The Role of Sleep Restriction Therapy in Cognitive-behavioral Therapy for Insomnia in School-aged Children: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 11
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Israel
Tel Aviv University
RECRUITING
Tel Aviv
Contact Information
Primary
Michal Kahn, PhD
michalkahn10@gmail.com
+972544682588
Backup
Shai Nimrodi, MA
shainimrodi@gmail.com
058-426-6060
Time Frame
Start Date: 2025-07-10
Estimated Completion Date: 2029-12-01
Participants
Target number of participants: 120
Treatments
Experimental: CBT-I
Families will receive the complete Cognitive Behavioral Therapy for Insomnia protocol (intake session + 4 CBT-I sessions).
Active_comparator: CBT-I without SRT
Families will receive the Cognitive Behavioral Therapy for Insomnia protocol (intake session + 4 CBT-I sessions), excluding the Sleep Restriction Therapy (SRT) components.
No_intervention: Waitlist control
Families will complete the intake session and then be placed on a waitlist and receive CBT-I 5 weeks after baseline.
Related Therapeutic Areas
Sponsors
Collaborators: Israel Science Foundation
Leads: Tel Aviv University

This content was sourced from clinicaltrials.gov