Arthritis, Dermatomyositis, JIA, Juvenile Idiopathic Arthritis, Juvenile Idiopathic Arthritis (JIA), Lupus, Lupus Arthritis, Systemic Lupus Erythematosus, Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese), Rheumatic Diseases, Vasculitis
Conditions
Keywords
Sleep Disturbance, Sleep Problems, Insomnia, Cognitive behavioural therapies, CBT, Psychoeducation, Sleep Hygiene, Healthy Sleep Practices, Web-based, Digital, Better Nights, Better Days, Pediatric, Adolescents, Pain, Rheumatic Diseases, JIA, Juvenile Idiopathic Arthritis, SLE, Lupus, Vasculitis, Juvenile Dermatomyositis
Brief summary
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.
Detailed description
Across two phases, this research will use an explanatory sequential mixed methods design involving (1) a single-arm trial of Better Nights, Better Days for Youth (BNBD-Youth) with 30 adolescents, aged 12-18, with a chronic pediatric rheumatic disease to characterize the correlational pain-sleep relationship and to estimate the preliminary effectiveness of the web-based sleep program on sleep and pain outcomes. These quantitative findings will guide the selection of participants, and the interview questions asked in the (2) subsequent qualitative study involving individual, semi-structured interviews with 10-26 quantitative participants to further contextualize the pain-sleep relationship using the personal pain and sleep experiences reported by participants. The quantitative and qualitative datasets will be analyzed separately and then merged during the interpretation phase.
Interventions
BEHAVIORALBetter Nights, Better Days for Youth
BNBD-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.
Sponsors
The Hospital for Sick Children
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Able to provide informed consent, 2. Can speak, read, and write in English, 3. Are an adolescent between the ages of 12 and 18 years, 4. Have a confirmed diagnosis of a chronic pediatric rheumatic disease, 5. Report at least a one-month history of dissatisfactory sleep quantity or quality with difficulty initiating sleep, difficulty maintaining sleep, or early-morning awakenings with an inability to return to sleep experienced at least three nights a week, 6. Report a minimum of mild pain (i.e., at least 1/10 pain on a numeric rating scale) at least once in the past week, and 7. Have access to the Internet and an email account.
Exclusion criteria
1. Have a hearing, visual, or cognitive impairment that would prevent the completion of outcome measures, as indicated by the healthcare team, 2. Have a sleep disorder that requires medical or surgical intervention, 3. Are currently receiving sleep-related psychosocial care, or 4. Have used 'Better Nights, Better Days for Youth' before.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | Baseline and immediately post-intervention (5 weeks post intervention-start) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pediatric Pain Interference - Short Form 8a | Baseline and immediately post-intervention (5 weeks post intervention-start) | 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 | Baseline and immediately post-intervention (5 weeks post intervention-start) | 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 | Baseline and immediately post-intervention (5 weeks post intervention-start) | 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 | Baseline and immediately post-intervention (5 weeks post intervention-start) | 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. |
Contacts
CONTACTKelly Nguyen
Outcome results
None listed