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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to use digital therapy for individuals with both insomnia (trouble sleeping) and depression (persistent sadness or low mood). It tests different sequences of online cognitive-behavioral therapy (CBT) for insomnia and depression to determine the most effective approach. Participants will use a self-managed online platform with access to a coach. U.S. military veterans experiencing both insomnia and depression may be well-suited for this trial.

As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance digital therapy options for insomnia and depression.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) is both effective and safe. It matches the effectiveness of sleep medications but lacks their side effects. People using CBT-I often experience fewer relapses and continue to improve their sleep over time. Additionally, digital versions of CBT-I, such as those in apps, have proven effective in many studies.

Cognitive Behavioral Therapy for Depression (CBT) is also safe with minimal risk. Some individuals might experience uncomfortable emotions during therapy, but this is a normal part of the process. A large review of many studies confirmed that CBT effectively treats depression. It can be used alone or alongside medications.

In this study, both treatments are available online, accessible through a computer or phone app. This format has been tested and supports the therapy's safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer an accessible and flexible approach to managing insomnia and depression. Unlike traditional in-person therapy, these treatments are delivered online and can be accessed via computer or phone apps, making it easier for people to fit therapy into their busy lives. Additionally, each treatment provides access to a coach, offering personalized support while still allowing self-management. This innovative format combines the effectiveness of cognitive-behavioral therapy with the convenience and reach of digital platforms, potentially broadening access to care for many who might otherwise struggle to get help.

What evidence suggests that this trial's treatments could be effective for insomnia and depression?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I), one of the treatments in this trial, works well. It helps people sleep better, longer, and more efficiently, often matching the effectiveness of sleep medications but without the side effects. Approximately 70% to 80% of people with insomnia notice improvements with CBT-I.

For depression, Cognitive Behavioral Therapy (CBT), another treatment option in this trial, is also effective. It significantly reduces symptoms of depression and anxiety and can be as helpful as medication over time.

This trial will explore different approaches, including treating insomnia and depression separately or in sequence. When addressing both insomnia and depression, using digital CBT for insomnia can also help lessen depression symptoms. Some studies suggest that addressing insomnia first can improve both sleep and mood more than focusing on depression alone. This combined approach might be the best option for people dealing with both issues. ^{2 6 7 8 9}

Who Is on the Research Team?

Wilfred Pigeon, PhD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 (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 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 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]

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]

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 (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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34375199/

Cognitive behavioral therapy for depressive disorders Results: Participants with moderate to severe depression who participated in CBT reported a significant decrease in depression and anxiety ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9840507/

Cognitive behavior therapy vs. control conditions, other ... CBT appears to be as effective as pharmacotherapies at the short term, but more effective at the longer term. Keywords: Depression, cognitive ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0165032725012339

Cognitive behavioral therapies are evidence-based – ... Within CBTs for depression specifically, a systematic review and meta-analysis showed that lower age, higher initial depression severity, individual treatment ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032721007400

Cognitive behavioral therapy for depressive disorders Results. Participants with moderate to severe depression who participated in CBT reported a significant decrease in depression and anxiety ...

5. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2730724

Effectiveness and Acceptability of Cognitive Behavior ... Randomized clinical trials have shown that cognitive behavior therapy (CBT) is effective in treating depression and at least as effective as any ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8489050/

Cognitive–behavioral therapy for management of mental ... Cognitive–behavioral therapy (CBT) helps individuals to eliminate avoidant and safety-seeking behaviors that prevent self-correction of faulty beliefs.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7001356/

Cognitive Behavioral Therapy for Depression - PMC A meta-analysis of 115 studies has shown that CBT is an effective treatment strategy for depression and combined treatment with pharmacotherapy is ...

8. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/article-abstract/2832696

Cognitive Behavior Therapy for Mental Disorders in Adults In this unified series of meta-analyses, CBT was probably effective in the treatment of mental disorders, including major depression, anxiety disorders, PTSD, ...

9. mayoclinic.org mayoclinic.org/tests-procedures/cognitive-behavioral-therapy/about/pac-20384610

Cognitive behavioral therapy Risks. In general, there's little risk in getting cognitive behavioral therapy. But you may feel emotions that aren't comfortable at times. ...