About this trial
This randomized controlled trial will test the efficacy of CBT-I intervention for school-aged children (7-11 years old) with insomnia. The trial will focus on the role of sleep restriction therapy in treatment. Children will be randomized to one of three groups: (1) CBT-I; (2) CBT-I without SRT; or (3) a waitlist control group. Assessments will occur at baseline, mid-treatment, post-treatment, and a 3-month follow up. Some measures (e.g., child motivation) will also be assessed after each therapy session. Insomnia and sleep-wake patterns will be assessed objectively using actigraphy, and subjectively using sleep diaries, a clinical diagnostic interview, and questionnaires. Parent and child questionnaires will be administered to assess moderators and mediators of treatment outcomes.
Eligibility criteria
Qualifiers
Child aged 7-11 years
Parents aged over 18 years
Child meets the International Classification of Sleep Disorders - Third Edition (ICSD-3) criteria for chronic insomnia disorder with sleep difficulties occurring at least 3 times a week and lasting at least 3 months (Insomnia diagnosis will be determined during a clinical interview).
Disqualifiers
Child receiving concurrent CBT treatment for sleep or anxiety disorders.
Child diagnosed with a medical sleep problem (e.g., OSA, RLS)
Significant health or neurodevelopmental problems (e.g., intellectual disability)
Current psychotropic medications, or sleep aid medications
Trial design
Treatments tested in this trial
- Cognitive Behavioral Therapy for Insomnia
- Cognitive Behavioral Therapy for Insomnia without SRT
Treatment groups
Sponsors and collaborators
Tel Aviv University
Lead sponsor
Israel Science Foundation
Collaborator