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  • Research & Results
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  • Comparing Two Ways to Help Patients w...

Comparing Two Ways to Help Patients with Sickle Cell Disease Manage Pain

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Project Summary  

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Sickle cell disease, or SCD, is an inherited blood disease. In SCD, blood cells have a sickle shape that may cause blood cells to lodge in small blood vessels. SCD can cause both daily chronic pain and sudden severe pain that requires prompt medical care. The main way that doctors treat SCD pain is with opioids. But opioids can have serious side effects and don’t work well to treat long-term pain.

In this study, the research team is comparing two ways to treat SCD pain that don’t involve opioids. Both ways are effective at treating pain for other health problems. The first way is cognitive behavioral therapy, or CBT. CBT helps patients learn to change patterns in their thinking to better manage their pain. The second is pain education, which teaches patients about SCD and its symptoms.

Who can this research help?

Results may help patients, doctors, and clinic directors when considering ways to treat SCD pain.

What is the research team doing?

The research team is recruiting 350 adults with SCD and chronic pain from clinics and community-based organizations. The team is assigning patients by chance to receive 12 months of either CBT or pain education.  

In both programs, patients receive information via a smartphone or mobile device at a time that works for them. Patients also use their smartphone or mobile device to track their daily pain, mood, and medicines. Patients receive weekly follow-up with a health coach who helps them identify goals, develop coping strategies, and make healthy lifestyle changes. Patients can take part in an online Facebook group to discuss issues related to SCD with other patients.

In the CBT program, patients learn how to recognize negative thoughts and emotions, solve problems, and use coping behaviors such as relaxation techniques. In the pain education program, patients learn about chronic pain and SCD and get healthy lifestyle tips.

The research team is surveying patients about their day-to-day pain, how much their pain interferes with their daily activities, and their mental health. The team is comparing how well CBT and pain education improve these outcomes.

Patients, family members, community-based organizations, SCD clinical care teams, and members of SCD advocacy groups are helping to design and conduct the study.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population 350 adults with SCD who report chronic pain (pain more days than not for more than 3 months)
Interventions/
Comparators
  • CBT via smartphone app
  • Pain education via smartphone app
Outcomes

Primary: daily pain intensity, pain interference

Secondary: depressive symptoms, healthcare utilization (opioid prescriptions, acute care visits), opioid misuse behaviors 

Timeframe 12-month follow-up for primary outcomes

Project Details

Principal Investigator
Charles Jonassaint, PhD, MHS
Other Principal Investigator
Kaleab Z. Abebe, PhD
Project Status
In progress; Recruiting
Project Title
Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell via Mobile Applications (CaRISMA)
Board Approval Date
April 2019
Project End Date
August 2024
Organization
University of Pittsburgh
Year Awarded
2019
State
Pennsylvania
Project Type
Research Project
Health Conditions  
Blood Disorders
Sickle Cell Disease
Genetic Disorders
Mental/Behavioral Health
Anxiety
Depression
Neurological Disorders
Chronic Pain
Rare Diseases
Intervention Strategies
Behavioral Interventions
Other Clinical Interventions
Other Health Services Interventions
Technology Interventions
Training and Education Interventions
Populations
Individuals with Multiple Chronic/co-morbid Conditions
Individuals with Rare Disease
Racial/Ethnic Minorities
Funding Announcement
Assessment of Prevention, Diagnosis, and Treatment Options
Project Budget
$4,343,821
Study Registration Information
HSRP20202778
Page Last Updated: 
December 8, 2020

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Meetings & Events

January 21
Cycle 1 2021 Broad PFA Applicant Town Hall
February 2
PCORI 2021 and Beyond: Opportunities for Funding and Involvement in Patient-Centered Research
February 9
Board of Governors Meeting: February 9, 2021

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