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Program for Perinatal Mental Health Promotion and Work-Life Balance

Perinatal mental health promotion and work-life balance: the effect of an intervention program on postpartum depression among Portuguese women.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001273875
Acronym
MAternal Mental Health in the WORKplace - MAMH@WORK
Enrollment
225
Registered
2021-09-20
Start date
2022-01-01
Completion date
Unknown
Last updated
2021-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Background: Women are exposed to an increased burden of mental disorders during the perinatal period and 13-19% of them are diagnosed with postpartum depression. Perinatal psychological suffering affects early mother-child relationship, with relevant consequences for the child’s emotional and cognitive development. Return to work brings additional vulnerability given the required balance between parenting and job demands. This project aims to develop and evaluate the effectiveness of a brief and sustainable intervention that (a) promotes maternal mental health throughout pregnancy and beyond, (b) promotes the quality of mother-child interactions, child emotional self-regulation and cognitive self-control, and (c) reduces absenteeism and presenteeism among working-age women during this period. Study hypothesis: A brief psychoeducation intervention delivered to pregnant women and recent mothers contributes to significantly improve mental health and wellbeing compared to care-as-usual from the health units. Methods: MAMH@WORK is a three-arm randomized controlled trial of women to be followed from the last trimester of pregnancy until 12 months postpartum. A short-term cognitive-behavioural therapy-based psychoeducation plus biofeedback intervention will be implemented by trained psychiatrists and psychologists, according to a standardized procedure manual developed after scoping literature reviews and consensus using the Delphi technique. Participants (n=225, primiparous, singleton pregnant women at 28-30 weeks gestational age, aged 18-40 years, employed) will be randomly allocated to one of three arms: psychoeducation intervention, with brief cognitive-behavioural therapy-based group sessions, including mindfulness; psychoeducation (the same as before) plus biofeedback intervention; and control. Assessments will take place twice before delivery, and three times after childbirth. Main outcomes are the mothers’ psychological wellbeing, quality of mother-child interaction, child-mother attachment, child emotional self-regulation and cognitive self-control, job engagement and presenteeism. Intention-to-treat and per-protocol analyses will be conducted; Cohen’s d coefficient, Cramer’s V and odds ratio will be used to assess the effect size of the intervention.

Interventions

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 spec

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.

Sponsors

Instituto de Saúde Ambiental, Faculdade de Medicina da Universidade de Lisboa
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
2 Weeks to 40 Years
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026