Using web-based CBT-I to improve sleep to prevent depression and anxiety in adolescents at high risk: a randomized controlled trial protocol.
Athina Spiropoulos, Norah Vincent, Lianne Tomfohr-Madsen...
https://pubmed.ncbi.nlm.nih.gov/41749363Actively Recruiting
Phase Not Applicable
Age: 12Years - 18Years
All Genders
ID06358495
Improving Sleep to Prevent Depression and Anxiety in Adolescents at High Risk Using Online Cognitive Behavioral Therapy for Insomnia
Led by University of Calgary · Updated on 2024-12-05
50
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University of Calgary
Lead Sponsor
H
Hotchkiss Brain Institute, University of Calgary
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether a brief sleep intervention called Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve sleep and reduce early signs of depression and anxiety in adolescents who are at high risk due to having a parent with a history of these disorders. This pilot trial focuses on teens aged 12 to 18 who have insomnia symptoms but no clinical diagnosis of internalizing disorders themselves. Improving sleep may help prevent the first onset of depression and anxiety, which are common and serious conditions in adolescence. Participants will be randomly assigned to one of two groups. One group will receive a six-week online CBT-I program that includes cognitive and behavioral techniques along with a virtual psychoeducation session for their parents. The other group will receive a pamphlet about good sleep habits and continue any current treatments they may have. After a follow-up period of 19 weeks, those in the control group can choose to receive the digital CBT-I intervention. During the study, participants will complete assessments at baseline, 7 weeks, and 19 weeks to measure insomnia severity, sleep quality, and internalizing symptoms using validated questionnaires and sleep logs. Researchers will monitor changes in sleep patterns and mood symptoms throughout the study. The total participation time includes the treatment period and follow-up assessments to evaluate the intervention's impact on sleep and emotional health.
CONDITIONS
Brief Title
Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk
Who Can Participate
Age: 12Years - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Between the ages of 12 and 18 years
- Have at least one parent with a history of depressive or anxiety disorders
- No clinically significant history of internalizing disorders themselves
- Score 10 or higher on the Insomnia Severity Index indicating subthreshold insomnia or greater
You will not qualify if you...
- Experiencing symptoms of sleep disorders other than insomnia, such as restless legs syndrome or sleep-disordered breathing
- History of untreated serious psychiatric illness like bipolar disorder or schizophrenia
- Active suicidal thoughts
- Currently taking prescribed medications for sleep problems
- Moderate to severe head injury
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 weeks
Participants complete a 6 week online Cognitive Behavioral Therapy for Insomnia (CBT-I) consisting of six self-guided modules, including behavioral and cognitive techniques, with parental involvement through one virtual psychoeducation session. Control group participants receive a psychoeducational pamphlet and continue usual care.
Baseline visit and weekly online sessions during treatment
Follow-up
Duration - 13 weeks
Participants are followed to assess changes in sleep quality and internalizing symptoms after treatment completion.
Follow-up visits at 7 weeks and 19 weeks after baseline
Trial Site Locations
Total: 1 location
1
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Actively Recruiting
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Research Team
D
Daniel Kopala-Sibley, PhD
H
Hayley Schmidtler, BSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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