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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 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
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 moreSecondary study objectives
Change in Adolescent Sleep Wake Scale (ASWS) Score
Brain
C-reactive protein
+12 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with sickle cell disease, regardless of the type.You experience long-term pain.You have not started or significantly increased dosages of any medication for your condition in the last three months.You must be able to understand and communicate in English.
Research Study Groups:
This trial has the following groups:- Group 1: Back2Life Program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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