Online prenatal CBT‑I program to improve sleep and reduce postpartum stress and depression risk
Official title: Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health: A Translational, Longitudinal and Clinical Study. Maternal Outcome After THERapy for Sleep (MOTHERS)
Run by University of Rome G. Marconi · NCT06379074 · Data updated 2026-11-12
This project will try an online cognitive behavioral sleep program for pregnant women with insomnia to see if better sleep lowers postpartum stress and depression.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 114 (estimated) |
| Sponsor | University of Rome G. Marconi Academic / other |
| Locations | 2 sites (Bologna, Bologna and 1 other locations) |
| Status | Recruiting |
| Started | May 6, 2024 |
| Main results expected | August 6, 2026 |
| Study ends | October 6, 2026 |
| Registry record updated | March 2, 2026 |
| Trial ID | NCT06379074 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant women aged 18 or older, within 15 weeks of gestation, BMI 18–30, fluent in Italian, intending to continue the pregnancy, and without major psychiatric or severe medical comorbidities.
✕Probably not a fit
Women with current psychiatric disorders, active smoking, alcohol or illegal drug use, severe somatic illnesses, who are beyond 15 weeks' gestation, or who cannot participate in Italian-language online procedures are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional trial recruits 114 pregnant women early in pregnancy to test a digital, automated psychoeducational module based on cognitive behavioral therapy for insomnia (CBT‑I). Participants will be followed from early pregnancy through six months postpartum and will complete online questionnaires, sleep diaries, and wearable actigraphy recordings, with cortisol sampling for biological stress markers. The trial will also collect data on fathers' and infants' sleep and perceived stress to evaluate family-level effects. The intervention targets sleep continuity in women without psychiatric comorbidities and excludes smokers, recent alcohol or illegal drug users, and those with severe somatic disorders.
Why it matters
Potential benefit: If successful, the intervention could lower rates of postpartum stress and depressive symptoms by improving maternal sleep and associated biological stress markers.
How similar studies have gone: Previous trials of CBT‑I in pregnancy have shown promising improvements in sleep and reductions in postpartum depressive symptoms, so this study builds on limited but positive evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age ≥ 18 yrs. old; 2. good knowledge of Italian language; 3. intention to continue pregnancy; 4. BMI ranging 18-30 (i.e., without underweight or obesity following international criteria; WHO, 2013); 5. ≤ 15th week of pregnancy at the time of recruitment. Exclusion Criteria: 1. severe diagnosis of relevant somatic disorder; 2. smoking; 3. alcohol intake; 4. assumption of illegal drugs;
Where it's running
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Department of Biomedical and Neuromotor Sciences, Physiology campus, University of Bologna, Bologna, Italy
Bologna, Bologna, Italy Recruiting -
Department of Human Sciences, Guglielmo Marconi university
Rome, Rome, Italy Recruiting
Study contacts
- Study coordinator: Chiara Baglioni, PhD
- Email: c.baglioni@unimarconi.it
- Phone: 06377251
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.