Development and Adaptation of I-STRONG for SCD

Sickle Cell Disease Clinical Trial

Official title:

Integrative Training Program for Pediatric Sickle Cell Pain: Development and Adaptation of I-STRONG for SCD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06110754
• Other study ID #: STUDY00005410
• Secondary ID: R61AT012421-01
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: Emory University
• Contact: Soumitri Sil, PhD
• Phone: 404-727-2712
• Email: soumitri.sil[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta (CHOA)	Atlanta	Georgia
United States	Cincinanti Childrens Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 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, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
Secondary	Change in Brief Pain Inventory (BPI) Pain Interference Score	Functional interference due to pain rated with the impact of pain on daily functions 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, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
Secondary	Change in Patient Health Questionnaire (PHQ-8) Score	Depressive symptoms in past two weeks among teen study participants and parents is assessed with the Patient Health Questionnaire (PHQ-8). The PHQ-8 has 8 items that are responded to on a 4-point scale where " not at all" = 0 and "nearly every day" = 3. Total scores range from 0 to 24 where higher scores indicate increased symptoms of depression.	Baseline, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
Secondary	Change in General Anxiety Disorder (GAD-2) Score	General worry in past two weeks among teen study participants and parents is assessed with the General Anxiety Disorder (GAD-2) instrument. The GAD-2 has 2 items that are responded to on a 4-point scale where " not at all" = 0 and "nearly every day" = 3. Total scores range from 0 to 6 where higher scores indicate increased experiences of worry.	Baseline, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
Secondary	Change in Pain Catastrophizing Scale Score	Exaggerated worried thoughts of pain will be assessed among teen study participants and parents. The Pain Catastrophizing Scale, Child and Parent Report, is a 13-item well-validated self-report and parent-report measure of worried thoughts about pain. Items are answered on a 5-point scale where 0 = not true at all and 4 = very true. Total scores range from 0 to 52 and higher scores indicate increased catastrophic thinking.	Baseline, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
Secondary	Change in Pediatric Quality of Life Inventory (PedsQL) Score	Health-related quality of life and impact on child and family in the past month is assessed among teen study participants and parents with the Pediatric Quality of Life Inventory (PedsQL). The 23-item PedsQL was developed as part of the NIH Roadmap Initiative to create universal measures for patient-reported outcomes, and contains questions in the domains of social-peer, depression, anxiety, mobility, and function. Responses are given on a 5-point scale where 0 = never and 4 = almost always. Items are reverse scored and linearly transformed to a scale of 0 to 100, where higher total mean scores indicate a better quality of life.	Baseline, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
Secondary	Change in Adolescent Sleep-Wake Scale (ASWS) Score	The Adolescent Sleep Wake Scale (ASWS) is a 28-item patient-reported describing the occurrence and frequency of various behavioral sleep characteristics over the past month. Responses are given on a 6-point Likert scale where 1 = always and 6 = never. Total scores range from 28 to 168 and higher scores indicate better sleep quality.	Baseline, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
Secondary	Change in National Institute on Drug Abuse (NIDA)-Modified ASSIST (NM ASSIST) Tool Level 2	Substance use among teen study participants during the past 3 months is assessed with the NIDA-Modified Assist Tool Level 2 for children aged 11-17. The instrument asks respondents how often they have used 15 different substances. Responses are given on a 4-point scale where "not at all" = 0 and "nearly every day" = 4. The tool is scored as the number of items with a score of greater than 0 and multiple items with a score above 0 indicates increased substance use.	Baseline, Month 5 (post-treatment 3-month follow-up)
Secondary	Change in Opioid Use	Daily use of opioid pain medication will be determined based on participant completion of daily diaries for 1-week at each assessment visit. Participants will record opioid use daily (presence/absence).	Baseline, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
Secondary	Change in Patient Global Impression of Change (PGIC) Score	The overall self-reported rating of the efficacy of treatment is assessed with the Patient Global Impression of Change (PGIC) instrument.; The PGIC asks respondents to rate their overall improvement compared to baseline. Responses are indicated on a scale of 1 to 7 where 1 = very much improved and 7 = very much worse.	Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
Secondary	Change in Treatment Evaluation Inventory-Short Form (TEI-SF) Score	The Treatment Evaluation Inventory-Short Form will be completed at the end of treatment. It includes 9 items adapted to be specific to pediatric pain. Items are rated on a 5-point Likert scale ranging from 1 to 5. Total scores range from 9 to 45. Higher scores indicate increased acceptability with the study treatment.	Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)
Secondary	Change in Tampa Scale of Kinesiophobia (TSK) Score	Fear of movement related to fear of pain is assessed with the Tampa Scale of Kinesiophobia (TSK) instrument. The TSK is a 17-item questionnaire where responses are given on a 4-point Likert scale. Responses of "strongly agree" are coded as 1 and responses of "strongly agree" are coded as 4. Total scores range from 17 to 68 where higher scores indicate greater kinesiophobia.	Baseline, Week 8 (post-treatment), Month 5 (post-treatment 3-month follow-up)