Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT06374238

Conditions

Pain

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 16 - 30

Healthy Volunteers: Not accepted

Interventions

CBT+ Health coach

CBT w/o Health Coach ( self-guided)

Usual Care

Study Details

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.

Conditions

Pain

Sickle Cell Disease

Study ID

NCT06374238

Start date

Mar 10, 2025

Status verified date

Sep, 2025

Completion date

May, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Aged 16 to 30 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

Study Design

Enrollment

470 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CBT w/ Health Coach

Group will utilize the Presence app to undergo self CBT for EMA, but with addition of peer health coaches.

active comparator: 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.

active comparator: 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

Interventions

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

Primary outcome measure

  • 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 [ Time Frame: 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 [ Time Frame: Baseline and 6 months ]

Central Contacts and Locations

Central contacts

Steffi Siebert, MPH

877-649-0176presencestudy@pitt.edu

Locations

University of South Alabama Medical Center

Recruiting

Mobile, Alabama, United States, 36617

Contacts

Jessica King

(251) 445-9159jlking@health.southalabama.edu

T'Shemika Perryman

tperryman@health.southalabama.edu

Principal Investigator:

Antwan Hogue, MD

UCLA Mattel Children's Hospital Ronald Reagan Hospital

Recruiting

Los Angeles, California, United States, 90095

Contacts

Debbie Argueta Rufino

(424) 362-0037darguetarufino@mednet.ucla.edu

Principal Investigator:

Satiro De Oliveira, MD

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Christopher Theriault

(860) 837-5852ctheriault@connecticutchildrens.org

Principal Investigator:

William Zempsky, MD

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30345

Contacts

Katyria Thornton

(404) 785-6274katyria.thornton@choa.org

Vontarius Howard Jesse

(404) 785-3245vontarius.howard@choa.org

Principal Investigator:

Carlton Dampier, MD

Ann and Robert H. Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Kevin Guerrero

(312) 227-4824kguerrero@lueriechildrens.org

Principal Investigator:

Robert Liem, MD

The Regents of the University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109-1079

Contacts

Anela Mukherjee

7342329896mukherja@med.umich.edu

Principal Investigator:

Eric Scott, PhD

Rutgers New Jersey Medical School

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Kim White

(732) 277-7703whiteka@rwjms.rutgers.edu

Principal Investigator:

Ashwin Sridharan, MD

Weil Cornell Medical College

Recruiting

New York, New York, United States, 10065

Contacts

Masiel Infante

646-962-8311mai4011@med.cornell.edu

Principal Investigator:

Maria DeSancho, MD

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Priya Kaushal

(585) 275-2981priya_kaushal@urmc.rochester.edu

Principal Investigator:

Suzie Noronha, MD

Wake Forest Baptist Hospital

Recruiting

Durham, North Carolina, United States, 27106

Contacts

Julie Fountain

(980) 442-2000Julie.Fountain@Advocatehealth.org

Principal Investigator:

Alex George, MD

East Carolina University Health Medical Center

Recruiting

Greenville, North Carolina, United States, 27834

Contacts

Toria Wilson

(252) 744-0493wilsonto22@ecu.edu

Principal Investigator:

Darla Liles, MD

UPMC University of Pittsburgh Classical Hematology Adult Clinic

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Steffi Siebert, MPH

8776490176presencestudy@pitt.edu

Principal Investigator:

Laura De Castro, MD

UPMC Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Alex Berkebile

412-692-5964berkebileak@upmc.edu

Amy Travis

412-692-8575travisam@upmc.edu

Principal Investigator:

Dr. Cheryl Hillery, MD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23284

Contacts

Danie Sop, PhD

(804) 828-0810daniel.sop@vcuhealth.org

Principal Investigator:

Wally Smith, MD

More Information

Sponsor

University of Pittsburgh

Last update posted

Jan 7, 2026

Last verified

Sep, 2025

Keywords

  • Sickle Cell Disease
  • Pain management
  • Cognitive Behavioral Therapy
  • Wellness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-01-07.