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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two online sleep programs to determine which better helps pregnant individuals with insomnia prevent depression around childbirth. Participants will either engage in digital cognitive behavioral therapy for insomnia (CBT-I) or learn about sleep hygiene (SHE) through online sessions. The study aims to understand whether improving sleep can reduce depression and how the initial severity of depression affects outcomes. Pregnant individuals between 14 to 28 weeks, who struggle with insomnia but do not have major depression or take antidepressants, might be suitable candidates. Participants need daily internet access to join the online sessions and complete surveys until their baby is one year old.

As an unphased trial, this study offers participants the chance to contribute to important research that could enhance mental health care for pregnant individuals.

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 prior data suggests that these digital sleep programs are safe for pregnant people?

Research has shown that digital cognitive behavioral therapy for insomnia (dCBT-I) is well-received by pregnant individuals. Studies have found that it improves sleep quality without causing significant side effects. In one study, participants experienced better sleep and fewer insomnia symptoms without major issues.

While less research exists for digital sleep hygiene education (SHE), similar programs have been safely used in various settings to improve sleep habits. These programs teach better sleep practices and are generally considered safe with no known negative effects.

Overall, both digital CBT-I and SHE are non-invasive and have been used in other studies without major safety concerns. Participants can expect these treatments to be safe and aimed at improving sleep and reducing the risk of depression during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these digital sleep programs for preventing perinatal depression because they offer innovative, accessible approaches to mental health care. Digital cognitive behavioral therapy for insomnia (CBT-I) is unique because it leverages technology to provide structured, evidence-based therapy directly to users, helping them manage sleep issues without needing in-person sessions. Meanwhile, digital sleep hygiene education (SHE) serves as an active comparator, offering practical tips and strategies to improve sleep habits. These digital methods can be accessed anytime and anywhere, making them particularly appealing for new and expecting mothers who may have difficulty attending traditional therapy sessions.

What evidence suggests that this trial's treatments could be effective for preventing perinatal depression?

Research has shown that digital cognitive behavioral therapy for insomnia (CBT-I), one of the treatments in this trial, effectively reduces insomnia and depression symptoms in pregnant and new mothers. A review of several studies found that CBT-I improves sleep quality and lessens depression in these women. Another study discovered that using CBT-I during pregnancy helps with staying asleep, leading to better outcomes after childbirth.

Digital sleep hygiene education (SHE), another treatment option in this trial, also helps manage sleep issues. A review of research found that sleep programs like SHE can improve sleep for mothers, which might lower the risk of depression after childbirth. Technology-based methods, including SHE, have effectively reduced symptoms of depression and anxiety after childbirth. Both CBT-I and SHE aim to improve sleep and mental health, but CBT-I has shown stronger benefits in reducing depression symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Jennifer N Felder, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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]

Citations

1. samhsa.gov samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6990703/

Efficacy of Digital Cognitive Behavioral Therapy for the ... What is the efficacy of digital cognitive behavioral therapy compared with standard treatment among pregnant women with insomnia symptoms?

3. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.10572

Randomized controlled trial of cognitive behavioral therapy for ... For women with insomnia disorder during pregnancy, CBTI initiated during pregnancy conferred postpartum benefits in terms of wakefulness after sleep onset ( ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10959878/

Efficacy of cognitive behavioral therapy for insomnia in the ... This meta-analysis demonstrates that CBT-I is effective in alleviating insomnia, depression, and sleep quality among perinatal women.

5. foundation.aasm.org foundation.aasm.org/treating-perinatal-insomnia-and-rumination-to-reduce-postpartum-depression-symptoms-a-randomized-control-trial-of-digital-cognitive-behavioral-therapy-for-insomnia/

Treating perinatal insomnia and rumination to reduce ... ... depression symptoms: A randomized control trial of digital cognitive-behavioral therapy for insomnia. 2018 Focused Projects Grant for Junior ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8842335/

effects on postpartum insomnia and mental health - PMC To evaluate the effects of digital cognitive behavior therapy for insomnia (dCBT-I) delivered during pregnancy on subjective sleep outcomes, ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/98/NCT02805998/Prot_SAP_000.pdf

1 Study Protocol Digital cognitive behavior therapy for ... Secondary mental health outcomes include depressive symptom severity (Edinburgh Postnatal Depression. Scale) and anxiety (Generalized Anxiety Disorder Scale).