Digital Sleep Programs for Preventing Perinatal Depression

(PRISM Trial)

Overseen By Jennifer N Felder, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Antidepressants

Disqualifiers: Major depression, Bipolar, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

498 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two online sleep programs for pregnant people with insomnia to see if they can prevent depression. One program focuses on changing thoughts and behaviors about sleep, while the other teaches good sleep habits. The program that changes thoughts and behaviors has been shown to be effective in various populations, including shift workers, menopausal women, and cancer survivors.

Do I have to stop taking my current medications?

The trial requires that participants do not take or plan to take antidepressant medication. If you are on antidepressants, you would need to stop taking them to participate.

What data supports the idea that Digital Sleep Programs for Preventing Perinatal Depression is an effective treatment?

The available research shows that Digital Sleep Programs, like Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I), are effective in improving sleep quality and overall well-being. For example, one study found that dCBT-I improved people's health and psychological well-being, and these benefits lasted over time. Another study showed that dCBT-I helped reduce the need for sleep medication and healthcare use. While these studies focus on insomnia, they suggest that improving sleep through digital programs can have positive effects on mental health, which could be beneficial for preventing perinatal depression. ^{1 2 3 4 5}

What safety data exists for digital sleep programs like dCBT-I?

The research indicates that digital cognitive behavioral therapy for insomnia (dCBT-I) is an effective treatment for insomnia, improving sleep quality, psychological well-being, and quality of life. While the studies focus on efficacy, they do not explicitly mention safety concerns, suggesting that no significant safety issues were reported. The long-term benefits and scalability of dCBT-I further imply a favorable safety profile. ^{1 2 3 4 5}

Is Digital CBT-I a promising treatment for preventing perinatal depression?

Yes, Digital CBT-I is a promising treatment because it effectively improves sleep quality, reduces insomnia, and enhances overall well-being and quality of life, which can help prevent perinatal depression. ^{1 2 4 5 6}

Research Team

Jennifer N Felder, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for pregnant individuals between 14-28 weeks gestation, aged 18 or older, who have insomnia and access to the internet. They must speak English but can't join if they work night shifts, have other sleep disorders or severe psychiatric conditions like bipolar disorder or active suicidality, are currently majorly depressed, or take antidepressants.

Inclusion Criteria

I am between 14 and 28 weeks pregnant.

English speaking

Daily access to a web-enabled computer, smart phone, or tablet

Exclusion Criteria

Night shift worker

I am currently on or planning to start antidepressant medication.

I do not have severe psychiatric issues or conditions requiring bed rest.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either digital cognitive behavioral therapy for insomnia (CBT-I) or digital sleep hygiene education (SHE) over six weekly online sessions

6 weeks

6 online sessions

Follow-up

Participants complete surveys and interviews to monitor outcomes until 1 year postpartum

12 months

Treatment Details

Interventions

• Digital CBT-I
• Digital SHE

Trial Overview The study compares two digital programs for improving sleep in pregnant people with insomnia: cognitive behavioral therapy (CBT-I) and sleep hygiene education (SHE). Each participant will follow one of these six-week online courses to see which is better at preventing depression during and after pregnancy.

Participant Groups

Group I: Digital cognitive behavior therapy for insomnia (CBT-I) Experimental Treatment 1 Intervention

Group II: Digital sleep hygiene education (SHE) Active Control 1 Intervention

Digital CBT-I is already approved in United States, European Union for the following indications:

Approved in United States as Digital Cognitive Behavioral Therapy for Insomnia for:

• Insomnia during pregnancy
• Prevention of perinatal depression

Approved in European Union as Digital Cognitive Behavioral Therapy for Insomnia for:

• Insomnia during pregnancy
• Prevention of perinatal depression

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Findings from Research

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]

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]

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 (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) during pregnancy did not show significantly greater improvements in insomnia severity compared to standard care, but it did lead to higher rates of insomnia remission and lower insomnia caseness at 6 months postpartum.

Participants receiving dCBT-I experienced greater reductions in depressive and anxiety symptoms postpartum, with a significantly lower proportion of probable major depression at 3 months postpartum compared to those receiving standard care, suggesting dCBT-I may help prevent postpartum depression and anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of digital cognitive behavior therapy for prenatal insomnia symptoms: effects on postpartum insomnia and mental health. Felder, JN., Epel, ES., Neuhaus, J., et al.[2022]

References

1. 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]

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

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

3. 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]

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. 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]

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

Randomized controlled trial of digital cognitive behavior therapy for prenatal insomnia symptoms: effects on postpartum insomnia and mental health. [2022]