Building Adaptive Coping and Knowledge to Improve Daily Life (Back2Life): A Pilot Feasibility Clinical Trial for Youth With Chronic Sickle Cell Pain

Study point of contact

Soumitri Sil, PhD
404-727-2712
[email protected]

Locations

3 United States sites

Age

10 to 18 Years

Phase

N/A

Study type

Interventional

Gender

All

Interventions

Behavioral

Compensation

Unknown

About the study

The purpose of this study is to find out how teenagers with chronic pain and sickle cell
disease respond to a new training program called Back2Life and get their feedback about how
to modify the program to best fit their needs. The Back2Life training program focuses on
teaching pain coping skills (also known as cognitive-behavioral therapy). The program teaches
skills and strategies that may help teens improve chronic pain management and get back into
their everyday activities.

participation requirements

for Youth:

– diagnosed with SCD (any genotype)

– report chronic pain

– speak and read English

– have not initiated new disease modifying-treatments (e.g, hydroxyurea, Endari,
voxeletor, crizanlizumab, chronic transfusions) or significantly increased dosages of
any disease-modifying treatments in the past 3 months

Inclusion Criteria for Parents or Caregivers:

– speak and read English

participation restrictions

for Youth:

– have comorbid medical conditions typically associated with pain but unrelated to SCD
(e.g., rheumatologic disorders or inflammatory bowel disease)

– are receiving chronic transfusion indicated for central nervous system risks and/or
complications, previous overt strokes, or significant cognitive or developmental
limitations, as per their healthcare provider or parent, that would impair completion
of self-report measures or engagement in treatment sessions

– received ≥ 3 sessions of outpatient psychological therapy for pain management in the 6
months prior to screening

Exclusion Criteria for Parents or Caregivers:

– have significant cognitive limitations or severe psychiatric conditions, as per the
child’s healthcare team or history, that would impair completion of self-report
measures or engagement in treatment sessions

Locations

  • Atlanta, Georgia, United States, Children's Healthcare of Atlanta at Hugh Spalding, 30303 [Recruiting]
  • Atlanta, Georgia, United States, Chilldren's Healthcare of Atlanta, 30322 [Recruiting]
  • Atlanta, Georgia, United States, Emory Children's Center, 30322 [Recruiting]