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RECRUITING
NCT06379074
NA

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

Sponsor: University of Rome G. Marconi

View on ClinicalTrials.gov

Summary

Improving maternal mental health is a worldwide health priority. Nevertheless, several scientific sources highlighted lack of empirical data which could drive clinical practice. The present project addresses psychobiological mechanisms leading to peripartum mental disorders. It focuses on one key risk factor for psychopathology, which is poor sleep continuity. The project aims to describe the link between maternal poor sleep quality and the cascade of events which may enhance vulnerability to stress and risk for mental disorders and to evaluate the efficacy of an online automated psychological prenatal intervention directed to sleep problems in preventing these negative outcomes.

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)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2024-05-06

Completion Date

2026-10-06

Last Updated

2026-03-02

Healthy Volunteers

No

Interventions

BEHAVIORAL

Improving sleep health and resilience during pregnancy

Weekly sessions include: a video clip (ca. 20 min) and a pdf; short questions on participants' experience related to the session's content; brief feedback questions on session's contents. Participants will have weekly opportunity for private online chats with a clinician. Sessions' contents: 1. Aims of the intervention; introducing the physiological regulation of sleep, sleep health and how sleep changes during pregnancy; 2. Psychological regulation of sleep and the impact of behaviors on sleep regulation; introducing the basics of CBT-I behavioral techniques; 3. Cognitive factors maintaining sleep difficulties; introducing cognitive techniques; 4. Emotional factors maintaining sleep difficulties and on the bidirectional association between sleep and emotions; introducing emotion regulation techniques; 5. Sleep in the postpartum and the development of sleep regulation in children; 6. Relapse prevention and focus on acquired skills and how to prioritize sleep.

BEHAVIORAL

Information on pregnancy-related issues

Each session will include: video clip (ca. 20 minutes) on aspects related to pregnancy and sleep; brief feedback questions. Participants in the placebo intervention will not be given specific indications on skills or techniques for sleep difficulties and will not have access to the weekly chat with the clinician. Sessions will cover the following contents: Session 1: phases of pregnancy; Session 2: sleep disorders; Session 3: nutrition and physical activity during pregnancy; Session 4: childbirth; Session 5: psychophysical development of the child in the first three years of life; Session 6: synthesis of previous sessions.

Locations (2)

Department of Biomedical and Neuromotor Sciences, Physiology campus, University of Bologna, Bologna, Italy

Bologna, Bologna, Italy

Department of Human Sciences, Guglielmo Marconi university

Rome, Rome, Italy