Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain
PRESENCE
2 other identifiers
interventional
470
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Mar 2025
Longer than P75 for not_applicable pain
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2024
CompletedFirst Posted
Study publicly available on registry
April 18, 2024
CompletedStudy Start
First participant enrolled
March 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
January 7, 2026
September 1, 2025
2.3 years
April 15, 2024
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain intensity for AYAs with SCD and chronic pain
Mean change in pain intensity as measured by the Pain, Enjoyment of Life and General Activity (PEG-3) scale. Item 1 asks individuals to rate their pain, on average, over the past week, using a 0-10 rating scale.
Baseline and 6 months
Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain interference for AYAs with SCD and chronic pain
Mean change in pain interference as measured by the PEG-3 items 2 and 3 that ask individuals to rate how pain has interfered with their enjoyment and general activities, in the past week, using a 0-10 rating scale.
Baseline and 6 months
Secondary Outcomes (6)
Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain intensity for AYAs with SCD and chronic pain
Baseline and 6 months
Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain interference for AYAs with SCD and chronic pain
Baseline and 6 months
Determine the sustained effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs UC to improve pain intensity for AYAs with SCD and chronic pain
Baseline and 12 months
Determine the sustained effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs UC to improve pain interference for AYAs with SCD and chronic pain
Baseline and 12 months
Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain intensity of AYAs with SCD and chronic pain
Baseline and 12 Months
- +1 more secondary outcomes
Study Arms (3)
CBT w/ Health Coach
EXPERIMENTALGroup will utilize the Presence app to undergo self CBT for EMA, but with addition of peer health coaches.
CBT w/o Health coach (self-guided)
ACTIVE COMPARATORGroup will utilize the Presence app to undergo self-guided CBT for EMA, but without peer health coaches.
Usual Care with no access to CBT
ACTIVE COMPARATORParticipants in the UC group will have access to 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
Interventions
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.
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.
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
You may qualify if:
- 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
You may not qualify if:
- Unable to speak or read English
- Prior hematopoietic stem cell transplant for sickle cell disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
University of South Alabama Medical Center
Mobile, Alabama, 36617, United States
UCLA Mattel Children's Hospital Ronald Reagan Hospital
Los Angeles, California, 90095, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30345, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
The Regents of the University of Michigan
Ann Arbor, Michigan, 48109-1079, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07103, United States
Weil Cornell Medical College
New York, New York, 10065, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Wake Forest Baptist Hospital
Durham, North Carolina, 27106, United States
East Carolina University Health Medical Center
Greenville, North Carolina, 27834, United States
UPMC University of Pittsburgh Classical Hematology Adult Clinic
Pittsburgh, Pennsylvania, 15213, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Virginia Commonwealth University
Richmond, Virginia, 23284, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Jonassaint, PhD
University of Pittsburgh
- PRINCIPAL INVESTIGATOR
Ana Radovic, MD
University of Pittsburgh
- PRINCIPAL INVESTIGATOR
Alicia Colvin, PhD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 15, 2024
First Posted
April 18, 2024
Study Start
March 10, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
May 1, 2028
Last Updated
January 7, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share