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Recruiting NCT06358495

NCT06358495 Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk

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Clinical Trial Summary
NCT ID NCT06358495
Status Recruiting
Phase
Sponsor University of Calgary
Condition Insomnia
Study Type INTERVENTIONAL
Enrollment 50 participants
Start Date 2024-11-01
Primary Completion 2025-06-30

Eligibility & Interventions

Sex All sexes
Min Age 12 Years
Max Age 18 Years
Study Type INTERVENTIONAL
Interventions
Cognitive Behavioral Therapy for InsomniaActive Control

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 50 participants in total. It began in 2024-11-01 with a primary completion date of 2025-06-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Emerging evidence has shown that sleep interventions such as Cognitive Behavioral Therapy for Insomnia (CBT-I) improve depressive and anxiety symptoms in adults, even when the intervention is brief, such as four to six sessions. The overarching aim of the proposed research is to conduct a pilot trial to evaluate whether a brief intervention for insomnia adapted for improves sleep and subthreshold depressive and anxiety symptoms in adolescents at risk (i.e., with a parental history of depressive or anxiety disorders).

Eligibility Criteria

Inclusion Criteria: * Between the ages of 12 and 18. * Having at least one parent with a history of depressive or anxiety disorders but having no clinically significant history (per the Diagnostic and Statistical Manual of Mental Disorders 5) of internalizing disorders themselves. * Adolescents who score 10/25 or greater on the Insomnia Severity Index, indicating subthreshold insomnia or greater. Exclusion Criteria: * Experiencing symptoms of sleep disorders other than insomnia (i.e. restless legs syndrome \[RLS\], sleep-disordered breathing \[SDB\]. * Having a history of untreated, serious psychiatric illness (i.e., bipolar disorder, schizophrenia). * Active suicidal ideation. * Currently taking prescribed medications for sleep problems. * Moderate to severe head injury.

Contact & Investigator

Central Contact

Daniel Kopala-Sibley, PhD

✉ daniel.kopalasibley@ucalgary.ca

📞 4039510811

Principal Investigator

Daniel Kopala-Sibley, PhD

PRINCIPAL INVESTIGATOR

University of Calgary

Frequently Asked Questions

Who can join the NCT06358495 clinical trial?

This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06358495 currently recruiting?

Yes, NCT06358495 is actively recruiting participants. Contact the research team at daniel.kopalasibley@ucalgary.ca for enrollment information.

Where is the NCT06358495 trial being conducted?

This trial is being conducted at Calgary, Canada.

Who is sponsoring the NCT06358495 clinical trial?

NCT06358495 is sponsored by University of Calgary. The principal investigator is Daniel Kopala-Sibley, PhD at University of Calgary. The trial plans to enroll 50 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: September 2026  ·  Data Methodology