Building Adaptive Coping and Knowledge to Improve Daily Life (Back2Life)
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|ClinicalTrials.gov Identifier: NCT04602728|
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : September 22, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease||Behavioral: Back2Life||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||25 youth and parent/caregiver dyads will participate in the same intervention.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Building Adaptive Coping and Knowledge to Improve Daily Life (Back2Life): A Pilot Feasibility Clinical Trial for Youth With Chronic Sickle Cell Pain|
|Actual Study Start Date :||January 27, 2021|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
Experimental: Back2Life Program
Youth with chronic SCD pain and their parents or caregivers receiving an adaptive cognitive behavioral treatment program for pain coping skills.
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.
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Short Form Pain Interference Score [ Time Frame: Baseline, Immediately Post-Treatment, Month 3, Month 6 ]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.
- Change in Sickle Cell Disease Pain Burden Interview-Youth (SCPBI-Y) Score [ Time Frame: Baseline, Immediately Post-Treatment, Month 3, Month 6 ]The Sickle Cell Pain Burden Interview for Youth, Self- and Caregiver-Proxy 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. Both the patient self-report and parent-proxy ask respondents to report 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.
- Change in PROMIS Pediatric Short Form Pain Behaviors Score [ Time Frame: Baseline, Immediately Post-Treatment, Month 3, Month 6 ]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.
- Change in Child Self-Efficacy Scale Score [ Time Frame: Baseline, Immediately Post-Treatment, Month 3, Month 6 ]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.
- Number of Dyads Completing the Study [ Time Frame: Month 6 ]Treatment feasibility will be assessed by the number of participant dyads who complete the study.
- Percent of Study Assignments Completed [ Time Frame: Month 6 ]Treatment feasibility will be assessed by completion of study assignments.
- Participant Evaluation of the Intervention [ Time Frame: Immediately Post-Treatment ]Treatment feasibility will be assessed via a qualitative interview where participants are asked open ended questions. Participants will be asked if they thought the Back2Life program is a reasonable approach for chronic pain management, if the program was helpful, and if it could be integrated into their lifestyle. Participants will also be asked to describe barriers in implementing the program.
- Treatment Evaluation Inventory-Short Form (TEI-SF) Score [ Time Frame: Immediately Post-Treatment ]The Treatment Evaluation Inventory-Short Form will be 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.
- Number of Emergency Department Visits [ Time Frame: 12 months prior to Baseline to 12 months post-treatment ]Healthcare utilization will be extracted from the medical record to document the total number of emergency department (ED) visits for pain for 6-months and 12-months pre- and post-treatment.
- Number of Hospital Admissions [ Time Frame: 12 months prior to Baseline to 12 months post-treatment ]Healthcare utilization will be extracted from the medical record to document the total number of hospital admissions for pain for 6-months and 12-months pre- and post-treatment.
- Change in Daily Opioid Use [ Time Frame: Baseline, Immediately Post-Treatment, Month 3, Month 6 ]Daily use of opioid pain medication will be determined based on participant completion of daily diaries for 1-week at each assessment visit. Participants will record opioid use daily (presence/absence).
- Change in Pediatric Inventory for Parents (PIP) Score [ Time Frame: Baseline, Immediately Post-Treatment, Month 3, Month 6 ]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.
- Change in Adolescent Sleep Wake Scale (ASWS) Score [ Time Frame: Baseline, Immediately Post-Treatment, Month 3, Month 6 ]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 range from 28 to 168 and higher scores indicate better sleep quality.
- Change in PROMIS Pediatric Short Form Depressive Symptoms Score [ Time Frame: Baseline, Immediately Post-Treatment, Month 3, Month 6 ]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.
- Change in Pain Catastrophizing Scale Score [ Time Frame: Baseline, Immediately Post-Treatment, Month 3, Month 6 ]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.
- Change in Pain Stages of Change Questionnaire (PSOCQ) Score [ Time Frame: Baseline, Immediately Post-Treatment, Month 3, Month 6 ]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 to items are given on a 5-point scale where 1 = strongly disagree and 5 = strongly agree. Average scores are obtained for categories of precontemplation, contemplation, action, and maintenance and the category with the highest score indicates where the youth participant is in terms of stages of change related to pain management.
- Change in Interleukin -1β (IL-1β), Concentration [ Time Frame: Baseline, Month 3, Month 6 ]Plasma concentration of the inflammatory biomarker IL-1β will be assessed. IL-1β increases in response to inflammation, pain, and autoimmune diseases.
- Change in Interleukin 6 (IL-6) Concentration [ Time Frame: Baseline, Month 3, Month 6 ]Plasma concentration of the inflammatory biomarker IL-6 will be assessed. IL-6 is increased during injury or illness.
- Change in Interleukin 8 (IL-8) Concentration [ Time Frame: Baseline, Month 3, Month 6 ]Plasma concentration of the inflammatory biomarker IL-8 will be assessed. IL-8 is produced when inflammation is present.
- Change in Tumor Necrosis Factor - Alpha (TNF-α) Concentration [ Time Frame: Baseline, Month 3, Month 6 ]Plasma concentration of the inflammatory biomarker TNF-α will be assessed. TNF-α is a pro-inflammatory cytokine that regulates the inflammatory response and it is elevated during illness or injury.
- Change in C-Reactive Protein (CRP) Concentration [ Time Frame: Baseline, Month 3, Month 6 ]Plasma concentration of the inflammatory biomarker CRP will be assessed. CRP increases in response to bodily inflammation.
- Change in Brain-Derived Neurotrophic Factor (BDNP) Concentration [ Time Frame: Baseline, Month 3, Month 6 ]Plasma concentration of the inflammatory biomarker BDNP will be assessed. BDNP expression is reduced when high bodily inflammation is present.
- Change in Interferon Gamma (IFN-y) Concentration [ Time Frame: Baseline, Month 3, Month 6 ]Plasma concentration of the inflammatory biomarker IFN-y will be assessed. IFN-y is involved with regulating immune and inflammatory responses. IFN-y concentration is elevated during illness.
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|Ages Eligible for Study:||10 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04602728
|Contact: Soumitri Sil, PhDfirstname.lastname@example.org|
|United States, Georgia|
|Children's Healthcare of Atlanta at Hugh Spalding||Recruiting|
|Atlanta, Georgia, United States, 30303|
|Chilldren's Healthcare of Atlanta||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Emory Children's Center||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Soumitri Sil, PhD||Emory University|
|Responsible Party:||Soumitri Sil, Associate Professor, Emory University|
|Other Study ID Numbers:||
1K23HL133457 ( U.S. NIH Grant/Contract )
R03HL164333 ( U.S. NIH Grant/Contract )
|First Posted:||October 26, 2020 Key Record Dates|
|Last Update Posted:||September 22, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Cognitive behavioral therapy
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn