Improving sleep and mental health in pregnant individuals
Efficacy of Digital Cognitive Behavior Therapy for Insomnia for the Prevention of Perinatal Depression
This study is testing two online sleep programs to see which one helps pregnant people with insomnia feel better and reduces the risk of depression during and after pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 498 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05596318 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two digital sleep programs, cognitive behavioral therapy for insomnia (CBT-I) and sleep hygiene education (SHE), in pregnant individuals experiencing insomnia. Participants, who are between 14 to 28 weeks gestation, will be randomly assigned to one of the two programs, each consisting of six weekly online sessions. The study will assess the impact of these interventions on preventing perinatal depression and explore how improvements in insomnia symptoms may influence depressive outcomes. Participants will complete surveys and interviews throughout the study period, which extends until one year postpartum.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals between 14 to 28 weeks gestation who are experiencing elevated insomnia symptoms.
Not a fit: Patients with current major depression or those taking antidepressant medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective non-pharmacological interventions to improve sleep and mental health in pregnant individuals, potentially reducing the incidence of perinatal depression.
How similar studies have performed: Other studies have shown promising results with digital CBT-I for insomnia, suggesting that this approach may be effective in similar populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant 14-28 weeks gestation * 18 years or older * Daily access to a web-enabled computer, smart phone, or tablet * Current elevated insomnia symptom severity and insomnia disorder * English speaking Exclusion Criteria: * Current major depression * Taking or planning to take antidepressant medication (ADM) * Other diagnosed or suspected sleep disorder * Other psychiatric or medical issues (e.g., bipolar disorder, active suicidality, bed rest) * Night shift worker
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer N Felder, PhD — University of California, San Francisco
- Study coordinator: Jennifer N Felder, PhD
- Email: jennifer.felder@ucsf.edu
- Phone: 415-476-7014
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.