Mindfulness-Based Intervention for Sickle Cell Disease

(REMedy Trial)

Overseen By Dahee Wi, PhD, RN

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Cognitive limitations, Current MBI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile mindfulness program to help manage pain and sleep issues in people with sickle cell disease. The researchers aim to determine if this smartphone-based program can improve daily life for those dealing with chronic pain and sleep problems in a practical and enjoyable way. Participants will use the app, which includes mindfulness exercises, for about eight weeks. Ideal candidates are aged 15-39, diagnosed with sickle cell disease, and experiencing pain or sleep troubles, with access to the internet on a smartphone or similar device. As an unphased trial, this study provides a unique opportunity to explore innovative ways to enhance quality of life.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mindfulness app, so you might not need to change your medication routine.

What prior data suggests that this mindfulness-based intervention is safe for adolescents and young adults with sickle cell disease?

Research shows that mindfulness exercises are generally well-received by people with sickle cell disease. In earlier studies, participants reported feeling less pain, anxiety, and depression after practicing mindfulness. Researchers noted no major side effects, indicating that this approach is safe for most people. These exercises usually include guided activities that help reduce stress and improve sleep. Since mindfulness practices do not involve any medical procedures, they are considered low-risk. This makes them a promising choice for people who want to manage sickle cell symptoms without using medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mindfulness-based mobile intervention for sickle cell disease because it offers a new way to manage pain and stress without medication. Unlike traditional treatments that focus on pain relief through drugs like opioids, this intervention uses a smartphone app to teach mindfulness techniques over about eight weeks. This approach could empower patients to better handle their symptoms and improve their quality of life, making it an innovative complement to existing care options.

What evidence suggests that this mindfulness-based intervention is effective for managing pain and sleep in sickle cell disease?

Research has shown that mindfulness practices can improve well-being in people with sickle cell disease. Studies have found that these techniques can reduce pain, anxiety, and depression. For example, one mindfulness program helped participants experience less pain and improved emotional health. In this trial, participants will receive a mindfulness-based mobile intervention delivered via a smartphone application over approximately 8 weeks. This suggests that using a mindfulness app might help manage ongoing pain and sleep problems in teenagers and young adults with sickle cell disease. While more research is needed, early results are encouraging for using mindfulness as a supportive treatment. ^{1 2 3 5 6}

Who Is on the Research Team?

Dahee Wi, PhD, RN

Principal Investigator

University of Illinois Chicago

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults with sickle cell disease who often experience chronic pain and sleep issues. The study will help determine if a mobile mindfulness program can improve their daily functioning and quality of life.

Inclusion Criteria

Able to complete questionnaires with minimal or no assistance from a caregiver

Have access to the internet on a smartphone, tablet, or computer

Able to speak and understand English

Exclusion Criteria

I have cognitive issues that affect my understanding or use of the MBI.

I am currently undergoing or have completed more than 4 MBI sessions in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a smartphone-based mindfulness program for pain and sleep management

8 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mobile Mindfulness-Based Intervention

Trial Overview

The trial tests a smartphone-based mindfulness program, which includes structured modules and guided exercises over about 8 weeks, to manage pain and sleep problems in those with sickle cell disease.

How Is the Trial Designed?

Group I: Mindfulness-based intervention Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5432983/

A telephonic mindfulness-based intervention for persons with ...

One of the most difficult symptoms for persons with sickle cell disease (SCD) to manage is chronic pain. Chronic pain impacts approximately one-third of persons ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07402811

Mindfulness-Based Intervention for Pain and Sleep in ...

The study aims to evaluate whether the intervention is feasible and acceptable for adolescents and young adults with sickle cell disease. Official Title.

3.

medschool.uci.edu

medschool.uci.edu/news/uci-led-research-team-discovers-mindfulness-techniques-and-online-tools-ease-sickle-cell

UCI-led research team discovers mindfulness techniques ...

Participants experienced a decrease in pain intensity, anxiety and depression after completing the study exercises.

4.

link.springer.com

link.springer.com/article/10.1186/s13063-017-1948-x

A telephonic mindfulness-based intervention for persons with ...

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial. Study ...

5.

researchgate.net

researchgate.net/publication/317008371_A_telephonic_mindfulness-based_intervention_for_persons_with_sickle_cell_disease_Study_protocol_for_a_randomized_controlled_trial

A telephonic mindfulness-based intervention for persons ...

A telephonic mindfulness-based intervention for persons with sickle cell disease: Study protocol for a randomized controlled trial

6.

longdom.org

longdom.org/open-access-pdfs/acceptability-of-an-online-brief-mindfulness-intervention-for-sickle-cell-disease-pain.pdf

Acceptability of an Online Brief Mindfulness Intervention for ...

ABSTRACT. Background: Sickle Cell Disease (SCD) pain negatively impacts the quality of life among People Living With Sickle.