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Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06379074

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

Led by University of Rome G. Marconi · Updated on 2026-03-02

114

Participants Needed

2

Research Sites

8 weeks

Total Duration

On this page

Sponsors

U

University of Rome G. Marconi

Lead Sponsor

U

University of Bologna

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how poor sleep during pregnancy may increase the risk of stress and mental health problems after childbirth. This study focuses on pregnant women without psychiatric disorders who experience insomnia symptoms. It aims to understand the biological and psychological processes involved and to test if an online psychological intervention based on cognitive behavioral therapy for insomnia CBT-I can help prevent these issues. The study includes 114 expectant mothers divided into three groups healthy pregnant women without insomnia symptoms, women with insomnia receiving a CBT-I based intervention, and women with insomnia receiving a placebo psychoeducation intervention. The interventions consist of six weekly online sessions, with the CBT-I group receiving specific techniques for improving sleep and the placebo group watching educational videos about pregnancy and sleep. The study follows participants from early pregnancy up to six months postpartum. Participants will complete assessments at six time points including questionnaires, sleep diaries, saliva samples to measure cortisol stress hormones, and wearing wrist actigraphs to monitor sleep patterns. The study will also collect data from the partners of participants. Researchers will measure outcomes such as stress reactivity, sleep efficiency, insomnia and depressive symptoms, anxiety, emotional states, and parenting stress. This detailed monitoring will help evaluate the long-term effects of the intervention on mothers, partners, and infants.

CONDITIONS

Brief Title

Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Good knowledge of the Italian language
  • Planning to continue the pregnancy
  • Body mass index (BMI) between 18 and 30
  • At or before the 15th week of pregnancy at recruitment
Not Eligible

You will not qualify if you...

  • Having a severe diagnosis of a significant physical illness
  • Current smoking
  • Alcohol consumption
  • Use of illegal drugs

Research Team

C

Chiara Baglioni, PhD

D

Debora Meneo, M.Sc

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