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Behavioral Intervention

Back2Life Program for Sickle Cell Disease (Back2Life Trial)

N/A

Waitlist Available

Led By Soumitri Sil, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months prior to baseline to 12 months post-treatment

Awards & highlights

Back2Life Trial Summary

This trial is testing a new training program, Back2Life, to see how well it works for teenagers with chronic pain and sickle cell disease. The program focuses on teaching pain coping skills.

Who is the study for?

This trial is for teenagers with sickle cell disease (SCD) who experience chronic pain. They should not have started new SCD treatments or increased dosages in the past 3 months and must be able to speak and read English.Check my eligibility

What is being tested?

The study tests a training program called Back2Life, which teaches coping skills for managing chronic pain associated with SCD. The goal is to help teens manage their pain better and engage more in daily activities.See study design

What are the potential side effects?

Since Back2Life involves cognitive-behavioral therapy focusing on skill development, there are no direct medical side effects; however, participants may experience emotional discomfort while discussing personal experiences with pain.

Back2Life Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months prior to baseline to 12 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months prior to baseline to 12 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months prior to baseline to 12 months post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Child Self-Efficacy Scale Score

Change in PROMIS Pediatric Short Form Pain Behaviors Score

Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Short Form Pain Interference Score

+5 more

Secondary outcome measures

Change in Adolescent Sleep Wake Scale (ASWS) Score

Brain

C-reactive protein

+12 more

Back2Life Trial Design

1Treatment groups

Experimental Treatment

Group I: Back2Life ProgramExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,833 Previous Clinical Trials

47,306,456 Total Patients Enrolled

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,533 Total Patients Enrolled

Soumitri Sil, PhDPrincipal Investigator - Emory University

Emory University

1 Previous Clinical Trials

12 Total Patients Enrolled

Media Library

Back2Life (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04602728 — N/A

Sickle Cell Disease Research Study Groups: Back2Life Program

Sickle Cell Disease Clinical Trial 2023: Back2Life Highlights & Side Effects. Trial Name: NCT04602728 — N/A

Back2Life (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04602728 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary goal of this research endeavor?

"This clinical trial will assess the efficacy of a certain intervention over 6 months, using PROMIS Pediatric Short Form Depressive Symptoms Score to measure depression levels and Brain-Derived Neurotrophic Factor (BDNP) and Interleukin 6 (IL-6) Concentrations as secondary indicators of bodily inflammation."

Answered by AI

What is the total number of persons being enrolled in this trial?

"Indeed, the information available through clinicaltrials.gov affirms that this medical trial is actively enrolling participants. It was initially published on January 27th 2021 and last updated on September 20th 2022; with a recruitment goal of 50 individuals from 3 sites."

Answered by AI

Is eligibility for this study limited to adults aged 40 or younger?

"This medical trial requires that its participants are within the age range of 10 to 18 years old. There is an abundance of clinical trials available for individuals in this demographic, with 131 studies specifically designed for children and 86 more tailored towards senior citizens."

Answered by AI

What is the eligibility criterion for participation in this experiment?

"The trial is searching for 50 participants between the ages of 10 and 18, who have been diagnosed with anemia or sickle cell disease. To qualify, they must be able to read and speak English fluently, report chronic pain from their condition(s) and not have increased dosages of any existing treatments in the past 3 months (e.g., hydroxyurea, Endari, voxelotor, crizanlizumab)."

Answered by AI

Are individuals currently allowed to sign up for this research endeavor?

"According the clinicaltrials.gov, this trial is actively recruiting individuals to participate in it. Initially posted on January 27th 2021, the study was most recently refreshed on September 20th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Building Adaptive Coping and Knowledge to Improve Daily Life

Soumitri Sil 2021. "Building Adaptive Coping and Knowledge to Improve Daily Life". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04602728.