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

Stress Clinical Trial

— MOTHERS  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06379074
• Other study ID #: 2022PMFMSE
• Secondary ID: C53D23004250008
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: October 6, 2025

Study information

• Verified date: April 2024
• Source: University of Rome G. Marconi
• Contact: Chiara Baglioni, PhD
• Phone: 06377251
• Email: c.baglioni[@]unimarconi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: October 6, 2025
• Est. primary completion date: August 6, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Depression, Postpartum
• Insomnia
• Postpartum Depression
• Sleep Initiation and Maintenance Disorders
• Stress

Intervention

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.
• 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

Country	Name	City	State
Italy	Department of Biomedical and Neuromotor Sciences, Physiology campus, University of Bologna, Bologna, Italy	Bologna

Sponsors (3)

Lead Sponsor	Collaborator
University of Rome G. Marconi	University of Bologna, University of the Italian Switzerland

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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/

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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