Improving sleep to prevent depression and anxiety in at-risk adolescents
Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk
This study is testing if a short therapy for sleep problems can help prevent depression and anxiety in teens aged 12 to 18 who are at risk because of their family history.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT06358495 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to evaluate the effectiveness of a brief intervention for insomnia, specifically Cognitive Behavioral Therapy for Insomnia (CBT-I), in improving sleep and reducing subthreshold depressive and anxiety symptoms in adolescents aged 12 to 18 who are at high risk due to a parental history of these disorders. The study will involve a small group of participants who will receive the intervention over four to six sessions. By focusing on adolescents who have not yet developed significant internalizing disorders, the research seeks to provide preliminary evidence that sleep interventions can prevent the onset of these debilitating conditions. The findings could lead to non-invasive and cost-effective strategies for mental health prevention in youth.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12 to 18 with a parental history of depressive or anxiety disorders and subthreshold insomnia.
Not a fit: Patients with other sleep disorders, serious untreated psychiatric illnesses, or active suicidal ideation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the risk of developing depression and anxiety in adolescents at high risk.
How similar studies have performed: While similar interventions have shown success in adults, this approach in adolescents is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Daniel Kopala-Sibley, PhD — University of Calgary
- Study coordinator: Daniel Kopala-Sibley, PhD
- Email: daniel.kopalasibley@ucalgary.ca
- Phone: 4039510811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.