Cognitive Behavioral Therapy for Sickle Cell Disease
(PRESENCE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether digital Cognitive Behavioral Therapy (CBT) can reduce pain, opioid use, and healthcare visits for young people with Sickle Cell Disease (SCD). It compares two groups: one using a self-guided app with peer health coaches (CBT+ Health Coach) and another using just the app (CBT without Health Coach). A third group will continue their usual care without the app. Suitable candidates for this trial are individuals with SCD who experience chronic pain at least four days a week and have access to a smartphone with internet.
As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve pain management for SCD patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current pain management routine, as the study focuses on adding digital therapy to your existing care.
What prior data suggests that digital CBT is safe for individuals with SCD?
Research has shown that Cognitive Behavioral Therapy (CBT), with or without a health coach, is generally easy for people to handle. Although specific safety information for individuals with sickle cell disease (SCD) is lacking, CBT is commonly used and considered safe for many health issues. Other studies have found that digital CBT can help reduce pain and assist in managing symptoms.
Pairing CBT with a health coach often makes it more engaging, as the coach provides personalized support and motivation. Self-guided CBT is also safe, allowing individuals to manage their therapy at their own pace.
Overall, evidence suggests that both types of CBT are safe options for people with SCD who want to manage pain and improve their quality of life.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how Cognitive Behavioral Therapy (CBT) can be tailored to help individuals with Sickle Cell Disease manage pain and improve mood. Unlike standard pain management treatments that often rely on medications, this trial utilizes the Presence app to offer CBT in two innovative ways: with and without the guidance of a health coach. The addition of peer health coaches aims to provide personalized support, potentially making CBT more effective and engaging. Both approaches focus on empowering individuals to manage their condition actively, which could offer a non-drug alternative to traditional therapies and improve overall well-being.
What evidence suggests that this trial's treatments could be effective for sickle cell disease?
Research shows that digital cognitive behavioral therapy (CBT) can help reduce pain for people with sickle cell disease (SCD). This trial will assign participants to different treatment arms to evaluate the effectiveness of these approaches. One group will receive digital CBT with a health coach, which studies have found to be as effective as traditional methods in reducing pain and improving mental health. Another group will undergo self-guided digital CBT, which has also successfully reduced pain and helped adolescents with SCD cope better. Overall, digital CBT, whether with a health coach or self-guided, appears to be a promising tool for managing pain in people with SCD.16789
Who Is on the Research Team?
Charles Jonassaint, PhD
Principal Investigator
University of Pittsburgh
Ana Radovic, MD
Principal Investigator
University of Pittsburgh
Alicia Colvin, PhD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for young people aged 16-30 with Sickle Cell Disease who experience chronic pain or use pain management treatments regularly. They must have a smartphone with internet to participate and be able to provide proof of their diagnosis.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Pre-randomization baseline measures and rescreen if SCD verification is not provided within 30 days
Randomization and Intervention
Participants are randomized into one of three groups: Digital CBT with peer support, Digital CBT without peer support, or Usual Care. Pain and mood diary using EMA assessed daily for 14 days
Follow-up
Participants are monitored for primary and secondary outcomes at 6 months post-randomization
Long-term Follow-up
Assessment of sustained effectiveness of interventions at 12 months post-randomization
What Are the Treatments Tested in This Trial?
Interventions
- CBT+ Health coach
- CBT w/o Health Coach (self-guided)
- Usual Care
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator