Digital cognitive behavioral therapy with peer support for young adults with sickle cell pain
Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain: Promoting Engagement in Cognitive Behavioral Therapy
NA · University of Pittsburgh · NCT06374238
This study is testing if a new online therapy with peer support can help young adults with sickle cell disease manage their pain better than standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 470 (estimated) |
| Ages | 16 Years to 30 Years |
| Sex | All |
| Sponsor | University of Pittsburgh (other) |
| Locations | 14 sites (Mobile, Alabama and 13 other locations) |
| Trial ID | NCT06374238 on ClinicalTrials.gov |
What this trial studies
The PRESENCE initiative aims to evaluate the effectiveness of digital cognitive behavioral therapy (CBT) in managing pain for adolescents and young adults with sickle cell disease (SCD). This multisite, randomized controlled trial will involve 470 participants who will be assigned to one of three groups: digital CBT with peer support, self-guided digital CBT, or usual care. The study seeks to understand how personalized peer support can enhance engagement and outcomes in pain management. By leveraging virtual peer support and tailored CBT programs, the study aims to provide insights into alternative pain management strategies for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents and young adults aged 16 to 30 with a diagnosis of sickle cell disease who experience chronic pain.
Not a fit: Patients who do not speak or read English or have undergone a hematopoietic stem cell transplant for sickle cell disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and reduce reliance on opioids for young adults with sickle cell disease.
How similar studies have performed: Other studies have shown promise in using digital CBT for chronic pain management, suggesting that this approach may be effective for similar populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Mobile, Alabama and 13 other locations
- University of South Alabama Medical Center — Mobile, Alabama, United States (RECRUITING)
- UCLA Mattel Children's Hospital Ronald Reagan Hospital — Los Angeles, California, United States (RECRUITING)
- Connecticut Children's Medical Center — Hartford, Connecticut, United States (RECRUITING)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (RECRUITING)
- Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (RECRUITING)
- The Regents of the University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
- Rutgers New Jersey Medical School — Newark, New Jersey, United States (RECRUITING)
- Weil Cornell Medical College — New York, New York, United States (RECRUITING)
- University of Rochester Medical Center — Rochester, New York, United States (RECRUITING)
- Wake Forest Baptist Hospital — Durham, North Carolina, United States (RECRUITING)
- East Carolina University Health Medical Center — Greenville, North Carolina, United States (RECRUITING)
- UPMC University of Pittsburgh Classical Hematology Adult Clinic — Pittsburgh, Pennsylvania, United States (RECRUITING)
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (RECRUITING)
- Virginia Commonwealth University — Richmond, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: Charles Jonassaint, PhD — University of Pittsburgh
- Study coordinator: Steffi Siebert, MPH
- Email: presencestudy@pitt.edu
- Phone: 877-649-0176
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain, Sickle Cell Disease, Pain management, Cognitive Behavioral Therapy, Wellness