Clinical Research Directory
Browse clinical research sites, groups, and studies.
Cognitive-behavioral Therapy for Insomnia in School-aged Children
Sponsor: Tel Aviv University
Summary
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.
Official title: The Role of Sleep Restriction Therapy in Cognitive-behavioral Therapy for Insomnia in School-aged Children: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
7 Years - 11 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-07-10
Completion Date
2029-12-01
Last Updated
2025-09-18
Healthy Volunteers
No
Conditions
Interventions
Cognitive Behavioral Therapy for Insomnia
CBT-I intervention will include four 45-60 minute sessions with a clinician. The sessions will include CBT-I components such as sleep psychoeducation, bedtime routines and sleep hygiene, graduated exposure, cognitive restructuring, and SRT in one of the intervention groups. The protocol is based on previous studies of CBT-I for school-aged children.
Cognitive Behavioral Therapy for Insomnia without SRT
This intervention will include four 45-60 minute sessions with a clinician. The sessions will include CBT-I components such as sleep psychoeducation, bedtime routines and sleep hygiene, graduated exposure, and cognitive restructuring. Sleep Restriction Therapy will not be included in the intervention. The protocol is based on previous studies that delivered CBT-I to school-aged children.
Locations (1)
Tel Aviv University
Tel Aviv, Israel, Israel