Cognitive Behavioral Therapy for Insomnia to Prevent Depression & Anxiety

Overseen By Hayley Schmidtler, BSc

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: Sleep medications

Disqualifiers: Sleep disorders, Untreated psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a short online program called Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve sleep and reduce signs of depression and anxiety in teens. It targets those who struggle with sleep and have a parent with anxiety or depression, but who do not have a significant history of these conditions themselves. Participants will either receive the CBT-I treatment or be placed on a waitlist with additional sleep tips. Teens aged 12 to 18 who frequently experience sleep difficulties might be suitable for this trial. As an unphased study, this trial offers a unique opportunity for teens to potentially enhance their sleep and mental well-being through innovative online therapy.

Will I have to stop taking my current medications?

If you are currently taking prescribed medications for sleep problems, you cannot participate in this trial.

What prior data suggests that Cognitive Behavioral Therapy for Insomnia is safe for adolescents?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally safe and manageable. Studies have found that online versions of CBT-I can improve sleep and may also reduce anxiety and depression symptoms. These studies report good results with few side effects.

For instance, one study found that digital CBT-I helped older adults sleep better without major side effects. Another study suggested it could reduce negative thoughts in people with sleep problems. Overall, CBT-I appears to be a safe choice that helps improve sleep and mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy for Insomnia (CBT-I) because it takes a different approach from typical treatments for insomnia, like medication. Unlike sleeping pills, which mainly focus on inducing sleep, CBT-I addresses the root causes of insomnia by changing thought patterns and behaviors around sleep. This therapy is delivered online, making it accessible and convenient, and it also involves parents, adding a supportive family component that is not common in many sleep treatments. Overall, CBT-I not only aims to improve sleep but also seeks to prevent depression and anxiety, providing a holistic approach to mental health.

What evidence suggests that Cognitive Behavioral Therapy for Insomnia is effective for improving sleep and reducing depressive and anxiety symptoms in adolescents?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I), which participants in this trial may receive, can greatly improve sleep problems and reduce symptoms of depression and anxiety. Studies have found that even short versions of CBT-I, such as those delivered through apps, can prevent major depression and improve sleep in young people with insomnia and mild depression. Evidence from trials suggests that CBT-I often outperforms medication alone for long-term results. This therapy uses techniques to change thought patterns and sleep habits to enhance sleep quality. Overall, CBT-I is considered a top treatment for insomnia and positively impacts mental health. ^{1 6 7 8 9}

Who Is on the Research Team?

Daniel Kopala-Sibley, PhD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-18 with sleep issues, as indicated by scoring at least 10 on the Insomnia Severity Index. They must have a parent with a history of depression or anxiety but not have significant internalizing disorders themselves.

Inclusion Criteria

My parent has a history of depression or anxiety, but I do not have any significant mental health issues.

I have trouble sleeping, as shown by my score on a sleep test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-week online Cognitive Behavioral Therapy for Insomnia (CBT-I) intervention

6 weeks

1 virtual session for parents

Follow-up

Participants are monitored for changes in internalizing symptoms and sleep quality

19 weeks

Assessments at 7-week and 19-week follow-ups

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Insomnia

Trial Overview The study tests if Cognitive Behavioral Therapy for Insomnia (CBT-I), adapted for teens, can improve their sleep and reduce symptoms of depression and anxiety. Participants will receive brief CBT-I sessions in comparison to an active control group.

How Is the Trial Designed?

Group I: Cognitive-Behavioural Therapy Group Experimental Treatment 1 Intervention

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.

Group II: Treatment as Usual waitlist with Psychoeducational Pamphlet Active Control 1 Intervention

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.

Cognitive Behavioral Therapy for Insomnia is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as CBT-I for:

• Insomnia
• Depression

Approved in European Union as CBT-I for:

• Insomnia
• Depression

Approved in United States as Somryst for:

• Chronic Insomnia

Approved in United Kingdom as Sleepio for:

• Insomnia

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Hotchkiss Brain Institute, University of Calgary

Collaborator

Trials

12

Recruited

2,400+

Published Research Related to This Trial

Digital cognitive behavioral therapy for insomnia (dCBT-I) was found to be more effective than medication alone in reducing insomnia symptoms, with significant improvements in Pittsburgh Sleep Quality Index scores over 6 months for dCBT-I and combination therapy.

While dCBT-I showed comparable effectiveness to combination therapy, its benefits were less stable over time, indicating that while it is a strong treatment option, further research is needed to understand its long-term reliability in different patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Digital Cognitive Behavioral Therapy vs Medication Therapy Among Patients With Insomnia. Lu, M., Zhang, Y., Zhang, J., et al.[2023]

Digital cognitive behavioural therapy for insomnia (dCBT-I) significantly reduces insomnia severity, with a mean difference of -5.00 on the Insomnia Severity Index (ISI) immediately after treatment, based on a meta-analysis of 33 studies involving nearly 9,400 participants.

The benefits of dCBT-I are sustained over time, showing continued improvement at both short-term (4 weeks to 6 months) and 1-year follow-ups, making it a promising alternative to traditional face-to-face therapy, which, while slightly more effective, falls within a non-inferiority margin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of digital cognitive behavioural therapy for insomnia: a meta-analysis of randomised controlled trials. Soh, HL., Ho, RC., Ho, CS., et al.[2021]

Digital cognitive behavioral therapy for chronic insomnia (D-CBT-I) is effective, with 46.4% of 414 participants achieving remission after a 6-week treatment, making it a strong first-line option for chronic insomnia.

Factors such as longer early morning awakening times and higher baseline insomnia severity negatively impacted treatment outcomes, suggesting that patients with milder insomnia and more severe depressive symptoms may benefit more from D-CBT-I.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing the effectiveness of digital cognitive behavioural therapy for chronic insomnia in clinical practice. Shi, Y., Ren, R., Zhang, Y., et al.[2023]

A smartphone-based, culturally adapted digital cognitive behavioral therapy for insomnia (DCBT-I) significantly reduced insomnia severity compared to sleep education in a randomized trial with 82 participants over 6 weeks.

Participants in the DCBT-I group experienced greater improvements in total sleep time and sleep efficiency at both 3 and 6 months follow-up, indicating its efficacy in enhancing sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. Zhang, C., Liu, Y., Guo, X., et al.[2023]

In a study involving 1720 adults with insomnia, digital cognitive behavioral therapy for insomnia (dCBT-I) significantly reduced intraindividual variability in sleep metrics, particularly in sleep onset latency, which is crucial for improving sleep quality.

The reduction in variability in sleep metrics was found to mediate significant improvements in both insomnia severity and psychological distress, highlighting the effectiveness of dCBT-I as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. Vestergaard, CL., Vedaa, Ø., Simpson, MR., et al.[2021]

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in adults with chronic insomnia, with these benefits sustained up to 48 weeks after treatment.

dCBT also reduces the use of both prescription and non-prescription sleep medications compared to sleep hygiene education, indicating its effectiveness in managing insomnia without relying heavily on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. Luik, AI., Marsden, A., Emsley, R., et al.[2021]

Digital cognitive behavioral therapy for insomnia (dCBT-I) significantly improves sleep outcomes with a large effect size (SMD = -0.76) and also alleviates depressive (SMD = -0.42) and anxiety symptoms (SMD = -0.29) in adults with insomnia, based on a meta-analysis of 22 randomized controlled trials involving 2504 articles.

Higher treatment adherence to dCBT-I correlates with better outcomes in alleviating depression, anxiety, and insomnia symptoms, and fully automated dCBT-I treatments show significant effects without the need for therapist support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital cognitive behavioral therapy for insomnia on depression and anxiety: a systematic review and meta-analysis. Lee, S., Oh, JW., Park, KM., et al.[2023]

Digital cognitive behavior therapy for insomnia (dCBT-I) significantly improves sleep quality in patients with insomnia, particularly in those with anxiety disorders, as shown in a study of 6,002 patients over a 12-week period.

Patients receiving dCBT-I monotherapy and those with combined therapy showed notable improvements in sleep quality, with the most significant changes observed in the anxiety group, indicating that dCBT-I is a practical and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. Liang, S., Mao, H., Yang, J., et al.[2022]

In a study of 208 adults, those who previously underwent digital cognitive behavioral therapy for insomnia (dCBT-I) showed increased self-efficacy in managing their insomnia symptoms, which was linked to better outcomes during the COVID-19 pandemic.

Self-efficacy was found to mediate a significant portion of the benefits from dCBT-I, accounting for 49% of the reduction in insomnia symptoms and 67% of the reduction in depressive symptoms during the pandemic, highlighting its role as a crucial factor in treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-efficacy in Insomnia Symptom Management after Digital CBT-I Mediates Insomnia Severity during the COVID-19 Pandemic. Cheng, P., Casement, MD., Kalmbach, DA., et al.[2023]

Digital cognitive behavioral therapy (dCBT) significantly improves functional health, psychological well-being, and sleep-related quality of life in individuals with insomnia, based on a study of 1711 participants over 24 weeks.

The reduction in insomnia symptoms was a key factor mediating these improvements, highlighting that dCBT effectively addresses both daytime and nighttime issues related to poor sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. Espie, CA., Emsley, R., Kyle, SD., et al.[2023]

Citations

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Digital cognitive behavioral therapy for insomnia on ... The results demonstrated that digital intervention for insomnia yielded significant effects on alleviating depressive and anxiety symptoms as well as insomnia ...

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Effects of cognitive behavioral therapy for insomnia (CBT-I) ... The effects of cognitive behavioral therapy for insomnia (CBT-I) have consistently been shown to improve insomnia symptoms and other health-related outcomes.

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A randomized clinical trial | PLOS Medicine App-based CBT-I is effective in preventing future onset of major depression and improving insomnia outcomes among youth with insomnia and subclinical depression ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2803668

Digital Cognitive Behavioral Therapy vs Medication ... In this study, clinical evidence suggested that combination therapy was optimal, and dCBT-I was more effective than medication therapy, with long-term benefits ...

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1450275/full

The applicability and effectiveness of the cognitive ... Cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment, but the existing CBT-I ignores the intervention for anxiety-depressive symptoms, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9742891/

Cognitive-behavioral therapy for insomnia prevents and ... Emerging evidence suggests that cognitive-behavioral therapy for insomnia (CBTI) may reduce suicidal ideation (SI). However, the role of digital therapeutics in ...

7. hsrd.research.va.gov hsrd.research.va.gov/impacts/digital-cbt-for-insomnia.cfm

Digital Cognitive Behavioral Therapy for Insomnia The page features direct links to didactic content and courses that can help Veterans who struggle with sleep problems, and includes a link to ...

8. nature.com nature.com/articles/s41746-025-01847-0

A randomized controlled trial of a digital cognitive ... Results indicate that digital CBT-I provides important benefits for older adults, offering strong potential to expand access to insomnia ...

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Innovative Digital Cognitive Behavioral Treatment for ... Methods: The program was constructed based on validated CBT-i theory and practice, incorporating the latest scientific data on CBT for insomnia.