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NCT Number: NCT07797582

MBI for Pain and Sleep in Adolescents and Young Adults With Sickle Cell Disease

This study examines the efficacy of a mindfulness-based intervention designed to support pain and sleep management in adolescents and young adults with sickle cell disease. Participants will be assigned to either an intervention or usual care group. Participants who are assigned to the intervention group will use a smartphone-based mindfulness program that includes structured modules and guided mindfulness exercises over an approximately 8-week period.

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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 Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Sickle Cell Disease Signs and Symptoms Sleep

Age range

15 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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

Mindfulness-based Intervention

Behavioral

Mobile mindfulness-based intervention for pain and sleep in adolescents and young adults with sickle cell disease

Primary outcomes

  1. Pain interference

    Time frame: At 8 weeks

    Pain interference will be measured using Brief Pain Inventory (higher scores indicating greater pain-related interference).

Secondary outcomes

  1. Pain intensity

    Time frame: At 8 weeks

    Pain intensity will be measured using Brief Pain Inventory (higher scores indicating greater pain-related intensity).

  2. Physical function

    Time frame: At 8 weeks

    Physical function will be assessed using the PROMIS Physical Function Short Form 6b, a 6-item patient-reported measure of self-reported capability for physical activities. Items are scored on a T-score metric (mean 50, SD 10), with higher scores indicating better physical function.

  3. Pain catastrophizing

    Time frame: At 8 weeks

    Pain catastrophizing will be assessed using the Concerns About Pain (CAP) Scale, which measures catastrophic thinking about pain (higher scores indicating greater pain catastrophizing).

  4. Sleep disturbance

    Time frame: At 8 weeks

    Sleep disturbance will be assessed using the PROMIS Sleep Disturbance Short Form 6a. Items are scored on a T-score metric (mean 50, SD 10), with higher scores indicating greater sleep disturbance.

  5. Fatigue

    Time frame: At 8 weeks

    Fatigue will be assessed using the PROMIS Fatigue Short Form 7a, a 7-item patient-reported measure of the experience and impact of fatigue. Items are scored on a T-score metric (mean 50, SD 10), with higher scores indicating greater fatigue.

  6. Anxiety

    Time frame: At 8 weeks

    Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report measure of anxiety symptom severity over the past 2 weeks (higher scores indicating greater anxiety severity).

  7. Depression

    Time frame: At 8 weeks

    Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report measure of depressive symptom severity over the past 2 weeks (higher scores indicating greater depression severity).

  8. Intention

    Time frame: At 8 weeks

    Behavioral intention to engage in mindfulness practice will be assessed using items adapted from the Theory of Planned Behavior (TPB) framework, measuring participants' intention to perform the target behavior (e.g., regular mindfulness practice). Items are rated on a Likert-type scale, with higher scores indicating stronger intention.

  9. Dose intensity

    Time frame: At 8 weeks

    Dose intensity for the intervention group will be quantified using REMedy app usage data, including: (1) total number of modules completed (out of 8), and (2) which specific modules were completed. Higher values indicate greater intervention engagement/dose.

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

Registry information

Official study title

Mindfulness-based Intervention for Pain and Sleep in Adolescents and Young Adults With Sickle Cell Disease: Randomized Clinical Trial

Acronym: REMedy_RCT

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Sep 1, 2026
Registry last updated
Sep 1, 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.

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