Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06374238 |
| Other study ID # |
UG3HL165839 |
| Secondary ID |
UG3HL165839 |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 2024 |
| Est. completion date |
May 2028 |
Study information
| Verified date |
April 2024 |
| Source |
University of Pittsburgh |
| Contact |
Eilene Pham |
| Phone |
919-660-7253 |
| Email |
presence[@]duke.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
