Health TrialsbyHealthPanel

MBI for Pain and Sleep in Adolescents and Young Adults With Sickle Cell Disease

ConditionsChronic PainSickle Cell DiseaseSleep
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-39
SponsorUniversity of Illinois at Chicago

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Mindfulness-based intervention

    Behavioral

    Mobile mindfulness-based intervention for pain and sleep in adolescents and young adults with sickle cell disease

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Mindfulness-based interventionExperimental treatment 1 intervention
Group B: Usual care groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Chicago

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: