NCT07196332 · University of North Carolina, Chapel Hill
Recovering Sleep After Trauma
(REST)
What this study is about
The main objective of this pilot trial is to assess the feasibility and preliminary effectiveness of telehealth-delivered behavioral therapy to reduce the development of posttraumatic stress and depressive symptoms following motor vehicle collision among individuals at high risk. This pilot trial will provide the data necessary to design and support a large-scale trial.
View original scientific description
The main objective of this pilot trial is to assess the feasibility and preliminary efficacy of telehealth-delivered behavioral therapy to reduce the development of posttraumatic stress and depressive symptoms following motor vehicle collision among individuals at high risk. This pilot trial will provide the data necessary to design and support a large-scale trial.
Interventions
BEHAVIORAL
Brief Behavioral Treatment for Insomnia (BBTI)
In the first week, treatment consists of a 60-minute video individual intervention session; in the second week, participants receive a 30-minute phone call; in the third week, treatment consists of a 45-minute video individual session; the final session consists of a 30-minute phone call. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of homeostatic and circadian mechanisms of human sleep regulation. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
BEHAVIORAL
Progressive Muscle Relaxation Training (PMRT)
In the first week, treatment consists of a 60-minute video individual intervention session; in the second week, participants receive a 30-minute phone call; in the third week, treatment consists of a 45-minute video individual session; the final session consists of a 30-minute phone call. Treatment begins with learning how to alternately tense and relax 14 major muscle groups, and then to use progressively more efficient tensing-relaxing and passive relaxation exercises, with sessions used to teach techniques and problem-solve barriers to its daily use.
Primary outcome measures
Changes in PTSD Symptom Severity Over Time
Time frame: Baseline, Week 4, Week 8, Month 3
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure designed to assess PTSD symptoms as defined by the Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5). The PCL-5 will be completed in reference to the motor vehicle collision (MVC) that occurred just before enrollment into the study. Each item of the PCL-5 is scored on a five-point scale ranging from 0 ("not at all") to 4 ("extremely"). Items are summed to provide a total severity score (range = 0-80), with higher scores indicating greater symptom severity. PTSD symptom severity will be compared between treatment groups over time.
Recruitment Rates
Time frame: Baseline
To assess the feasibility of the study recruitment protocol, the proportion of eligible participants who enroll in the study and are randomized will be calculated.
Retention Rates
Time frame: Month 3
To assess feasibility of the study protocol, the proportion of participants who complete the study protocol, according to study arm and in total, will be calculated.
Treatment Completion Rates
Time frame: Week 4
To assess feasibility of the treatment protocol, treatment completion rates will be calculated according to the study arm and in total. Treatment completers will be defined as participants who complete at least 3 out of 4 REST or control sessions.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Alert and oriented at time of screening
- Written and spoken English
- Presents to the ED within 72 hours of MVC
- Discharged home after ED evaluation
- Has an email and mailing address
- Owns a smartphone compatible with iOS or Android, has not experienced service interruption due to non-payment in the past year, and has maintained the same phone number for at least one year
- Meets PTSD risk score criteria (score of ≥ 16 on the PTSD risk stratification tool)
- Willing to participate in four remote therapy sessions
Exclusion criteria
- Age \<18 or \>65
- Prisoner or in police custody
- Present to ED \>72 hours after trauma
- Admitted to the hospital after ED evaluation
- Severely injured (e.g., severely broken bones) as a result of the MVC that, in the opinion of the investigator, may impact PTSD trajectories
- Had a change in psychiatric medication or psychotherapy regimen within 1 month of enrollment
- Currently receiving or planning to receive evidence-based treatments that directly target insomnia or PTSD (e.g., CBT-I, Cognitive Processing Therapy, or Prolonged Exposure Therapy)
- MVC was self-inflicted or occupation-related
- Report or indicate that they are experiencing ongoing domestic violence
- Has conditions that may be associated with comorbid insomnia, including a lifetime history of any psychiatric disorder with psychotic features, manic or hypomanic episodes. We will not exclude individuals based on any other mental health condition, including depression
Where
- Chapel Hill, North Carolina
Collaborators
Heart and Armor Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations