NCT07797582

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
27mo left

Started Feb 2027

Typical duration for not_applicable chronic-pain

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2027

Expected
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

2.2 years

First QC Date

August 26, 2026

Last Update Submit

September 15, 2026

Conditions

Chronic PainSickle Cell DiseaseSleep

Keywords

sleepmindfulness-based interventionmobile healthpilot studypain management

Outcome Measures

Primary Outcomes (1)

  • Pain interference

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

    At 8 weeks

Secondary Outcomes (9)

  • Pain intensity

    At 8 weeks

  • Physical function

    At 8 weeks

  • Pain catastrophizing

    At 8 weeks

  • Sleep disturbance

    At 8 weeks

  • Fatigue

    At 8 weeks

  • +4 more secondary outcomes

Study Arms (2)

Mindfulness-based intervention

EXPERIMENTAL

Participants who are assigned to an intervention group receive a mindfulness-based mobile intervention delivered via a smartphone application over approximately 8 weeks.

Behavioral: Mindfulness-based intervention

Usual care group

NO INTERVENTION

Participants who are assigned to a usual care group receive usual care over approximately 8 weeks.

Interventions

Mindfulness-based interventionBEHAVIORAL

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

Mindfulness-based intervention

Eligibility Criteria

Age15 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic PainAnemia, Sickle CellAgnosia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Dahee Wi, PhD, RN

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dahee Wi, PhD, RN

CONTACT

312-996-4473dwi3@uic.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 26, 2026

First Posted

September 1, 2026

Study Start (Estimated)

February 1, 2027

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

September 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share