MamaConecta: Digital Tool for Maternal Mental Health

NCT06442774 | Recruiting DMC

• 1 other identifier: ATC/CT001/2023
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this randomized controlled trial is to validate a digital health tool, Dana app, that enhances well-being and supports mental health monitoring for women during the perinatal period. The primary purpose is to improve maternal well-being, early detection of mental health issues, and aid in the diagnosis and monitoring by healthcare professionals in women transitioning into motherhood. The main questions it aims to answer are:

• Does the app improve overall maternal well-being during the perinatal period?
• Can the app increase the early detection rates of perinatal mental health disorders?
• Can the app be an effective tool to support healthcare professionals to diagnose perinatal mental health problems?
• How effective is the app in improving obstetric outcomes and the psychological and cognitive development of infants? Researchers will compare the group using the app with a control group not using the digital tool to see if Dana provides significant improvements in maternal and infant health outcomes. Participants will:
• Use the mobile application from 12-14 weeks of gestation until 24 months postpartum.
• Undergo regular assessments to monitor their emotional state, lifestyle, clinical, and obstetric data.
• Participate in evaluations for their infants' psychological and cognitive development at various stages from birth to two years old. This trial is conducted at multiple centers, including Hospital Vall d'Hebron, the Sexual and Reproductive Health Care Services (ASSIR) in Tarragona and ASSIR Litoral (Barcelona), Hospital del Mar, following CONSORT standards. The study aligns with the Health and Culture priorities of the Spanish Government's Scientific, Technical, and Innovation Research Plan 2021-2023.

Conditions

Pregnancy Related; Mental Health Issue; Postpartum Depression; Postpartum Anxiety; Well-Being, Psychological

Keywords

mental health; pregnancy; mobile application; wellbeing; child neurodevelopment; antenatal depression screening; early detection; postpartum; digital health

Outcome Measures

Primary Outcomes (1)

• Maternal well-being

  Assessed using the World Health Organization-5 Well-Being Index (WHO-5). The WHO-5 is a brief 5-item self-report instrument designed to measure current mental well-being. It has adequate validity for screening depression and measuring clinical trial outcomes, with good properties when used in pregnant women (Mortazavi et al., 2021). Min value: 0 Max value: 25 Higher scores: Indicate better well-being. Scores below 13 suggest poor well-being, indicative of depression.

  12-14 weeks, 33-34 weeks of gestation, 6 weeks, 6, 12, 24 months postpartum.

Secondary Outcomes (34)

• Depression

  12-14 and 29-30 weeks of pregnancy, 6 weeks, 6, 12, 24 months postpartum.

• Anxiety

  12-14 and 33-34 weeks of pregnancy, 6 weeks, 6, 12, 24 months postpartum.

• Birth Fear

  12-14 and 33-34 weeks of pregnancy, 6 weeks postpartum.

• Sleep

  12-14 and 33-34 weeks of pregnancy

• Maternal Antenatal attachment

  29-30 weeks of pregnancy.

Study Arms (2)

Control

ACTIVE COMPARATOR

Participants of this group will have care as usual from healthcare providers. Participants will have the study variables measured (by questionnaires and monitoring via wearable).

Other: Monitoring via wearable

Mobile application

EXPERIMENTAL

Participants of this group will have access to the content of the application and will use it regularly from the start of the study until 4 months postpartum. Participants will have the study variables measured (by questionnaires and monitoring via wearable)

Other: Mobile application; Other: Monitoring via wearable

Interventions

Mobile application OTHER

The intervention that has been developed is a digital tool of a biopsychosocial nature based on the main cognitive-behavioral strategies: psychoeducation, reflection, self-observation, guided visualizations, mindfulness and progressive muscle relaxation. The intervention consists of 3 main areas of work: * Programs: Biopsychosocial programs in text and audio format. * Community: Forum with directed questions and space to share experiences between mothers. * Diary: Space to record mood and emotional record. The entire tool works transversally in 4 dimensions: self-care, relationship with perinatal changes, relationship with the baby, social relationship. The tool itself includes 3 mental health and well-being screening questionnaires: Whooley Questionnaire and the Edinburgh Postnatal Depression Scale (EPDS).

Mobile application

Monitoring via wearable OTHER

Participants that own a wearable will connect it to monitor variables related to sleeping patterns, activity and stress (see variables section).

Control; Mobile application

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age between 12-14 weeks of gestation.
• The first obstetric ultrasound has been performed.
• Women who know how to read and understand Spanish.
• Women who have access to a mobile phone with an internet connection (data or wifi)
• Women who have knowledge of technology tools via app.
• Have signed the informed consent to participate in the study.

You may not qualify if:

• Termination of pregnancy, or early miscarriage
• Perinatal loss at any time during pregnancy.
• Severe mental pathology or moderate unstable mental pathology.
• Consumption of toxic substances.

Sponsors & Collaborators

• A Thousand Colibris, S.L: lead
• Hospital Universitari Vall d'Hebron Research Institute (VHIR): collaborator
• Universitat Rovira i Virgili (URV): collaborator
• Hospital del Mar Research Institute (IMIM): collaborator

Study Sites (3)

Hospital Vall d'Hebron

Barcelona, Catalonia, 08550, Spain

RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

ASSIR Tarragona

Tarragona, 43007, Spain

RECRUITING

Related Publications (35)

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  BACKGROUND

Related Links

• Study Website: MamaConecta is the name under which we publicly present the clinical study investigating perinatal mental health and the impact of digital health tools on prevention and treatment. The co-promoters of this study are A THOUSAND COLIBRIS S.L

MeSH Terms

Conditions

Depression, Postpartum; Psychological Well-Being

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Roser Palau-Costafreda, PhD

  A Thousand Colibris, S.L

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Montesinos

CONTACT

+34622353245; veronica@athousandcolibris.com

Roser Palau-Costafreda, PhD

CONTACT

roser@dana.health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will download an app that will randomise them on the intervention or control group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: June 4, 2024
• Study Start: December 28, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)