Recruiting

Sleep Improvement

Sponsor:

University of Calgary

Code:

NCT06358495

Conditions

Insomnia

Sleep Disturbance

Depressive Symptoms

Anxiety Symptoms

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

Cognitive Behavioral Therapy for Insomnia

Active Control

Study Details

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).

Conditions

Insomnia

Sleep Disturbance

Depressive Symptoms

Anxiety Symptoms

Study ID

NCT06358495

Start date

Nov 1, 2024

Status verified date

Dec, 2024

Completion date

Aug 30, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Daniel Kopala-Sibley, PhD

4039510811daniel.kopalasibley@ucalgary.ca

Hayley Schmidtler, BSc

403-210-6839hayley.schmidtler@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

Daniel C Kopala-Sibley

4039510811daniel.kopalasibley@ucalgary.ca

Hayley Schmidtler, BSc

403210-6839hayley.schmidtler@ucalgary.ca

More Information

Sponsor

University of Calgary

Last update posted

Dec 5, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2024-12-05.