Clinical trial NCT04602728: Building Adaptive Coping and Knowledge to Improve Daily Life
Official title: Building Adaptive Coping and Knowledge to Improve Daily Life (Back2Life): A Pilot Feasibility Clinical Trial for Youth With Chronic Sickle Cell Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Pediatrics
Cognitive behavioral therapy
Behavioral intervention
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-10-26
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Youth and parent/caregiver dyads will participate in the same intervention.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 will utilize 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.

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

Primary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Short Form Pain Interference Score
timeFrame: Baseline, Immediately Post-Treatment, Month 3, Month 6
measure: Sickle Cell Disease Pain Burden Interview-Youth (SCPBI-Y) Score
timeFrame: Baseline, Immediately Post-Treatment, Month 3, Month 6
measure: PROMIS Pediatric Short Form Pain Behaviors, Parent-Proxy Report Score
timeFrame: Baseline, Immediately Post-Treatment, Month 3, Month 6
measure: Child Self-Efficacy Scale Score
timeFrame: Baseline, Immediately Post-Treatment, Month 3, Month 6
measure: Number of Dyads Completing the Study
timeFrame: Month 6
measure: Number of Dyads Completing Study Assignments Within Six Months
timeFrame: Month 6
measure: Number of Participants With Positive Experiences During Participant Evaluation of the Intervention Interview
timeFrame: Immediately Post-Treatment
measure: Treatment Evaluation Inventory-Short Form (TEI-SF) Score
timeFrame: Immediately Post-Treatment
Secondary outcomes:
measure: Emergency Department Visits Per Participant
timeFrame: 12 months prior to Baseline, 12 months post-treatment
measure: Hospital Admissions Per Participant
timeFrame: 12 months prior to Baseline, 12 months post-treatment
measure: Days Per Week of Opioid Use
timeFrame: Baseline, Immediately Post-Treatment, Month 3, Month 6
measure: Pediatric Inventory for Parents (PIP) Score
timeFrame: Baseline, Immediately Post-Treatment, Month 3, Month 6
measure: Adolescent Sleep Wake Scale (ASWS) Score
timeFrame: Baseline, Immediately Post-Treatment, Month 3, Month 6
measure: PROMIS Pediatric Short Form Depressive Symptoms Score
timeFrame: Baseline, Immediately Post-Treatment, Month 3, Month 6
measure: Pain Catastrophizing Scale Score
timeFrame: Baseline, Immediately Post-Treatment, Month 3, Month 6
measure: Pain Stages of Change Questionnaire (PSOCQ) Action Scale Score
timeFrame: Baseline, Immediately Post-Treatment, Month 3, Month 6
measure: Interleukin -1β (IL-1β), Concentration
timeFrame: Baseline, Month 3, Month 6
measure: Interleukin 6 (IL-6) Concentration
timeFrame: Baseline, Month 3, Month 6
measure: Interleukin 8 (IL-8) Concentration
timeFrame: Baseline, Month 3, Month 6
measure: Tumor Necrosis Factor - Alpha (TNF-α) Concentration
timeFrame: Baseline, Month 3, Month 6
measure: C-Reactive Protein (CRP) Concentration
timeFrame: Baseline, Month 3, Month 6
measure: Brain-Derived Neurotrophic Factor (BDNP) Concentration
timeFrame: Baseline, Month 3, Month 6
measure: Interferon Gamma (IFN-y) Concentration
timeFrame: Baseline, Month 3, Month 6
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Hughes Spalding
state: Georgia
city: Atlanta
country: United States
facility: Chilldren's Healthcare of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Emory Children's Center
state: Georgia
Study officials:
affiliation: Emory University
name: Soumitri Sil, PhD
role: PRINCIPAL_INVESTIGATOR
References: