Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk
NCT ID: NCT06358495
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-11-01
2025-08-30
Brief Summary
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Detailed Description
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Among adolescents, internalizing disorders are a leading cause of global burden of disability, and unfortunately one of the leading causes of death due to suicide. Children with a parental history of internalizing disorders are 3-7 times more likely to develop internalizing disorders relative to children with no such family history. Approximately 75% of internalizing disorder onsets occur in adolescence. Affected youth are at risk for several sequelae including substance dependence, educational underachievement, and unemployment. For the majority of those who have had one episode, the disorder will become chronic. With each recurrence, treatment prognosis worsens. There is thus a critical need to prevent first lifetime onsets of internalizing disorders, among high-risk adolescents in particular, through interventions targeting modifiable risk factors. Improving sleep may be a feasible, economic, and effective method for prevention of internalizing disorders in high-risk teens.
Research Aims:
1. To examine if brief web-based CBT-I reduces insomnia symptoms and improves sleep quality in teens at risk for internalizing disorders, compared to a treatment as usual (TAU) waitlist group who receive a psychoeducational pamphlet about sleep hygiene.
2. To examine if CBT-I improves subthreshold internalizing symptoms in teens who have a family history of depressive or anxiety disorders but no clinically significant history themselves.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cognitive-Behavioural Therapy Group
Participants will receive a 6 week online Cognitive behavioural therapy for insomnia (CBT-I) evidence-based psychotherapeutic intervention that combines cognitive and behavioural principles. Their parents will also be invited to participant in 1 virtual psychoeducation session.
Cognitive Behavioral Therapy for Insomnia
Digital CBT-I is an online, six-module, self-guided CBT-I intervention. It includes videos and read information on behavioral (e.g., stimulus control, relaxation) and cognitive (e.g., restructuring, reducing arousal, and problem-solving) techniques, as well as psychoeducation (e.g., sleep hygiene). Participants complete homework following each session and track their sleep using an online diary. Young people could choose to involve their parents, for example, through completing sessions together. However, we will add a virtual session for parents as their involvement may improve adolescent engagement with the intervention as well as outcomes for adolescent sleep problems (Gradisar et al., 2011). This module will include an overview of the program components (behavioural, cognitive, and educational), goals and homework, and addresses parents' beliefs about sleep.
Treatment as Usual waitlist with Psychoeducational Pamphlet
Control group participants will receive a pamphlet providing information on sleep hygiene that matches the information in CBT-I arm (e.g., having a bedtime routine, maintaining a sleep schedule, avoiding exercise within several hours of bed, avoiding bright screens before bed). Otherwise, they will be encouraged to continue with treatment they are receiving, if any. After the 19 week follow-up assessment, participants have the option of receiving the digitized CBT-I intervention.
Active Control
Participants are encouraged to continue any care they are already receiving and will be placed on a wait-list for digital CBT-I after their final assessment. All activities participants try for improving their own sleep problems between assessments will be recorded and coded for.
Interventions
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Cognitive Behavioral Therapy for Insomnia
Digital CBT-I is an online, six-module, self-guided CBT-I intervention. It includes videos and read information on behavioral (e.g., stimulus control, relaxation) and cognitive (e.g., restructuring, reducing arousal, and problem-solving) techniques, as well as psychoeducation (e.g., sleep hygiene). Participants complete homework following each session and track their sleep using an online diary. Young people could choose to involve their parents, for example, through completing sessions together. However, we will add a virtual session for parents as their involvement may improve adolescent engagement with the intervention as well as outcomes for adolescent sleep problems (Gradisar et al., 2011). This module will include an overview of the program components (behavioural, cognitive, and educational), goals and homework, and addresses parents' beliefs about sleep.
Active Control
Participants are encouraged to continue any care they are already receiving and will be placed on a wait-list for digital CBT-I after their final assessment. All activities participants try for improving their own sleep problems between assessments will be recorded and coded for.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
18 Years
ALL
No
Sponsors
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Hotchkiss Brain Institute, University of Calgary
OTHER
University of Calgary
OTHER
Responsible Party
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Daniel Kopala Sibley
Associate Professor
Principal Investigators
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Daniel Kopala-Sibley, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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University of Calgary
Calgary, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Daniel C Kopala-Sibley
Role: primary
Hayley Schmidtler, BSc
Role: backup
Other Identifiers
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REB24-0253
Identifier Type: -
Identifier Source: org_study_id