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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
No Placebo-Only Group

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.
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.
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.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Change in Adolescent Sleep Wake Scale (ASWS) Score
Brain
C-reactive protein
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Back2Life
2021
N/A
~40

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,919 Previous Clinical Trials
47,759,788 Total Patients Enrolled
Emory UniversityLead Sponsor
1,693 Previous Clinical Trials
2,603,956 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
~8 spots leftby Oct 2025