Date trial registered
Mar 8, 2023
Incorporation of the first participant
Sep 8, 2021
Recruitment status
Completed
Academic title
(Data source: WHO)
Comparing the MyDoula app intervention with standard care for pregnant women regarding mental wellbeing: Randomized controlled trial
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Pre/post longitudinal experimental design with group randomization (Prevention)
Phase
(Data source: WHO)
Not Applicable
Primary end point
(Data source: WHO)
1. Negative birth expectations measured using the Wijma Delivery Expectations (W-DEQ) questionnaire at baseline and after 8 weeks
2. Support within the relationship measured using the ?Relationship Assessment Scale? questionnaire at baseline
3. Depression Scores are measured using the ?Edinburgh Depression Scale? questionnaire at baseline and 8 weeks later
4. Support within relationships measured using the ?Social support instrument? questionnaire at baseline
5. Mother-Child-Bonding measured using the ?Maternal antenatal attachment scale? questionnaire at baseline and 8 weeks later
6. Mental Wellbeing measured using the ?Mental Wellbeing Scale? questionnaire at baseline and 8 weeks later
7. Mindfulness measured using the ?Frankfurter Fragebogen Achtsamkeit (FFA)? questionnaire at baseline and 8 weeks later
8. Birth mindset measured using the ?Mindset and Birth? questionnaire at baseline
Secundary end point
(Data source: WHO)
1. Dyadic coping mechanisms of participants measured using two items of the dyadic coping inventory (DCI) at baseline
2. Quality of current relationship measured using the relationship assessment scale (RAS) at baseline
3. Social support measured using the social support instrument (ESSI) at baseline
4. Prenatal mother-child bonding measured using the Maternal antenatal attachment scale (MAAS) at baseline and 8 weeks after baseline
5. Mental wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline and 8 weeks after baseline
6. Mindfulness measured using the Frankfurter Fragebogen Achtsamkeit (FFA) at baseline and 8 weeks after baseline
7. Birthyear, sex, gender, German spoken and understood as native language, graduation, professional qualification, employment, professional position, management position, salary, number of persons in household, persons under 14 in household, marital status, taking psychotropic drugs (exclusion criteria), having psychotherapy (exclusion criteria), having a psychological diagnosis (exclusion criteria), having biological children, type of previous birth(s), type of previous negative birth experiences, abortion, miscarriage, pregnancy week, single/multiple pregnancy, planned pregnancy, worries about high/size of baby, complications during pregnancy, diseases regarding the unborn child, medical risk during pregnancy, worries/fears, main care person, satisfaction with pregnancy care, planned caesarian section (CS) and reasons, trauma, carrying out mindfulness exercises regularly, regular use of other pregnancy apps, using a birth preparation course, use of health apps, using online/offline offers regarding mental health, using online/offline offers regarding mindfulness measured using a Likert scale questionnaire at baseline
8. Pregnancy week, worries about high/size of the unborn baby, complications during pregnancy, diseases regarding the unborn child, medical risk during pregnancy, worries/fears, and planned CS measured using a Likert scale questionnaire at 8 weeks after baseline
9. A possible stressful event during pregnancy measured using a Likert scale questionnaire at 8 weeks after baseline
10. Stress tracking measured daily using a Likert scale questionnaire from baseline until 8 weeks after baseline
Contact information
(Data source: WHO)
European Regional Development Fund
