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 CBT+ Health coach, CBT w/o Health Coach ( self-guided), or Usual Care. The registry lists allocation as randomized. The study, known as the Peer suppoRt for adolescents and Emerging adults with Sickle cell pain: promoting ENgagement in Cognitive behavioral thErapy (PRESENCE), aims to determine the effectiveness of digital CBT in reducing pain, opioid use, and healthcare utilization among AYAs with SCD.
They plan to enroll about 390 people at 14 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.
Official title (unrewritten)
Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain: Promoting Engagement in Cognitive Behavioral Therapy
Interventions: CBT+ Health coach, CBT w/o Health Coach ( self-guided), Usual Care
Primary outcome (registry wording): Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain intensity for AYAs with SCD and chronic pain