Post-traumatic Stress DisorderRESTNCT07196332
Recovering Sleep After Trauma
A study testing Brief Behavioral Treatment for Insomnia (BBTI) and Progressive Muscle Relaxation Training (PMRT) in people with Post-traumatic Stress Disorder, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Brief Behavioral Treatment for Insomnia (BBTI) and Progressive Muscle Relaxation Training (PMRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2026to Sep 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
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
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27516
Andrea A Massa, PhD, 919-966-1644, REST@unc.edu
Jenni Shafer, PhD, (919) 966-1644, REST@unc.edu
About this study
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.
Read the detailed description
Each year, more than 40 million Americans present to US emergency departments (EDs) for evaluation after traumatic stress exposure. The overwhelming majority of these individuals are discharged home after evaluation. A wealth of data demonstrates that the development of adverse posttraumatic neuropsychiatric sequelae such as posttraumatic stress disorder (PTSD) is common in this population, and that individuals with a history of traumatic stress exposure and/or posttraumatic stress symptoms-such as military veterans-are at increased risk. Unfortunately, no secondary preventive interventions are currently widely available that can prevent PTSD among those at high risk. This pilot REST trial will assess the ability of brief behavioral treatment for insomnia (BBTI) to reduce the incidence and severity of PTSD and depression after one of the most common traumatic stress exposures in industrialized countries, motor vehicle collision (MVC). BBTI is an evidence-based, low-cost intervention that has been demonstrated to be effective in treating insomnia and reducing PTSD symptoms. However, BBTI has never been tested as a secondary preventive intervention for PTSD and depression. In addition, the efficacy of BBTI when administered as a telehealth intervention has never been assessed. This REST pilot trial will randomize 20 (N=20) individuals who present to a study ED for care after MVC to four sessions of brief behavioral treatment for insomnia (BBTI) versus a progressive muscle relaxation training (PMRT) control. Both interventions will be administered via telehealth, with 10 individuals receiving BBTI and 10 receiving PMRT. Each therapist will administer both interventions. Participants will be assessed via traditional self-report surveys and sleep diaries. Results of this trial will demonstrate the feasibility and potential efficacy of BBTI to prevent the development of PTSD and depression after traumatic stress exposure and will provide the data necessary to design/support a large-scale trial. Developing preventive interventions to reduce PTSD and depression among individuals experiencing civilian trauma exposures would reduce suffering and considerable costs associated with these disorders.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Brief Behavioral Treatment for Insomnia (BBTI), Progressive Muscle Relaxation Training (PMRT)
- Keywords
- Trauma and Stressor Related Disorders, Mental Disorders, Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic, Motor Vehicle Collision
- Medical subject headings
- Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders, Mental Disorders, Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Treatment for Insomnia (BBTI)Behavioural
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.
Progressive Muscle Relaxation Training (PMRT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Brief Behavioral Treatment for Insomnia (BBTI) | Experimental | Four sessions of telehealth-delivered brief behavioral treatment for insomnia Receives: Behavioral: Brief Behavioral Treatment for Insomnia (BBTI) |
| Progressive Muscle Relaxation Training (PMRT) | Active comparator | Four sessions of telehealth-delivered progressive muscle relaxation training Receives: Behavioral: Progressive Muscle Relaxation Training (PMRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 4
Secondary outcomes (3)
Change in Depressive Symptom Score Over Time
The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form 8b is an 8-item scale developed to assess depression in individuals 18 and older. Each item is rated on a five-point scale. For this study, response options are slightly altered for greater consistency across measures and precision in response levels (i.e., 1 = "never" is changed to none of the time and 5 = "always" is changed to "all or almost all of the time."). Items are summed to provide a total severity score (range = 8-40), with higher scores indicating greater severity of depression. Depressive symptom severity will be compared between treatment groups over time.
Measured: Baseline, Week 4, Week 8, Month 3
Change in Somatic Score Symptoms Over Time
Somatic symptoms will be assessed using a modified version of the Pennebaker Inventory of Limbic Languidness (PILL), which assesses the frequency of common physical symptoms and sensations. Each item is scored on a 0-10 scale where 0 indicates no problems. Number of moderate to severe somatic symptoms (scores ≥ 4) will be compared between groups.
Measured: Baseline, Week 4, Week 8, Month 3
Change in Pain Symptom Severity and Extent Over Time
Pain severity and extent will be evaluated using a modified version of the Regional Pain Scale, where each item is scored on a 0-10 numeric rating with 0 indicating no pain and 10 indicating severe pain. Pain symptom severity and extent will be compared between treatment groups over time.
Measured: Baseline, Week 4, Week 8, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start30 Apr 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Armor Foundation
- Responsible party
- Sponsor
- Investigators
- Samuel McLean, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196332
- Sponsor's protocol ID
- 25-1574
- Acronym
- REST
- Status last verified
- Feb 2026
- First submitted
- 19 Sep 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovering Sleep After Trauma
- ClinicalTrials.gov ID
- NCT07196332
- Acronym / sponsor ID
- REST / 25-1574
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- Trauma and Stressor Related Disorders, Mental Disorders, Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic, Motor Vehicle Collision
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Heart and Armor Foundation
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 29 Sep 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 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.
Detailed description
Each year, more than 40 million Americans present to US emergency departments (EDs) for evaluation after traumatic stress exposure. The overwhelming majority of these individuals are discharged home after evaluation. A wealth of data demonstrates that the development of adverse posttraumatic neuropsychiatric sequelae such as posttraumatic stress disorder (PTSD) is common in this population, and that individuals with a history of traumatic stress exposure and/or posttraumatic stress symptoms-such as military veterans-are at increased risk. Unfortunately, no secondary preventive interventions are currently widely available that can prevent PTSD among those at high risk. This pilot REST trial will assess the ability of brief behavioral treatment for insomnia (BBTI) to reduce the incidence and severity of PTSD and depression after one of the most common traumatic stress exposures in industrialized countries, motor vehicle collision (MVC). BBTI is an evidence-based, low-cost intervention that has been demonstrated to be effective in treating insomnia and reducing PTSD symptoms. However, BBTI has never been tested as a secondary preventive intervention for PTSD and depression. In addition, the efficacy of BBTI when administered as a telehealth intervention has never been assessed. This REST pilot trial will randomize 20 (N=20) individuals who present to a study ED for care after MVC to four sessions of brief behavioral treatment for insomnia (BBTI) versus a progressive muscle relaxation training (PMRT) control. Both interventions will be administered via telehealth, with 10 individuals receiving BBTI and 10 receiving PMRT. Each therapist will administer both interventions. Participants will be assessed via traditional self-report surveys and sleep diaries. Results of this trial will demonstrate the feasibility and potential efficacy of BBTI to prevent the development of PTSD and depression after traumatic stress exposure and will provide the data necessary to design/support a large-scale trial. Developing preventive interventions to reduce PTSD and depression among individuals experiencing civilian trauma exposures would reduce suffering and considerable costs associated with these disorders.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Behavioral Treatment for Insomnia (BBTI) | Experimental | Behavioral: Brief Behavioral Treatment for Insomnia (BBTI)Four sessions of telehealth-delivered brief behavioral treatment for insomnia |
| Progressive Muscle Relaxation Training (PMRT) | Active comparator | Behavioral: Progressive Muscle Relaxation Training (PMRT)Four sessions of telehealth-delivered progressive muscle relaxation training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- Age <18 or >65
- Pregnant
- Prisoner or in police custody
- Present to ED >72 hours after trauma
- Admitted to the hospital after ED evaluation
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 |
|---|---|---|
| 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. | Behavioural | Brief Behavioral Treatment for Insomnia (BBTI) |
| 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. | Behavioural | Progressive Muscle Relaxation Training (PMRT) |
Primary outcome
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.
3 secondary outcomes
Change in Depressive Symptom Score Over Time
Time frame: Baseline, Week 4, Week 8, Month 3
Change in Somatic Score Symptoms Over Time
Time frame: Baseline, Week 4, Week 8, Month 3
Change in Pain Symptom Severity and Extent Over Time
Time frame: Baseline, Week 4, Week 8, Month 3
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 4 May 2026.
- Individual participant dataSharing planned: Yes. 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).
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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.
Samuel McLean, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Treatment for Insomnia (BBTI) and Progressive Muscle Relaxation Training (PMRT) in people with Post-traumatic Stress Disorder, run by University of North Carolina, Chapel Hill 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 11 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 4 May 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 Andrea A Massa, PhD ((919) 966-1644, REST@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in PTSD Symptom Severity Over Time (time frame: Baseline, Week 4, Week 8, Month 3). 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?
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 4 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.