Save the children by treating their mothers (PriVileG-M-study) - study protocol: a sequentially randomized controlled trial of individualized psychotherapy and telemedicine to reduce mental stress in pregnant women and young mothers and to improve Child’s health

Abstract

Background: As early as pregnancy, maternal mental stress impinges on the child's development and health. Thus, this may cause enhanced risk for premature birth, lowered fetal growth, and lower fetal birth weight as well as enhanced levels of the stress hormone cortisol and lowered levels of the bonding hormone oxytocin. Maternal stress further reduces maternal sensitivity for the child's needs which impairs the mother-child-interaction and bonding. Therefore, prevention and intervention studies on mental stress are necessary, beginning prenatally and applying rigorous research methodology, such as randomized controlled trials, to ensure high validity. Methods: A randomized controlled trial is used to assess the impact of psychotherapy and telemedicine on maternal mental stress and the child's mental and physical health. Mentally stressed pregnant women are randomized to an intervention (IG) and a not intervened control group. The IG receives an individualized psychotherapy starting prenatal and lasting for 10 months. Afterwards, a second randomization is used to investigate whether the use of telemedicine can stabilize the therapeutic effects. Using ecological momentary assessments and video recordings, the transfer into daily life, maternal sensitivity and mother-child-bonding are assessed. Psycho-biologically, the synchronicity of cortisol and oxytocin levels between mother and child are assessed as well as the peptidome of the colostrum and breast milk, which are assumed to be essential for the adaptation to the extra-uterine environment. All assessments are compared to an additional control group of healthy women. Finally, the results of the study will lead to the development of a qualification measure for health professionals to detect mental stress, to treat it with low-level interventions and to refer those women with high stress levels to mental health professionals.

Maternal pre‐pregnancy underweight as a risk factor for the offspring: Survey of Neonates in Pomerania

“…The latter is addressed by our institution because socio-economic disadvantages among others may increase emotional stress in pregnancy. 22 The risk for complications during pregnancy like pregnancy-induced hypertension, gestational diabetes mellitus and preeclampsia was not increased in underweight women in our cohort. Other reported even a lower risk for these complications in women with pre-pregnancy underweight.…”

“…A greater understanding and attention by prenatal health care providers of the non‐medical risks of adverse pregnancy outcomes may benefit those social groups at greater risk in daily practice and research. The latter is addressed by our institution because socio‐economic disadvantages among others may increase emotional stress in pregnancy 22 …”

“The Mental Health Piece is Huge”: perspectives on developing a prenatal maternal psychological intervention for congenital heart disease

“…These findings are consistent with previous studies within this population examining their psychological functioning and perspectives on coping within the context of congenital heart disease. [20][21][22][23][24][26][27][28][29] Given the distress women endorse and their agreement on the benefit of a prenatal psychotherapeutic intervention, development of an evidence-based targeted intervention is warranted. Pregnant women and mothers in this study provided important information on the preferred structure and content of potential interventions.…”

“…14,17,18,25 Further, the amount of stress significantly increases with this diagnosis, and parents report greater stress, anxiety, trauma, and depression relative to the general population. 20,21,26,27 Research has demonstrated the efficacy of psychological interventions implemented during pregnancy in reducing maternal anxiety, depression, and stress, 19,[28][29][30] but very few trials have included pregnant women receiving fetal cardiac diagnoses 31 even though studies assessing prenatal counselling and pre-surgery education have supported a reduction in parental anxiety. 30 As greater insights into fetal brain growth and development emerge, the need for surveillance, assessment, and targeted psychological interventions prenatally are warranted, 11 to ensure children with congenital heart disease are given the best opportunity to thrive from the outset.…”

Daily Time-Use Patterns and Quality of Life in Parents: Protocol for a Pilot Quasi-Experimental, Nonrandomized Controlled Trial Using Ecological Momentary Assessment

“…The type of day (eg, ordinary working day or vacation day) is asked using the item from the Harmonised European Time Use Surveys [ 50 ]. The received and desired social support of significant others [ 51 ] is surveyed. Finally, the 3 dimensions of state mindfulness—present-moment attention, acting with awareness, and nonjudgmental acceptance—are measured using the Multidimensional State Mindfulness Questionnaire [ 52 ].…”