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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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 470
Est. completion date May 2028
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender All
Age group 16 Years to 30 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
CBT+ Health coach
Participants will complete the pre-enrollment clinical screening measures (PHQ-9M, GAD-7, and PEG-3) and will repeat those assessments, as well as outcome assessments, at 3 months, 6 months, and 12 months. Participants in CBT w/ Health coach group will engage with the 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. In addition participants will have weekly contact with a peer health coach.
CBT w/o Health Coach ( self-guided)
Participants will complete the pre-enrollment clinical screening measures (PHQ-9M, GAD-7, and PEG-3) and will repeat those assessments, as well as outcome assessments, at 3 months, 6 months, and 12 months. Participants CBT w/o Health coach groups will engage with the 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.
Usual Care
Participants will complete the pre-enrollment clinical screening measures (PHQ-9M, GAD-7, and PEG-3) and will repeat those assessments, as well as outcome assessments, at 3 months, 6 months, and 12 months. Participants in the UC group will be asked to engage with the 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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Mean change in pain intensity as measured by the Pain, Enjoyment of Life and General Activity (PEG-3) scale. Item 1 asks individuals to rate their pain, on average, over the past week, using a 0-10 rating scale. Baseline and 6 months
Primary 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 Mean change in pain interference as measured by the PEG-3 items 2 and 3 that ask individuals to rate how pain has interfered with their enjoyment and general activities, in the past week, using a 0-10 rating scale. Baseline and 6 months
Secondary Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain intensity for AYAs with SCD and chronic pain Mean change in pain intensity as measured by the PEG-3 Baseline and 6 months
Secondary Determine the effectiveness of CBT+ peer vs. self-guided CBT to improve pain interference for AYAs with SCD and chronic pain Mean change in pain interference as measured by the PEG-3 Baseline and 6 months
Secondary 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 Mean change in pain intensity as measured by the PEG-3 Baseline and 12 months
Secondary 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 Mean change in pain interference as measured by the PEG-3 Baseline and 12 months
Secondary Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain intensity of AYAs with SCD and chronic pain Mean change in pain intensity as measured by the PEG-3 Baseline and 12 Months
Secondary Determine the sustained effectiveness of CBT+ peer vs self-guided CBT to improve pain interferences of AYAs with SCD and chronic pain Mean change in pain interference as measured by the PEG-3 Baseline and 12 Months
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