University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27516, United States
Location status: Recruiting
Location contact
Andrea A Massa, PhD
CONTACT
Jenni Shafer, PhD
CONTACT
NCT Number: NCT07196332
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Chapel Hill, North Carolina, 27516, United States
Location status: Recruiting
Andrea A Massa, PhD
CONTACT
Jenni Shafer, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
Time frame: Baseline, Week 4, Week 8, Month 3
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.
Time frame: Baseline, Week 4, Week 8, Month 3
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.
Time frame: Baseline, Week 4, Week 8, Month 3
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.
Contact information is provided by the study sponsor or research team.
Andrea A Massa, PhD
CONTACT
Romina Soudavari, MPH
CONTACT
University of North Carolina, Chapel Hill
Other
Acronym: REST
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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