RecruitingNot ApplicableNCT07048340

Cognitive-behavioral Therapy for Insomnia in School-aged Children

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


Sponsor

Tel Aviv University

Enrollment

120 participants

Start Date

Jul 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 7 YearsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Cognitive Behavioral Therapy for Insomnia and Cognitive Behavioral Therapy for Insomnia without SRT for people with insomnia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 7 Years to 11 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALCognitive 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.

BEHAVIORALCognitive 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

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NCT07048340


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