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"Mamá, te Entiendo" App-based Intervention for Reducing Depressive Symptoms in Postpartum Women

NCT05643898 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-12-09

No results posted yet for this study

Summary

Title: "Feasibility and acceptability study of "Mamá, te entiendo": an app-based intervention for reducing depressive symptoms in postpartum women"

Funding: This work was funded by the Chilean National Agency of Research and Development (ANID Doctorado Nacional 2019 - 21190745).

General objective: To assess the feasibility and acceptability of a guided 8-week cognitive-behavioral app-based intervention for Chilean postpartum women with depressive symptoms.

Design: A small-scale parallel 2-arms trial will be conducted. Postpartum women with minor or major depression will be randomized to the app-based intervention or waitlist. The primary outcomes are feasibility and acceptability variables, mainly; recruitment and eligibility rates, intervention and study adherence, and participants' intervention satisfaction, use, and engagement. Semi-structured interviews with a sub-sample will provide more information about the participants' experience with the intervention. Women's depression diagnostic status will be assessed at pre-treatment, post-treatment, and 1-month follow-up. Other secondary outcomes will include participants' perceived social support, mother-infant bonding, and maternal satisfaction and self-efficacy.

Conditions

Interventions

BEHAVIORAL

Mamá, te entiendo (Mom, I get you)

"Mamá, te entiendo" is a guided 8-week cognitive-behavioral app-based intervention that targets postpartum women with minor and major depression. The development of the intervention followed the "CeHRes Roadmap". It includes some elements from attachment and mentalization theories. The intervention consists of six main sequential modules and three optional modules. All modules except the two psychoeducational ones include homework. Participants will receive feedback from an e-coach. They also can contact the e-coach to solve doubts about the app content and exercises. Other sections of the app include infographics about other relevant topics (for example, How to strengthen the couple relationship), a shareable document with reading about how to support a loved one struggling with depression and a resources section with links to websites and documents of interest.

Sponsors & Collaborators

  • Agencia Nacional de Investigación y Desarrollo

    collaborator OTHER

  • Instituto Milenio para Investigación en Depresión y Personalidad

    collaborator OTHER

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-11-01
Completion
2023-11-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05643898 on ClinicalTrials.gov