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

February 11, 2026 updated by: Dahee Wi, University of Illinois at Chicago
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dahee Wi, PhD, RN
  • Phone Number: 312-996-4473
  • Email: dwi3@uic.edu

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Chicago
        • Contact:
          • Dahee Wi, PhD, RN
          • Phone Number: 312-996-4473
          • Email: dwi3@uic.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-based intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 8 weeks (post-intervention)
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
Throughout the 8-week intervention period
Weekly module completion rate
Time Frame: At 8 weeks (post-intervention)
Percentage of assigned weekly modules completed by participants
At 8 weeks (post-intervention)
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.
At 8 weeks (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Dahee Wi, PhD, RN, University of Illinois Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY2024-0914-MOD007
  • K99NR021195-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Clinical Trials on Mobile bindfulness-based intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe