PainPRESENCENCT06374238
Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain
A study testing CBT+ Health coach and CBT w/o Health Coach ( self-guided) in people with Pain and Sickle Cell Disease, run by University of Pittsburgh at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 39 years
- Conditions the study is for
- Pain, Sickle Cell Disease
- What is being tested?
- CBT+ Health coach and CBT w/o Health Coach ( self-guided)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 14 sitesUnited States
- Study dates
- 10 Mar 2025to Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 16 to 39 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
Who cannot join
- Unable to speak or read English
- Prior hematopoietic stem cell transplant for sickle cell disease
- Not living in the United States throughout enrollment and duration of the study period
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
The Regents of the University of Michigan
Ann Arbor, Michigan, 48109-1079
Anela Mukherjee, 7342329896, mukherja@med.umich.edu
Eric Scott, PhD
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30345
Katyria Thornton, (404) 785-6274, katyria.thornton@choa.org
Vontarius Howard Jesse, (404) 785-3245, vontarius.howard@choa.org
- Recruiting
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Kevin Guerrero, (312) 227-4824, kguerrero@lueriechildrens.org
Robert Liem, MD
- Recruiting
Wake Forest Baptist Hospital
Durham, North Carolina, 27106
Julie Fountain, (980) 442-2000, Julie.Fountain@Advocatehealth.org
Alex George, MD
- Recruiting
East Carolina University Health Medical Center
Greenville, North Carolina, 27834
Toria Wilson, (252) 744-0493, wilsonto22@ecu.edu
Darla Liles, MD
- Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Christopher Theriault, (860) 837-5852, ctheriault@connecticutchildrens.org
William Zempsky, MD
- Recruiting
UCLA Mattel Children's Hospital Ronald Reagan Hospital
Los Angeles, California, 90095
Debbie Argueta Rufino, (424) 362-0037, darguetarufino@mednet.ucla.edu
Satiro De Oliveira, MD
- Recruiting
University of South Alabama Medical Center
Mobile, Alabama, 36617
Jessica King, (251) 445-9159, jlking@health.southalabama.edu
T'Shemika Perryman, tperryman@health.southalabama.edu
- Recruiting
Weil Cornell Medical College
New York, New York, 10065
Masiel Infante, 646-962-8311, mai4011@med.cornell.edu
Maria DeSancho, MD
- Recruiting
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
Kim White, (732) 277-7703, whiteka@rwjms.rutgers.edu
Ashwin Sridharan, MD
- Recruiting
UPMC University of Pittsburgh Classical Hematology Adult Clinic
Pittsburgh, Pennsylvania, 15213
Steffi Siebert, MPH, 8776490176, presencestudy@pitt.edu
Laura De Castro, MD
- Recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Alex Berkebile, 412-692-5964, berkebileak@upmc.edu
Amy Travis, 412-692-8575, travisam@upmc.edu
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23284
Danie Sop, PhD, (804) 828-0810, daniel.sop@vcuhealth.org
Wally Smith, MD
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Priya Kaushal, (585) 275-2981, priya_kaushal@urmc.rochester.edu
Suzie Noronha, MD
About this study
Official title: Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain: Promoting Engagement in Cognitive Behavioral Therapy
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.
Read the detailed description
The PRESENCE study aims to address the pressing issue of inadequate pain management for adolescents and young adults (AYAs) with sickle cell disease (SCD). Despite pain being the primary clinical symptom of SCD, effective treatment options are limited, leading to repeated hospitalizations and negative impacts on patients' physical and mental well-being. Opioids, the primary treatment for chronic SCD pain, often fail to provide long-term relief and can result in harmful consequences.
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 390 AYAs with SCD who have experienced frequent pain over the past three months. Participants will be randomized into one of three groups:
- Digital CBT with weekly one-on-one peer support (CBT+peer)
- Digital CBT without peer support (self-guided CBT)
- 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
- 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
- Pain, Sickle Cell Disease
- Being tested
- CBT+ Health coach, CBT w/o Health Coach ( self-guided), Usual Care
- Keywords
- Sickle Cell Disease, Pain management, Cognitive Behavioral Therapy, Wellness
- Medical subject headings
- Pain, Anemia, Sickle Cell, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT+ Health coachBehavioural
Also called CBT+peer
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)Behavioural
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 CareBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| CBT w/ Health Coach | Experimental | Group will utilize the Presence app to undergo self CBT for EMA, but with addition of peer health coaches. Receives: Behavioral: CBT+ Health coach |
| CBT w/o Health coach (self-guided) | Active comparator | Group will utilize the Presence app to undergo self-guided CBT for EMA, but without peer health coaches. Receives: Behavioral: CBT w/o Health Coach ( self-guided) |
| Usual Care with no access to CBT | Active comparator | 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 Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Mean change in pain intensity as measured by the PEG-3
Measured: 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
Mean change in pain interference as measured by the PEG-3
Measured: 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
Mean change in pain intensity as measured by the PEG-3
Measured: 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
Mean change in pain interference as measured by the PEG-3
Measured: 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
Mean change in pain intensity as measured by the PEG-3
Measured: Baseline and 12 Months
Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain interferences of AYAs with SCD and chronic pain
Mean change in pain interference as measured by the PEG-3
Measured: Baseline and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start10 Mar 2025
- Primary completionFeb 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm, phase III randomized controlled effectiveness trial. Participants will be randomized 3:3:2 into (1) CBT + peer, (2) self-guided CBT, or (3) UC, stratified by site
- Masking
- None (open label)
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Bruce Rollman, University of Pittsburgh
- Investigators
- Ana Radovic, MD, Principal investigator, University of PittsburghAlicia Colvin, PhD, Principal investigator, University of PittsburghBruce Rollman, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374238
- Sponsor's protocol ID
- STUDY24040171
- Other IDs
- UG3HL165839, UH3HL165839
- Acronym
- PRESENCE
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Brien JA, Colvin AB, Radovic A, Oluwole OB, Smith WR, Palermo TM, Rollman BL, Dampier C, Zempsky W, DeCastro LM, Stinson J, Jonassaint CR. Digital cognitive behavioral therapy and peer support for adolescents and young adults with sickle cell disease and chronic pain: study protocol of a parallel, three-arm, randomized controlled trial (PRESENCE). Trials. 2026 May 12;27(1):466. doi: 10.1186/s13063-025-08963-y.
PubMed 42121176