Overall, our understanding of how pain and sleep are experienced and how they can be treated in teenagers with rheumatic diseases is limited. This two-phased study aims to deepen our understanding of pain and sleep in this population using 'Better Nights, Better Days for Youth' (BNBD-Youth). 'BNBD-Youth' is a self-guided web-based sleep program for teenagers with sleep problems that uses educational and behavioural strategies, such as understanding sleep processes and changing unhelpful thoughts about sleep, to help improve sleep experiences. In Phase One, participants will use daily diaries to record their sleep and pain, and then use 'BNBDYouth' for five weeks to test whether it improves these outcomes. Then, in Phase Two, these participants will take part in an interview to further describe their experiences using 'BNBD-Youth' and their pain and sleep.
Able to provide informed consent,
Can speak, read, and write in English,
Are an adolescent between the ages of 12 and 18 years,
Have a confirmed diagnosis of a chronic pediatric rheumatic disease,
Have a hearing, visual, or cognitive impairment that would prevent the completion of outcome measures, as indicated by the healthcare team,
Have a sleep disorder that requires medical or surgical intervention,
Are currently receiving sleep-related psychosocial care, or
Have used 'Better Nights, Better Days for Youth' before.
Single group
Better Nights, Better Days for Youth
BehavioralBNBD-Youth is a web-based sleep program, available only for research, designed to introduce healthy sleep practices to adolescents and young adults with sleep disturbances, aiming to improve their sleep quality and duration. It is entirely self-guided and adolescent-based (i.e., does not involve the caregiver or healthcare professional) and accessed on the individual's personal device (e.g., smartphone, tablet, computer). This program comprises 31 short, interactive microlessons organized into 4 overarching sessions.
Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a 7-item, validated self-report questionnaire that assesses the nature, severity, and impact of sleep over the past 2 weeks, with a total score ranging from 0-28. It has an acceptable internal consistency (Cronbach's α = 0.74) and is selected as Phase One's primary outcome because it is: 1. Frequently used in sleep research with older children, 2. Brief and easy to complete, and 3. Sensitive to perceived sleep impact after treatment.
PROMIS Pediatric Pain Interference - Short Form 8a
The PROMIS Pediatric Pain Interference - Short Form 8a is an 8-item self-report tool that assesses the impact of pain on function over the past seven days. It has high internal consistency in children, 8-18 years old, with chronic pain (Cronbach's α = 0.90). PROMIS instruments are scored using item-level calibrations and response pattern scoring. PROMIS scores will be calculated via REDCap auto-score, guided by the HealthMeasures Scoring.
Pain Symptom Tracker
Daily pain will be collected via the "Check-in" feature on iCanCope, a smartphone-based pain self-management app developed through a phased, user-centred design study with adolescents with chronic pain and healthcare providers. Using numeric rating scales ranging from 0-10, the Check-in feature collects self-reported data on pain intensity, pain interference, mood, physical activity, sleep quality, and energy. The Check-in feature uses adolescent-friendly language, pictorial response options, and daily push notifications at a time of their choice to promote engagement. In previous iCanCope studies with adolescents (12 to 18 years) with chronic pain and JIA, over half of the participants were shown to have high to moderate levels of adherence to the application. Participants will be asked to complete three check-in entries each day. Each entry is estimated to take up to 1 minute to complete.
Sleep Diary
In sleep research, sleep diaries are considered the "golden standard" for subjective sleep assessment. This study will use an investigator-developed sleep diary on REDCap that participants will complete upon waking to capture participants' sleep patterns close to the time they occur, including sleep efficiency (i.e., the percentage of total time spent asleep while in bed), a composite of total sleep time and total time in bed, and sleep quality. The necessary fields selected to calculate these sleep parameters were selected based on (1) this study's research objectives and (2) a previous research consensus-based panel. Participants will be advised to complete 1 daily sleep diary entry shortly upon waking, reflecting the night before and the day of. Each diary entry is estimated to take up to 5 minutes to complete. Data entered by participants is automatically populated into REDCap.
Actigraphy
Objective sleep-wake activity will be captured using an actigraph wrist device (ActiGraph GT9X Link \[Ametris\] and Actiwatch 2 \[Philips Respironics\]), which measures movement using a 3-axis accelerometer to detect raw position and rotational data. In sleep research, actigraphy is preferred to polysomnography, the "golden standard" for objective sleep measurement, due to practicality reported by research participants. In this study, actigraph data is compared with sleep diary data to screen for potential artifacts.
Pediatric Anxiety - Short Form 8a
The PROMIS Pediatric Depressive Symptoms - Short Form 8a and PROMIS Pediatric Anxiety - Short Form 8a scales are 8-item tools that assess symptomology during the past seven days. PROMIS instruments are scored using item-level calibrations and response pattern scoring. PROMIS scores will be calculated via REDCap auto-score, guided by the HealthMeasures Scoring.
PROMIS Pediatric Depressive Symptoms - Short Form 8a
The PROMIS Pediatric Depressive Symptoms - Short Form 8a and PROMIS Pediatric Anxiety - Short Form 8a scales are 8-item tools that assess symptomology during the past seven days. PROMIS instruments are scored using item-level calibrations and response pattern scoring. PROMIS scores will be calculated via REDCap auto-score, guided by the HealthMeasures Scoring.
Patient Global Assessment
The Patient Global Assessment is a 21-point visual analogue scale widely used in pediatric rheumatic diseases to allow patients to subjectively rate their disease status. The 21-point scale was selected over the traditional 10-cm horizontal line scale because evidence indicates it is more feasible and may increase the precision of patient assessment.
Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales
The Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales is a 23-item self-report tool comprising 4 dimensions (i.e., physical, emotional, social, and school functioning) to determine HRQoL. The PedsQL has high internal consistency in children up to 18 years (Cronbach's α = 0.88).
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
