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

NCT06379074 | Recruiting

• 2 other identifiers: 2022PMFMSEC53D23004250008
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Postpartum Depression; Insomnia; Stress

Keywords

Insomnia; Pregnancy; Stress; Sleep health; Postpartum; Actigraphy; Cortisol; DNA methylation; CBT-I

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Mothers' parenting stress

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

• Partners' insomnia symptoms

  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

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

Other Outcomes (3)

• Partners' sleep efficiency

  One week at baseline; after 6 weeks from baseline; 6 monhts post-partum

• Fathers' parenting stress

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

• Daytime 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

Study Arms (3)

Subgroup B2: CBT-I derived intervention

EXPERIMENTAL

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

Subgroup B1: psychological placebo intervention

PLACEBO COMPARATOR

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

Group A: control group

NO INTERVENTION

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.

Interventions

Improving sleep health and resilience during pregnancy BEHAVIORAL

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.

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

Subgroup B2: CBT-I derived intervention

Information on pregnancy-related issues BEHAVIORAL

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.

Also known as: Getting to know pregnancy ... pregnancy and postpartum information meetings

Subgroup B1: psychological placebo intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Rome G. Marconi: lead
• University of Bologna: collaborator
• University of the Italian Switzerland: collaborator

Study Sites (2)

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

Bologna, Bologna, 40126, Italy

RECRUITING

Department of Human Sciences, Guglielmo Marconi university

Rome, Rome, 00193, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 17490753 BACKGROUND

• 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

  BACKGROUND

• 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/

  BACKGROUND

• 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.

  PMID: 38858743 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Chiara Baglioni, Professor

  Department of Human Sciences, Guglielmo Marconi University, Rome, Italy

  STUDY DIRECTOR

Central Study Contacts

Chiara Baglioni, PhD

CONTACT

06377251; c.baglioni@unimarconi.it

Debora Meneo, M.Sc

CONTACT

06377251; d.meneo@unimarconi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Each participant will be assigned an identification code (ID-code) randomly generated by a computer. The codes associated to participants in Group B will be randomly assigned to intervention (Group B2) or placebo (Group B1). E-mail addresses will be created for each participant using the ID-code to access the private area of the study website. The code will be associated with responses to online questionnaires, actigraphy recording, saliva samples and sleep diaries.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 23, 2024
• Study Start: May 6, 2024
• Primary Completion (Estimated): August 6, 2026
• Study Completion (Estimated): October 6, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)