Training program to help teens with sickle cell pain
Integrative Strong Body and Mind Training for Pediatric Sickle Cell Pain (I-STRONG for SCD): Multi-site, Randomized Clinical Trial
NA · Emory University · NCT06691867
This study is testing a new training program to see if it can help teens with sickle cell disease manage their pain and improve their daily activities.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 155 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Emory University (other) |
| Drugs / interventions | crizanlizumab |
| Locations | 4 sites (Hartford, Connecticut and 3 other locations) |
| Trial ID | NCT06691867 on ClinicalTrials.gov |
What this trial studies
This research evaluates the I-STRONG program, which combines mind-body, cognitive-behavioral, and neuromuscular movement training to assist adolescents with chronic sickle cell disease pain. The program consists of 16 group-based telehealth sessions over 8 weeks, aimed at improving everyday functioning and reducing pain symptoms. Participants will be randomly assigned to either start the program immediately or receive enhanced usual care before starting the program later. The study will assess the effectiveness of this intervention compared to standard care alone over a 3-month follow-up period.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-18 with a documented diagnosis of sickle cell disease and chronic pain.
Not a fit: Patients with significant comorbid medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve pain management and quality of life for teens suffering from sickle cell disease.
How similar studies have performed: Other studies have shown promise with similar integrative approaches, but this specific program is novel in its design and focus on adolescents with sickle cell disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of signed and dated informed consent form for adolescents 18 years old and caregivers' participation * For children \<18, informed assent and parental informed consent to participate in the study * Willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study * Males and females; Ages 12-18 years for adolescents; no age limitations for caregivers * Documented diagnosis of sickle cell disease (any genotype) for adolescents * Adolescent scores at least 3 on the Pediatric Pain Screening Tool * Adolescent reports typical pain intensity in the past week at least 4 on a 0-10 cm Visual Analog Scale * Adolescent on stable disease-modifying treatments, if applicable (e.g., hydroxyurea, glutamine, voxelotor, crizanlizumab) as defined by not newly initiated or significantly increased dosages (mg/kg) in the past 3 months * Speak and read English Exclusion Criteria: * An adolescent has comorbid medical conditions typically associated with pain but unrelated to SCD (e.g., rheumatologic disorders or inflammatory bowel disease) * Adolescent has undergone genetic or hematopoietic stem cell therapy * Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation * Adolescents receiving active treatment (e.g., weekly appointments with a provider) for nonpharmacological therapies (e.g., structured behavioral pain management, physical therapy, or acupuncture program) that overlap with the active phase of the study intervention
Where this trial is running
Hartford, Connecticut and 3 other locations
- Connecticut Children's Medical Center — Hartford, Connecticut, United States (RECRUITING)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (RECRUITING)
- Arthur M. Blank Hospital | Children's Healthcare of Atlanta — Atlanta, Georgia, United States (RECRUITING)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Soumitri Sil, PhD, ABPP — Emory University
- Study coordinator: Soumitri Sil, PhD, ABPP
- Email: sil@emory.edu
- Phone: 404-727-2712
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sickle Cell Disease, Sickle Cell Pain, Lifestyle considerations, Pediatrics, Behavioral intervention, Mind-body intervention