NCT04602728Completed
Building Adaptive Coping and Knowledge to Improve Daily Life
Building Adaptive Coping and Knowledge to Improve Daily Life (Back2Life): A Pilot Feasibility Clinical Trial for Youth With Chronic Sickle Cell Pain
Source: ClinicalTrials.gov · Last updated 29 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 20 Oct 2020
- Start date
- 27 Jan 2021
- Primary completion date
- 23 Aug 2023
- Lead sponsor
- Emory University
- Diseases
- Sickle cell disease
- NCT number
- NCT04602728
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 27 Jan 2021 to the primary completion date, 23 Aug 2023
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- have comorbid medical conditions typically associated with pain but unrelated to SCD (e.g., rheumatologic disorders or inflammatory bowel disease)
- 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
Who the study is looking for
- diagnosed with SCD (any genotype)
- report chronic pain
- speak and read English
- have not initiated new disease modifying-treatments (e.g, hydroxyurea, Endari, voxelotor, crizanlizumab, chronic transfusions) or significantly increased dosages of any disease-modifying treatments in the past 3 months
- speak and read English
Age in the registry: 10 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Healthcare of Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Emory Children's Center Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Children's Healthcare of Atlanta at Hughes Spalding Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.