N/A
N=40
Building Adaptive Coping and Knowledge to Improve Daily Life
Sickle Cell Disease
Bottom Line
View on ClinicalTrials.gov: NCT04602728 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Short Form Pain Interference Score — 61.5; 62.1; 58.2; 59.4 T-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Back2Life (Behavioral)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Short Form Pain Interference Score |
61.5; 62.1; 58.2; 59.4; 50.4; 53.7 | — |
| PRIMARY Sickle Cell Disease Pain Burden Interview-Youth (SCPBI-Y) Score |
13.8; 9.5; 9.1; 7.0 | — |
| PRIMARY PROMIS Pediatric Short Form Pain Behaviors, Parent-Proxy Report Score |
52.7; 52.0; 46.2; 50.8 | — |
| PRIMARY Child Self-Efficacy Scale Score |
23.0; 24.6; 20.0; 24.1; 18.3; 24.3 | — |
| PRIMARY Number of Dyads Completing the Study |
16 | — |
| PRIMARY Number of Dyads Completing Study Assignments Within Six Months |
16 | — |
| PRIMARY Number of Participants With Positive Experiences During Participant Evaluation of the Intervention Interview |
15; 16; 16; 16; 16; 16 | — |
| PRIMARY Treatment Evaluation Inventory-Short Form (TEI-SF) Score |
32.0; 31.5 | — |
| SECONDARY Emergency Department Visits Per Participant |
0.86; 0.9 | — |
| SECONDARY Hospital Admissions Per Participant |
1.19; 1.25 | — |
| SECONDARY Days Per Week of Opioid Use |
3.9; 1.5; 1.8; 1.2 | — |
| SECONDARY Pediatric Inventory for Parents (PIP) Score |
104.5; 91.0; 72.0; 71.0 | — |
| SECONDARY Adolescent Sleep Wake Scale (ASWS) Score |
2.9; 3.1; 2.8; 3.0 | — |
| SECONDARY PROMIS Pediatric Short Form Depressive Symptoms Score |
71.1; 55.4; 68.9; 52.6; 65.5; 48.2 | — |
| SECONDARY Pain Catastrophizing Scale Score |
27.8; 33.3; 24.9; 35.8; 18.1; 25.6 | — |
| SECONDARY Pain Stages of Change Questionnaire (PSOCQ) Action Scale Score |
3.7; 3.9; 3.9; 4.3; 4.0; 3.9 | — |
| SECONDARY Interleukin -1β (IL-1β) Concentration |
1.25; 1.15; 0.95 | — |
| SECONDARY IInterleukin 6 (IL-6) Concentration |
1.88; 2.24; 1.91 | — |
| SECONDARY Interleukin 8 (IL-8) Concentration |
10.28; 27.70; 14.28 | — |
| SECONDARY Tumor Necrosis Factor - Alpha (TNF-α) Concentration |
2.05; 2.57; 2.04 | — |
| SECONDARY C-Reactive Protein (CRP) Concentration |
1710.74; 4795.63; 5206.06 | — |
| SECONDARY Brain-Derived Neurotrophic Factor (BDNF) Concentration |
4052.33; 3823.00; 4867.50 | — |
| SECONDARY Interferon Gamma (IFN-y) Concentration |
19.26; 20; 19.70 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria 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, voxelotor, 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
Exclusion Criteria 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
Data sourced from ClinicalTrials.gov (NCT04602728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.