Digital CBT for Insomnia and Depression

Overseen By Michelle Carr, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Must not be taking: Antipsychotics, Mood stabilizers

Disqualifiers: Pregnancy, Bipolar, Psychosis, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

1500 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses online therapy programs to help Veterans with both sleep and mood problems. It focuses on those who have limited access to traditional therapy. The therapies work by teaching skills to change negative thoughts and behaviors affecting sleep and mood.

Will I have to stop taking my current medications?

The trial requires that you are not currently using anti-psychotic medications or mood stabilizers like lithium. If you are taking these, you would need to stop before participating.

What data supports the effectiveness of the treatment Digital CBT for Insomnia and Depression?

Research shows that digital cognitive behavioral therapy for insomnia (dCBT-I) is effective in improving sleep quality and reducing insomnia symptoms. Additionally, it has been found to have a small to moderate effect in reducing depressive symptoms, suggesting it may help with both insomnia and depression. ^{1 2 3 4 5}

Is digital cognitive behavioral therapy for insomnia and depression safe for humans?

Digital cognitive behavioral therapy for insomnia (dCBT-I) is considered safe for reducing insomnia and depression symptoms. ^{1 6 7 8 9}

How is digital CBT for insomnia and depression different from other treatments?

Digital CBT for insomnia and depression is unique because it is delivered online, making it more accessible and scalable compared to traditional in-person therapy. It specifically targets both insomnia and depression, which often occur together, and has been shown to improve sleep quality and alleviate depressive symptoms. ^{1 2 5 6 10}

Research Team

Wilfred Pigeon, PhD

Principal Investigator

University of Rochester

Eligibility Criteria

This trial is for U.S. military veterans who speak English and are experiencing both insomnia and depression, with scores indicating moderate to severe symptoms on standard questionnaires. It's not open to pregnant individuals, those with a history of bipolar disorder or psychosis, current users of antipsychotic medications or mood stabilizers like lithium, or anyone currently having suicidal thoughts with intent.

Inclusion Criteria

English-speaking

U.S. Military Veterans

Endorse depression (Patient Health Questionnaire-depression score > 10)

Exclusion Criteria

Pregnancy

History of bipolar disorder

Current suicidal ideation with active intent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive digital CBT for insomnia and/or depression over a 12-week period, with different sequences depending on the study arm

12 weeks

Remote participation

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3-month and 6-month intervals

6 months

Remote assessments at 3 and 6 months

Treatment Details

Interventions

• Cognitive Behavioral Therapy for Depression
• Cognitive Behavioral Therapy for Insomnia
• Mood Monitoring

Trial Overview The study is testing whether treating insomnia and depression one after the other works better than just treating one condition. It also aims to find out which treatment sequence might be best and if treatments should vary based on individual differences. Participants will receive digital Cognitive Behavioral Therapy (CBT) tailored either for insomnia or depression along with mood monitoring.

Participant Groups

Group I: Single Insomnia Treatment Experimental Treatment 1 Intervention

Cognitive-behavioral therapy for insomnia delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access for 12 weeks.

Group II: Single Depression Treatment Experimental Treatment 1 Intervention

Cognitive-behavioral therapy for depression delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access for 12 weeks.

Group III: Sequenced Insomnia and Depression Treatment Experimental Treatment 2 Interventions

Cognitive-behavioral therapy for insomnia followed by cognitive-behavioral therapy for depression each delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access to the insomnia treatment only for 4 weeks after which the access to the depression treatment is also made available. Total duration of access for 12 weeks.

Group IV: Sequenced Depression and Insomnia Treatment Experimental Treatment 2 Interventions

Cognitive-behavioral therapy for depression followed by cognitive-behavioral therapy for insomnia each delivered in a self-managed online format (computer or phone app) with access to a coach. Duration of access to the depression treatment only for 4 weeks after which the access to the insomnia treatment is also made available. Total duration of access for 12 weeks.

Group V: Control Active Control 1 Intervention

Online Mood Monitoring for 12 weeks

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

Approved in United States as CBT-I for:

• Insomnia
• Depression

Approved in European Union as CBT-I for:

• Insomnia
• Depression

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

Harvard University

Collaborator

Trials

237

Recruited

588,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

Findings from Research

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 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]

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 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 behavioral therapy for insomnia (dCBT-I) significantly reduces the severity of both insomnia and depression, with a large effect size for insomnia (SMD = -0.85) and a moderate effect size for depression (SMD = -0.47) based on a meta-analysis of 7 studies involving 3,597 participants.

The efficacy of dCBT-I is comparable to traditional face-to-face CBT-I, and its benefits are maintained over time, showing effectiveness in both short-term and long-term treatment for individuals with insomnia and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of digital cognitive behavioral therapy for insomnia and depression: a systematic review and meta-analysis of randomized controlled trials. Lin, W., Li, N., Yang, L., 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]

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) 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]

Guided Internet-based cognitive behavioral therapy for insomnia (ICBT-i) was found to be more effective than treatment for depression (ICBT-d) in patients with both conditions, although many still did not achieve remission.

Patients reported that symptoms of insomnia and depression hindered their progress more in ICBT-d than in ICBT-i, suggesting that addressing insomnia may improve treatment outcomes for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating and hindering factors in Internet-delivered treatment for insomnia and depression. Blom, K., Jernelöv, S., Lindefors, N., et al.[2023]

References

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

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

2. 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]

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

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

4. 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]

5. England pubmed.ncbi.nlm.nih.gov

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

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

The efficacy of digital cognitive behavioral therapy for insomnia and depression: a systematic review and meta-analysis of randomized controlled trials. [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. 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]

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

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

10. Netherlands pubmed.ncbi.nlm.nih.gov

Facilitating and hindering factors in Internet-delivered treatment for insomnia and depression. [2023]