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| Name | Class |
|---|---|
| American Academy of Sleep Medicine | OTHER |
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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:
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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Cognitive Behavioral Therapy (CBT) is an evidence-based treatment modality that focuses on modifying maladaptive or unhelpful thoughts and behaviors. |
|
| Sleep Education | Active Comparator | Sleep Education provides general information on human sleep and sleep hygiene guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Pre-Treatment to 1-Week Post-Treatment, 1-Month Post-Treatment, and 3-Months Post-Treatment |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anthony Reffi, PhD | Contact | 3138053080 | areffi1@hfhs.org | |
| Lily Jankowiak, BS | Contact | 3139165179 | ljankow2@hfhs.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital System | Recruiting | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11729023 | Background | 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. | |
| 21344046 | Background |
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|
| 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. |
|
| 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. | From Pre-Treatment to 1-Week Post-Treatment, 1-Month Post-Treatment, and 3-Months Post-Treatment |
| 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. |
| 37322836 | Background | 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. |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003130 | Combat Disorders |
| D014947 | Wounds and Injuries |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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