Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001273875
Ethics application status
Approved
Date submitted
26/06/2020
Date registered
20/09/2021
Date last updated
21/12/2021
Date data sharing statement initially provided
20/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Program for Perinatal Mental Health Promotion and Work-Life Balance
Scientific title
Perinatal mental health promotion and work-life balance: the effect of an intervention program on postpartum depression among Portuguese women.
Secondary ID [1] 301629 0
None
Universal Trial Number (UTN)
U1111-1254-2341
Trial acronym
MAternal Mental Health in the WORKplace - MAMH@WORK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 318027 0
Postpartum depression 318028 0
Postpartum blues 318029 0
Child-mother attachment 318030 0
Child emotional self-regulation 318031 0
Child cognitive self-control 318032 0
Poor sleep 318035 0
Postpartum bonding 321123 0
Condition category
Condition code
Mental Health 316063 316063 0 0
Anxiety
Mental Health 316064 316064 0 0
Depression
Reproductive Health and Childbirth 316065 316065 0 0
Other reproductive health and childbirth disorders
Public Health 316066 316066 0 0
Health promotion/education
Mental Health 318916 318916 0 0
Other mental health disorders
Reproductive Health and Childbirth 318917 318917 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MAternal Mental Health in the WORKplace (MAMH@WORK) intervention will address maternal mental health and well-being protection and promotion during late pregnancy, postpartum and return to work. More specifically, it will target women’s psychosocial adjustment and resilience during this life stage, while promoting several strategic skills: recognition of signals and symptoms of mental disorders; reduction of stigma against mental disorders; coping skills for stressful situations, with a special focus on e-training of mindfulness; enhancement of help-seeking efficacy; and strengthening of emotional and cognitive self-regulation.

Health education sessions will be conducted by trained psychologists and psychiatrists experienced in cognitive-behavioural therapy-based psychoeducation interventions, prevention and treatment of depression and anxiety disorders. The intervention will be either conducted on-site (Instituto de Saúde Ambiental da Faculdade de Medicina da Universidade de Lisboa) or live streaming online. The format, setting and contents of the intervention will be fully defined after scoping literature reviews and Delphi technique, which will assure its adequacy as a short-term and sustainable intervention.

Still, the intervention is planned as follows (slight changes are anticipated as a consequence of the scoping literature reviews and Delphi technique for consensus-building):
- Modules: mental health literacy, self- and perceived stigma towards mental illness, work-life balance, early signs of mental disorders, mother-child interaction and promotion of secure attachment, social support, information about biofeedback (including technical details about the wearable devices), and mindfulness concepts and exercises.
- Materials: a standardized operating procedure manual (with training and implementation material for facilitators); each participant will be provided with a booklet with mental health literacy contents and access to (online) e-mental health tools (i.e., easy-to-follow, short videos).
- Procedures: discussion of vignettes, discussion of illustrative cases (i.e., cases of postpartum depression, poor and adequate mother-child interaction), emotional and cognitive expression exercises, video demonstration, roleplay of mother-child interactions, and demonstration followed by practical exercises on how to use biofeedback devices (i.e., smartwatch and a sleep banner analyzer) and interpret biofeedback outputs.
- Intervention providers: trained psychologists and psychiatrists
- Mode of delivery: either face-to-face or live streaming online
- Number of sessions: short-term group intervention of 20h (4h/session) to be delivered in two blocks, one at pregnancy month 7, immediately after recruitment (block 1, two sessions) and the other at postpartum month 5 (block 2, three sessions). E-mental health tools are freely available to the participants, who can access them through their mobile phones or computer, at any time. Participants will be invited to access this content regularly (e.g., 10 minutes every other day) from allocation to arms until study close-out.
- Group size: group size per session should be =15
- Location: Instituto de Saúde Ambiental da Faculdade de Medicina da Universidade de Lisboa

Data collection will be performed by members of the research team through self-administered questionnaires, wearable devices for monitoring physiological signals (in association with a smartphone app), and direct observations of mother-child interactions. It will be conducted on five different moments: baseline (t0; 28–30 gestation weeks), one week after enrollment (t1; 29–31 gestation weeks), two weeks postpartum (t2), five months postpartum (t3), and twelve months postpartum (t4). Women in the intervention group with biofeedback will be provided with a smartwatch and a sleep analyzer device (free of charge for the participants). Participants will be instructed to wear the smartwatch every day, all day long (waterproof devices), and the sleep analyser during the night, when they go to bed.

The RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework will be used to assess the potential for translation and public health impact of this intervention as follows:
- Reach dimension: the participation rate given as the proportion of invited pregnant women that accepted to participate in the intervention will be calculated.
- Effectiveness dimension: a three-arm randomized controlled trial will be implemented to assess this dimension. The intervention arm 1 will go through cognitive-behavioural therapy-based (CBT-based) psychoeducation sessions (including mindfulness e-training) by formally trained psychiatrists and psychologists; the intervention arm 2 will benefit from the same CBT-based psychoeducation sessions (with mindfulness e-training) in addition to a biofeedback intervention; the control arm will receive the care-as-usual from their health units.
- Adoption dimension: does not apply, because the intervention will be delivered by members of the research team.
- Implementation dimension: adequacy of the syllabus and the monitoring of a set of progress objectives (e.g., number of the psychoeducation intervention hours delivered, sessions attendance, costs associated, and number of hours of online mindfulness exercises completed, health app analytics).
- Maintenance dimension: at both individual and setting levels will be measured at the last moment of data collection, respectively, by (a) the extent to which attendees maintain behavioural change after participating in the intervention and (b) the willingness of health unit managers to provide their users with this intervention.
Intervention code [1] 317931 0
Prevention
Intervention code [2] 317932 0
Lifestyle
Intervention code [3] 317933 0
Behaviour
Comparator / control treatment
The intervention will be assessed through a randomized controlled trial with three arms
- Arm 1: CBT-based psychoeducation sessions (including mindfulness e-training)
- Arm 2: CBT-based) psychoeducation sessions (including mindfulness e-training) plus biofeedback
- Arm 3: control group

The arm 3 group (control group) will receive the care-as-usual from their health units, i.e., regular appointments with GP; ultrasound scans every three months; and discussion of any doubts the mother and/or the father might have. Care-as-usual follow the WHO recommendations on antenatal care for a positive pregnancy.
Control group
Active

Outcomes
Primary outcome [1] 324260 0
Postnatal depression, assessed using the Edinburgh Postnatal Depression Scale (Cox et al., 1987) for the three arms.
Timepoint [1] 324260 0
2 weeks postpartum, 5 months postpartum and 12 months postpartum (primary endpoint)
Primary outcome [2] 324261 0
Postpartum bonding, assessed using the Postpartum Bonding Questionnaire (Brockington et al., 2006) for the three arms.
Timepoint [2] 324261 0
2 weeks postpartum, 5 months postpartum and 12 months postpartum (primary endpoint)
Primary outcome [3] 324262 0
Child attachment security assessed using the Strange Situation Procedure (Ainsworth & Bell, 1970).
Timepoint [3] 324262 0
12 months postpartum
Secondary outcome [1] 384192 0
Presenteeism assessed using the World Health Organization’s Heath and Work Performance Questionnaire (Kessler et al, 2003) for the three arms.
Timepoint [1] 384192 0
12 months postpartum
Secondary outcome [2] 384193 0
Participants’ mental health literacy assessed using the Mental Health Literacy Scale (O'Connor & Casey, 2015) at the study close-out.
Timepoint [2] 384193 0
Baseline (28-30 weeks gestation) and 12 months postpartum.
Secondary outcome [3] 384194 0
Child development assessed using the Schedule of Growing Skills II (Bellman et al, 2012).
Timepoint [3] 384194 0
5 months postpartum and 12 months postpartum
Secondary outcome [4] 384197 0
Sleep quality determined using app data from a wearable device (sleep analyzer).
Timepoint [4] 384197 0
Baseline (28-30 weeks gestation), 29-31 weeks gestation, 2 weeks postpartum, 5 months postpartum and 12 months postpartum
Secondary outcome [5] 384198 0
Resilience assessed using the Connor-Davidson Resilience Scale (Connor & Davidson, 2003).
Timepoint [5] 384198 0
Baseline (28-30 weeks gestation), 29-31 weeks gestation, 2 weeks postpartum, 5 months postpartum and 12 months postpartum

Eligibility
Key inclusion criteria
Native Portuguese speakers or women living in Portugal for at least 5 years; intended pregnancy; primiparous, singleton pregnant women at the gestational age of 28-30 weeks; aged 18-40 years; employed; with access to a smartphone; and have had understood and signed the project’s informed consent form.
Minimum age
2 Weeks
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy after infertility treatments; multiple pregnancy; episodes of obstetric emergencies; diagnosis of a) a serious mental disorder (e.g., schizophrenia, schizoaffective disorder, other psychotic disorders, bipolar and related disorders, personality disorders), b) a chronic disease resulting in functional impairment, or c) a neurodevelopmental disorder (e.g., autism spectrum disorders and intellectual disability); history of major depression; being under antidepressant medication; alcohol and/or drug addiction; high-risk pregnancy; and foetal malformations. In addition to these exclusion criteria, mother-child dyads will be excluded from the study (after enrolment) in case of preterm birth (less than 37 weeks of gestational age), very-low weight at birth (less than 1500 g) or unexpected newborn malformations.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
- Intention-to-treat and per-protocol analyses,
- central tendency (mean and median) and dispersion (standard deviation and range) measures for each moment of data collection,
- between-groups comparisons (for each data collection moment and for deltas between collection moments) will be tested through ANOVA or its non-parametric equivalent (Kruskal-Wallis) for continuous variables, and chi-square test for categorical variables,
- the intervention effect will be addressed through linear and logistic regressions for numerical and categorical dependent variables, respectively,
- Cohen’s d coefficientCramer’s V, and odds ratio for the effect size of the intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
225
Accrual to date
Final
Recruitment outside Australia
Country [1] 22696 0
Portugal
State/province [1] 22696 0
Lisbon Metropolitan Area

Funding & Sponsors
Funding source category [1] 306063 0
Self funded/Unfunded
Name [1] 306063 0
None
Country [1] 306063 0
Primary sponsor type
Other
Name
Instituto de Saúde Ambiental, Faculdade de Medicina da Universidade de Lisboa
Address
Instituto de Saúde Ambiental
Faculdade de Medicina da Universidade de Lisboa
Av. Prof. Egas Moniz
1649-028 Lisboa
Country
Portugal
Secondary sponsor category [1] 306523 0
None
Name [1] 306523 0
Address [1] 306523 0
Country [1] 306523 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306285 0
Comissão de Ética Comissão de Ética do Centro Hospitalar Lisboa Norte e do Centro Académico de Medicina de Lisboa
Ethics committee address [1] 306285 0
Ethics committee country [1] 306285 0
Portugal
Date submitted for ethics approval [1] 306285 0
30/06/2020
Approval date [1] 306285 0
23/09/2020
Ethics approval number [1] 306285 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103370 0
Dr Osvaldo Santos
Address 103370 0
Instituto de Saúde Ambiental
Faculdade de Medicina da Universidade de Lisboa
Av. Prof. Egas Moniz
1649-028 Lisboa
Portugal
Country 103370 0
Portugal
Phone 103370 0
+351 217985148
Fax 103370 0
Email 103370 0
[email protected]
Contact person for public queries
Name 103371 0
Osvaldo Santos
Address 103371 0
Instituto de Saúde Ambiental
Faculdade de Medicina da Universidade de Lisboa
Av. Prof. Egas Moniz
1649-028 Lisboa
Portugal
Country 103371 0
Portugal
Phone 103371 0
+351 217985148
Fax 103371 0
Email 103371 0
[email protected]
Contact person for scientific queries
Name 103372 0
Osvaldo Santos
Address 103372 0
Instituto de Saúde Ambiental
Faculdade de Medicina da Universidade de Lisboa
Av. Prof. Egas Moniz
1649-028 Lisboa
Portugal
Country 103372 0
Portugal
Phone 103372 0
+351 217985148
Fax 103372 0
Email 103372 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
De-identified data will only be accessible to selected members of the research team for confidentiality purposes.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8343Study protocolCosta J, Santos O, Virgolino A, Pereira ME, Stefanovska-Petkovska M, Silva H, Navarro-Costa P, Barbosa M, das Neves RC, Duarte e Silva I, Alarcão V, Vargas R, Heitor MJ. MAternal Mental Health in the WORKplace (MAMH@WORK): A protocol for promoting perinatal maternal mental health and Wellbeing. International Journal of Environmental Research and Public Health 18:2558. DOI: 10.3390/ijerph18052558   380078-(Uploaded-16-03-2021-01-37-54)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.