Clinical trial NCT06691867: Integrative Training Program for Pediatric Sickle Cell Pain
Official title: Integrative Strong Body and Mind Training for Pediatric Sickle Cell Pain (I-STRONG for SCD): Multi-site, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Pain
Lifestyle considerations
Pediatrics
Behavioral intervention
Mind-body intervention
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-11-18
Enrollment: 155
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research aims to answer the question: does a group training program specifically for teens with chronic sickle cell disease (SCD) pain that teaches skills to strengthen the mind and body help improve everyday functioning and reduce pain symptoms?

The program will be tailored to address challenges related to frequent or chronic sickle cell pain and may improve participants' physical and emotional health.

The program, called I-STRONG for SCD (Integrative Strong Body and Mind Training for Sickle Cell Disease), may help improve everyday functioning and pain symptoms in teens with chronic pain related to SCD. The research team aims to determine how participants (teens and parents) respond to this program.

Detailed description: I-STRONG for SCD integrates evidence-based mind-body, cognitive-behavioral, and neuromuscular movement training. It will be tested using an individually randomized group treatment (IRGT) design, comparing early start to the enhanced usual care. The primary objective is to determine whether I-STRONG for SCD combined with standard care is more effective than standard care alone in improving pain intensity from baseline to the 3-month follow-up in adolescents with SCD.

Adolescent participants with sickle cell disease and their caregivers will be recruited for this study. Participants of all genders, races, and ethnicities are eligible, with a majority expected to be Black or African American females, consistent with previous studies of individuals with SCD and chronic pain. The study will last approximately 36 months, with participant involvement lasting 9 months.

I-STRONG for SCD has been adapted based on feedback from patients and caregivers, focusing on chronic SCD pain. In addition to usual care, participants will receive the I-STRONG intervention, which consists of 16 group-based telehealth sessions (90 minutes each), held twice weekly for 8 weeks. All patients can participate in I-STRONG, with randomization determining whether they begin with Early Start (after completing the baseline assessment) or Enhanced Usual Care (approximately 8 months after the baseline assessment).

Eligibility 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

Primary outcomes:
measure: Brief Pain Inventory (BPI) Pain severity
timeFrame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
Secondary outcomes:
measure: Change in Brief Pain Inventory (BPI) Pain Interference Score
timeFrame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
measure: Patient Health Questionnaire (PHQ-8) Score
timeFrame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
measure: General Anxiety Disorder (GAD-2)
timeFrame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
measure: Pain Catastrophizing Scale
timeFrame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
measure: Pediatric Quality of Life Inventory (PedsQL) Score
timeFrame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
measure: Adolescent Sleep-Wake Scale (ASWS) Score Short Form
timeFrame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
measure: National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST) Tool Level 2 score
timeFrame: Baseline, 3 months post-intervention
measure: Opioid Use
timeFrame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
measure: Opioid morphine milligram equivalent Use
timeFrame: Baseline and 3 months post-intervention
measure: Patient Global Impression of Change (PGIC) Score
timeFrame: Baseline, 3 months and 6 months post-intervention
measure: Treatment Evaluation Inventory-Short Form (TEI-SF) Score
timeFrame: Immediately post-intervention
measure: Tampa Scale of Kinesiophobia (TSK) Score
timeFrame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
measure: PROMIS Pediatric Fatigue Short Form
timeFrame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
measure: Chronic Pain Acceptance Questionnaire (CPAQ)
timeFrame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
measure: Coping Self-Efficacy
timeFrame: Baseline, immediately post-intervention, 3 months and 6 months post-intervention
measure: Therapeutic Factor Inventory - 8 (TFI-8)
timeFrame: Immediately post-intervention
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Arthur M. Blank Hospital | Children's Healthcare of Atlanta
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, ABPP
role: PRINCIPAL_INVESTIGATOR
References: