Clinical trial NCT06110754: Development and Adaptation of I-STRONG for SCD
Official title: Integrative Training Program for Pediatric Sickle Cell Pain: Development and Adaptation of I-STRONG for SCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Sickle cell pain
Pediatrics
Mind-body intervention
Behavioral intervention
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2023-11-01
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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, Integrative Strong Body and Mind Training (I-STRONG) 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) 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.

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)

Primary outcomes:
measure: Change in Brief Pain Inventory (BPI) Pain Severity Score
timeFrame: Baseline, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
Secondary outcomes:
measure: Change in Brief Pain Inventory (BPI) Pain Interference Score
timeFrame: Baseline, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
measure: Change in Patient Health Questionnaire (PHQ-8) Score
timeFrame: Baseline, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
measure: Change in General Anxiety Disorder (GAD-2) Score
timeFrame: Baseline, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
measure: Change in Pain Catastrophizing Scale Score
timeFrame: Baseline, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
measure: Change in Pediatric Quality of Life Inventory (PedsQL) Score
timeFrame: Baseline, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
measure: Change in Adolescent Sleep-Wake Scale (ASWS) Score
timeFrame: Baseline, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
measure: Change in National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST) Tool Level 2
timeFrame: Baseline, Month 5 (post-treatment 3-month follow-up)
measure: Change in Opioid Use
timeFrame: Baseline, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
measure: Change in Patient Global Impression of Change (PGIC) Score
timeFrame: Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
measure: Change in Treatment Evaluation Inventory-Short Form (TEI-SF) Score
timeFrame: Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
measure: Change in Tampa Scale of Kinesiophobia (TSK) Score
timeFrame: Baseline, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta (CHOA)
state: Georgia
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Emory University
name: Soumitri Sil, PhD
role: PRINCIPAL_INVESTIGATOR
References: