Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07402811

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Pain Agnosia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Parasomnias Pathological Conditions, Signs and Symptoms Perceptual Disorders Sickle Cell Disease Signs and Symptoms Sleep Disturbance Sleep Wake Disorders

Age range

15 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location status: Recruiting

Location contact

Dahee Wi, PhD, RN

CONTACT

[email protected]

312-996-4473

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Participant retention rate

    Time frame: At 8 weeks (post-intervention)

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

  2. Attrition rate and reasons for withdrawal

    Time frame: Throughout the 8-week intervention period

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

  3. Weekly module completion rate

    Time frame: At 8 weeks (post-intervention)

    Percentage of assigned weekly modules completed by participants

  4. Acceptability of the Mindfulness-Based Intervention

    Time frame: At 8 weeks (post-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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dahee Wi, PhD, RN

CONTACT

[email protected]

312-996-4473

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: REMedy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.