Chronic PainREMedy_RCTNCT07797582
MBI for Pain and Sleep in Adolescents and Young Adults With Sickle Cell Disease
A study testing Mindfulness-based intervention in people with Chronic Pain and Sickle Cell Disease, run by University of Illinois Chicago.
Trial 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. 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
- What is being tested?
- Mindfulness-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Feb 2027to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Mindfulness-based Intervention for Pain and Sleep in Adolescents and Young Adults With Sickle Cell Disease: Randomized Clinical Trial
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.
- Conditions
- Chronic Pain, Sickle Cell Disease, Sleep
- Being tested
- Mindfulness-based intervention
- Keywords
- sleep, mindfulness-based intervention, mobile health, pilot study, pain management
- Medical subject headings
- Chronic Pain, Anemia, Sickle Cell, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based interventionBehavioural
Mobile mindfulness-based intervention for pain and sleep in adolescents and young adults with sickle cell disease
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain interference
Pain interference will be measured using Brief Pain Inventory and PROMIS pain interference short form (higher scores indicating greater pain-related interference).
Measured: At 8 weeks
Secondary outcomes (9)
Pain intensity
Pain intensity will be measured using Brief Pain Inventory and PROMIS pain intensity (higher scores indicating greater pain-related intensity).
Measured: At 8 weeks
Physical function
Physical function will be assessed using the PROMIS Physical Function Short Form 6b, a 6-item patient-reported measure of self-reported capability for physical activities. Items are scored on a T-score metric (mean 50, SD 10), with higher scores indicating better physical function.
Measured: At 8 weeks
Pain catastrophizing
Pain catastrophizing will be assessed using the Concerns About Pain (CAP) Scale, which measures catastrophic thinking about pain (higher scores indicating greater pain catastrophizing).
Measured: At 8 weeks
Sleep disturbance
Sleep disturbance will be assessed using the PROMIS Sleep Disturbance Short Form 6a. Items are scored on a T-score metric (mean 50, SD 10), with higher scores indicating greater sleep disturbance.
Measured: At 8 weeks
Fatigue
Fatigue will be assessed using the PROMIS Fatigue Short Form 7a, a 7-item patient-reported measure of the experience and impact of fatigue. Items are scored on a T-score metric (mean 50, SD 10), with higher scores indicating greater fatigue.
Measured: At 8 weeks
Anxiety
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report measure of anxiety symptom severity over the past 2 weeks (higher scores indicating greater anxiety severity).
Measured: At 8 weeks
Depression
Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report measure of depressive symptom severity over the past 2 weeks (higher scores indicating greater depression severity).
Measured: At 8 weeks
Intention
Behavioral intention to engage in mindfulness practice will be assessed using items adapted from the Theory of Planned Behavior (TPB) framework, measuring participants' intention to perform the target behavior (e.g., regular mindfulness practice). Items are rated on a Likert-type scale, with higher scores indicating stronger intention.
Measured: At 8 weeks
Dose intensity
Dose intensity for the intervention group will be quantified using REMedy app usage data, including: (1) total number of modules completed (out of 8), and (2) which specific modules were completed. Higher values indicate greater intervention engagement/dose.
Measured: At 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study startFeb 2027 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- 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
- NCT07797582
- Sponsor's protocol ID
- STUDY2024-0914
- Other IDs
- R00NR021195
- Acronym
- REMedy_RCT
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 21 Sep 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 21 Sep 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: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07797582
- Acronym / sponsor ID
- REMedy_RCT / STUDY2024-0914
- Conditions
- Chronic Pain, Sickle Cell Disease, Sleep
- Keywords
- sleep, mindfulness-based intervention, mobile health, pilot study, pain management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 1 Sep 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based intervention | Experimental | Behavioral: Mindfulness-based interventionParticipants who are assigned to an intervention group receive a mindfulness-based mobile intervention delivered via a smartphone application over approximately 8 weeks. |
| Usual care group | No intervention | –Participants who are assigned to a usual care group receive usual care 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 |
|---|---|---|
| Mindfulness-based interventionMobile mindfulness-based intervention for pain and sleep in adolescents and young adults with sickle cell disease | Behavioural | Mindfulness-based intervention |
Primary outcome
Pain interference
Time frame: At 8 weeks
Pain interference will be measured using Brief Pain Inventory and PROMIS pain interference short form (higher scores indicating greater pain-related interference).
9 secondary outcomes
Pain intensity
Time frame: At 8 weeks
Physical function
Time frame: At 8 weeks
Pain catastrophizing
Time frame: At 8 weeks
Sleep disturbance
Time frame: At 8 weeks
Fatigue
Time frame: At 8 weeks
Anxiety
Time frame: At 8 weeks
Depression
Time frame: At 8 weeks
Intention
Time frame: At 8 weeks
Dose intensity
Time frame: At 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 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.
Dahee Wi, PhD, RN principal investigator
University of Illinois Chicago
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based intervention in people with Chronic Pain and Sickle Cell Disease, run by University of Illinois Chicago.
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: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dahee Wi, PhD, RN (312-996-4473, dwi3@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain interference (time frame: At 8 weeks). 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 21 Sep 2026.