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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 114
- Locations
- 2
- Primary Endpoint
- Stress reactivity
Study Overview
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:
- 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;
- 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •severe diagnosis of relevant somatic disorder;
- •alcohol intake;
- •assumption of illegal drugs;
Arms & Interventions
Subgroup B2: CBT-I derived intervention
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.
Intervention: Improving sleep health and resilience during pregnancy (Behavioral)
Subgroup B1: psychological placebo intervention
Psychoeducation placebo control intervention: 6 weekly online sessions composed of educational videos (ca. 20 minutes) on aspects related to pregnancy and sleep.
Intervention: Information on pregnancy-related issues (Behavioral)
Group A: control group
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.
Outcomes
Primary Outcomes
Stress reactivity
Time Frame: Twice a day (morning and evening) once at baseline; after 6 weeks from baseline; 6 months post-partum
Salivary cortisol level by saliva sample provided by participants through swab
Emotion regulation
Time Frame: Baseline; after 6 weeks from baseline; 6 monhts post-partum
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)
Arousal of affective states
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-partum
Arousal of morning and evening affective states assessed through visual scale in sleep and emotion diaries
Sleep efficiency
Time Frame: One week at baseline; after 6 weeks from baseline; 6 months post-partum
Total Sleep Time (min)/Time In Bed (min) expressed in percentage and assessed through actigraphy monitoring
Depressive symptoms
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-partum
Edinburgh Postnatal Depression Scale (EPDS) total score (min. = 0; max. = 30; higher scores indicate a greater probability of having depression)
Insomnia symptoms
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-partum
Insomnia Severity Index total score (min. = 0; max. = 28; higher scores indicate a higher severity of insomnia)
Anxiety symptoms
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-partum
Generalized Anxiety Disorder questionnaire total score (min. = 0; max. = 21; higher scores indicate a higher level of generalized anxiety)
Valence of affective states
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-partum
Valence of morning and evening affective states assessed through visual scale in sleep and emotion diaries
Secondary Outcomes
- Children sleep difficulties(1-to-2-week after birth; 3 months post-partum; 6 months post-partum)
- 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)
Investigators
Chiara Baglioni
Professor
University of Rome G. Marconi