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RECRUITING
NCT06374238
NA

Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain

Sponsor: University of Pittsburgh

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

16 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

470

Start Date

2025-03-10

Completion Date

2028-05

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

BEHAVIORAL

CBT+ 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.

BEHAVIORAL

CBT 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.

BEHAVIORAL

Usual 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