InsomniaRESTEDNCT07121270
Restorative Early Sleep Treatment After the Emergency Department
A study testing Cognitive Behavioral Therapy for Insomnia, Cognitive Behavioral Therapy for Insomnia and Nightmares and Sleep Education in people with Insomnia and Nightmares Associated With Trauma and Stress, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Nightmares Associated With Trauma and Stress, Nightmares
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia, Cognitive Behavioral Therapy for Insomnia and Nightmares and Sleep Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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 cannot join
- 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
Show all 23Show fewer
- 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
- No cell phone, email address, or stable home address
- Evidence or risk of ongoing traumatic exposure (e.g., domestic violence)
- Adults in police custody or Dept of Correction patients
- Evidence of altered mental status, inability to understand study procedures/risks, or otherwise unable to give informed consent
- Admission to an intensive care unit, admission or surgery, medical instability or hemodynamic compromise
- Currently engaged in cognitive behavioral treatment
- Currently living in a nursing home
- Currently working non-standard shifts (outside the hours 7am - 6pm)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Henry Ford Hospital System
Detroit, Michigan, 48202
Anthony Reffi, PhD, 3138053080, areffi1@hfhs.org
Lily Jankowiak, BS, 3139165179, ljankow2@hfhs.org
About this study
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:
Read more
- Test the acceptability, feasibility, and satisfaction of sleep-focused CBT delivered early after trauma
- Evaluate the impact of sleep-focused CBT delivered early after trauma on sleep disturbance
- 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.
Read the detailed description
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).
- Conditions
- Insomnia, Nightmares Associated With Trauma and Stress, Nightmares, PTSD - Post Traumatic Stress Disorder
- Being tested
- Cognitive Behavioral Therapy for Insomnia, Cognitive Behavioral Therapy for Insomnia and Nightmares, Sleep Education, Sleep Education enhanced with Nightmare Education
- Keywords
- CBT-I, Nightmares, Insomnia, Trauma, Sleep Education, PTSD, CBT-I&N, Acute Trauma, RCT, Early intervention, Behavioral sleep medicine, Posttraumatic stress, Trauma-induced insomnia, Cognitive behavioral therapy, Prevention
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Combat Disorders, Wounds and Injuries, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
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 NightmaresBehavioural
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 EducationBehavioural
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 EducationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Cognitive Behavioral Therapy (CBT) is an evidence-based treatment modality that focuses on modifying maladaptive or unhelpful thoughts and behaviors. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: Cognitive Behavioral Therapy for Insomnia and Nightmares |
| Sleep Education | Active comparator | Sleep Education provides general information on human sleep and sleep hygiene guidelines. Receives: Behavioral: Sleep Education; Behavioral: Sleep Education enhanced with Nightmare Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Session Attendance
Session attendance (# visits attended/# of total visits) ≥ 65% indicates feasibility
Measured: 1-Week Post-Treatment
Retention Rate
Retention rate (# CBT patients who completed ≥ 4 sessions/ # randomized to CBT) ≥ 65% indicates acceptability
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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)
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.
Measured: From Pre-Treatment to 1-Week Post-Treatment, 1-Month Post-Treatment, and 3-Months Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start17 Mar 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Responsible party
- Principal investigator, Anthony Reffi, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121270
- Sponsor's protocol ID
- 17553-01
- Acronym
- RESTED
- Status last verified
- Nov 2026
- First submitted
- 21 Jul 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11729023Ulmer 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.
PubMed 21344046Taylor 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.
PubMed 37322836
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restorative Early Sleep Treatment After the Emergency Department
- ClinicalTrials.gov ID
- NCT07121270
- Acronym / sponsor ID
- RESTED / 17553-01
- Conditions
- Insomnia, Nightmares Associated With Trauma and Stress, Nightmares, PTSD - Post Traumatic Stress Disorder
- Keywords
- CBT-I, Nightmares, Insomnia, Trauma, Sleep Education, PTSD, CBT-I&N, Acute Trauma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Test the acceptability, feasibility, and satisfaction of sleep-focused CBT delivered early after trauma
- Evaluate the impact of sleep-focused CBT delivered early after trauma on sleep disturbance
- 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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia, Behavioral: Cognitive Behavioral Therapy for Insomnia and NightmaresCognitive Behavioral Therapy (CBT) is an evidence-based treatment modality that focuses on modifying maladaptive or unhelpful thoughts and behaviors. |
| Sleep Education | Active comparator | Behavioral: Sleep Education, Behavioral: Sleep Education enhanced with Nightmare EducationSleep Education provides general information on human sleep and sleep hygiene guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for InsomniaCognitive 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. | Behavioural | Cognitive Behavioral Therapy |
| Cognitive Behavioral Therapy for Insomnia and NightmaresCognitive 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. | Behavioural | Cognitive Behavioral Therapy |
| Sleep EducationSleep 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). | Behavioural | Sleep Education |
| Sleep Education enhanced with Nightmare EducationSleep 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. | Behavioural | Sleep Education |
Primary outcome
Session Attendance
Time frame: 1-Week Post-Treatment
Session attendance (# visits attended/# of total visits) ≥ 65% indicates feasibility
Retention Rate
Time frame: 1-Week Post-Treatment
Retention rate (# CBT patients who completed ≥ 4 sessions/ # randomized to CBT) ≥ 65% indicates acceptability
Patient Satisfaction
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.
Change in Insomnia Symptoms (Insomnia Severity Index)
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.
2 secondary outcomes
Change in Nightmare Symptoms (Nightmare Disorder Index)
Time frame: 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)
Time frame: From Pre-Treatment to 1-Week Post-Treatment, 1-Month Post-Treatment, and 3-Months Post-Treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 11729023Krakow 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.
- Background: PubMed 21344046Ulmer 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.
- Background: PubMed 37322836Taylor 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia, Cognitive Behavioral Therapy for Insomnia and Nightmares and Sleep Education in people with Insomnia and Nightmares Associated With Trauma and Stress, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony Reffi, PhD (3138053080, areffi1@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Session Attendance (time frame: 1-Week Post-Treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07121270, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.