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

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).

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Sleep Disturbance; Depressive Symptoms; Anxiety Symptoms
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy for Insomnia; Other: Active Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Kopala-Sibley, PhD; Phone Number: 4039510811; Email: daniel.kopalasibley@ucalgary.ca
• Study Contact Backup: Name: Hayley Schmidtler, BSc; Phone Number: 403-210-6839; Email: hayley.schmidtler@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • Recruiting
      • University of Calgary
      • Contact: Daniel C Kopala-Sibley; Phone Number: 4039510811; Email: daniel.kopalasibley@ucalgary.ca
      • Contact: Hayley Schmidtler, BSc; Phone Number: 403210-6839; Email: hayley.schmidtler@ucalgary.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Logs - Total sleep time	Sleep logs provide self-reported subjective sleep. Participants will be asked to report on their estimated total sleep time.	Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.
Sleep Logs - Onset latency	Sleep logs provide self-reported subjective sleep. One of the variables participants will report is the amount of time they think it takes them to fall asleep.	Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.
Sleep Logs - Wake after sleep onset	Sleep logs provide self-reported subjective sleep. One of the variables participants will report is the amount of time they think they spent awake at night after initially falling asleep.	Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.
Sleep Logs - Sleep efficiency	Sleep logs provide self-reported subjective sleep. Sleep efficiency (percent of time spent asleep while in bed) will be calculated based on participants reports of total sleep time divided by time spent in bed.	Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Hotchkiss Brain Institute, University of Calgary
• Investigators: Principal Investigator: Daniel Kopala-Sibley, PhD, University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Anxiety Disorders; Depression
• Other Study ID Numbers: REB24-0253

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No