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Recruiting NCT07402811

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

No phase Interventional Chronic Pain Sickle Cell Disease Sleep Disturbance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mobile bindfulness-based intervention.
Who it may be relevant to
Registry conditions: Chronic Pain, Sickle Cell Disease, Sleep Disturbance. Basic parameters: 15 years — 39 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Participant retention rate [Time frame: At 8 weeks (post-intervention)]
  • Attrition rate and reasons for withdrawal [Time frame: Throughout the 8-week intervention period]
  • Weekly module completion rate [Time frame: At 8 weeks (post-intervention)]
  • Acceptability of the Mindfulness-Based Intervention [Time frame: At 8 weeks (post-intervention)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Illinois Chicago — Chicago

Identifiers

NCT: NCT07402811 · STUDY2024-0914-MOD007 · K99NR021195-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗