Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-39
SponsorUniversity of Pittsburgh
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 16 to 39 years of age at time of enrollment
Sickle Cell Disease diagnosis of any genotype based on referral or documentation
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)
Access to an iOS or Android mobile device with internet access
Disqualifiers
Unable to speak or read English
Prior hematopoietic stem cell transplant for sickle cell disease
Not living in the United States throughout enrollment and duration of the study period
Trial design
Design model
Parallel
Treatments tested in this trial
CBT+ Health coach
BehavioralParticipants 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)
BehavioralParticipants 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
BehavioralParticipants 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
Treatment groups
390 Participants
are divided into 3 treatment groupsGroup A: CBT w/ Health CoachExperimental treatment 1 intervention
Group B: CBT w/o Health coach (self-guided)Active comparator 1 intervention
Group C: Usual Care with no access to CBTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 6 months2
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.
Time frame
Baseline and 6 monthsSecondary outcomes
1
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
Time frame
Baseline and 6 months2
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
Time frame
Baseline and 6 months3
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
Time frame
Baseline and 12 months4
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
Time frame
Baseline and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov