Development and Adaptation of I-STRONG for SCD

NCT ID: NCT06110754

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-08
• Study Completion Date: 2024-06-14

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.

Detailed Description

Pain is the hallmark feature of sickle cell disease (SCD), a life-limiting chronic illness that disproportionately affects African Americans. Well-documented racial disparities complicate effective pain control and the under-treatment of pain experienced by Black Americans with SCD. Approximately 20% of youth with SCD develop chronic pain and experience significant functional impairment, diminished quality of life, and comorbid depression and anxiety that can worsen over time. Youth with chronic SCD pain often are stuck in a vicious cycle of pain, functional impairment, and pain-related fear of movement that contributes to activity avoidance and exacerbates pain. The most effective chronic SCD pain management requires multicomponent, interdisciplinary treatment approaches that include integrative mind-body treatments. Mind-body approaches, specifically diaphragmatic breathing, progressive muscle relaxation, and guided imagery, can improve outcomes for youth with chronic pain. However, multicomponent interventions tailored for chronic SCD pain have never been established. Most pain interventions are developed and studied largely with white youth, do not address cultural influences, and consequently have limited generalizability for minoritized populations that experience health disparities like SCD. There is a critical need for effective, culturally tailored, integrative pain management approaches to address health disparities and improve outcomes for youth with SCD whose chronic pain can persist into adulthood.

To address this unmet need, the researchers will leverage an existing innovative intervention designed for juvenile fibromyalgia, the Fibromyalgia Integrative Training for Teens (FIT Teens). Recent clinical practice guidelines for SCD pain identified fibromyalgia as most closely aligned with chronic pain in SCD to inform treatment recommendations; thus, FIT Teens is well-suited for adaptation and testing for SCD. FIT Teens is an 8-week (16 session) group-based telehealth intervention that combines mind-body, cognitive-behavioral, and neuromuscular movement approaches. Early trials of FIT Teens found excellent patient engagement, and medium to large effects on reducing disability, pain, depressive symptoms, and fear of movement without adverse effects of pain exacerbation. An ongoing multicenter trial of FIT Teens has excellent patient retention (>80%, n=300 enrolled). The mind-body, cognitive-behavioral, and neuromuscular movement treatment components will form the basis of a new multicomponent integrative intervention tailored for SCD.

Aim 1 of this study is to adapt and refine the integrative components of the FIT Teens intervention to develop a new culturally tailored I-STRONG intervention for youth with chronic SCD pain. The investigators will conduct mixed method approaches and purposive sampling to collect qualitative feedback informed by patient and family lived experiences regarding intervention content, format, perceived benefits, and barriers/facilitators to engagement from 15 patients (12 to 18 years of age) with chronic SCD pain and their parents and about 8 adolescents and 8 parents to participate in stakeholder advisory boards. Community stakeholder advisory boards and iterative design will inform intervention adaptation and refinement to enhance clinical implementation. Outcome measures are not collected from participants in Aim 1 as the purpose of this part of the study is to prepare the I-STRONG intervention to be studied for Aim 2.

Aim 2 of the study is to assess feasibility and acceptability of I-STRONG intervention for youth with chronic SCD pain. The investigators will conduct a single-arm proof-of-concept study of the I-STRONG intervention with 12 adolescents (12 to 18 years of age), and the parents of adolescents under the age of 18, to iteratively optimize the feasibility and acceptability of I-STRONG in youth with chronic SCD pain. Feasibility will be demonstrated by rates of study enrollment, retention, and adherence (target goals set at ≥ 75%). Acceptability will be demonstrated by treatment burden, satisfaction, and tolerability. Qualitative feedback about the program format and content will inform additional intervention optimization, refinement, and enhance feasibility and acceptability.

Support from and inclusion in the National Institutes of Health (NIH) Helping to End Addiction Long-term Initiative (HEAL), or NIH HEAL Initiative, is provided for this study. For more information about the initiative visit the HEAL Initiative (https://heal.nih.gov/).

Conditions

Sickle Cell Disease

Keywords

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Development of I-STRONG for SCD

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

I-STRONG for SCD

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

Group Type: EXPERIMENTAL

I-STRONG for SCD

Intervention Type: 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.

Interventions

I-STRONG for SCD

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Soumitri Sil

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soumitri Sil, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Healthcare of Atlanta (CHOA)

Atlanta, Georgia, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

References

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 Jul 22:jsaf055. doi: 10.1093/jpepsy/jsaf055. Online ahead of print.

Reference Type: RESULT

PMID: 40694814 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R61AT012421-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023P005194

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00005410

Identifier Type: -

Identifier Source: org_study_id