RecruitingNot ApplicableNCT06374238

Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain

Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain: Promoting Engagement in Cognitive Behavioral Therapy


Sponsor

University of Pittsburgh

Enrollment

470 participants

Start Date

Mar 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 16 YearsMax Age: 30 Years

Inclusion Criteria4

  • Aged 16 to 30 years of age at time of enrollment
  • Sickle Cell Disease diagnosis of any genotype based on referral or documentation
  • 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)
  • Access to an iOS or Android mobile device with internet access

Exclusion Criteria2

  • Unable to speak or read English
  • Prior hematopoietic stem cell transplant for sickle cell disease

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Interventions

BEHAVIORALCBT+ Health coach

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.

BEHAVIORALCBT w/o Health Coach ( self-guided)

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.

BEHAVIORALUsual Care

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


Locations(14)

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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NCT06374238


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