Clinical trial NCT06640907: Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders as Normalized Routine Practice (e-Perinatal Pilot)
Official title: Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): Pilot Randomized Control Trial (WP2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perinatal Depression
Perinatal Anxiety
Keywords: Depression
Anxiety
Perinatal
Well-being
Prevention
mHealth
Lead sponsor: University of Seville
Sponsor class: OTHER
Collaborators: name: Health Service of Andalucia
name: Junta de Andalucia
First posted: 2024-10-15
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized hybrid type 1 controlled trial
Primary purpose: PREVENTION

Brief summary: This study is part of the e-Perinatal project, funded by the European Research Council. This research project will follow the first three phases recommended by the Medical Research Council (MRC) framework for the development and evaluation of complex interventions (Skivington et al., 2021).

The primary aim is to evaluate the feasibility and acceptability of implementing an innovative, personalized mobile health (mHealth) intervention designed for the universal prevention of perinatal mental disorders. Using a pilot, two-arm, cluster-randomized hybrid type 1 clinical trial, the study will assess key implementation outcomes and preliminary effectiveness indicators. The findings will inform the design of a future large clinical trial, intending to evaluate the effectiveness, cost-effectiveness, and implementation of the intervention as part of maternal care.

Detailed description: This pilot clinical study investigates the feasibility, acceptability, and preliminary implementation and effectiveness of the e-Perinatal app, an innovative, personalized mobile health (mHealth) intervention designed for the universal prevention of perinatal mental disorders. The study will be conducted as a two-arm, cluster-randomized, hybrid type 1 trial within routine maternal care settings in primary healthcare centers in Andalusia, Spain. Participants will include pregnant and postpartum women (up to five months postpartum) and their partners. Primary healthcare centers will be randomized to either the intervention or control arm.

The primary objective is to evaluate the feasibility of integrating the e-Perinatal app into routine maternal care. Secondary objectives include assessing the acceptability of the intervention among women, partners, and healthcare professionals and exploring preliminary effectiveness outcomes, such as the incidence of perinatal depression and anxiety in women, changes in depressive and anxiety symptoms in both women and their partners, and potential impacts on infant health and development.

The study hypothesizes that the e-Perinatal intervention will be feasible and acceptable for pregnant and postpartum women, their partners, and healthcare professionals involved in routine maternal care.

Participants will be recruited from primary healthcare centres and allocated by cluster randomization to either the intervention group, which will receive the e-Perinatal app along with standard maternal care, or the control group, which will receive standard maternal care and monthly psychoeducational emails.

Eligibility criteria: Inclusion criteria for mothers:

* Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers
* Must be pregnant for at least 16 weeks or have given birth within the last 5 months at the time of enrollment
* Must be at least 18 years old
* Must have access to a mobile phone and internet connection
* Must be able to read, write, and understand Spanish
* Must have a personal email account

Inclusion criteria for partners (or significant others):

* Must receive an invitation to participate from a woman already enrolled in the study
* Must be at least 18 years old
* Must have access to a mobile phone and internet connection
* Must be able to read, write, and understand Spanish
* Must have a personal email account

Exclusion criteria for mothers:

* Meet diagnostic criteria for anxiety or depression, as determined by a structured clinical interview
* Be on a waiting list or currently receiving psychological or pharmacological treatment for any mental health or substance use condition

Exclusion criteria for partners (or significant others):

* There are no exclusion criteria for partners

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: Measured at baseline and postintervention (2 months after baseline)
measure: Early acceptability
timeFrame: Measured at enrollment
measure: Final acceptability
timeFrame: Measured at postintervention (2 months after baseline)
Secondary outcomes:
measure: Adoption
timeFrame: Measured before recruitment
measure: Fidelity
timeFrame: Measured at postintervention (2 months after baseline)
measure: Early appropriateness
timeFrame: Measured at enrollment
measure: Final appropriateness
timeFrame: Measured at postintervention (2 months after baseline)
measure: Cumulative incidence of maternal perinatal depression and maternal perinatal anxiety
timeFrame: Measured at enrollment and postintervention (2 months after baseline)
measure: Depressive symptoms
timeFrame: Measured at enrollment, postintervention (2 months after baseline), and follow-up (1 month after postintervention)
measure: Anxiety symptoms
timeFrame: Measured at enrollment, postintervention (2 months after baseline), and follow-up (1 month after postintervention)
measure: Postnatal post-traumatic stress
timeFrame: Measured at baseline
measure: Well-being
timeFrame: Measured at baseline, postintervention (2 months after baseline), and follow-up (1 month after postintervention)
Other outcomes:
measure: Organizational readiness for implementing change
timeFrame: Measured before recruitment
measure: App quality
timeFrame: Measured at postintervention (2 months after baseline)
measure: Implementation process
timeFrame: Measured at postintervention (2 months after baseline)
measure: Barriers and facilitators
timeFrame: Measured at postintervention (2 months after baseline)
measure: PHC characteristics
timeFrame: Measured before recruitment
measure: Reasons for dropout
timeFrame: Measured at postintervention (2 months after baseline)
measure: Antenatal and postnatal risks
timeFrame: Measured at baseline
measure: Maternal antenatal attachment
timeFrame: Measured at baseline
measure: Paternal antenatal attachment
timeFrame: Measured at baseline
measure: Maternal postnatal attachment
timeFrame: Measured at baseline
measure: Paternal postnatal attachment
timeFrame: Measured at baseline
measure: Infant temperament
timeFrame: Measured at baseline
measure: Coparenting dynamics
timeFrame: Measured at baseline
measure: Parental role perception
timeFrame: Measured at baseline
measure: Infant development
timeFrame: Measured at baseline
measure: Partnership quality
timeFrame: Measured at baseline
measure: Sleep quality
timeFrame: Measured at baseline
measure: Life quality
timeFrame: Measured at baseline
measure: Maternal physical activity levels
timeFrame: Measured at baseline
measure: Paternal physical activity levels
timeFrame: Measured at baseline
measure: Physical condition
timeFrame: Measured at baseline
measure: Mood state
timeFrame: Measured at baseline
measure: Basic psychological needs
timeFrame: Measured at baseline
measure: Economic data
timeFrame: Measured at postintervention (2 months after baseline)
Locations:
city: Mairena del Aljarafe
country: Spain
facility: Primary Health Care Center Mairena del Aljarafe - Ciudad Expo
state: Seville
Study officials:
References: