Effects of an 8-week birth preparation intervention on women's mental well-being

ISRCTN	ISRCTN16756340
DOI	https://doi.org/10.1186/ISRCTN16756340
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Fachhochschule Potsdam
Funder	European Regional Development Fund

Submission date: 03/08/2022
Registration date: 08/03/2023
Last edited: 24/06/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
MyDoula is an 8-week online application. The program contains scientific-based elements for reducing fear of childbirth and depression, psycho-educational elements about pregnancy and birth, mindfulness and coping exercises. At the same time, personal resources and confidence-building exercises are implemented. In Germany, the MyDoula App is a novel approach to pregnancy apps, as it focuses on the mental health of the healthy population to prevent severe fear of childbirth and depression. Furthermore, it takes a systemic therapy approach into account. This study aims to investigate the potential effects of a smartphone app-based self-directed 8-week intervention on the mental well-being of pregnant women.

Who can participate?
Pregnant women between 20.1 and 27.0 weeks pregnant with an android system smartphone

What does the study involve?
The study participants will be randomly divided into two groups (intervention and control groups). The control group will do the pregnancy preparation as usual. The intervention group will get access to an 8-week pregnancy program run via an online application called MyDoula. The program consists of a daily morning mindfulness exercise as well as a daily evening mindfulness meditation. Additionally, the participants run units with psychoeducation and exercises related to certain psychological topics (e.g. stress relief). The daily stress level will be tracked.

Both the intervention and control groups will complete 2 questionnaires. The first of four before the app intervention and the second after the app intervention.

What are the possible benefits and risks of participating?
As a participation fee, the women received 30-50€ after completing the second questionnaire. There were no participating risks expected.

Where is the study run from?
University of Applied Sciences Potsdam (Fachhochschule Potsdam) (Germany)

When is the study starting and how long is it expected to run for?
March 2021 to October 2023

Who is funding this study?
European Regional Development Fund (Europäische Fonds für regionale Entwicklung – Land Brandenburg)

Who is the main contact?
1. Prof Dr Gerlind Große (Project Lead) (Germany)
grosse@fh-potsdam.de

Contact information

Mrs Carmen Birner
Scientific

Kiepenheuerallee 5
Potsdam
14469
Germany

ORCID ID	0000-0002-8605-7280
Phone	+49 151 12960013
Email	carmen.birner@fh-potsdam.de

Prof Gerlind Große
Scientific

Kiepenheuerallee 5
Potsdam
14469
Germany

ORCID ID	0000-0002-3596-5561
Phone	+49 331 580 4126
Email	gerlind.grosse@fh-potsdam.de

Study information

Primary study design	Interventional
Study design	Pre/post longitudinal experimental design with group randomization
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Comparing the MyDoula app intervention with standard care for pregnant women regarding mental wellbeing: Randomized controlled trial
Study acronym	MyDoula
Study objectives	1. Participants using MyDoula App will show greater reductions in fear of childbirth compared with CG participants 2. Participants using MyDoula App will show greater improvements in depressive scores compared with CG participants 3. Participants using MyDoula will show greater improvements in secondary outcomes (bonding, psychological wellbeing, mindfulness) compared to CG participants
Ethics approval(s)	Approved 08/09/2021, University of Potsdam Ethics Review Committee (Ethikkommission Universität Potsdam) (Universität Potsdam, Am Neuen Palais 10, Potsdam, 14469, Germany; +49 (0)3 31 9 77 17 91; Nadine.Mohaupt@uni-potsdam.de), ref: 40/2021
Health condition(s) or problem(s) studied	Fear of childbirth; mental health in pregnant women
Intervention	The intervention group undergoes an eight-week psychological birth preparation program, which is provided via an online application with the name MyDoula. The program contains daily morning mindfulness exercises, evening meditations and two units per week, each including psychoeducation and an exercise part (e.g. reflection exercises run via chatbot). The app use was self-guided. Participants randomized to the control group receive Treatment as Usual (TAU)/no treatment.
Intervention type	Behavioural
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/10/2023

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Female
Target sample size at registration	170
Key inclusion criteria	Pregnant women between the 20.1 and 27.0 week of pregnancy
Key exclusion criteria	1. Aged 17 years old and younger 2. German is not at a native language level 3. Taking psychotropic drugs, having a psychological diagnosis or being counselled by a psychologist, psychotherapist or psychiatrist at the time of the study 4. Pregnant women that give birth before finalizing the 8 weeks-MyDoula-App-Program (e.g. due to premature birth) 5. When people didn’t agree to be informed about incidental findings, e.g. high scores in the Edinburgh Postnatal Depression Scale (EPDS) screening
Date of first enrolment	08/09/2021
Date of final enrolment	15/10/2022

Locations

Countries of recruitment

Austria
Germany
Switzerland

Study participating centre

Fachhochschule Potsdam

Kiepenheuerallee 5
Potsdam
14469
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to these datasets comprising sensitive health data

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

24/06/2024: The following changes were made:
1. Ethics contact was amended.
2. The overall study end date was changed from 31/03/2023 to 31/10/2023.
3. The intention to publish date was changed from 31/12/2023 to 31/12/2024.
31/10/2023: The following changes were made to the trial record:
1. The acronym was added.
2. The study type was changed from Treatment to Prevention.
3. The overall end date was changed from 31/01/2023 to 31/03/2023.
4. The condition 'Fear of childbirth' was added.
5. The intention to publish date was changed from 31/10/2023 to 31/12/2023.
05/09/2022: Trial's existence confirmed by the University of Potsdam ethics review committee.