Henry Ford Hospital System
Detroit, Michigan, 48202, United States
Location status: Recruiting
Location contact
Anthony Reffi, PhD
CONTACT
Anthony Reffi, PhD
PRINCIPAL_INVESTIGATOR
Lily Jankowiak, BS
CONTACT
NCT Number: NCT07121270
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Detroit, Michigan, 48202, United States
Location status: Recruiting
Anthony Reffi, PhD
CONTACT
Anthony Reffi, PhD
PRINCIPAL_INVESTIGATOR
Lily Jankowiak, BS
CONTACT
Participants will be patients who present to Henry Ford Hospital's Emergency Department within >72hr following a potential trauma.
Eligible patients will be randomized (1:1) to the active treatment condition (CBT-I or CBT-I&N) or to the control condition (sleep education with or without nightmare education).
Patients with insomnia and comorbid nightmares who are randomized to the active treatment condition will be triaged to CBT-I&N, whereas patients with insomnia and comorbid nightmares who are randomized to the control condition will be triaged to receive sleep education + nightmare education. All other patients with insomnia only will be triaged to receive either CBT-I (active) or sleep education (control).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 (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 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 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.
Time frame: 1-Week Post-Treatment
Session attendance (# visits attended/# of total visits) ≥ 65% indicates feasibility
Time frame: 1-Week Post-Treatment
Retention rate (# CBT patients who completed ≥ 4 sessions/ # randomized to CBT) ≥ 65% indicates acceptability
Time frame: 1-Week Post-Treatment
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: From Pre-Treatment to 1-Week Post-Treatment, 1-Month Post-Treatment, and 3-Months Post-Treatment
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
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
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.
Contact information is provided by the study sponsor or research team.
Anthony Reffi, PhD
CONTACT
Lily Jankowiak, BS
CONTACT
Henry Ford Health System
Other
Acronym: RESTED
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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