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

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.

Study Overview

• Status: Recruiting
• Conditions: Stress; Insomnia; Postpartum Depression
• Intervention / Treatment: Behavioral: Improving sleep health and resilience during pregnancy; Behavioral: Information on pregnancy-related issues

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.

   1. Group A: control group of healthy pregnant women with no insomnia complaints (N=38);
   2. 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:

   1. Baseline: between the 11th and the 15th week of pregnancy;
   2. Follow-up-1: after 6 weeks from baseline;
   3. Follow-up-2: after 12 weeks from baseline;
   4. Follow-up-3: 1-to-2-weeks after birth;
   5. Follow-up-4: 3-months post-partum;
   6. 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.

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chiara Baglioni, PhD; Phone Number: 06377251; Email: c.baglioni@unimarconi.it
• Study Contact Backup: Name: Debora Meneo, M.Sc; Phone Number: 06377251; Email: d.meneo@unimarconi.it

Study Locations

• Italy
  • Bologna
    • Bologna, Bologna, Italy, 40126
      • Recruiting
      • Department of Biomedical and Neuromotor Sciences, Physiology campus, University of Bologna, Bologna, Italy
      • Contact: Debora Meneo, M.Sc; Phone Number: 06377251; Email: d.meneo@unimarconi.it
      • Contact: Viviana Lo Martire; Email: viviana.lomartire2@unibo.it
      • Principal Investigator: Debora Meneo, M.Sc
      • Sub-Investigator: Elisabetta Baldi, M.Sc
      • Sub-Investigator: Silvia Cerolini, PhD
      • Sub-Investigator: Viviana Lo Martire, PhD
      • Sub-Investigator: Giuliana Simonazzi, PhD
      • Sub-Investigator: Sara Curati, B.Sc
      • Sub-Investigator: Stefano Bastianini, PhD
      • Sub-Investigator: Chiara Berteotti, PhD
      • Sub-Investigator: Mauro Manconi, PhD
      • Sub-Investigator: Giovanna Zoccoli, PhD
      • Sub-Investigator: Francesca Gelfo, PhD
      • Principal Investigator: Chiara Baglioni, PhD
      • Sub-Investigator: Paola De Bartolo, PhD
  • Rome
    • Rome, Rome, Italy, 00193
      • Recruiting
      • Department of Human Sciences, Guglielmo Marconi university
      • Contact: Chiara Baglioni, PhD, Associate Professor; Phone Number: +39 06377251; Email: c.baglioni@unimarconi.it
      • Contact: Debora Meneo, PhD; Email: d.meneo@unimarconi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subgroup B2: CBT-I derived intervention; CBT-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.	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: Aims of the intervention; introducing the physiological regulation of sleep, sleep health and how sleep changes during pregnancy;; Psychological regulation of sleep and the impact of behaviors on sleep regulation; introducing the basics of CBT-I behavioral techniques;; Cognitive factors maintaining sleep difficulties; introducing cognitive techniques;; Emotional factors maintaining sleep difficulties and on the bidirectional association between sleep and emotions; introducing emotion regulation techniques;; Sleep in the postpartum and the development of sleep regulation in children;; Relapse prevention and focus on acquired skills and how to prioritize sleep.; Other Names: Sleeping for…2. Taking care of sleep during pregnancy and the post-partum
Placebo Comparator: Subgroup B1: psychological placebo intervention; Psychoeducation placebo control intervention: 6 weekly online sessions composed of educational videos (ca. 20 minutes) on aspects related to pregnancy and 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.; Other Names: Getting to know pregnancy ... pregnancy and postpartum information meetings
No Intervention: Group A: control group; A 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress reactivity	Salivary cortisol level by saliva sample provided by participants through swab	Twice a day (morning and evening) once at baseline; after 6 weeks from baseline; 6 months post-partum
Sleep efficiency	Total Sleep Time (min)/Time In Bed (min) expressed in percentage and assessed through actigraphy monitoring	One week at baseline; after 6 weeks from baseline; 6 months post-partum
Depressive symptoms	Edinburgh Postnatal Depression Scale (EPDS) total score (min. = 0; max. = 30; higher scores indicate a greater probability of having depression)	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
Insomnia symptoms	Insomnia Severity Index total score (min. = 0; max. = 28; higher scores indicate a higher severity of insomnia)	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
Anxiety symptoms	Generalized Anxiety Disorder questionnaire total score (min. = 0; max. = 21; higher scores indicate a higher level of generalized anxiety)	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
Valence of affective states	Valence of morning and evening affective states assessed through visual scale in sleep and emotion diaries	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
Arousal of affective states	Arousal of morning and evening affective states assessed through visual scale in sleep and emotion diaries	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
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)	Baseline; after 6 weeks from baseline; 6 monhts post-partum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1-to-2-week after birth; 3 months post-partum; 6 months post-partum
Partners' insomnia symptoms	Insomnia Severity Index total score (min. = 0; max. = 28; higher scores indicate a higher severity of insomnia)	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
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	1-to-2-week after birth; 3 months post-partum; 6 months post-partum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partners' sleep efficiency	Total Sleep Time (min)/Time In Bed (min) expressed in percentage and assessed through sleep diaries	One week at baseline; after 6 weeks from baseline; 6 monhts post-partum
Fathers' 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)	1-to-2-week after birth; 3 months post-partum; 6 months post-partum
Daytime sleepiness	Epworth Sleepiness Scale total score (min. = 0; max. = 24; higher scores indicate higher levels of sleepiness)	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

Collaborators and Investigators

• Sponsor: University of Rome G. Marconi
• Collaborators: University of Bologna; University of the Italian Switzerland
• Investigators: Study Director: Chiara Baglioni, Professor, Department of Human Sciences, Guglielmo Marconi University, Rome, Italy

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Estimated): August 6, 2026
• Study Completion (Estimated): October 6, 2026

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Stress; Pregnancy; Insomnia; Postpartum; Cortisol; DNA methylation; Actigraphy; CBT-I; Sleep health
• Additional Relevant MeSH Terms: Urogenital Diseases; Nervous System Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Sleep Wake Disorders; Mood Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Puerperal Disorders; Depressive Disorder; Sleep Initiation and Maintenance Disorders; Depression, Postpartum
• Other Study ID Numbers: 2022PMFMSE; C53D23004250008 (Other Grant/Funding Number: Italian Ministry of University and Research (MUR))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No