Chronic PainREMedyNCT07402811
Mindfulness-Based Intervention for Pain and Sleep in Adolescents and Young Adults With Sickle Cell Disease
A study testing Mobile bindfulness-based intervention in people with Chronic Pain and Sickle Cell Disease, run by University of Illinois Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 39 years
- Conditions the study is for
- Chronic Pain, Sickle Cell Disease, Sleep Disturbance
- What is being tested?
- Mobile bindfulness-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2025to 8 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Chicago
Chicago, Illinois, 60612
About this study
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.
- Conditions
- Chronic Pain, Sickle Cell Disease, Sleep Disturbance
- Being tested
- Mobile bindfulness-based intervention
- Keywords
- sleep, mindfulness-based intervention, mobile health, feasibility study, pain management
- Medical subject headings
- Chronic Pain, Anemia, Sickle Cell, Parasomnias, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile bindfulness-based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based intervention | Experimental | Participants are assigned to a single study arm and receive a mindfulness-based mobile intervention delivered via a smartphone application over approximately 8 weeks. Receives: Behavioral: Mobile bindfulness-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant retention rate
Percentage of enrolled participants who remain in the study through the 8-week intervention period
Measured: At 8 weeks (post-intervention)
Attrition rate and reasons for withdrawal
Percentage of participants who withdraw from the study and documented reasons for withdrawal
Measured: Throughout the 8-week intervention period
Weekly module completion rate
Percentage of assigned weekly modules completed by participants
Measured: At 8 weeks (post-intervention)
Acceptability of the Mindfulness-Based 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.
Measured: At 8 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start6 Dec 2025
- Primary completion8 May 2026
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Dahee Wi, University of Illinois Chicago
- Investigators
- Dahee Wi, PhD, RN, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402811
- Sponsor's protocol ID
- 2024-0914
- Other IDs
- K99NR021195-01A1
- Acronym
- REMedy
- Status last verified
- Aug 2026
- First submitted
- 26 Jan 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Intervention for Pain and Sleep in Adolescents and Young Adults With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT07402811
- Acronym / sponsor ID
- REMedy / 2024-0914
- Conditions
- Chronic Pain, Sickle Cell Disease, Sleep Disturbance
- Keywords
- sleep, mindfulness-based intervention, mobile health, feasibility study, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 6 Dec 2025 (actual)
- Primary completion
- 8 May 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based intervention | Experimental | Behavioral: Mobile bindfulness-based interventionParticipants are assigned to a single study arm and receive a mindfulness-based mobile intervention delivered via a smartphone application over approximately 8 weeks. |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile bindfulness-based interventionParticipants 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. | Behavioural | Mindfulness-based intervention |
Primary outcome
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
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
Weekly module completion rate
Time frame: At 8 weeks (post-intervention)
Percentage of assigned weekly modules completed by participants
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dahee Wi, PhD, RN principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile bindfulness-based intervention in people with Chronic Pain and Sickle Cell Disease, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant retention rate (time frame: At 8 weeks (post-intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.