Checklist for DSM-5)

    From Pre-Treatment to 1-Week Post-Treatment, 1-Month Post-Treatment, and 3-Months Post-Treatment

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

Cognitive Behavioral Therapy (CBT) is an evidence-based treatment modality that focuses on modifying maladaptive or unhelpful thoughts and behaviors.

Behavioral: Cognitive Behavioral Therapy for InsomniaBehavioral: Cognitive Behavioral Therapy for Insomnia and Nightmares

Sleep Education

ACTIVE COMPARATOR

Sleep Education provides general information on human sleep and sleep hygiene guidelines.

Behavioral: Sleep EducationBehavioral: Sleep Education enhanced with Nightmare Education

Interventions

Cognitive Behavioral Therapy for InsomniaBEHAVIORAL

Cognitive Behavioral Therapy for Insomnia (CBT-I) is delivered via 6 weekly 60-min sessions via telemedicine. CBT-I is a multisession treatment approach that focuses on sleep-specific behaviors and thoughts through various methods.

Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Insomnia and NightmaresBEHAVIORAL

Cognitive Behavioral Therapy for Insomnia and Nightmares (CBT-I\&N) is a combination of CBT for Insomnia (CBT-I) and Exposure, Relaxation, and Rescripting Therapy used for the treatment of nightmares (ERRT). CBT-I\&N is delivered via 6 weekly 60-min sessions via telemedicine and includes the modification of sleep habits, exposure, and progressive muscle relaxation.

Cognitive Behavioral Therapy
Sleep EducationBEHAVIORAL

Sleep education is delivered via telemedicine via 6 weekly 60-min sessions. These sessions will be focused on psychoeducation on sleep after trauma, including common sleep disturbances that may emerge and sleep hygiene guidelines to minimize these disruptions (e.g., wind-down routine, avoid caffeine).

Sleep Education
Sleep Education enhanced with Nightmare EducationBEHAVIORAL

Sleep education enhanced with nightmare education will include all the components of normal sleep education, as described above, in addition to normalizing the experience of nightmares after trauma and providing psychoeducation on nightmares. The treatment is provided over 6 weekly 60-min sessions via telemedicine.

Sleep Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Michigan residents treated at Henry Ford Hospital
  • Fluent in English
  • Age 18 years or older
  • Presenting to ED following exposure to Criterion A trauma (exposure to actual or threatened death, serious injury, or sexual violence) characterized by interpersonal violence (defined as any victimization experience that involved being intentionally and directly harmed by another individual
  • 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

You may not qualify if:

  • 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
  • Active suicidality:
  • Presented to ED with self-inflicted injury or attempted suicide
  • Current suicidal ideation with intent (with or without a specific plan) within past month
  • Suicide attempts during the past three months
  • Current homicidal ideation
  • Active substance withdrawal
  • Pregnant
  • Evidence of a current or past traumatic brain injury or loss of consciousness due to head injury at the time of trauma based on EMR data
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Hospital System

Detroit, Michigan, 48202, United States

RECRUITING

Related Publications (3)

  • Krakow B, Johnston L, Melendrez D, Hollifield M, Warner TD, Chavez-Kennedy D, Herlan MJ. An open-label trial of evidence-based cognitive behavior therapy for nightmares and insomnia in crime victims with PTSD. Am J Psychiatry. 2001 Dec;158(12):2043-7. doi: 10.1176/appi.ajp.158.12.2043.

    PMID: 11729023BACKGROUND

  • Ulmer CS, Edinger JD, Calhoun PS. A multi-component cognitive-behavioral intervention for sleep disturbance in veterans with PTSD: a pilot study. J Clin Sleep Med. 2011 Feb 15;7(1):57-68.

    PMID: 21344046BACKGROUND

  • Taylor DJ, Pruiksma KE, Mintz J, Slavish DC, Wardle-Pinkston S, Dietch JR, Dondanville KA, Young-McCaughan S, Nicholson KL, Litz BT, Keane TM, Peterson AL, Resick PA; Consortium to Alleviate PTSD. Treatment of comorbid sleep disorders and posttraumatic stress disorder in U.S. active duty military personnel: A pilot randomized clinical trial. J Trauma Stress. 2023 Aug;36(4):712-726. doi: 10.1002/jts.22939. Epub 2023 Jun 15.

    PMID: 37322836BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersCombat DisordersWounds and InjuriesStress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Anthony Reffi, PhD

CONTACT

3138053080areffi1@hfhs.org

Lily Jankowiak, BS

CONTACT

3139165179ljankow2@hfhs.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 21, 2025

First Posted

August 13, 2025

Study Start

March 17, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)