Sickle Cell DiseaseBack2LifeNCT04602728
Building Adaptive Coping and Knowledge to Improve Daily Life
A study testing Back2Life in people with Sickle Cell Disease, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Back2Life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Jan 2021to 18 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Healthcare of Atlanta at Hughes Spalding
Atlanta, Georgia, 30303
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Emory Children's Center
Atlanta, Georgia, 30322
About this study
Official title: 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.
Read the 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Back2Life
- Keywords
- Pediatrics, Cognitive behavioral therapy, Behavioral intervention
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back2LifeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Back2Life Program | Experimental | Youth with chronic SCD pain and their parents or caregivers receiving an adaptive cognitive behavioral treatment program for pain coping skills. Receives: Behavioral: Back2Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately Post-Treatment
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start27 Jan 2021
- Primary completion23 Aug 2023
- Study completion18 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Youth and parent/caregiver dyads will participate in the same intervention.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Soumitri Sil, Emory University
- Investigators
- Soumitri Sil, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602728
- Sponsor's protocol ID
- STUDY00000573
- Other IDs
- 1K23HL133457, R03HL164333
- Acronym
- Back2Life
- Status last verified
- Jun 2025
- First submitted
- 20 Oct 2020
- Last updated
- 29 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Adaptive Coping and Knowledge to Improve Daily Life (Back2Life): A Pilot Feasibility Clinical Trial for Youth With Chronic Sickle Cell Pain
- ClinicalTrials.gov ID
- NCT04602728
- Acronym / sponsor ID
- Back2Life / STUDY00000573
- Conditions
- Sickle Cell Disease
- Keywords
- Pediatrics, Cognitive behavioral therapy, Behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 18 May 2024 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Posted 13 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Youth and parent/caregiver dyads will participate in the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Back2Life Program | Experimental | Behavioral: Back2LifeYouth with chronic SCD pain and their parents or caregivers receiving an adaptive cognitive behavioral treatment program for pain coping skills. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Back2LifeThe 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. | Behavioural | Back2Life Program |
Primary outcome
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.
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-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.
PROMIS Pediatric Short Form Pain Behaviors, Parent-Proxy Report 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.
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 was assessed by the number of participant dyads who complete the study.
Number of Dyads Completing Study Assignments Within Six Months
Time frame: Month 6
Treatment feasibility was assessed by the number of dyads completing the 6-Month study assignment.
Number of Participants With Positive Experiences During Participant Evaluation of the Intervention Interview
Time frame: Immediately Post-Treatment
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.
Treatment Evaluation Inventory-Short Form (TEI-SF) Score
Time frame: Immediately Post-Treatment
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.
15 secondary outcomes
Emergency Department Visits Per Participant
Time frame: 12 months prior to Baseline, 12 months post-treatment
Hospital Admissions Per Participant
Time frame: 12 months prior to Baseline, 12 months post-treatment
Days Per Week of Opioid Use
Time frame: Baseline, Immediately Post-Treatment, Month 3, Month 6
Pediatric Inventory for Parents (PIP) Score
Time frame: Baseline, Immediately Post-Treatment, Month 3, Month 6
Adolescent Sleep Wake Scale (ASWS) Score
Time frame: Baseline, Immediately Post-Treatment, Month 3, Month 6
PROMIS Pediatric Short Form Depressive Symptoms Score
Time frame: Baseline, Immediately Post-Treatment, Month 3, Month 6
Pain Catastrophizing Scale Score
Time frame: Baseline, Immediately Post-Treatment, Month 3, Month 6
Pain Stages of Change Questionnaire (PSOCQ) Action Scale Score
Time frame: Baseline, Immediately Post-Treatment, Month 3, Month 6
Interleukin -1β (IL-1β) Concentration
Time frame: Baseline, Month 3, Month 6
IInterleukin 6 (IL-6) Concentration
Time frame: Baseline, Month 3, Month 6
Interleukin 8 (IL-8) Concentration
Time frame: Baseline, Month 3, Month 6
Tumor Necrosis Factor - Alpha (TNF-α) Concentration
Time frame: Baseline, Month 3, Month 6
C-Reactive Protein (CRP) Concentration
Time frame: Baseline, Month 3, Month 6
Brain-Derived Neurotrophic Factor (BDNF) Concentration
Time frame: Baseline, Month 3, Month 6
Interferon Gamma (IFN-y) Concentration
Time frame: Baseline, Month 3, Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soumitri Sil, PhD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Back2Life in people with Sickle Cell Disease, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Short Form Pain Interference Score (time frame: Baseline, Immediately Post-Treatment, Month 3, Month 6). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.