Systemic therapy with prenatal mothers presenting with anxiety and/or depression
| ISRCTN | ISRCTN17416582 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17416582 |
| Secondary identifying numbers | 1 |
- Submission date
- 12/09/2023
- Registration date
- 20/09/2023
- Last edited
- 25/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This study seeks to find out whether one of the policy measures in the Positive Parenting Strategy (i.e. that of providing therapeutic support to mothers during the prenatal period) is evidence-based. The study examines whether 12 sessions of systemic therapy offered to prenatal mothers suffering from anxiety and or depression who are randomly assigned to the intervention group would improve their levels of anxiety and/or depression when compared to those mothers who are randomly assigned to the control group who receive support provided by the midwife.
Who can participate?
Mothers aged 18 years and over attending their first prenatal visit at Mater Dei Hospital (normally after the 12th week of pregnancy) or referred by the midwives in charge at the Perinatal Mental Health Service
What does the study involve?
Those mothers who consent to participate in the study, are screened for depression and anxiety. The assessment includes a short questionnaire and questions to assess current mental health. Those mothers who after completing the questions are found to be suffering from anxiety and or depression are then asked to fill in more questionnaires and interviews. Those mothers whose diagnosis indicates serious mental health difficulties such as psychotic disorders and mood disorder with psychotic features, suicidal behaviour disorder, substance use disorders, post-traumatic stress disorder, anti-social personality disorder and borderline personality disorder are excluded from the study and referred for treatment within the Perinatal Mental Health Service at MaterDei Hospital or in the case of substance abuse disorders in the existing specialised centres available on the Island.
The remaining suffering from anxiety and or depression are randomly assigned into an intervention and control group. Mothers in the intervention group receive 12 online sessions from a systemic therapist. Mothers in the control group receive telephone calls from the midwife.
What are the possible benefits and risks of participating?
Possible benefits are that the level of anxiety and or depression would go down. There are no perceived risks for antenatal mothers participating.
Where is the study run from?
Mater Dei Hospital (Malta)
When is the study starting and how long is it expected to run for?
June 2020 to May 2024
Who is funding the study?
Committee for Positive Parenting and the Wellbeing of Families (Malta)
Who is the main contact?
Prof. Angela Abela, angela.abela@um.edu.mt
Contact information
Principal Investigator
Department of Child and Family Studies
Faculty dor Social Wellbeing
Old Humanities Building
Room 243
Msida
MSD2080
Malta
 ORCID ID |
0000-0002-9172-6530 |
|---|---|
| Phone | +356 (0)23403601 |
| angela.abela@um.edu.mt |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening, Treatment |
| Participant information sheet | 44272_PIS_07Sep23.pdf |
| Scientific title | Systemic therapy with prenatal mothers presenting with anxiety and/or depression: a randomised controlled trial |
| Study objectives | 1. Will 12 sessions in a systemic therapeutic modality significantly decrease symptoms of anxiety and/or depression in mothers forming part of the intervention (which also includes medication where needed) as opposed to those in the control group receiving treatment as usual (support by midwife & medication where needed)? 2. Will the therapeutic intervention also make a significant difference amongst Intervention Group mothers in terms of their evaluation of their couple relationship? |
| Ethics approval(s) |
Approved 06/01/2021, Faculty (for Social Wellbeing) Research Ethics Committee and the University (of Malta) Research Research Committee (University of Malta, MSIDA, MSD2080, Malta; +356 (0)23402340; research-ethics.fsw@um.edu.mt), ref: ID:753127.12.2020 |
| Health condition(s) or problem(s) studied | Antenatal anxiety and/or depression |
| Intervention | Current interventions as of 01/05/2024: Mothers who during the prenatal period score above the cutoff point on the Edinburgh Postnatal Scale (EPDS)_ (13 or higher) and or the Generalised Anxiety Disorder Assessment (GAD-7) (10 and up) and wish to continue with the study are asked to sit for the Mini International Neuropsychiatric interview with borderline personality disorder module (MINI). The Mini helps to provide us with a more complete profile of the mothers and to exclude those falling in the exclusion criteria (See section on exclusion criteria below). Mothers who are eligible and who consent to continue with the study are assigned by the Statistician on our research team. The allocation of participants to either intervention or control group is carried out through minimization to achieve balanced groups with respect to numbers and participant characteristics that are believed to be important for the study's outcome. In minimisation, participants are assigned to groups based on a set of predefined criteria or variables, such as labour status, relationship status, level of education completed, nationality, and financial impact of COVID-19. The allocation of participants is implemented by "MinimPy" which is an open-source desktop minimisation programme written in Python programming language with complete customisation of minimisation features for the allocation of patients to groups. For a complete description of the programme, please refer to: Saghae, M and Saga, S. (2011) Implementation of an open-source customizable minimization program for allocation of patients to parallel groups in clinical trials. Journal of Biomedical Science and Engineering,4,734 - 739.Http://www.scirp.org?journal/jbise/ Those in the intervention group receive 12 online sessions of systemic therapy. The sessions are spread over 19 weeks, the first 5 will take place every week, whereas the last 7 are offered on a fortnightly basis. Those needing medication are referred to a psychiatrist who prescribes medication if needed. The mothers in the control group are followed by the midwife through monthly calls over the 19 weeks. Those needing medication are referred to a psychiatrist who prescribes medication if needed. _____ Previous interventions: Mothers who during the antenatal period score above the cut-off point on the Edinburgh Postnatal Depression Scale (EPDS) (13 or higher) and/or the Generalised Anxiety Disorder Assessment (GAD-7) (10 or higher) were assigned by the Statistician on the research team. The allocation of participants to either intervention or control group was carried out through minimization in order to achieve balanced groups with respect to numbers and participant characteristics that are believed to be important for the study's outcomes. In minimization, subjects were assigned to groups based on a set of predefined criteria or variables, such as labour status, relationship status, level of education completed, nationality and financial impact of COVID-19. The allocation of participants was implemented by “MinimPy” which is an open-source desktop minimization program written in Python programming language with complete customization of minimization features for the allocation of patients to groups. For a complete description of the program used, please refer to the following journal: Saghae, M. and Sagaei, S. (2011) Implementation of an open-source customizable minimization program for allocation of patients to parallel groups in clinical trials. Journal of Biomedical Science and Engineering, 4, 734-739. http://www.scirp.org/journal/jbise/ Those in the intervention group receive 12 online sessions of systemic therapy. The sessions are spread over 19 weeks, the first 5 will take place on a weekly basis, whereas the last 7 are offered on a fortnightly basis. Those needing medication are referred to a psychiatrist who prescribes medication if needed. The mothers in the control group are followed by the midwife through monthly phone calls over the 19-week period. Those needing medication are referred to a psychiatrist who prescribes medication if needed. |
| Intervention type | Behavioural |
| Primary outcome measure | Level of anxiety and/or depression measured using EPDS, GAD-7 immediately after the end of the intervention |
| Secondary outcome measures | Distress in couple relationship measured using the Revised Dyadic Adjustment Scale (RDAS) post-intervention period |
| Overall study start date | 09/06/2020 |
| Completion date | 31/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Expecting a baby and not exceeding 20 weeks of pregnancy to be able to receive the intervention (over a 19-week period) and be post-tested before giving birth 2. Scoring above the cut-off point on GAD and EPDS 3. Accepting to take part in the study |
| Key exclusion criteria | 1. Lone parents meaning mothers 2. Mothers with psychotic disorders and mood disorder with psychotic features 3. Suicidal behaviour disorder 4. Substance use disorder 5. Alcohol use disorder 6. Post-traumatic stress disorder 7. Anti-social personality disorder 8. Borderline personality disorder Criteria 2 -8 were identified through the use of the MINI |
| Date of first enrolment | 01/03/2022 |
| Date of final enrolment | 14/12/2023 |
Locations
Countries of recruitment
- Malta
Study participating centre
Msida
MSD2090
Malta
Sponsor information
Government
c/o Ministry for Social Policy and Children's Rights
310, Palazzo Ferreira
Triq ir-Repubblika
Valletta
VLT1110
Malta
| Phone | +356 (0)25903106 |
|---|---|
| ruth-rose.sciberras@gov.mt | |
| Website | https://familja.gov.mt/entitajiet-pubblici/kumitat-ghal-trobbija-pozittiva-u-t-tishih-tal-familja/ |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/08/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact systemic journal |
| IPD sharing plan | The dataset generated during the current study will be available upon request from the principal investigator Prof. Angela Abela (angela.abela@um.edu.mt). • The type of data that will be shared: Microdata (upon request) and the aggregated results once the data analysis is ready • Dates of availability: Once the data is checked and cleaned, ideally after the analysis. • Whether consent from participants was required and obtained: Consent obtained :Data is anonymised • Comments on data anonymization: names, surnames, addresses, age and any other factors that might detect who the person will be all removed. Instead the Index No of the person, the factors used for the minimization process (labour status, education level, impact of COVID-19, nationality, etc.) and their corresponding measurements pre- and post- (EPDS, ANRQ etc). will be retained. • Any ethical or legal restrictions:Not to our knowledge • Any additional comments:None |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 07/09/2023 | 14/09/2023 | No | Yes | |
| Protocol file | 24/04/2024 | No | No | ||
| Other unpublished results | 27/01/2025 | No | No |
Additional files
Editorial Notes
25/02/2025: Total final enrolment added. The intention to publish date was changed from 30/09/2024 to 31/08/2025.
27/01/2025: A file of unpublished results was uploaded as an additional file.
01/05/2024: The following changes were made to the trial record:
1. The interventions were changed.
2. The overall end date was changed from 30/04/2024 to 31/05/2024.
24/04/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/10/2023 to 14/12/2023.
2. The overall end date was changed from 01/03/2024 to 30/04/2024.
3. The plain English summary was updated to reflect these changes.
4. Uploaded protocol (not peer-reviewed) as an additional file.
21/09/2023: The participant level data sharing statement was updated.
14/09/2023: Study's existence confirmed by the Committee for Positive Parenting and the Wellbeing of Families.
