Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavioral Therapy for Insomnia, Active Control.
- Who it may be relevant to
- Registry conditions: Insomnia, Sleep Disturbance, Depressive Symptoms, Anxiety Symptoms. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Detailed description
A substantial body of literature has linked poor sleep or insomnia to the development of internalizing (i.e., depression and anxiety) disorders in adolescents. Emerging evidence has also shown that sleep interventions such as Cognitive Behavioral Therapy for Insomnia (CBT-I) substantially improve depressive and anxiety symptoms in adults, even when the intervention is brief, such as four to six sessions. However, no research has examined whether sleep interventions may be effective in preventing first lifetime onsets of internalizing disorders in adolescents at high risk of internalizing disorders, but who have yet to develop them. The overarching aim of the proposed research is to conduct a pilot trial to evaluate whether a brief intervention for insomnia adapted for adolescents improves sleep and subthreshold internalizing symptoms in high-risk adolescents. Results of this project would provide crucial preliminary evidence that a non-invasive, economical, and easily administered sleep-based intervention may prevent first onsets of the most common and debilitating illnesses in teens.
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.
Interventions
- Behavioral 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 - Other 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.
Primary outcome measures
- Insomnia Severity Index [Time frame: Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.]
- Pittsburgh Sleep Quality Index [Time frame: Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.]
- Internalizing Symptoms Subscale of the Youth Self-Report [Time frame: Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.]
Secondary outcome measures (4)
- Sleep Logs - Total sleep time [Time frame: Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.]
- Sleep Logs - Onset latency [Time frame: Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.]
- Sleep Logs - Wake after sleep onset [Time frame: Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.]
- Sleep Logs - Sleep efficiency [Time frame: Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- University of Calgary — Calgary
Publications
- Spiropoulos A, Vincent N, Tomfohr-Madsen L, Brost A, Schmidtler H, MacKinnon AL, Kopala-Sibley DC. Using web-based CBT-I to improve sleep to prevent depression and anxiety in adolescents at high risk: a randomized controlled trial protocol. Trials. 2026 Feb 26;27(1):265. doi: 10.1186/s13063-026-09542-5. PMID 41749363
Identifiers
NCT: NCT06358495 · REB24-0253