Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Rome G. Marconi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
severe diagnosis of relevant somatic disorder;
smoking;
alcohol intake;
assumption of illegal drugs;
Trial design
Design model
Parallel
Treatments tested in this trial
Improving sleep health and resilience during pregnancy
BehavioralWeekly 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.
Information on pregnancy-related issues
BehavioralEach 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.
Treatment groups
114 Participants
are divided into 3 treatment groupsGroup A: Subgroup B2: CBT-I derived interventionExperimental treatment 1 intervention
Group B: Subgroup B1: psychological placebo interventionPlacebo comparator 1 intervention
Group C: Group A: control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Stress reactivity
Salivary cortisol level by saliva sample provided by participants through swab
Time frame
Twice a day (morning and evening) once at baseline; after 6 weeks from baseline; 6 months post-partum2
Sleep efficiency
Total Sleep Time (min)/Time In Bed (min) expressed in percentage and assessed through actigraphy monitoring
Time frame
One week at baseline; after 6 weeks from baseline; 6 months post-partum3
Depressive symptoms
Edinburgh Postnatal Depression Scale (EPDS) total score (min. = 0; max. = 30; higher scores indicate a greater probability of having depression)
Time frame
Baseline; after 6 weeks from baseline; after 12 weeks from baseline; 1-to-2-week after birth; 3 months post-partum; 6 months post-partum4
Insomnia symptoms
Insomnia Severity Index total score (min. = 0; max. = 28; higher scores indicate a higher severity of insomnia)
Time frame
Baseline; after 6 weeks from baseline; after 12 weeks from baseline; 1-to-2-week after birth; 3 months post-partum; 6 months post-partumSecondary outcomes
1
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)
Time frame
1-to-2-week after birth; 3 months post-partum; 6 months post-partum2
Partners' insomnia symptoms
Insomnia Severity Index total score (min. = 0; max. = 28; higher scores indicate a higher severity of insomnia)
Time frame
Baseline; after 6 weeks from baseline; after 12 weeks from baseline; 1-to-2-week after birth; 3 months post-partum; 6 months post-partum3
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
Time frame
1-to-2-week after birth; 3 months post-partum; 6 months post-partumOther outcomes
1
Partners' sleep efficiency
Total Sleep Time (min)/Time In Bed (min) expressed in percentage and assessed through sleep diaries
Time frame
One week at baseline; after 6 weeks from baseline; 6 monhts post-partum2
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)
Time frame
1-to-2-week after birth; 3 months post-partum; 6 months post-partum3
Daytime sleepiness
Epworth Sleepiness Scale total score (min. = 0; max. = 24; higher scores indicate higher levels of sleepiness)
Time frame
Baseline; after 6 weeks from baseline; after 12 weeks from baseline; 1-to-2-week after birth; 3 months post-partum; 6 months post-partumSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Rome G. Marconi
Lead sponsor
University of Bologna
Collaborator
University of the Italian Switzerland
Collaborator
Source ClinicalTrials.gov