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

University of Rome G. Marconi

Status: Not yet enrolling

Conditions: Insomnia; Postpartum Depression; Stress

Treatments: Behavioral: Improving sleep health and resilience during pregnancy; Behavioral: Information on pregnancy-related issues

Study type: Interventional

Funder types: Other

Identifiers

NCT06379074

2022PMFMSE

C53D23004250008 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 3 patient groups, including a placebo group

Subgroup B2: CBT-I derived intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Improving sleep health and resilience during pregnancy

Subgroup B1: psychological placebo intervention

Placebo Comparator group

Description:

Psychoeducation placebo control intervention: 6 weekly online sessions composed of educational videos (ca. 20 minutes) on aspects related to pregnancy and sleep.

Treatment:

Behavioral: Information on pregnancy-related issues

Group A: control group

No Intervention group

Description:

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.