An interventional study of Mindfulness-based intervention in Chronic Pain, Sickle Cell Disease and Sleep, sponsored by University of Illinois at Chicago. Not yet recruiting. Open to participants aged 15 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Supportive care
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.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 48 is below the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →University of Illinois at Chicago is the lead sponsor of 506 studies on the registry; 120 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
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Exclusion Criteria:
Participants who are assigned to an intervention group receive a mindfulness-based mobile intervention delivered via a smartphone application over approximately 8 weeks.
Behavioral: Mindfulness-based intervention
Participants who are assigned to a usual care group receive usual care over approximately 8 weeks.
Mobile mindfulness-based intervention for pain and sleep in adolescents and young adults with sickle cell disease
Pain interference
Pain interference will be measured using Brief Pain Inventory and PROMIS pain interference short form (higher scores indicating greater pain-related interference).
Time frame: At 8 weeks
Pain intensity
Pain intensity will be measured using Brief Pain Inventory and PROMIS pain intensity (higher scores indicating greater pain-related intensity).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: At 8 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for May 2029, 27 months later.
Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 27 months is above that.
Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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