Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain
NCT ID: NCT06374238
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
470 participants
INTERVENTIONAL
2025-03-10
2028-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Recognizing the need for alternative approaches, the study hopes to investigate the effectiveness of digital cognitive behavioral therapy (CBT), both with and without personalized peer support delivered through community-based organizations (CBOs). CBT is a well-established method for managing pain in the general population, and digital CBT has shown promise in improving outcomes for individuals with chronic conditions.
The study will involve a multisite, randomized controlled trial with 470 AYAs with SCD who have experienced frequent pain over the past three months. Participants will be randomized into one of three groups:
1. Digital CBT with weekly one-on-one peer support (CBT+peer)
2. Digital CBT without peer support (self-guided CBT)
3. Usual care (UC)
The primary hypotheses of the study are:
Hypothesis 1. AYAs receiving any digital CBT (CBT + peer or self-guided CBT) will have greater improvements in primary pain outcomes (PEG-3 pain intensity and pain interference), and larger decreases in secondary pain outcomes (mean daily pain intensity, pain days, average weekly opioid dose, emergency department visits, hospitalizations) and in psychological outcomes (MoSCS internalized stigma, SCSES sickle cell self-efficacy, PHQ-9M depression, GAD-7 anxiety) than AYAs receiving UC at 6 months post initiation of intervention.
Hypothesis 2. AYAs receiving CBT + peer will have greater improvements in the primary and secondary outcomes described above at 6 months, and greater app engagement, than AYAs receiving self-guided CBT.
This study will have the following assessment time points.
* Baseline = pre-randomization baseline measures
o Rescreen if SCD verification is not provided within 30 days
* At Randomization = Pain and mood diary using Ecological Momentary Assessment (EMA) assessed daily for a total of 14 days with the first entry occuring immediately prior to randomization/intervention start and then continuing daily post-randomization
* 3-month = end of intervention period assessment 90 days (3 months) post -randomization
* 6-month = primary endpoint 180 days (6 months) post-randomization
* 12-month = long-term endpoint 365 days (12 months) post-randomization
The study intervention and EMA data collection is performed via an iOS and Android application called CaRISMA that will be called "the app" or the "CaRISMA app" hereafter.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CBT w/ Health Coach
Group will utilize the Presence app to undergo self CBT for EMA, but with addition of peer health coaches.
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.
CBT w/o Health coach (self-guided)
Group will utilize the Presence app to undergo self-guided CBT for EMA, but without peer health coaches.
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.
Usual Care with no access to CBT
Participants 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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
2. Prior hematopoietic stem cell transplant for sickle cell disease
16 Years
30 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Pittsburgh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Charles Jonassaint
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Charles Jonassaint, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Ana Radovic, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Alicia Colvin, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jessica King
Role: primary
T'Shemika Perryman
Role: backup
Debbie Argueta Rufino
Role: primary
Christopher Theriault
Role: primary
Katyria Thornton
Role: primary
Vontarius Howard Jesse
Role: backup
Kevin Guerrero
Role: primary
Anela Mukherjee
Role: primary
Kim White
Role: primary
Masiel Infante
Role: primary
Priya Kaushal
Role: primary
Julie Fountain
Role: primary
Steffi Siebert, MPH
Role: primary
Alex Berkebile
Role: primary
Amy Travis
Role: backup
Danie Sop, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY24040171
Identifier Type: -
Identifier Source: org_study_id