Cognitive Behavioral Therapy for Sickle Cell Disease

(PRESENCE Trial)

Recruiting at 2 trial locations

Overseen By Steffi Siebert

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Non-English speakers, Prior stem cell transplant

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

470 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Sickle Cell Disease?

Research shows that computerized cognitive behavioral therapy (cCBT) can help reduce depression and improve daily pain in adults with sickle cell disease. This suggests that CBT, especially with support, might be beneficial for managing mental health and pain in these patients. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy (CBT) safe for people with sickle cell disease?

The research does not provide specific safety data for Cognitive Behavioral Therapy (CBT) in people with sickle cell disease, but CBT is generally considered safe for various conditions and is widely used to help manage chronic pain and improve mental health. ^{1 2 6 7 8}

How does the CBT treatment for sickle cell disease differ from other treatments?

This treatment is unique because it combines cognitive behavioral therapy (CBT) with a health coach to help patients manage sickle cell disease by improving self-management skills and promoting behavior changes. Unlike traditional treatments that focus on medical interventions, this approach emphasizes psychological support and self-care education to enhance patients' ability to manage their condition. ^{2 6 9 10 11}

What is the purpose of this trial?

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.

Research Team

Alicia Colvin, PhD

Principal Investigator

University of Pittsburgh

Charles Jonassaint, PhD

Principal Investigator

University of Pittsburgh

Ana Radovic, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

I have a smartphone with internet.

I am between 16 and 30 years old.

I have been diagnosed with Sickle Cell Disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Pre-randomization baseline measures and rescreen if SCD verification is not provided within 30 days

4 weeks

1 visit (virtual)

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

3 months

Daily virtual engagement via app

Follow-up

Participants are monitored for primary and secondary outcomes at 6 months post-randomization

6 months

2 visits (virtual)

Long-term Follow-up

Assessment of sustained effectiveness of interventions at 12 months post-randomization

12 months

1 visit (virtual)

Treatment Details

Interventions

• CBT+ Health coach
• CBT w/o Health Coach (self-guided)
• Usual Care

Trial Overview The PRESENCE study tests if digital Cognitive Behavioral Therapy (CBT) can reduce pain, opioid use, and healthcare visits in adolescents and young adults with SCD. It also examines the impact of peer support on engaging patients in this therapy.

Participant Groups

Group I: CBT w/ Health Coach Experimental Treatment 1 Intervention

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

Group II: CBT w/o Health coach (self-guided) Active Control 1 Intervention

Group will utilize the Presence app to undergo self-guided CBT for EMA, but without peer health coaches.

Group III: Usual Care with no access to CBT Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Depression in sickle cell disease. [2022]

2. Scotland pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of the clinical implementation of cognitive-behavioral therapy for chronic pain management in pediatric sickle cell disease. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Feasibility of implementing mobile technology-delivered mental health treatment in routine adult sickle cell disease care. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A review of empirically supported psychosocial interventions for pain and adherence outcomes in sickle cell disease. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of Music Therapy on Quality of Life in Adults with Sickle Cell Disease (MUSIQOLS): A Mixed Methods Feasibility Study. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Toward a Conversational Agent to Support the Self-Management of Adults and Young Adults With Sickle Cell Disease: Usability and Usefulness Study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

A systematic review of the association between depression and health care utilization in children and adults with sickle cell disease. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Primary care use and depression screening among young adults with sickle cell disease during their final year of pediatric hematology care. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Preliminary Evaluation of a mHealth Coaching Conversational Artificial Intelligence for the Self-Care Management of People with Sickle-Cell Disease. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Improving self-management in adolescents with sickle cell disease. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

Self-efficacy and readiness for transition from pediatric to adult care in sickle cell disease. [2017]