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

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I) in preventing depression and anxiety?

Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has been shown to effectively improve sleep quality and well-being, which can help reduce the risk of depression and anxiety. Studies indicate that dCBT-I not only alleviates insomnia but also enhances overall quality of life and psychological well-being. ^{1 2 3 4 5}

Is digital cognitive behavioral therapy for insomnia safe for humans?

Digital cognitive behavioral therapy for insomnia (dCBT-I) is generally considered safe for humans, as it has been studied in many clinical trials and is recommended as a first-line treatment option for insomnia. ^{2 3 4 6 7}

How is Cognitive Behavioral Therapy for Insomnia (CBT-I) different from other treatments for insomnia?

Cognitive Behavioral Therapy for Insomnia (CBT-I), especially in its digital form (dCBT-I), is unique because it is a non-drug treatment that focuses on changing sleep habits and behaviors to improve sleep quality. Unlike medications, it addresses the root causes of insomnia and can also help reduce symptoms of depression and anxiety, making it a comprehensive approach to improving overall mental health. ^{2 4 8 9 10}

Research Team

Daniel Kopala-Sibley, PhD

Principal Investigator

University of Calgary

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 (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]

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 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]

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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Factors influencing the effectiveness of digital cognitive behavioural therapy for chronic insomnia in clinical practice. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. [2021]

4. United States 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. [2023]

5. United States 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Digital Cognitive Behavioral Therapy vs Medication Therapy Among Patients With Insomnia. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of digital cognitive behavioural therapy for insomnia: a meta-analysis of randomised controlled trials. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Self-efficacy in Insomnia Symptom Management after Digital CBT-I Mediates Insomnia Severity during the COVID-19 Pandemic. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Digital cognitive behavioral therapy for insomnia on depression and anxiety: a systematic review and meta-analysis. [2023]