Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379074
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-02
Brief Title:
Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health
Sponsor:
University of Rome G Marconi
Organization:
University of Rome G Marconi
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOTHERS
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
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 fathers and childs 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 studys 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 Studys 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 eg 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 N38
2 Group B pregnant women complaining of subthreshold or clinical insomnia N76 further assigned to the following subgroups Subgroup B1 psychological placebo intervention N38 Subgroup B2 CBT-I derived intervention N38
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-MSMS 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 n114 will also be invited to take part to the study by filling out online questionnaire and sleep diaries for each assessment point detailed above
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 fathers and childs 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 studys 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 Studys 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 eg 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 N38
2 Group B pregnant women complaining of subthreshold or clinical insomnia N76 further assigned to the following subgroups Subgroup B1 psychological placebo intervention N38 Subgroup B2 CBT-I derived intervention N38
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-MSMS 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 n114 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C53D23004250008 | OTHER_GRANT | Italian Ministry of University and Research MUR | None |