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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
48
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
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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