SPECIFIC AIMS
Pain is the most common and distressing feature of sickle cell disease (SCD) resulting in extraordinary
economic costs. Clinical practice guidelines for managing SCD pain encourage the use of treatments such as
hydroxyurea for all patients with SCD to minimize the burden of sickle cell pain. However, at least 23% of
children and adolescents with SCD are known to suffer from recurrent and chronic pain. Chronic pain in SCD
results in considerable functional disability, anxiety and depressive symptoms, and reduced quality of life that
can persist into adulthood. For these youth, chronic pain cannot be reversed with medication alone; in fact,
there are clear psychosocial, emotional, and sociocultural factors that can contribute to the onset and
maintenance of chronic sickle pain into adulthood.
Racial minority groups, such as those with SCD, are known to receive inadequate pain treatment, evidence
inequities in pain-related outcomes, and demonstrate lower rates and patterns of engaging in behavioral and
mental health treatment. Recent randomized controlled trials of cognitive-behavioral therapy (CBT)
interventions for pediatric chronic pain have demonstrated robust effects for improving function and pain;
however, these trials primarily were evaluated among Caucasian, middle-upper class families and the
generalizability to minority, disadvantaged populations is not well-known. This gap in knowledge ultimately
limits our ability to utilize and refine effective behavioral pain interventions to improve the quality of SCD pain
care provided and reduce pain disparities. This project will address this vital gap by adapting and evaluating a
family-focused behavioral intervention that bridges existing evidence-based CBT pain interventions with
patient-centered values and preferences to reduce disparities in pain treatment in youth with SCD.
Aim 1: Adapt an existing evidence-based cognitive-behavioral pain intervention for chronic sickle pain
by integrating patient-centered values and preferences and identifying sociocultural determinants of
disparities in pain management.
Aim 1a: Identify the barriers of seeking behavioral pain treatment and sociocultural determinants (e.g.,
parent education, SES, access to healthcare) that contribute to disparities in pain management.
Aim 1b: Determine the facilitators of pursuing behavioral pain treatment and preferences for the
delivery, content, and format of a behavioral intervention to promote effective pain management and
treatment response.
Aim 2: Develop and test proof-of-concept of the SCD-adapted CBT intervention. Utilizing major themes
that emerge from the qualitative interviews (e.g., frequency or number of sessions, group versus individual
treatment), up to 4 adapted treatment arms will be tested simultaneously.
Aim 2a: Determine whether the SCD-adapted CBT intervention can promote treatment completion
(defined as completing at least 75% of intervention sessions) and facilitate a clinically significant
change (>40%) in functional disability among youth with chronic sickle pain at 6-month follow-up.
Aim 2b: Optimize intervention based on post-treatment qualitative interviews and treatment completion
to promote clinically significant treatment response.
Aim 3: Pilot test and assess the feasibility, acceptability, and preliminary efficacy of the family-focused
SCD-adapted CBT intervention compared to wait-list control using assessments of participant
engagement, satisfaction, and pain outcomes.
Hypotheses: At least 80% of adolescents and parents assigned to SCD-adapted CBT will complete
treatment. We expect that the majority of participants will rate SCD-adapted CBT as an acceptable and
satisfactory treatment. Further, we expect adolescents who receive CBT will have better physical and
emotional functioning compared to controls at post-treatment and at 3- and 6-month follow-up.
Exploratory aim: Potential predictors of pain disparities and treatment response will be explored,
including sociocultural determinants, trust of healthcare providers, and perceived injustice.
This research will produce a novel approach to addressing pain disparities in an underserved, high-risk
population. The patient-centered qualitative methodology for intervention development will be generalizable to
other disproportionately affected, underserved populations. These data will inform the development of a multisite study of SCD-adapted CBT pain intervention to maximize clinically significant and long-term improvements
in pain outcomes (R01 proposal). This K23 Award will enable the PI to gain the skills and knowledge
necessary for establishing an independent program of research on chronic pain behavioral interventions that
incorporates understanding the causes of and reducing disparities in pain care.