PRESENCE

Currently Recruiting: Participants

Study Drug/Intervention: Cognitive-Based Therapy

Anticipated Sample Size: 470 participants

Study Timeline: This study is expected to recruit through August 2027.

Study Website: PRESENCEstudy.org

ClinicalTrials.gov ID: NCT06374238

What is PRESENCE?

PRESENCE aims to determine the effectiveness of digital Cognitive-Based Therapy (CBT) in reducing pain, opioid use, and healthcare utilization among adolescents and young adults (aged 16-30) with Sickle Cell Disease (SCD). It also seeks to understand the role of personalized peer support in enhancing engagement and outcomes of digital CBT interventions.

Study Objective

Recognizing the need for alternative approaches to pain management for persons living with SCD, the study hopes to investigate the effectiveness of digital CBT, both with and without personalized peer support.

Inclusion Criteria

To be eligible to participate in this study, an individual must meet all of the following criteria: 

• Aged 16 to 30 years at the 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 
  • Being prescribed pain medication to be taken (≥4 days/week for the past 3 months or more) OR 
  • Taking pain medication (≥4 days/week for past 3 months or more) 
• Access to an iOS or Android mobile device with internet access

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study: 

• Unable to speak or read English. 
• Currently reside or plan to relocate outside of the United States within the 12-month study time period.  
• Prior hematopoietic stem cell transplant 
• Indicate imminent suicidal risk, which is defined as either answering “yes” to ASQ #5 or being categorized as imminent risk after the safety assessment is conducted by a study Safety Research Coordinators (SRCs).

Adolescents and young adults (AYAs) aged 16-30 years old living in the US who are diagnosed with SCD and who report chronic pain (≥4 days/week for the past 3 months or more)

Study Sites

PRESENCE plans to activate ~16 clinics for enrollment and collaborate with ~5 Community-Based Organizations (CBOs) for referrals to meet the planned sample size of 470. Clinics enrolling participants in this study include:

• CHIC - Lurie Children’s of Chicago
• CONN - CT Children's Medical Center
• CWUH - Rainbow Babies, Case Western
• ECUV - East Carolina University
• EMUH - Emory University
• GRDY - Grady Sickle Cell Clinic
• JHMI - Johns Hopkins University
• MICH - University of Michigan at Ann Arbor
• NYPH - Weill Cornell Medical College
• ROCH - University of Rochester
• RUNJ - Rutgers, The State University of NJ
• UCLA - University of California, Los Angeles
• UOSA - University of South Alabama
• UPIT - University of Pittsburgh (CBO)
• UPIT - University of Pittsburgh (virtual)
• UPMC - Children’s Hospital of Pittsburgh
• VCUH - Virginia Commonwealth University
• WAKE - Wake Forest School of Medicine

Duration of Study Participation

12 months

Participant Follow-Up

Participants will complete health assessments at screening to ensure that they meet eligibility criteria. These assessments will be used as baseline measures and repeated at 3, 6, and 12 months.

Sponsor

University of Pittsburgh

Funding

Funding is provided by NHLBI (for UPitt) and NCATS for the HEAL Resource Centers (HRCs) supporting this study.

Clinical Coordinating Resource Center

Duke Clinical Research Institute

Project Leads: Eilene Pham and Mali Gunawardena

Study Website: PRESENCEstudy.org