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RECRUITING Not applicable ClinicalTrials.gov

Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain

Sponsor: University of Pittsburgh • ClinicalTrials.gov ID: NCT06374238

Registry updated: 2026-10-08
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Description

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.

Interventions

  • CBT+ Health coach (Behavioral)
    Participants will complete the pre-enrollment clinical screening measures (PHQ-9M, GAD-7, and PEG-3) and will repeat those assessments, as well as outcome assessments, at 3 months, 6 months, and 12 months. Participants in CBT w/ Health coach group will engage with the CaRISMA app to complete a daily pain and mood e-diary, daily record of opiate use, and weekly assessment of pain via the Painimation tool. In addition participants will have weekly contact with a peer health coach.
  • CBT w/o Health Coach ( self-guided) (Behavioral)
    Participants will complete the pre-enrollment clinical screening measures (PHQ-9M, GAD-7, and PEG-3) and will repeat those assessments, as well as outcome assessments, at 3 months, 6 months, and 12 months. Participants CBT w/o Health coach groups will engage with the CaRISMA app to complete a daily pain and mood e-diary, daily record of opiate use, and weekly assessment of pain via the Painimation tool.
  • Usual Care (Behavioral)
    Participants will complete the pre-enrollment clinical screening measures (PHQ-9M, GAD-7, and PEG-3) and will repeat those assessments, as well as outcome assessments, at 3 months, 6 months, and 12 months. Participants in the UC group will be asked to engage with the CaRISMA app to complete a daily pain and mood e-diary, daily record of opiate use, and weekly assessment of pain via the Painimation tool. All other care will be at the discretion of their treating provider

Eligibility criteria

Inclusion Criteria: 1. Aged 16 to 39 years of age at time of enrollment 2. Sickle Cell Disease diagnosis of any genotype based on referral or documentation 3. Reports chronic pain (≥4 days/week for past 3 months or more) OR A) Being prescribed pain medication to be taken (≥4 days/week for past 3 months or more) OR B) Taking pain medication (≥4 days/week for past 3 months or more) OR C) Receiving non-pharmaceutical pain treatment (≥4 days/week for past 3 months or more) 4. Access to an iOS or Android mobile device with internet access Exclusion Criteria: 1. Unable to speak or read English 2. Prior hematopoietic stem cell transplant for sickle cell disease 3. Not living in the United States throughout enrollment and duration of the study period

Conditions

Pain Sickle Cell Disease

Locations

  • University of South Alabama Medical Center — Mobile, Alabama, United States
  • UCLA Mattel Children's Hospital Ronald Reagan Hospital — Los Angeles, California, United States
  • Connecticut Children's Medical Center — Hartford, Connecticut, United States
  • Children's Healthcare of Atlanta — Atlanta, Georgia, United States
  • Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
  • The Regents of the University of Michigan — Ann Arbor, Michigan, United States
  • Rutgers New Jersey Medical School — Newark, New Jersey, United States
  • Weil Cornell Medical College — New York, New York, United States
  • University of Rochester Medical Center — Rochester, New York, United States
  • Wake Forest Baptist Hospital — Durham, North Carolina, United States
  • East Carolina University Health Medical Center — Greenville, North Carolina, United States
  • UPMC University of Pittsburgh Classical Hematology Adult Clinic — Pittsburgh, Pennsylvania, United States
  • UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
  • Virginia Commonwealth University — Richmond, Virginia, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record