Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374238
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Brief Title:
Peer Support for Adolescents and Emerging Adults with Sickle Cell Pain
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Peer Support for Adolescents and Emerging Adults with Sickle Cell Pain Promoting Engagement in Cognitive Behavioral Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRESENCE
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
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 CBTpeer
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 randomizationintervention 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
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 CBTpeer
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 randomizationintervention 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UG3HL165839 | NIH | None | httpsreporternihgovquickSearchUG3HL165839 |