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NCT Number: NCT07775612

Pain-Sleep in Rheumatic Disease

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.

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Key information

Conditions

Rheumatic Diseases Arthritis Arthritis, Juvenile Autoimmune Diseases Behavior Cardiovascular Diseases Connective Tissue Diseases Dermatomyositis Dyssomnias Health Behavior Immune System Diseases JIA Joint Diseases Juvenile Idiopathic Arthritis Juvenile Idiopathic Arthritis (JIA) Lupus Lupus Arthritis, Systemic Lupus Erythematosus Lupus Erythematosus, Systemic Mental Disorders Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Parasomnias Pathological Conditions, Signs and Symptoms Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese) Polymyositis Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Hygiene Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Vascular Diseases Vasculitis

Age range

12 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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,
  • 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,
  • 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
  • Have access to the Internet and an email account.

Exclusion criteria

  • 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.

Treatment and study plan

Better Nights, Better Days for Youth

Behavioral

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.

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: 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:

    • Frequently used in sleep research with older children,
    • Brief and easy to complete, and
    • Sensitive to perceived sleep impact after treatment.

Secondary outcomes

  1. PROMIS Pediatric Pain Interference - Short Form 8a

    Time frame: 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.

  2. Pain Symptom Tracker

    Time frame: 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.

  3. Sleep Diary

    Time frame: 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.

  4. Actigraphy

    Time frame: 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.

Other outcomes

  1. Pediatric Anxiety - Short Form 8a

    Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)

    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.

  2. PROMIS Pediatric Depressive Symptoms - Short Form 8a

    Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)

    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.

  3. Patient Global Assessment

    Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)

    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.

  4. Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales

    Time frame: Baseline and immediately post-intervention (5 weeks post intervention-start)

    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).

  5. Patient Global Impression of Change

    Time frame: Immediately post-intervention (5 weeks post intervention-start)

    The Patient Global Impression of Change is a single-item, self-reported 7-point rating of participants' perceived change at the end of the study. In pediatric chronic pain clinical trials, the PGIC is recommended for its clinical utility and ease of use.

Study contacts

Contact information is provided by the study sponsor or research team.

Kelly Nguyen

CONTACT

[email protected]

(416) 813-1500

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Understanding the Pain-Sleep Relationship in Adolescents With Pediatric Rheumatic Disease Using 'Better Nights, Better Days for Youth': A Mixed-Methods Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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