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

Trial Summary

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

Research shows that digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) not only helps improve sleep quality but also has a small to moderate effect in reducing symptoms of depression and anxiety. This suggests that improving sleep through dCBT-I can positively impact mental health. ^{1 2 3 4 5}

Is digital cognitive behavioral therapy for insomnia safe for humans?

Digital cognitive behavioral therapy for insomnia (dCBT-I) has been studied in various trials and is generally considered safe for humans, with no significant safety concerns reported in the research. ^{3 4 5 6 7}

How is the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I) unique for treating depression and anxiety?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is unique because it is a digital therapy that not only improves sleep quality but also has a positive impact on depression and anxiety symptoms, offering a non-drug approach to managing these conditions. ^{1 2 3 4 5}

What is the purpose of this trial?

This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I) on engagement of the emotion regulation brain network as a putative mechanistic target.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

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 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]

References

1. 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]

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

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

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. England pubmed.ncbi.nlm.nih.gov

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

5. 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]

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]