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.
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.12456
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.12356
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 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.12356
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.Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Digital cognitive behavior therapy for insomnia (CBT-I)Experimental Treatment1 Intervention
Group II: Digital sleep hygiene education (SHE)Active Control1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of California, San FranciscoSan Francisco, CA
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
Stanford UniversityCollaborator
References
Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial. [2023]Digital cognitive behavioral therapy (dCBT) is a scalable and effective intervention for treating insomnia. Most people with insomnia, however, seek help because of the daytime consequences of poor sleep, which adversely affects quality of life.
Long-term benefits of digital cognitive behavioural therapy for insomnia: Follow-up report from a randomized clinical trial. [2021]Digital cognitive behavioural therapy (dCBT) is an effective treatment for chronic insomnia and also improves well-being and quality of life (QoL). We assessed whether these benefits are sustained and if the effects of dCBT extend to the use of sleep medication and healthcare. In total 1,711 adults (48.0 ± 13.8 years, 77.6% female) with complaints of chronic insomnia participated in a previously published randomized controlled trial (ISRCTN 60530898) comparing dCBT (n = 853) with sleep hygiene education (SHE, n = 858). At weeks 0, 4, 8, 24, 36 and 48, we assessed functional health (Patient-Reported Outcomes Measurement Information System: Global Health Scale); psychological well-being (Warwick-Edinburgh Mental Well-being Scale) and sleep-related QoL (Glasgow Sleep Impact Index), prescribed and non-prescribed sleep medication use, and healthcare utilization. At week 25, those who received SHE at baseline were offered dCBT. dCBT improved functional health (difference: 2.45, 95% confidence interval [CI]: 2.03; 2.88, Cohen's d: 0.50, p
The effect of sleep-wake intraindividual variability in digital cognitive behavioral therapy for insomnia: a mediation analysis of a large-scale RCT. [2021]Digital cognitive behavioral therapy for insomnia (dCBT-I) is an effective treatment for insomnia. However, less is known about mediators of its benefits. The aim of the present study was to test if intraindividual variability in sleep (IIV) was reduced with dCBT-I, and whether any identified reduction was a mediator of dCBT-I on insomnia severity and psychological distress.
Randomized controlled trial of digital cognitive behavior therapy for prenatal insomnia symptoms: effects on postpartum insomnia and mental health. [2022]To evaluate the effects of digital cognitive behavior therapy for insomnia (dCBT-I) delivered during pregnancy on subjective sleep outcomes, depressive symptoms, and anxiety symptoms through 6 months postpartum.
Digital cognitive behavior therapy for insomnia improving sleep quality: a real-world study. [2022]Digital cognitive behavior therapy for insomnia (dCBT-I) is an effective treatment in alleviating insomnia. This study examined the effect of dCBT-I for improving sleep quality in patients with insomnia complaints from a clinical population in a real-world setting.
Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial. [2023]Digital cognitive behavioral therapy for insomnia (DCBT-I) requires adaptation to different sociocultural contexts. Moreover, studies comparing DCBT-I and sleep education in the same operating interface are lacking.