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Behavioral Intervention

I-STRONG Program for Sickle Cell Disease

N/A

Recruiting

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

Diagnosed with SCD (any genotype)

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8 (post-treatment), month 5 (post-treatment 3-month follow-up)

Awards & highlights

Study Summary

This trial tests an adapted exercise and mental health program to help adolescents with pain from sickle cell disease.

Who is the study for?

This trial is for adolescents with sickle cell disease who speak English and have a medium to high risk for chronic pain. They should be on stable treatments without significant changes in the past 3 months. Those with other painful conditions or severe physical/psychological limitations, or currently receiving certain nonpharmacological therapies are excluded.Check my eligibility

What is being tested?

The study is testing I-STRONG for SCD, an adapted intervention aimed at strengthening both body and mind to help manage pain in adolescents with sickle cell disease. It will assess how practical and acceptable this approach is for these patients.See study design

What are the potential side effects?

Since I-STRONG for SCD focuses on integrative training rather than medication, specific side effects are not listed; however, any potential discomfort from participation would be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with sickle cell disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8 (post-treatment), month 5 (post-treatment 3-month follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8 (post-treatment), month 5 (post-treatment 3-month follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 (post-treatment), month 5 (post-treatment 3-month follow-up) 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 Brief Pain Inventory (BPI) Pain Severity Score

Secondary outcome measures

Change in Adolescent Sleep-Wake Scale (ASWS) Score

Change in Brief Pain Inventory (BPI) Pain Interference Score

Change in General Anxiety Disorder (GAD-2) Score

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: I-STRONG for SCDExperimental Treatment1 Intervention

Adolescents with sickle cell disease and their parents participating in a multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,640 Previous Clinical Trials

2,560,645 Total Patients Enrolled

National Center for Complementary and Integrative Health (NCCIH)NIH

833 Previous Clinical Trials

669,441 Total Patients Enrolled

Soumitri Sil, PhDPrincipal InvestigatorEmory University

1 Previous Clinical Trials

40 Total Patients Enrolled

Frequently Asked Questions

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

Are there any slots available in this research project?

"According to the data hosted on clinicaltrials.gov, this investigation is in its recruitment phase and needs volunteers for participation. The first posting of this trial was November 1st 2023 with the latest update being October 26th 2023."

Answered by AI

Am I eligible to join this medical experimentation?

"This clinical trial, which is recruiting a total of 12 people, requires that applicants have sickle cell disease and are between the ages of 12 to 18."

Answered by AI

How many subjects are enrolled in this experiment?

"Affirmative, the medical trial is actively looking for volunteers. The original posting of this study was on November 1st 2023 and it has since been updated to October 26th 2023. 12 participants are required from two distinct locations."

Answered by AI

Does this experiment include elderly participants?

"This specific clinical trial is recruiting adolescents in the age range of 12-18. Additionally, there are 120 trials that accept young participants and 78 for geriatric patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Development and Adaptation of I-STRONG for SCD

Soumitri Sil 2023. "Development and Adaptation of I-STRONG for SCD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06110754.