Integrative Training for Sickle Cell Disease Pain

(I-STRONG SCD Trial)

Recruiting at 3 trial locations

Overseen By Soumitri Sil, PhD, ABPP

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must be taking: Disease-modifying treatments

Disqualifiers: Rheumatologic disorders, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

155 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special training program can help teens with chronic sickle cell disease (SCD) pain improve their daily life and reduce pain. The program, called I-STRONG for SCD, focuses on teaching skills to strengthen both mind and body. Participants will either start this program early or continue with their usual care and join the program later. It suits teens aged 12-18 who have sickle cell disease, experience regular pain, and are on stable treatments. As an unphased study, this trial offers a unique opportunity for teens to learn new skills that may enhance their quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that adolescents should be on stable disease-modifying treatments, meaning no new or significantly increased dosages in the past 3 months.

What prior data suggests that this program is safe for teens with sickle cell disease?

Research has shown that the methods used in the I-STRONG for SCD program are safe. These methods include mind-body techniques, cognitive and behavioral strategies, and exercises that enhance coordination between the brain and muscles. Studies have found that these approaches can reduce pain and decrease hospital visits for individuals with sickle cell disease. Although this program is still under evaluation, the methods are considered safe and promising for managing sickle cell pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the I-STRONG for SCD treatment because it integrates a holistic training program specifically designed for young people with sickle cell disease (SCD) and their caregivers, alongside traditional medical care. Unlike standard treatments that primarily focus on managing pain through medication, I-STRONG aims to empower patients by teaching them skills to cope with pain, potentially improving their overall quality of life. This approach could provide a more comprehensive way to manage SCD pain, addressing both physical symptoms and emotional well-being, which is why it stands out from conventional options.

What evidence suggests that the I-STRONG program is effective for improving functioning and reducing pain in teens with sickle cell disease?

Research has shown that activities like yoga and mindfulness can help manage long-term pain in people with sickle cell disease (SCD). In this trial, participants may receive the I-STRONG for SCD program, which combines these activities with techniques to change thinking patterns and movement exercises. Early results suggest this program is feasible, well-received, and may improve pain management and daily life. Previous studies have found that such programs can enhance both physical and emotional health. The goal is to help teens with SCD experience less pain and enjoy better overall health. ^{1 3 4 5 6}

Who Is on the Research Team?

Soumitri Sil, PhD, ABPP

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for teenagers with chronic pain due to sickle cell disease (SCD). It's designed to help them manage their condition better. To join, participants must have SCD and experience frequent or long-lasting pain from it.

Inclusion Criteria

Willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study

Speak and read English

I have been diagnosed with sickle cell disease.

Exclusion Criteria

I am currently in a non-drug treatment program like physical therapy.

I have received genetic or stem cell therapy.

Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the I-STRONG for SCD intervention, consisting of 16 group-based telehealth sessions over 8 weeks

8 weeks

16 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Enhanced Usual Care

Participants continue with standard care and optimal management of their SCD and chronic pain

8 months

What Are the Treatments Tested in This Trial?

Interventions

• I-STRONG for SCD

Trial Overview The study tests a group training program called I-STRONG, which aims to strengthen both mind and body in teens with SCD. The effectiveness of this program will be compared against Enhanced Usual Care (EUC) in improving daily function and reducing pain symptoms.

How Is the Trial Designed?

Group I: I-STRONG - Early Start Experimental Treatment 1 Intervention

Youth and caregivers will receive the I-STRONG for SCD intervention in addition to standard care.

Group II: Enhanced Usual Care (EUC) Experimental Treatment 1 Intervention

Participants randomized to EUC will continue with standard care and optimal management of their SCD and chronic pain for approximately 8 months. After completing the 6-month follow-up assessment, participants will have the opportunity to start the I-STRONG SCD intervention.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

Providers at a large urban children's hospital generally have a positive attitude towards using integrative medicine (IM) for managing pain in children with sickle cell disease (SCD), but they do not optimally utilize these therapies due to barriers like lack of integration processes and transient resources.

To enhance the use of IM for SCD-related pain, there is a need for better education for providers about the efficacy of IM and the development of protocols to incorporate these therapies into patient management plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider Perspective on Integrative Medicine for Pediatric Sickle Cell Disease-related Pain. Neri, CM., Beeson, T., Mead, H., et al.[2020]

This study aims to evaluate the acceptability and preliminary efficacy of a telephonic mindfulness-based intervention (MBI) for managing chronic pain in 60 adults with sickle cell disease (SCD).

Participants will be randomized into an MBI group or a wait-listed control group, with the MBI consisting of six 60-minute sessions, and outcomes will be assessed through questionnaires and interviews to measure pain catastrophizing and overall intervention acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial. Williams, H., Silva, S., Simmons, LA., et al.[2018]

Adults with sickle cell disease (SCD) showed significantly lower levels of cardiorespiratory endurance and muscle strength compared to healthy controls, indicating potential fitness challenges associated with the condition.

A positive correlation was found between muscular strength and cardiorespiratory endurance in adults with SCD, suggesting that improving muscle strength may benefit overall cardiopulmonary health in these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of cardiopulmonary endurance and muscular strength in adults living with sickle cell disease. Ogunsile, FJ., Stewart, KJ., Kanter, J., et al.[2022]

Inspiratory muscle training (IMT) significantly improved respiratory muscle strength, lung function, and exercise tolerance in adults with sickle cell anemia, regardless of whether they received true or sham training, indicating a potential benefit of IMT for this patient group.

After 18 weeks of home-based IMT, both groups experienced reductions in dyspnea during daily activities and improvements in fatigue impact, suggesting that IMT can enhance quality of life for individuals with sickle cell anemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of home-based inspiratory muscle training on sickle cell disease (SCD) patients. Galvão, F., Zanoni, CT., Moreira, MM., et al.[2021]

In a study of 156 adults with sickle cell disease, somatization was found to significantly predict pain severity and intensity, indicating that those who focus excessively on their health may experience more pain.

Somatization also correlated with negative psychological outcomes such as depression and anxiety, suggesting that mental health is closely linked to pain perception in patients with sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Somatization in the conceptualization of sickle cell disease. Wellington, C., Edwards, CL., McNeil, J., et al.[2022]

There is a need for clear exercise guidelines for individuals with sickle cell trait (SCT) and sickle cell anemia (SCA) due to concerns about the risks of high-intensity exercise, which may lead to complications like pain and collapse.

Understanding the distinct issues and mechanisms that affect exercise-related risks in SCT and SCA is crucial for developing safe and effective exercise prescriptions, highlighting the importance of balancing the benefits of exercise against potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balancing exercise risk and benefits: lessons learned from sickle cell trait and sickle cell anemia. Liem, RI.[2019]

In a study involving 37 children and adolescents with sickle cell disease, cognitive-behavioral and physical pain management activities were reported to be used alongside analgesics on 77% of pain days, indicating a common practice of combining these methods for pain relief.

The findings suggest that as pain intensity increases, patients, particularly females, are more likely to engage in various pain management activities, highlighting the need for additional training and support for families in using these non-pharmacologic strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and cognitive-behavioral activities used in the home management of sickle pain: a daily diary study in children and adolescents. Dampier, C., Ely, E., Eggleston, B., et al.[2022]

The Balance Program, a four-week telemedicine intervention for youth with sickle cell disease (SCD), was found to be feasible and highly acceptable, with 90% of participants completing all sessions and positive feedback from both youth and caregivers.

Approximately 44% of youth and 47% of caregivers reported significant improvements in pain interference after the intervention, indicating that behavioral approaches can effectively complement traditional pharmacological treatments for managing pain in SCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of the Balance Program to reduce pain-related disability in pediatric sickle cell disease. Connolly, ME., Forman, S., Sharkey, CM., et al.[2023]

The American Society of Hematology developed 18 evidence-based recommendations for managing acute and chronic pain in individuals with sickle cell disease, emphasizing a comprehensive approach that includes both pharmacological and nonpharmacological interventions.

Most recommendations are conditional due to low-certainty evidence, highlighting the need for patient preferences in clinical decisions and the necessity for further research, including randomized controlled trials, to improve pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American Society of Hematology 2020 guidelines for sickle cell disease: management of acute and chronic pain. Brandow, AM., Carroll, CP., Creary, S., et al.[2021]

Adolescents with sickle cell disease (SCD) and chronic pain generally have a positive attitude towards yoga, indicating potential acceptability for a yoga program as a complementary therapy.

Despite the positive opinions, the study faced significant challenges in recruitment and retention, with only 60% of surveyed participants moving to the yoga intervention, and very low attendance at the sessions, highlighting feasibility issues for in-person group yoga interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of the acceptability, feasibility and safety of yoga for chronic pain in sickle cell disease. Bakshi, N., Cooley, A., Ross, D., et al.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124030386

Integrative Strong Body and Mind Training for Sickle Cell ... I-STRONG is an integrative, multicomponent program for chronic SCD pain management with strong feasibility, acceptability, and preliminary efficacy to improve ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06691867

Integrative Training Program for Pediatric Sickle Cell Pain I-STRONG for SCD integrates evidence-based mind-body, cognitive-behavioral, and neuromuscular movement training. It will be tested using an individually ...

3. researchgate.net researchgate.net/publication/386473541_Integrative_Strong_Body_and_Mind_Training_for_Sickle_Cell_Disease_I-STRONG-an_Interdisciplinary_Multicomponent_Treatment_Approach_for_Pediatric_Chronic_SCD_Pain

Integrative Strong Body and Mind Training for Sickle Cell ... Results informed further optimization of I-STRONG toward a planned multi-site, randomized clinical trial to address critical gaps in evidence of integrative ...

4. withpower.com withpower.com/trial/integrative-training-for-sickle-cell-disease-pain-2213d

Integrative Training for Sickle Cell Disease Pain Research suggests that integrative approaches like yoga and mindfulness can help manage chronic pain in sickle cell disease. These methods are considered safe ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06110754/development-and-adaptation-of-i-strong-for-scd

Development and Adaptation of I-STRONG for SCD This study develops and tests the feasibility and acceptability of an adapted intervention, Integrative Strong Body and Mind Training (I-STRONG) ...

6. ash.confex.com ash.confex.com/ash/2024/webprogram/Paper209083.html

Integrative Strong Body and Mind Training for Sickle Cell ... We aimed to 1) utilize community engagement and patient and caregiver perspectives to adapt and refine an integrative multicomponent treatment program (I-STRONG) ...