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A smartphone-assisted brief online cognitive-behavioral intervention for pregnant women with depression: a study protocol of a randomized controlled trial
BACKGROUND: Pregnancy is strongly associated with increased risk for depression. Approximately 25% of pregnant women develop depression. Treatment for depression during pregnancy has several complexities: the use of psychiatric medications during pregnancy might result in developmental problems in t...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7985923/ https://www.ncbi.nlm.nih.gov/pubmed/33757591 http://dx.doi.org/10.1186/s13063-021-05179-8 |
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author | Zuccolo, Pedro Fonseca Xavier, Mariana O. Matijasevich, Alicia Polanczyk, Guilherme Fatori, Daniel |
author_facet | Zuccolo, Pedro Fonseca Xavier, Mariana O. Matijasevich, Alicia Polanczyk, Guilherme Fatori, Daniel |
author_sort | Zuccolo, Pedro Fonseca |
collection | PubMed |
description | BACKGROUND: Pregnancy is strongly associated with increased risk for depression. Approximately 25% of pregnant women develop depression. Treatment for depression during pregnancy has several complexities: the use of psychiatric medications during pregnancy might result in developmental problems in the child and must be used with caution. Psychosocial interventions are effective, but they require specialized professionals. Low- and middle-income countries (LMIC) such as Brazil do not have enough mental health professionals needed to meet this demand. In this context, smartphone-based interventions show immense potential. We developed Motherly, a smartphone application (app) designed to treat maternal depression. We aim to test the efficacy of Motherly in addition to brief cognitive-behavioral therapies (CBT) to treat maternal depression. METHODS: We will conduct a 2-arm parallel-randomized controlled clinical trial in which 70 pregnant women aged between 16 and 40 years with depression will be randomized to intervention or active control. The intervention group will have access to Motherly, a smartphone app based on three concepts: psychoeducation, behavior monitoring, and gaming elements. Motherly is composed of a package of interventions composed of modules: mental health, sleep, nutrition, physical activity, social support, prenatal/postnatal support, and educational content. The main focus of Motherly is delivering behavioral activation (BA), a brief and structured psychological treatment. The app allows participants to schedule and engage in, and monitor activities according to a plan to avoid acting exclusively according to their mood. The active control group will have access to a simplified version of the app consisting of educational content about various aspects of pregnancy, maternal physical and mental health, and infant development (BA, activity scheduling, sleep hygiene, among other functionalities, will not be present in this version). Both groups will receive four sessions of brief CBT in 8 weeks. Participants will be evaluated by assessors blind to randomization and allocation status. Assessments will occur at baseline (T0), midpoint (T1, week 4–5), posttreatment (T2, week 8), and follow-up (T3, when the child is 2 months old). Maternal mental health (prenatal anxiety, psychological well-being, perceived stress, depression, depression severity, and sleep quality), quality of life, physical activity levels, and infant developmental milestones and social/emotional problems will be measured. Our primary outcome is the change in maternal prenatal depression from baseline to posttreatment (8 weeks). DISCUSSION: The potential of digital technology to deliver mental health interventions has been increasingly recognized worldwide. There is a growing literature on interventions using smartphone applications to promote mental health, both with or without the intermediation of a mental health professional. Our study adds to the literature by testing whether an app providing an intervention package, including CBT, psychoeducation, nutrition, physical activity, and social support, can promote maternal and child health and well-being. In particular, we aim to treat depression, for which the use of digital technologies is still scarce. Smartphone applications designed to treat maternal depression are especially relevant because of the potential to circumvent barriers that prevent pregnant women from accessing mental health care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04495166. Prospectively registered on July 29, 2020. |
format | Online Article Text |
id | pubmed-7985923 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-79859232021-03-23 A smartphone-assisted brief online cognitive-behavioral intervention for pregnant women with depression: a study protocol of a randomized controlled trial Zuccolo, Pedro Fonseca Xavier, Mariana O. Matijasevich, Alicia Polanczyk, Guilherme Fatori, Daniel Trials Study Protocol BACKGROUND: Pregnancy is strongly associated with increased risk for depression. Approximately 25% of pregnant women develop depression. Treatment for depression during pregnancy has several complexities: the use of psychiatric medications during pregnancy might result in developmental problems in the child and must be used with caution. Psychosocial interventions are effective, but they require specialized professionals. Low- and middle-income countries (LMIC) such as Brazil do not have enough mental health professionals needed to meet this demand. In this context, smartphone-based interventions show immense potential. We developed Motherly, a smartphone application (app) designed to treat maternal depression. We aim to test the efficacy of Motherly in addition to brief cognitive-behavioral therapies (CBT) to treat maternal depression. METHODS: We will conduct a 2-arm parallel-randomized controlled clinical trial in which 70 pregnant women aged between 16 and 40 years with depression will be randomized to intervention or active control. The intervention group will have access to Motherly, a smartphone app based on three concepts: psychoeducation, behavior monitoring, and gaming elements. Motherly is composed of a package of interventions composed of modules: mental health, sleep, nutrition, physical activity, social support, prenatal/postnatal support, and educational content. The main focus of Motherly is delivering behavioral activation (BA), a brief and structured psychological treatment. The app allows participants to schedule and engage in, and monitor activities according to a plan to avoid acting exclusively according to their mood. The active control group will have access to a simplified version of the app consisting of educational content about various aspects of pregnancy, maternal physical and mental health, and infant development (BA, activity scheduling, sleep hygiene, among other functionalities, will not be present in this version). Both groups will receive four sessions of brief CBT in 8 weeks. Participants will be evaluated by assessors blind to randomization and allocation status. Assessments will occur at baseline (T0), midpoint (T1, week 4–5), posttreatment (T2, week 8), and follow-up (T3, when the child is 2 months old). Maternal mental health (prenatal anxiety, psychological well-being, perceived stress, depression, depression severity, and sleep quality), quality of life, physical activity levels, and infant developmental milestones and social/emotional problems will be measured. Our primary outcome is the change in maternal prenatal depression from baseline to posttreatment (8 weeks). DISCUSSION: The potential of digital technology to deliver mental health interventions has been increasingly recognized worldwide. There is a growing literature on interventions using smartphone applications to promote mental health, both with or without the intermediation of a mental health professional. Our study adds to the literature by testing whether an app providing an intervention package, including CBT, psychoeducation, nutrition, physical activity, and social support, can promote maternal and child health and well-being. In particular, we aim to treat depression, for which the use of digital technologies is still scarce. Smartphone applications designed to treat maternal depression are especially relevant because of the potential to circumvent barriers that prevent pregnant women from accessing mental health care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04495166. Prospectively registered on July 29, 2020. BioMed Central 2021-03-23 /pmc/articles/PMC7985923/ /pubmed/33757591 http://dx.doi.org/10.1186/s13063-021-05179-8 Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Zuccolo, Pedro Fonseca Xavier, Mariana O. Matijasevich, Alicia Polanczyk, Guilherme Fatori, Daniel A smartphone-assisted brief online cognitive-behavioral intervention for pregnant women with depression: a study protocol of a randomized controlled trial |
title | A smartphone-assisted brief online cognitive-behavioral intervention for pregnant women with depression: a study protocol of a randomized controlled trial |
title_full | A smartphone-assisted brief online cognitive-behavioral intervention for pregnant women with depression: a study protocol of a randomized controlled trial |
title_fullStr | A smartphone-assisted brief online cognitive-behavioral intervention for pregnant women with depression: a study protocol of a randomized controlled trial |
title_full_unstemmed | A smartphone-assisted brief online cognitive-behavioral intervention for pregnant women with depression: a study protocol of a randomized controlled trial |
title_short | A smartphone-assisted brief online cognitive-behavioral intervention for pregnant women with depression: a study protocol of a randomized controlled trial |
title_sort | smartphone-assisted brief online cognitive-behavioral intervention for pregnant women with depression: a study protocol of a randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7985923/ https://www.ncbi.nlm.nih.gov/pubmed/33757591 http://dx.doi.org/10.1186/s13063-021-05179-8 |
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