Mindfulness-Based Intervention for Pain and Sleep in Adolescents and Young Adults With Sickle Cell Disease

NCT07402811 | Recruiting

• 2 other identifiers: STUDY2024-0914-MOD007K99NR021195-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the feasibility and acceptability of a mindfulness-based mobile intervention designed to support pain and sleep management among adolescents and young adults with sickle cell disease. Chronic pain and sleep problems are common in this population and can negatively affect daily functioning and quality of life. Participants will use a smartphone-based mindfulness program that includes structured modules and guided mindfulness exercises over an approximately 8-week period. The study aims to evaluate whether the intervention is feasible and acceptable for adolescents and young adults with sickle cell disease.

Conditions

Chronic Pain; Sickle Cell Disease; Sleep Disturbance

Keywords

sleep; mindfulness-based intervention; mobile health; feasibility study; pain management

Outcome Measures

Primary Outcomes (4)

• Participant retention rate

  Percentage of enrolled participants who remain in the study through the 8-week intervention period

  At 8 weeks (post-intervention)

• Attrition rate and reasons for withdrawal

  Percentage of participants who withdraw from the study and documented reasons for withdrawal

  Throughout the 8-week intervention period

• Weekly module completion rate

  Percentage of assigned weekly modules completed by participants

  At 8 weeks (post-intervention)

• Acceptability of the Mindfulness-Based Intervention

  Acceptability of the digital mindfulness-based intervention assessed using a study-specific acceptability questionnaire. The questionnaire measures multiple dimensions including comfort level, effort required to engage, perceived fairness for patients with sickle cell disease, perceived effectiveness for pain and sleep management, clarity of intervention purpose, confidence in the intervention, interference with other priorities, and overall acceptability. The questionnaire uses 5-point rating scales for all items. The questionnaire also includes open-ended questions about device use, suggested improvements, and helpful and unhelpful aspects of the intervention.

  At 8 weeks (post-intervention)

Study Arms (1)

Mindfulness-based intervention

EXPERIMENTAL

Participants are assigned to a single study arm and receive a mindfulness-based mobile intervention delivered via a smartphone application over approximately 8 weeks.

Behavioral: Mobile bindfulness-based intervention

Interventions

Mobile bindfulness-based intervention BEHAVIORAL

Participants receive a mindfulness-based mobile intervention designed to support symptom management related to pain and sleep. The intervention is delivered via a smartphone application and includes structured mindfulness content such as guided meditation and brief mindfulness exercises. Participants are asked to engage with the intervention over an approximately 8-week period. The study evaluates feasibility and acceptability.

Mindfulness-based intervention

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Individuals aged 15-39 years
• Have been diagnosed with SCD
• Are able to speak and understand English
• Are able to complete questionnaires with minimal or no assistance from a caregiver
• Report pain and/or sleep problems as assessed by the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) short forms
• Have access to the internet on a smartphone, tablet, or computer

You may not qualify if:

• Individuals who have significant cognitive limitations that will impair their ability to use and understand the MBI, as per their health care provider or caregiver
• Are currently receiving an MBI or have received more than 4 sessions of any MBI in the 6 months prior to the screening

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Anemia, Sickle Cell; Parasomnias; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations

Study Officials

• Dahee Wi, PhD, RN

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dahee Wi, PhD, RN

CONTACT

312-996-4473; dwi3@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Associate

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 11, 2026
• Study Start: December 6, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)