Restorative Early Sleep Treatment After the Emergency Department

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT07121270
Status
Recruiting
Apply to this trial

Conditions

  • Insomnia
  • Nightmares
  • Nightmares Associated With Trauma and Stress
  • PTSD - Post Traumatic Stress Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 17, 2025
Status verified
Aug 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cognitive Behavioral Therapy
    Cognitive Behavioral Therapy (CBT) is an evidence-based treatment modality that focuses on modifying maladaptive or unhelpful thoughts and behaviors.
  • Active Comparator: Sleep Education
    Sleep Education provides general information on human sleep and sleep hygiene guidelines.

Primary Outcome Measure

Session Attendance [ Time Frame: 1-Week Post-Treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford Hospital SystemDetroitMichigan48202
Anthony Reffi, PhD
[email protected]
313-805-3080
Lily Jankowiak, BS
[email protected]
3139165179
Anthony Reffi, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Detroit, MI

By condition
Insomnia
By specialty
Mental healthSleep medicine
By research site
Henry Ford Hospital System· Detroit, MI

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