Digital cognitive behavioral therapy with peer support for young adults with sickle cell pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PRESENCE initiative aims to evaluate the effectiveness of digital cognitive behavioral therapy (CBT) in managing pain for adolescents and young adults with sickle cell disease (SCD). This multisite, randomized controlled trial will involve 470 participants who will be assigned to one of three groups: digital CBT with peer support, self-guided digital CBT, or usual care. The study seeks to understand how personalized peer support can enhance engagement and outcomes in pain management. By leveraging virtual peer support and tailored CBT programs, the study aims to provide insights into alternative pain management strategies for this vulnerable population.

Why it matters

Who can join: the full rules

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

Where it's running

• University of South Alabama Medical Center
  Mobile, Alabama, United States Recruiting
• UCLA Mattel Children's Hospital Ronald Reagan Hospital
  Los Angeles, California, United States Recruiting
• Connecticut Children's Medical Center
  Hartford, Connecticut, United States Recruiting
• Children's Healthcare of Atlanta
  Atlanta, Georgia, United States Recruiting
• Ann and Robert H. Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting
• The Regents of the University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Ana Radovic, MD — University of Pittsburgh
• Study coordinator: Steffi Siebert, MPH
• Email: presencestudy@pitt.edu
• Phone: 877-649-0176

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• Virtual reality options to help with VOC pain in adults with SCD

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.