Clinical trial NCT06374238: Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain
Official title: Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain: Promoting Engagement in Cognitive Behavioral Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Sickle Cell Disease
Keywords: Sickle Cell Disease
Pain management
Cognitive Behavioral Therapy
Wellness
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-04-18
Enrollment: 470
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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 470 AYAs with SCD who have experienced frequent pain over the past three months. Participants will be randomized into one of three groups:

1. Digital CBT with weekly one-on-one peer support (CBT+peer)
2. Digital CBT without peer support (self-guided CBT)
3. 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

  o 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.

Eligibility 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

Primary outcomes:
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
timeFrame: Baseline and 6 months
measure: 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
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain intensity for AYAs with SCD and chronic pain
timeFrame: Baseline and 6 months
measure: Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain interference for AYAs with SCD and chronic pain
timeFrame: Baseline and 6 months
measure: 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
timeFrame: Baseline and 12 months
measure: 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
timeFrame: Baseline and 12 months
measure: Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain intensity of AYAs with SCD and chronic pain
timeFrame: Baseline and 12 Months
measure: Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain interferences of AYAs with SCD and chronic pain
timeFrame: Baseline and 12 Months
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Charles Jonassaint, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Ana Radovic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Alicia Colvin, PhD
role: PRINCIPAL_INVESTIGATOR
References: