Recovering Sleep After Trauma
REST
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2025
CompletedFirst Posted
Study publicly available on registry
September 29, 2025
CompletedStudy Start
First participant enrolled
April 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
May 4, 2026
February 1, 2026
4 months
September 19, 2025
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Changes in PTSD Symptom Severity Over Time
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.
Baseline, Week 4, Week 8, Month 3
Recruitment Rates
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.
Baseline
Retention Rates
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.
Month 3
Treatment Completion Rates
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.
Week 4
Secondary Outcomes (3)
Change in Depressive Symptom Score Over Time
Baseline, Week 4, Week 8, Month 3
Change in Somatic Score Symptoms Over Time
Baseline, Week 4, Week 8, Month 3
Change in Pain Symptom Severity and Extent Over Time
Baseline, Week 4, Week 8, Month 3
Study Arms (2)
Brief Behavioral Treatment for Insomnia (BBTI)
EXPERIMENTALFour sessions of telehealth-delivered brief behavioral treatment for insomnia
Progressive Muscle Relaxation Training (PMRT)
ACTIVE COMPARATORFour sessions of telehealth-delivered progressive muscle relaxation training
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Alert and oriented at time of screening
- Written and spoken English
- Age 18-65
- 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
You may not qualify if:
- Age \<18 or \>65
- Pregnant
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27516, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel McLean, MD, MPH
University of North Carolina, Chapel Hill
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2025
First Posted
September 29, 2025
Study Start
April 30, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
May 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Beginning 12 months following publication and continuing for 36 months.
- Access Criteria
- Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Deidentified individual data that supports the results will be shared on request provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).