Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk
1 other identifier
interventional
50
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2024
CompletedFirst Posted
Study publicly available on registry
April 10, 2024
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2025
CompletedDecember 5, 2024
December 1, 2024
8 months
April 5, 2024
December 3, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Insomnia Severity Index
The ISI is a 7-item questionnaire designed to identify cases of insomnia and evaluate treatment outcomes. The ISI assesses severity of sleep onset, sleep maintenance and early wakening problems, sleep dissatisfaction, and perceived distress caused by sleep problems. It was found to be a clinically useful tool in assessing changes in insomnia symptoms and had been reliably used in treatment research with adolescents. Scores on the ISI range from 0-28 with higher scores indicating greater insomnia severity.
Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.
Pittsburgh Sleep Quality Index
The PSQI instrument is used in assessing one's sleep quality during the previous month. It consists of 19 self-rated items. It has been reliably used in treatment research with adolescents. Scores range from 0 to 19, with higher scores indicating worse sleep quality.
Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.
Internalizing Symptoms Subscale of the Youth Self-Report
The internalizing symptoms subscale of the Youth Self Report (YSR) questionnaire is a widely used measure of global internalizing (depression, anxiety, and somatic) symptoms. T-scores which range from 26 to 100 are generated, with higher scores indicating greater symptom severity.
Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.
Secondary Outcomes (4)
Sleep Logs - Total sleep time
Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.
Sleep Logs - Onset latency
Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.
Sleep Logs - Wake after sleep onset
Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.
Sleep Logs - Sleep efficiency
Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.
Study Arms (2)
Cognitive-Behavioural Therapy Group
EXPERIMENTALParticipants 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.
Treatment as Usual waitlist with Psychoeducational Pamphlet
ACTIVE COMPARATORControl 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.
Interventions
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.
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
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Calgary
Calgary, Alberta, T2N 1N4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Kopala-Sibley, PhD
University of Calgary
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcomes assessor will be blinded to participants' assigned condition.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 5, 2024
First Posted
April 10, 2024
Study Start
November 1, 2024
Primary Completion
June 30, 2025
Study Completion
August 30, 2025
Last Updated
December 5, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- Data can be shared no later than 6 months after publication, and will be available until study records are destroyed in accordance with research ethics board requirements (min 10 years post collection).
Recognizing the importance of sharing results, data will be shared in accordance with the International Committee of Medical Journal Editors' guidelines, which state that authors can share with others the deidentified individual participant data underlying results presented in the trial reports (including tables, figures, and appendices or supplementary material) no later than 6 months after publication. Data will be made available upon request to the primary investigator.