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Restorative Early Sleep Treatment After the Emergency Department

ConditionsInsomniaNightmares Associated With Trauma and StressNightmaresPTSD - Post Traumatic Stress Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenry Ford Health System

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cognitive Behavioral Therapy for Insomnia

    Behavioral

    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 for Insomnia and Nightmares

    Behavioral

    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.

  • Sleep Education

    Behavioral

    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 enhanced with Nightmare Education

    Behavioral

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Cognitive Behavioral TherapyExperimental treatment 2 interventions
Group B: Sleep EducationActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Session Attendance

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

Time frame
1-Week Post-Treatment
2

Retention Rate

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

Time frame
1-Week Post-Treatment
3

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.

Time frame
1-Week Post-Treatment
4

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.

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

Secondary outcomes

1

Change in Nightmare Symptoms (Nightmare Disorder Index)

The Nightmare Disorder Index (NDI) is a commonly used self-report measure of nightmare severity. Scores on the NDI range from 0-20, with a higher score indicating greater nightmare disorder severity.

Time frame
From Pre-Treatment to 1-Week Post-Treatment, 1-Month Post-Treatment, and 3-Months Post-Treatment
2

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

The PTSD Checklist for DSM-5 (PCL-5) is a commonly used self-report measure of PTSD severity. Scores on the PCL-5 range from 0-80, with a higher score indicating greater PTSD severity.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henry Ford Health System

Lead sponsor

American Academy of Sleep Medicine

Collaborator

Source ClinicalTrials.gov
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