Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk

NCT06358495 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-12-05

No results posted yet for this study

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).

Conditions

  • Insomnia
  • Sleep Disturbance
  • Depressive Symptoms
  • Anxiety Symptoms

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. 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.

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.

Sponsors & Collaborators

  • Hotchkiss Brain Institute, University of Calgary

    collaborator OTHER
  • University of Calgary

    lead OTHER

Principal Investigators

  • Daniel Kopala-Sibley, PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-06-30
Completion
2025-08-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06358495 on ClinicalTrials.gov