Development and Adaptation of I-STRONG for SCD

NCT06110754 | Completed Results DMC

• 3 other identifiers: STUDY00005410R61AT012421-012023P005194
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

This study develops and tests the feasibility and acceptability of an adapted intervention, Integrative Strong Body and Mind Training (I-STRONG), in adolescents with pain from sickle cell disease.

Conditions

Sickle Cell Disease

Keywords

Sickle cell pain; Pediatrics; Mind-body intervention; Behavioral intervention

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (BPI) Pain Severity Score

  Pain intensity is rated with the pain severity item of the Brief Pain Inventory (BPI). The single item is scored on a scale from 0 to 10 where no pain = 0 and severe pain = 10.

  Baseline, Post-treatment (Week 8), 3 Months Post-treatment (Month 5)

Secondary Outcomes (11)

• Brief Pain Inventory (BPI) Pain Interference Score

  Baseline, Post-treatment (Week 8), 3 Months Post-treatment (Month 5)

• Patient Health Questionnaire (PHQ-8) Score

  Baseline, Post-treatment (Week 8), 3 Months Post-treatment (Month 5)

• General Anxiety Disorder (GAD-2) Score

  Baseline, Post-treatment (Week 8), 3 Months Post-treatment (Month 5)

• Pain Catastrophizing Scale Score

  Baseline, Post-treatment (Week 8), 3 Months Post-Treatment (Month 5)

• Pediatric Quality of Life Inventory (PedsQL) Score

  Baseline, Post-treatment (Week 8), 3 Months Post-treatment (Month 5)

Study Arms (2)

Development of I-STRONG for SCD

NO INTERVENTION

Adolescents with sickle cell disease and their parents participating completing in-depth interviews over two sessions as part of adapting an integrative, multicomponent, behavioral intervention combining mind-body, cognitive, and behavioral coping skills with neuromuscular exercise training for adolescents with chronic SCD pain.

I-STRONG for SCD

EXPERIMENTAL

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

Behavioral: I-STRONG for SCD

Interventions

I-STRONG for SCD BEHAVIORAL

I-STRONG for SCD is a group-based, multi-component intervention that includes mind-body, cognitive-behavioral, and neuromuscular movement training. The intervention includes 16 sessions that occur over 8 weeks. Adolescents attend every session and parents attend 6 of the 16 sessions.

I-STRONG for SCD

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with SCD (any genotype)
• Score of at least 3 (indicating medium to high risk for chronic pain) on the Pediatric Pain Screening Tool
• Stable disease-modifying treatments, if applicable, as defined by no newly initiated or significantly increased dosages (mg/kg) in the past 3 months (Aim 2 only)
• English fluency (Aim 2 only)

You may not qualify if:

• Comorbid medical conditions typically associated with pain but unrelated to SCD (e.g., rheumatologic disorders or inflammatory bowel disease)
• Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation (e.g., severe avascular necrosis with limited or non-weight bearing restrictions, significant cognitive or developmental limitations, active suicidal ideation) (Aim 2 only)
• Adolescent 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 (Aim 2 only)

Sponsors & Collaborators

• Emory University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (2)

Children's Healthcare of Atlanta (CHOA)

Atlanta, Georgia, 30322, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Mooney JT, Sinha C, Bakshi N, Nunez A, Adkins T, Thomas S, Beasley K, Akintobi T, Crosby L, Kashikar-Zuck S, Dampier C, Myer GD, Kesar T, Quinn CT, Sil S. Physical activity among adolescents and young adults living with chronic pain and sickle cell disease: a qualitative examination. J Pediatr Psychol. 2025 Dec 1;50(12):1079-1087. doi: 10.1093/jpepsy/jsaf055.

  PMID: 40694814 RESULT

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Soumitri Sil, PhD
• Organization: Emory University

soumitri.sil@emory.edu

404-727-2712

Study Officials

• Soumitri Sil, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants in Aim 1 provide feedback for adapting I-STRONG for SCD while participants in Aim 2 receive the I-STRONG for SCD intervention.

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: June 8, 2023
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2024
• Last Updated: December 19, 2025
• Results First Posted: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available for sharing one year after the end date for this study.
• Access Criteria: Data for sharing will be in a public use, NIH HEAL-approved data repository.

Locations

US (2)