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Not Yet Recruiting NCT05643898

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

Conditions: Minor Depressive Disorder, Major Depressive Disorder, Post Partum Depression

Sex: Female
Ages: 18 Years – N/A
Phase: NA
Enrollment: 66
Sponsor: Pontificia Universidad Catolica de Chile

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.

Eligibility Criteria

Inclusion Criteria:Women will be included if they:have a < 6-month-old baby,have a PHQ-9 (Kroenke et al., 2001; Diez-Quevedo et al., 2001) score ≥ 5 points,have minor or major depression according to the Mini-International Neuropsychiatric Interview (MINI: Sheehan et al., 1999; Ferrando et al., 2000),are at least 18 years old,are Chilean residents,are fluent in written and spoken Spanish,self-report ownership of a smartphone, andself-report regular access to the internet.Minor depression will be defined as the presence of two to four concurrent symptoms of depressive disorder (one of which is depressed mood or anhedonia) present most or all the time for at least two weeks, with symptoms causing dysfunction and negative impact on the individual's life (American Psychiatric Association, 2013). Major depression will be defined as the presence of five or more concurrent symptoms of depressive disorder (one of which is depressed mood or anhedonia) present most or all the time for at least two weeks, with symptoms causing dysfunction and a negative impact on the individual's life (American Psychiatric Association, 2013).Exclusion Criteria:Participants exclusion criteria will be the following: illiteracy, risk of suicide, alcohol or substance abuse, bipolar disorder, and psychotic disorder.

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Source: ClinicalTrials.gov (NCT05643898). StuddyBuddy aggregates publicly available trial information.