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Postpartum DepressionMOTHERSNCT06379074

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

A study testing Improving sleep health and resilience during pregnancy and Information on pregnancy-related issues in people with Postpartum Depression and Insomnia, run by University of Rome G. Marconi at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Postpartum Depression, Insomnia, Stress
What is being tested?
Improving sleep health and resilience during pregnancy and Information on pregnancy-related issues
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
114 participants
Where
2 sitesItaly
Study dates
6 May 2024to 6 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age ≥ 18 yrs. old;
  • good knowledge of Italian language;
  • intention to continue pregnancy;
  • BMI ranging 18-30 (i.e., without underweight or obesity following international criteria; WHO, 2013);
  • ≤ 15th week of pregnancy at the time of recruitment.

Who cannot join

  • severe diagnosis of relevant somatic disorder;
  • smoking;
  • alcohol intake;
  • assumption of illegal drugs;

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chiara Baglioni, PhD contact

06377251

c.baglioni@unimarconi.it

Debora Meneo, M.Sc contact

06377251

d.meneo@unimarconi.it

Italy2 sites, 2 recruiting

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

    Bologna, Bologna, 40126

    Viviana Lo Martire, viviana.lomartire2@unibo.it

    Debora Meneo, M.Sc, 06377251, d.meneo@unimarconi.it

    Recruiting

  • Department of Human Sciences, Guglielmo Marconi university

    Rome, Rome, 00193

    Chiara Baglioni, PhD, Associate Professor, 06377251 ext. +39, c.baglioni@unimarconi.it

    Debora Meneo, PhD, d.meneo@unimarconi.it

    Recruiting

Other trials in Italy

About this study

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)

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.

Read the detailed description

The present trial aims to evaluate long-term effectiveness of a digital psychoeducational module based on CBT-I for expectant mothers complaining insomnia symptoms without psychiatric comorbidities on:

  1. physiological, biological, genetical and subjective indices of maternal psychopathology, stress, and emotional processes. These outcomes will be assessed through online questionnaires and sleep diaries, cortisol levels, and recording of the sleep-wake activity through actigraphy;
  2. father's and child's sleep and perceived stress. These outcomes will be assessed through online questionnaires and sleep diaries. 114 expectant mothers will be evaluated from early pregnancy until 6 months post-partum. For power calculation of human studies, efficacy of clinical intervention for insomnia during pregnancy in preventing and ameliorating sleep, psychopathology and attachment with future child at post-partum was considered the primary outcome. A study that compared scores on the Edinburgh Postnatal Depression Scale (EPDS) in 132 women divided into cognitive-behavioral therapy for insomnia (N = 89) or control group (N = 43) before, during and after pregnancy was used. G-Power software estimated that 114 women in total would be needed to have an effect power of at least 80%. Women will be recruited primarily in the area of Bologna and Rome (Italy) and study's materials will be conserved in the Department of Biomedical and Neuromotor Sciences, University of Bologna (Italy). Screening: all interested women will be contacted for an appointment with a clinical psychologist for the screening, which will be conducted in a confidential space in a room at the Universities' Department involved (Department of Biomedical and Neuromotor Sciences, University of Bologna; Department of Human Sciences, Guglielmo Marconi University of Rome). These spaces will be used for all in-person contact with the participants (details below). Study's materials, including biological samples, will be conserved in a secured room in the Department of Biomedical and Neuromotor Sciences, University of Bologna for the whole duration of the study. All women will be asked to read and sign the informed consent before proceeding. Women will be evaluated through a widely used psychological structured interview (Structured Clinical Interview for DSM-5, SCID-5 in the brief version QuickSCID-5) and an interview about sleep. Furthermore, data on pregnancy and socioeconomic variables will be collected. Women will be asked to share, along with their consent, gynecological medical data on their health status (e.g. information on pregnancy). This face-to-face screening procedure will be conducted for checking inclusion criteria. The full sample will be divided in the following groups matched for age.
  3. Group A: control group of healthy pregnant women with no insomnia complaints (N=38);
  4. Group B: pregnant women complaining of subthreshold or clinical insomnia (N=76), further assigned to the following subgroups: Subgroup B1: psychological placebo intervention (N=38), Subgroup B2: CBT-I derived intervention (N=38). Insomnia complaints will be assessed through a validated questionnaire 'Insomnia Severity Index'. No insomnia complaints (Group A) vs insomnia complaints (Group B) will be operationalized using the cut-off of 7 (subthreshold insomnia). Group B will be randomly assigned to Subgroup B1 and to Subgroup B2. After the baseline interview, all women will be monitored longitudinally in 6 assessment evaluations:
  5. Baseline: between the 11th and the 15th week of pregnancy;
  6. Follow-up-1: after 6 weeks from baseline;
  7. Follow-up-2: after 12 weeks from baseline;
  8. Follow-up-3: 1-to-2-weeks after birth;
  9. Follow-up-4: 3-months post-partum;
  10. Follow-up-5: 6-monhts post-partum. For women who will be offered clinical treatment, baseline and follow-up-1 assessments will be conducted pre- and post-treatment. At three time points (Baseline, Follow-up 1, and Follow-up 5) an ecological-momentary-assessment (EMA) design will be used to collect data on sleep and emotions (sleep diary), sleep-wake parameters (actigraphy) and stress reactivity (salivary cortisol). Women will be asked, for each EMA week, to complete a sleep and emotion diary twice a day (in the morning and evening), to wear a wrist actigraph for 7 days, and to collect, on the first day of each EMA week, saliva samples through swabs. Saliva samples will be collected in the morning and the evening and will be used to evaluate salivary cortisol levels by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Cortisol levels will be used as index of stress reactivity. Aliquots of morning salivary (1 assessment per person) will be used for the analysis of DNA methylation of the genes FKBP5, BDNF, and NR3C1, by Sequenom MALDI-TOF mass spectrometry, as potential biomarkers of prenatal poor sleep. The partner of each participant (n=114) will also be invited to take part to the study by filling out online questionnaire and sleep diaries for each assessment point detailed above.
Being tested
Improving sleep health and resilience during pregnancy, Information on pregnancy-related issues
Keywords
Insomnia, Pregnancy, Stress, Sleep health, Postpartum, Actigraphy, Cortisol, DNA methylation, CBT-I
Medical subject headings
Depression, Postpartum, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Improving sleep health and resilience during pregnancyBehavioural

    Also called Sleeping for…2. Taking care of sleep during pregnancy and the post-partum

    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.

  • Information on pregnancy-related issuesBehavioural

    Also called Getting to know pregnancy ... pregnancy and postpartum information meetings

    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.

Study groups in NCT06379074
Study groupRoleWhat they receive
Subgroup B2: CBT-I derived interventionExperimentalCBT-I derived intervention: 6 weekly online sessions with psychoeducation on sleep adapted to pregnancy, introduction of CBT-I techniques, discussion of sleep diaries and of acquired skills.
Receives: Behavioral: Improving sleep health and resilience during pregnancy
Subgroup B1: psychological placebo interventionPlacebo comparatorPsychoeducation placebo control intervention: 6 weekly online sessions composed of educational videos (ca. 20 minutes) on aspects related to pregnancy and sleep.
Receives: Behavioral: Information on pregnancy-related issues
Group A: control groupNo interventionA control group of healthy pregnant women with no insomnia complaints (ISI < 8) will be followed parallel to the intervention and control group, from the first trimester of pregnancy to 6 months post-partum to assess changes in sleep and psychological indices in pregnancy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stress reactivity

    Salivary cortisol level by saliva sample provided by participants through swab

    Measured: Twice a day (morning and evening) once at baseline; after 6 weeks from baseline; 6 months post-partum

  2. Sleep efficiency

    Total Sleep Time (min)/Time In Bed (min) expressed in percentage and assessed through actigraphy monitoring

    Measured: One week at baseline; after 6 weeks from baseline; 6 months post-partum

  3. Depressive symptoms

    Edinburgh Postnatal Depression Scale (EPDS) total score (min. = 0; max. = 30; higher scores indicate a greater probability of having depression)

    Measured: Baseline; after 6 weeks from baseline; after 12 weeks from baseline; 1-to-2-week after birth; 3 months post-partum; 6 months post-partum

  4. Insomnia symptoms

    Insomnia Severity Index total score (min. = 0; max. = 28; higher scores indicate a higher severity of insomnia)

    Measured: Baseline; after 6 weeks from baseline; after 12 weeks from baseline; 1-to-2-week after birth; 3 months post-partum; 6 months post-partum

  5. Anxiety symptoms

    Generalized Anxiety Disorder questionnaire total score (min. = 0; max. = 21; higher scores indicate a higher level of generalized anxiety)

    Measured: Baseline; after 6 weeks from baseline; after 12 weeks from baseline; 1-to-2-week after birth; 3 months post-partum; 6 months post-partum

  6. Valence of affective states

    Valence of morning and evening affective states assessed through visual scale in sleep and emotion diaries

    Measured: Baseline; after 6 weeks from baseline; after 12 weeks from baseline; 1-to-2-week after birth; 3 months post-partum; 6 months post-partum

  7. Arousal of affective states

    Arousal of morning and evening affective states assessed through visual scale in sleep and emotion diaries

    Measured: Baseline; after 6 weeks from baseline; after 12 weeks from baseline; 1-to-2-week after birth; 3 months post-partum; 6 months post-partum

  8. Emotion regulation

    Cognitive Emotion Regulation Questionnaire - Italian Short-Version (each of the nine subscales' scores ranges from 2 to 10; higher scores indicate a greater use of a specific emotion regulation strategy)

    Measured: Baseline; after 6 weeks from baseline; 6 monhts post-partum

Secondary outcomes (3)

  1. Mothers' parenting stress

    Parenting Stress Index-SF total and subscales score (subscales scores range from 12 to 60 and total score ranges from 36 to 180; higher scores indicate higher level of stress)

    Measured: 1-to-2-week after birth; 3 months post-partum; 6 months post-partum

  2. Partners' insomnia symptoms

    Insomnia Severity Index total score (min. = 0; max. = 28; higher scores indicate a higher severity of insomnia)

    Measured: Baseline; after 6 weeks from baseline; after 12 weeks from baseline; 1-to-2-week after birth; 3 months post-partum; 6 months post-partum

  3. Children sleep difficulties

    Brief Infant Sleep Questionnaire total score. Sleep difficulties are defined as: (1) the child wakings > 3 times per night; (2) the nocturnal wakefulness period > 1 h; or (3) the total sleep time < 9 h

    Measured: 1-to-2-week after birth; 3 months post-partum; 6 months post-partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2024
  2. Study start6 May 2024
  3. Primary completion6 Aug 2026 (estimated)
  4. Study completion6 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will receive a personal e-mail address to access their reserved area of the study's website. Each e-mail address is created using the pre-defined pseudonymized code, which will be assigned to each participant after screening (participants with sleep difficulties will be randomly assigned a code for condition B1 or B2). This procedure is designed to increase privacy protection, allow for matching of responses throughout study's phases, and blind outcome assessors to participants allocation. The personal website areas include contents based on their group allocation: * A: online questionnaire and sleep diaries; * B1: online questionnaire and sleep diaries; placebo intervention's contents (videos and pdf); * B2: online questionnaire and sleep diaries; intervention's contents (videos and pdf); weekly optional private chat with a clinician (a psychotherapist expert in CBT-I and insomnia during pregnancy).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06379074
Sponsor's protocol ID
2022PMFMSE
Other IDs
C53D23004250008
Acronym
MOTHERS
Status last verified
Feb 2026
First submitted
2 Apr 2024
Last updated
2 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Austin MP, Frilingos M, Lumley J, Hadzi-Pavlovic D, Roncolato W, Acland S, Saint K, Segal N, Parker G. Brief antenatal cognitive behaviour therapy group intervention for the prevention of postnatal depression and anxiety: a randomised controlled trial. J Affect Disord. 2008 Jan;105(1-3):35-44. doi: 10.1016/j.jad.2007.04.001. Epub 2007 May 8.

    PubMed 17490753

  • First & Williams. QuickSCID-5. Raffaello Cortina Editore - Libro Raffaello Cortina Editore; 2020. https://www.raffaellocortina.it/scheda-libro/michael-b-first-janet-bw-williams/quickscid-5-9788832853629-3590.html

  • Meneo D, Bacaro V, Buonanno C, Baglioni C. La valutazione del sonno in psicoterapia: una proposta di intervista clinica semistrutturata | Giovanni Fioriti Editore. Cognitivismo clinico. Published online November 9, 2023. https://www.fioritieditore.com/la-valutazione-del-sonno-in-psicoterapia-una-proposta-di-intervista-clinica-semistrutturata/

  • Meneo D, Baldi E, Cerolini S, Curati S, Bastianini S, Berteotti C, Simonazzi G, Manconi M, Zoccoli G, De Bartolo P, Gelfo F, Martire VL, Baglioni C. Promoting sleep health during pregnancy for enhancing women's health: a longitudinal randomized controlled trial combining biological, physiological and psychological measures, Maternal Outcome after THERapy for Sleep (MOTHERS). BMC Psychol. 2024 Jun 10;12(1):340. doi: 10.1186/s40359-024-01827-1.

    PubMed 38858743

Questions about this trial

What is this clinical trial studying?

A study testing Improving sleep health and resilience during pregnancy and Information on pregnancy-related issues in people with Postpartum Depression and Insomnia, run by University of Rome G. Marconi at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chiara Baglioni, PhD (06377251, c.baglioni@unimarconi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stress reactivity (time frame: Twice a day (morning and evening) once at baseline; after 6 weeks from baseline; 6 months post-partum). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06379074, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

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