Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain

Conditions

• Pain
• Sickle Cell Disease

Eligibility Criteria

Sex

ALL

Age

16 Years - 30 Years

Healthy Volunteers

Not accepted

Interventions

• CBT+ Health coach — BEHAVIORAL
  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) — BEHAVIORAL
  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 — BEHAVIORAL
  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

Study Details

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.

Key Dates

Start date

Mar 10, 2025

Status verified

Sep 2025

Primary completion

Jul 31, 2027

Completion

May 31, 2028

Study Design

Enrollment

470 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CBT w/ Health Coach
  Group will utilize the Presence app to undergo self CBT for EMA, but with addition of peer health coaches.
• Active Comparator: CBT w/o Health coach (self-guided)
  Group will utilize the Presence app to undergo self-guided CBT for EMA, but without peer health coaches.
• Active Comparator: Usual Care with no access to CBT
  Participants in the UC group will have access to 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

Primary Outcome 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 [ Time Frame: Baseline and 6 months ]

Central Contacts

• Steffi Siebert, MPH
  877-649-0176
  [email protected]

Locations (14)

Find similar trials in Mobile, AL

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