Pain-Sleep in Rheumatic Disease

NCT07775612 | Not Yet Recruiting

• 1 other identifier: 4161
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatic Diseases; Arthritis; Lupus; Lupus Arthritis, Systemic Lupus Erythematosus; JIA; Dermatomyositis; Vasculitis; Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese); Juvenile Idiopathic Arthritis; Juvenile Idiopathic Arthritis (JIA)

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and immediately post-intervention (5 weeks post intervention-start)

Secondary Outcomes (4)

• PROMIS Pediatric Pain Interference - Short Form 8a

  Baseline and immediately post-intervention (5 weeks post intervention-start)

• Pain Symptom Tracker

  Baseline and immediately post-intervention (5 weeks post intervention-start)

• Sleep Diary

  Baseline and immediately post-intervention (5 weeks post intervention-start)

• Actigraphy

  Baseline and immediately post-intervention (5 weeks post intervention-start)

Other Outcomes (5)

• Pediatric Anxiety - Short Form 8a

  Baseline and immediately post-intervention (5 weeks post intervention-start)

• PROMIS Pediatric Depressive Symptoms - Short Form 8a

  Baseline and immediately post-intervention (5 weeks post intervention-start)

• Patient Global Assessment

  Baseline and immediately post-intervention (5 weeks post intervention-start)

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Behavioral: Better Nights, Better Days for Youth

Interventions

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.

Intervention Arm

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

MeSH Terms

Conditions

Rheumatic Diseases; Arthritis; Lupus Erythematosus, Systemic; Dermatomyositis; Vasculitis; Arthritis, Juvenile; Parasomnias; Sleep Initiation and Maintenance Disorders; Sleep Hygiene; Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Autoimmune Diseases; Immune System Diseases; Polymyositis; Myositis; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Skin Diseases; Vascular Diseases; Cardiovascular Diseases; Sleep Wake Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Health Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kelly Nguyen

CONTACT

(416) 813-1500; kelly.nguyen@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist, Child Health Evaluative Sciences

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 20, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share