What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Brief Behavioral Treatment for Insomnia (BBTI), or Progressive Muscle Relaxation Training (PMRT). The registry lists allocation as randomized. The main objective of this pilot trial is to assess the feasibility and preliminary how well it works of telehealth-delivered behavioral therapy to reduce the development of posttraumatic stress and depressive symptoms following motor vehicle collision among individuals at high risk.
They plan to enroll about 20 people at Chapel Hill. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
Recovering Sleep After Trauma
Interventions: Brief Behavioral Treatment for Insomnia (BBTI), Progressive Muscle Relaxation Training (PMRT)
Primary outcome (registry wording): Changes in PTSD Symptom Severity Over Time