Mindfulness-based Intervention for Pain and Sleep in Adolescents and Young Adults With Sickle Cell Disease: Randomized Clinical Trial
| Registry | NCT07797582, acronym REMedy_RCT |
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| Status | Not yet recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, supportive care |
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| Enrollment | 48 (Estimated) |
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| Sponsor | University of Illinois at Chicago (Other) |
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| Conditions | Chronic Pain, Sickle Cell Disease, Sleep |
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| Interventions | Mindfulness-based intervention (Behavioral) |
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| Dates | start 2027-02-01 (estimated), primary completion 2029-05-01 (estimated), completion 2029-05-01 (estimated), first posted 2026-09-01, last updated 2026-09-21 |
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Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Pain All trials for Sickle Cell Disease All trials of Mindfulness-based intervention
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Mindfulness-based intervention | Experimental | Behavioral: Mindfulness-based intervention | Participants 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. |
- Mindfulness-based intervention (Behavioral): Mobile mindfulness-based intervention for pain and sleep in adolescents and young adults with sickle cell disease
+Outcome measures
Primary outcomes
- Pain interference [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).
Secondary outcomes
- Pain intensity [At 8 weeks]: Pain intensity will be measured using Brief Pain Inventory and PROMIS pain intensity (higher scores indicating greater pain-related intensity).
- Physical function [At 8 weeks]: 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.
- Pain catastrophizing [At 8 weeks]: Pain catastrophizing will be assessed using the Concerns About Pain (CAP) Scale, which measures catastrophic thinking about pain (higher scores indicating greater pain catastrophizing).
- Sleep disturbance [At 8 weeks]: 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.
- Fatigue [At 8 weeks]: 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.
- Anxiety [At 8 weeks]: 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).
- Depression [At 8 weeks]: 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).
- Intention [At 8 weeks]: 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.
- Dose intensity [At 8 weeks]: 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.
+Eligibility
Sex: All, ages: 15 Years to 39 Years
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
+Investigators
+Funding