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Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain

Study acronym: PRESENCE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Jul 2027 → Feb 2028
Enrollment reduced 17% 470 → 390 participants
See other at-risk trials from University of Pittsburgh

Record History

  1. Primary completion pushed from Jul 2027 to Feb 2028 Enrollment reduced: 470 → 390 participants · Completion pushed from May 2028 to Aug 2028 · Interventions: CBT w/o Health Coach ( self-guided) (Behavioral), CBT+ Health coach (Behavioral), Usual Care (Behavioral) to CBT w/o Health Coach ( self-guided) (Behavioral), CBT+ Health coach (Behavioral), Usual Care (Behavioral) · 4 more Show 7 more changesShow less
    • Enrollment reduced: 470 → 390 participants
    • Completion pushed from May 2028 to Aug 2028
    • Interventions: CBT w/o Health Coach ( self-guided) (Behavioral), CBT+ Health coach (Behavioral), Usual Care (Behavioral) to CBT w/o Health Coach ( self-guided) (Behavioral), CBT+ Health coach (Behavioral), Usual Care (Behavioral)
    • Eligibility criteria expanded, about 21 words
    • Study description expanded, about 8 words
    • Site details revised at 6 of 14 sites
    • Publications: details revised at 1 of 1 entry
  2. Study sites: 13 to 14v11
  3. Study sites: 12 to 13v10
  4. Study sites: 10 to 12v9
  5. Study sites: 8 to 10v8
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 3 to 8v7
  2. Study sites: 1 to 3 Primary completion date: Dec 2027 to Jul 2027 · Start date changed from estimate of Mar 2025 to Mar 10, 2025v6 Show 2 more changesShow less
    • Primary completion date: Dec 2027 to Jul 2027
    • Start date changed from estimate of Mar 2025 to Mar 10, 2025
  3. Trial status: Not Yet Recruiting to Recruiting Site details revisedv5 Show 1 more changeShow less
    • Site details revised
  4. Study sites: 0 to 1 Start date: Feb 2025 to Mar 2025v4 Show 1 more changeShow less
    • Start date: Feb 2025 to Mar 2025
  5. Start date: Jan 2025 to Feb 2025v3
  6. Start date: Aug 2024 to Jan 2025v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. It also seeks to understand the role of personalized peer support in enhancing engagement and outcomes of digital CBT interventions. By leveraging existing infrastructure for delivering virtual peer support interventions, tailored digital CBT programs for individuals with SCD, and partnerships with CBOs, the study aims to provide valuable insights into the feasibility and effectiveness of digital CBT as a pain management strategy for this vulnerable population.
Trial Details
NCT Number NCT06374238
Lead Sponsor University of Pittsburgh
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Pain, Sickle Cell Disease
Enrollment 390 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov