NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Effectiveness and Implementation of a Personalized mHealth Intervention for the Universal Prevention of Maternal Perinatal Mental Disorders

NCT07613008

RecruitingNA

Sponsor: University of Seville

Conditions: Perinatal Depression, Perinatal Anxiety

Interventions: The e-Perinatal intervention is a personalized mobile health (mHealth) program, Standard routine maternal care

Countries: Spain

This study is part of the ERC-funded e-Perinatal project and represents a large-scale hybrid type 1 effectiveness-implementation cluster randomized controlled trial. The primary aim is to evaluate the effectiveness of a personalized and complex mobile health (mHealth) intervention (e-Perinatal) in the universal prevention of maternal perinatal depression and anxiety disorders. Secondary aims include evaluating the impact on paternal mental health and child development, as well as examining implementation outcomes in real-world primary healthcare settings.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

\- Inclusion Criteria (Women)

Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers

Must be pregnant for at least 11 weeks 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

No diagnosis of depression or anxiety disorder at baseline Forma

\- Inclusion Criteria (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:

* Exclusion Criteria (Women)

Current diagnosis of depression or anxiety disorder

Receiving psychological or pharmacological treatment for mental health or substance use conditions

\- Exclusion criteria for partners (or significant others):

There are no exclusion criteria for partners

Locations (1)

Mairena del Aljarafe, Sevilla, Spain