Building Adaptive Coping and Knowledge to Improve Daily Life (Back2Life)

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

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.

Study Overview

• Status: Completed
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Behavioral: Back2Life

Detailed Description

Sickle cell disease (SCD) is a genetic disorder of the hemoglobin in which the course of acute pain from vaso-occlusion and its sequelae vary widely across genotypes and individual patients. SCD pain often begins during childhood and can progress to chronic pain for approximately 23% of children and adolescents. Youth with chronic SCD pain, that is pain that is present on most days per month and persists for at least 6 months, report high levels of functional disability, elevated depressive and anxiety symptoms, and reduced quality of life relative to youth with SCD without chronic pain. The complex, multifactorial nature of chronic SCD pain can also contribute to increased healthcare utilization for pain. The most effective management and treatment of chronic SCD pain likely requires individualized, multimodal, multidisciplinary treatments that go beyond pharmacological management alone. A range of evidence-based non-pharmacological treatments, such as behavioral health, complementary, and integrative health approaches, are recommended for chronic pain management and are gaining greater awareness and integration into comprehensive chronic pain care.

Behavioral health treatment, such as cognitive-behavioral therapy (CBT) for pain, focuses on improved daily functioning and coping through several core treatment components such as psychoeducation about how the body processes pain, relaxation skills training, and cognitive strategies. Youth with chronic SCD pain need an evidence-based, culturally informed, adaptive treatment. Behavioral treatments that are tailored to patient and family needs are beneficial when patients may require different levels of care. Adaptive designs are more effective in improving health outcomes, satisfaction with treatment, and reducing healthcare use than standard protocols where patients receive a fixed "one size fits all" treatment that is not personalized to their needs; adaptive designs are also recommended for tailoring evidence-based interventions with culturally diverse populations. Adaptive treatments can integrate evidence-based strategies to address common co-morbid problems associated with chronic pain, such as elevated anxiety or depressive symptoms or sleep disturbance. Teaching parents problem-solving skills can reduce caregiver stress among families managing chronic pain and illness.

This study utilizes an adaptive behavioral treatment to target psychosocial risk factors for youth with chronic SCD pain as a first step towards developing a stepped care model for SCD pain. The proposed treatment, called Back2Life, is innovative because it is culturally informed by families' and patients' feedback regarding their treatment preferences and targets psychological co-morbidities that are often excluded in clinical trials. The overarching hypothesis driving the proposed intervention is that disrupting the complex interacting psychosocial factors that can exacerbate chronic SCD pain will prevent and/or reduce poor health outcomes in children and adolescents with SCD. Reductions in inflammatory biomarkers are examined as an exploratory hypothesis and participants can consent to an optional blood draw for this portion of the study.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta
    • Atlanta, Georgia, United States, 30322
      • Emory Children's Center
    • Atlanta, Georgia, United States, 30303
      • Children's Healthcare of Atlanta at Hughes Spalding

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Back2Life Program; Youth with chronic SCD pain and their parents or caregivers receiving an adaptive cognitive behavioral treatment program for pain coping skills.

Behavioral: Back2Life; The Back2Life intervention uses an adaptive treatment approach with module-based treatment sessions selected on the basis of baseline assessment (rather than a fixed treatment approach) to allow flexibility in tailoring treatment components to meet individual family needs. All youth participants will receive the standard 6-session pain coping skills training program, consisting of learning ways to cope with and manage chronic sickle cell pain. The standard program includes topics that were identified by young people with chronic sickle cell pain and their parents as important skills for all youth with chronic pain and sickle cell disease. In addition to the standard 6-session program, youth participants may receive an additional 1 to 4 sessions that may help with specific problems and/or co-morbidities related to pain. At least one parent or guardian is required to attend the sessions with their child.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Short Form Pain Interference Score	The PROMIS Pediatric Short Form for Pain Interference, Self- and Parent-Proxy Report, is an 8-item self-report measure assessing functional interference due to pain in the past 7 days. Total scores are standardized to a T-score with a mean of 50 and a standard deviation of 10, where higher scores indicate increased hindrance of life activities due to pain.	Baseline, Immediately Post-Treatment, Month 3, Month 6
Sickle Cell Disease Pain Burden Interview-Youth (SCPBI-Y) Score	The Sickle Cell Pain Burden Interview for Youth, Self-Report is a 7-item, validated measure of pain burden in 7-21 year olds. Responses are given on a 5-point Likert scale where 0 = none and 4 = every. The patient self-reports the amount of days in the past month where pain occurred or pain impacted daily life. Total scores range from 0 to 28 and higher scores indicate a greater pain burden.	Baseline, Immediately Post-Treatment, Month 3, Month 6
PROMIS Pediatric Short Form Pain Behaviors, Parent-Proxy Report Score	The PROMIS Pediatric Short Form Pain Behaviors, Parent-Proxy Report is an 8-item measure completed by parents that assesses pain behaviors displayed by their child in the past 7 days. Total scores are standardized to a T-score with a mean of 50 and a standard deviation of 10, where higher scores indicate increased behaviors due to pain.	Baseline, Immediately Post-Treatment, Month 3, Month 6
Child Self-Efficacy Scale Score	Child Self-Efficacy Scale, Self- and Parent-Proxy Report is a well-established, 7-item measure of self-efficacy for functioning despite pain for 8-19 year olds. Respondents report how sure about their (or their child's) ability to perform certain daily tasks when they have pain, on a scale from 1 to 5 where 1 = very sure and 5 = very unsure. Total scores range from 7 to 35 and lower scores indicate greater self-efficacy.	Baseline, Immediately Post-Treatment, Month 3, Month 6
Number of Dyads Completing the Study	Treatment feasibility was assessed by the number of participant dyads who complete the study.	Month 6
Number of Dyads Completing Study Assignments Within Six Months	Treatment feasibility was assessed by the number of dyads completing the 6-Month study assignment.	Month 6
Number of Participants With Positive Experiences During Participant Evaluation of the Intervention Interview	Treatment feasibility was assessed via a qualitative interview where participants were asked open ended questions. Participants were asked if they thought the Back2Life program helpful, if delivering the program through telemedicine was reasonable, and if the program was a reasonable approach for chronic pain management of sickle cell disease.	Immediately Post-Treatment
Treatment Evaluation Inventory-Short Form (TEI-SF) Score	The Treatment Evaluation Inventory-Short Form was completed at the end of treatment. It includes 9 items adapted to be specific to pediatric pain. Items are rated on a 5-point Likert scale ranging from 1 to 5. Total scores range from 9 to 45. Higher scores indicate increased acceptability with the study treatment.	Immediately Post-Treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergency Department Visits Per Participant	Healthcare utilization was extracted from the medical record to document the mean number of emergency department (ED) visits for pain per participant during the 12 months preceding the intervention period and the 12-month period post-treatment.	12 months prior to Baseline, 12 months post-treatment
Hospital Admissions Per Participant	Healthcare utilization was extracted from the medical record to document the mean number of hospital admissions for pain per participant during the 12 months preceding the intervention and the 12-month period post-treatment.	12 months prior to Baseline, 12 months post-treatment
Days Per Week of Opioid Use	Daily use of opioid pain medication was determined based on participant completion of daily diaries for 1-week at each assessment visit. Participants recorded opioid use daily (presence/absence).	Baseline, Immediately Post-Treatment, Month 3, Month 6
Pediatric Inventory for Parents (PIP) Score	The Pediatric Inventory for Parents is a 42-item parent-reported measure of caregiver stress related to child chronic illness. Responses are given on a 5-point Likert scale where 1 = not at all and 5 = extremely. Total scores range from 42 to 210 and higher scores indicate greater caregiver stress.	Baseline, Immediately Post-Treatment, Month 3, Month 6
Adolescent Sleep Wake Scale (ASWS) Score	The Adolescent Sleep Wake Scale (ASWS) is a 28-item patient-reported describing the occurrence and frequency of various behavioral sleep characteristics over the past month. Responses are given on a 6-point Likert scale where 1 = always and 6 = never. Total scores are calculated as the mean score from each time and range from 1 to 6 where higher scores indicate better sleep quality.	Baseline, Immediately Post-Treatment, Month 3, Month 6
PROMIS Pediatric Short Form Depressive Symptoms Score	The PROMIS Pediatric Short Form Depressive Symptoms questionnaire, Self- and Parent-Proxy Report is an 8-item measure designed for youth to assess self-reported symptoms of depression. Total scores are standardized to a T-score with a mean of 50 and a standard deviation of 10, where higher scores indicate increased depression.	Baseline, Immediately Post-Treatment, Month 3, Month 6
Pain Catastrophizing Scale Score	The Pain Catastrophizing Scale, Child and Parent Report, is a 13-item well-validated self-report and parent-report measure of worried thoughts about pain. Items are answered on a 5-point scale where 0 = not true at all and 4 = very true. Total scores range from 0 to 52 and higher scores indicate increased catastrophic thinking.	Baseline, Immediately Post-Treatment, Month 3, Month 6
Pain Stages of Change Questionnaire (PSOCQ) Action Scale Score	The Pain Stages of Change Questionnaire, Adolescent and Parent Report is a 30-item measure designed to evaluate parent and adolescent perceptions of readiness to adopt a self-management approach to pain. Responses are given on a 5-point scale where 1 = strongly disagree and 5 = strongly agree. Average scores are obtained for categories of Pre-contemplation (believing pain management is solely the responsibility of medical professionals), Contemplation (considering using self-management for pain), Action (starts taking ownership of pain control and self-management of pain), and Maintenance (continuous development and self-management of chronic pain); the category with the highest score indicates where the youth participant is in terms of stages of change related to pain management. For this outcome measure, the average scores for the Action scale are reported. Total scores for the Action scale range from 1 to 5 and higher scores indicate increased readiness to self-manage pain.	Baseline, Immediately Post-Treatment, Month 3, Month 6
Interleukin -1β (IL-1β) Concentration	Plasma concentration of the inflammatory biomarker IL-1β is assessed among youth participants who opted for blood sample collection. IL-1β increases in response to inflammation, pain, and autoimmune diseases.	Baseline, Month 3, Month 6
IInterleukin 6 (IL-6) Concentration	Plasma concentration of the inflammatory biomarker IL-6 is assessed among youth participants who opted for blood sample collection. IL-6 is increased during injury or illness.	Baseline, Month 3, Month 6
Interleukin 8 (IL-8) Concentration	Plasma concentration of the inflammatory biomarker IL-8 is assessed among youth participants who opted for blood sample collection. IL-8 is produced during the presence of inflammation.	Baseline, Month 3, Month 6
Tumor Necrosis Factor - Alpha (TNF-α) Concentration	Plasma concentration of the inflammatory biomarker TNF-α is assessed among youth participants who opted for blood sample collection. TNF-α is a pro-inflammatory cytokine that regulates the inflammatory response and it is elevated during illness or injury.	Baseline, Month 3, Month 6
C-Reactive Protein (CRP) Concentration	Plasma concentration of the inflammatory biomarker CRP is assessed among youth participants who opted for blood sample collection. CRP increases in response to bodily inflammation.	Baseline, Month 3, Month 6
Brain-Derived Neurotrophic Factor (BDNF) Concentration	Plasma concentration of the inflammatory biomarker BDNF is assessed among youth participants who opted for blood sample collection. BDNF expression is reduced when high bodily inflammation is present.	Baseline, Month 3, Month 6
Interferon Gamma (IFN-y) Concentration	Plasma concentration of the inflammatory biomarker IFN-y is assessed among youth participants who opted for blood sample collection. IFN-y is involved with regulating immune and inflammatory responses. IFN-y concentration is elevated during illness.	Baseline, Month 3, Month 6

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Soumitri Sil, PhD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Actual): August 23, 2023
• Study Completion (Actual): May 18, 2024

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Cognitive behavioral therapy; Pediatrics; Behavioral intervention
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: STUDY00000573; 1K23HL133457 (U.S. NIH Grant/Contract); R03HL164333 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No