Sleep Therapy for Depression and Anxiety

(SleepMORE Trial)

Overseen By Andrea Goldstein-Piekarski, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Psychotropics, Antidepressants, Sleep medications

Disqualifiers: Substance abuse, Bipolar, Psychosis, 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: 6

Duration: 8 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how Cognitive Behavioral Therapy for Insomnia (CBT-I) can aid individuals with depression and anxiety by examining its effects on the brain's emotion regulation. The study includes two groups: one receives the sleep therapy immediately, while the other begins with basic sleep tips and receives the full therapy later. It suits those who have struggled with insomnia and daytime issues for over three months and feel depressed, impacting their daily life. Participants must live within 60 miles of Stanford University and speak English. As an unphased trial, this study offers a unique opportunity to contribute to understanding how CBT-I can enhance mental health.

Will I have to stop taking my current medications?

If you are taking medications specifically for sleep disturbances, you may need to stop them more than one week before the trial starts. If you are on antidepressants, you may need to stop them more than two weeks before the trial begins.

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

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally safe and manageable. This non-medication treatment improves sleep patterns and reduces insomnia. Studies have found that CBT-I works as well as sleep medications but without side effects. Participants often experience lasting improvements in sleep without reverting to poor sleep habits.

Additionally, CBT-I can reduce symptoms of depression and anxiety, benefiting both mental health and sleep. Overall, strong evidence supports CBT-I as a safe choice for better sleep and emotional well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Cognitive Behavioral Therapy for Insomnia (CBT-I) for depression and anxiety because it tackles sleep issues directly, which are often a hidden driver of these conditions. Unlike traditional treatments like antidepressants or anti-anxiety medications that primarily target mood symptoms, CBT-I focuses on improving sleep patterns, which can indirectly alleviate mood disorders. Another exciting aspect is the Enhanced Sleep Hygiene approach, which combines CBT-I with education on sleep habits and ongoing support, offering a holistic way to manage mood symptoms by improving sleep quality over time. This could lead to more sustainable and side-effect-free relief compared to typical medication-based treatments.

What is the effectiveness track record for Cognitive Behavioral Therapy for Insomnia in treating depression and anxiety?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) effectively treats both sleep problems and depression. In this trial, participants in the Immediate Treatment group will receive CBT-I treatment right after randomization. Studies have found that CBT-I can improve sleep and help prevent depression in those with sleep difficulties. One review found that CBT-I led to a 32% improvement in depression symptoms, nearly double the improvement seen without the therapy. Another study showed that CBT-I is more effective than medication for long-term sleep improvement. Overall, CBT-I is a reliable option for better sleep and mood. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who are experiencing sleep disorders, depression, and insomnia. Participants should be interested in a non-medication approach to improve their condition.

Inclusion Criteria

Reside within 60 miles of Stanford University

I have had trouble sleeping for at least 3 months.

Fluent and literate in English

Exclusion Criteria

I do not have any health conditions that would affect the study's assessments.

I have undergone therapy for insomnia in the last year.

Presence of other sleep or circadian rhythm disorders that significantly contribute to their sleep disturbance. The presence of these disorders will be assessed by the DUKE structured interview for sleep disorders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six sessions of CBT-I over eight weeks or sleep hygiene education with additional monitoring

8 weeks

Weekly visits for monitoring and treatment sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up assessments at 6 months

Open-label extension (optional)

Participants in the Enhanced Sleep Hygiene group may opt into CBT-I treatment after follow-up

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Insomnia

Trial Overview The study is testing Cognitive Behavioral Therapy for Insomnia (CBT-I) to see if it can help manage symptoms of depression and anxiety by targeting the brain's emotion regulation network.

How Is the Trial Designed?

Group I: Immediate Treatment Experimental Treatment 1 Intervention

Participants randomized to the Immediate Treatment group will receive CBT-I treatment immediately after randomization.

Group II: Enhanced Sleep Hygiene Experimental Treatment 1 Intervention

Participants randomized to the Enhanced Sleep Hygiene (ESH) group will be offered the same CBT-I described above approximately 7 months after being randomized. We will also provide a list of referrals for treatment upon completion of their end of treatment visit (approx. week 11) should they choose to seek treatment sooner. In the interim, they will be provided with two sessions of sleep hygiene / sleep education and four additional meetings including monitoring of sleep and mood symptoms.

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?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

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 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 (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 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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10039857/

Digital cognitive behavioral therapy for insomnia on ... According to these results, dCBT-I is an effective treatment alternative for insomnia, both in terms of clinical effectiveness and positive ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39836656/

Effectiveness of app-based cognitive behavioral therapy for ... App-based CBT-I is effective in preventing future onset of major depression and improving insomnia outcomes among youth with insomnia and subclinical ...

3. nature.com nature.com/articles/s41746-025-01514-4

Systematic review and meta-analysis on fully automated ... This systematic review and meta-analysis evaluated the effectiveness of FA dCBT-I across 29 randomized controlled trials (RCTs) involving 9475 participants.

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. sciencedirect.com sciencedirect.com/science/article/pii/S0165032724014952

Review Article Cognitive behavioral therapy for insomnia to ... With a control depression response rate of 17 %, CBT-I yielded a 32 % response rate. •. CBT-I is an effective treatment option for depression ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6796223/

Cognitive-Behavioral Therapy for Insomnia: An Effective ... CBT-i produces results that are equivalent to sleep medication, with no side effects, fewer episodes of relapse, and a tendency for sleep to continue to improve ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2590142725000205

Internet-delivered Cognitive Behavioral Therapy for Insomnia In patients with insomnia without psychiatric co-morbidities, CBT-I has demonstrated significant efficacy in improving subjective insomnia ...