A Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women with Depression: a Study Protocol of a Randomized Controlled Trial

Abstract Background: Pregnancy is strongly associated with increased risk for depression, but treating pregnant women is challenging. The use of psychiatric medications might result in developmental problems in the child, therefore must be used with caution. Psychosocial interventions require specialized professionals which are scarce, especially in low- and middle-income countries. In this context, smartphone-based interventions show immense potential. We created Motherly, a smartphone app designed to promote maternal mental health. The Motherly app delivers a package of interventions, including mental health, sleep, nutrition, physical activity, social support, prenatal/postnatal support, and psychoeducational content. With this study, we will test the effectiveness of the Motherly app 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 between 16-40 years with depression will be randomized to intervention or active control. The intervention group will have access to the Motherly app. The active control group will have access to a simplified version of the app consisting exclusively of psychoeducational content. Both groups will undergo four sessions of CBT in 8 weeks. Participants will be evaluated by assessors blind to randomization and allocation status at baseline (T0), midpoint (T1, week 4-5), posttreatment (T2, week 8), and follow-up (T3, when the child is two 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: 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 treat depression, a condition for which the use of digital technologies is still scarce. Smartphone applications designed to treat maternal depression have the potential to circumvent barriers that prevent pregnant women from accessing mental health care.Trial Registration: A Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression (clinicaltrials.gov, registry number: NCT04495166, prospectively registered in 29/07/2020).

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A Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women with Depression: a Study Protocol of a Randomized Controlled Trial

10.31234/osf.io/bmgzd ◽

2020 ◽

Author(s):

Pedro Zuccolo ◽

Mariana O. Xavier ◽

Alicia Matijasevich ◽

Guilherme Polanczyk ◽

Daniel Fatori

Keyword(s):

Mental Health ◽

Physical Activity ◽

Social Support ◽

Pregnant Women ◽

Maternal Depression ◽

Active Control ◽

Well Being ◽

Smartphone Applications ◽

Educational Content ◽

Randomized Controlled

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) countries 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 16-40 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 two 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.

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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

Trials ◽

10.1186/s13063-021-05179-8 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Pedro Fonseca Zuccolo ◽

Mariana O. Xavier ◽

Alicia Matijasevich ◽

Guilherme Polanczyk ◽

Daniel Fatori

Keyword(s):

Mental Health ◽

Physical Activity ◽

Social Support ◽

Pregnant Women ◽

Maternal Depression ◽

Active Control ◽

Well Being ◽

Smartphone Applications ◽

Educational Content ◽

Randomized Controlled

Abstract 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.

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The ‘new normal’ includes online prenatal exercise: Exploring pregnant women’s experiences during the pandemic and the role of virtual group fitness on maternal mental health

10.21203/rs.3.rs-151871/v1 ◽

2021 ◽

Author(s):

Cristina Silva-Jose ◽

Taniya S Nagpal ◽

Javier Coterón ◽

Ruben Barakat ◽

Michelle F Mottola

Keyword(s):

Mental Health ◽

Physical Activity ◽

Pregnant Women ◽

Maternal Mental Health ◽

Exercise Program ◽

Well Being ◽

Group Exercise ◽

Exercise Classes ◽

Prenatal Exercise ◽

Online Group

Abstract Background: Prenatal anxiety and depressive symptoms have significantly increased since the onset of the coronavirus (COVID-19) pandemic. Furthermore, home confinement regulations have caused a drastic increase in time spent sedentary. Online group fitness classes may be an effective strategy that can increase maternal physical activity and improve mental health outcomes by providing an opportunity for social connectedness. The present study explores the experiences of pregnant women who participated in an online group exercise program during the pandemic and identifies relationships with maternal mental health and well-being. In addition, we present person-informed recommendations on how to improve the delivery of future online prenatal exercise programs.Methods: Semi-structured interviews were conducted with pregnant women (8-39 weeks of pregnancy) who participated in an online group exercise program, from March to October 2020 in Spain. A phenomenological approach was taken, and open-ended questions were asked to understand women’s experiences throughout the pandemic and the role the online exercise classes may have had on their physical activity levels, mental health, and other health behaviours such as diet. A thematic analysis was performed to evaluate data. In addition, women completed the State-Trait Anxiety Inventory (STAI) and these data supplemented qualitative findings. Results: Twenty-four women were interviewed, and the average STAI score was 32.23 ± 9.31, ranging from low to moderate anxiety. Thematic analysis revealed that women felt safe exercising from home, an increased availability of time to schedule a structured exercise class, and consequently an improvement in their adherence to the program and other behaviours (i.e., healthier diet). Women emphasized feeling connected to other pregnant women when they exercised online together, and overall, this had a positive effect on their mental well-being. Women suggested that future online exercise programs should include flexible options, detailed instructions and facilitation by a qualified exercise professional.Conclusion: Pregnant women are receptive to online group exercise classes and expressed that these are an accessible option to accommodating physical activity during the pandemic. In addition, the online group environment provides an important sense of connectivity among pregnant women exercising together and this may mitigate the detrimental effect of COVID-19 on maternal mental health.

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Dietary patterns in obese pregnant women; influence of a behavioral intervention of diet and physical activity in the UPBEAT randomized controlled trial

International Journal of Behavioral Nutrition and Physical Activity ◽

10.1186/s12966-016-0450-2 ◽

2016 ◽

Vol 13 (1) ◽

Cited By ~ 19

Author(s):

Angela C. Flynn ◽

◽

Paul T. Seed ◽

Nashita Patel ◽

Suzanne Barr ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Pregnant Women ◽

Behavioral Intervention ◽

Dietary Patterns ◽

Controlled Trial ◽

Randomized Controlled ◽

Diet And Physical Activity

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Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention (eMBI) on maternal mental health during pregnancy: the mindmom study protocol for a randomized controlled clinical trial

Trials ◽

10.1186/s13063-020-04873-3 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Mitho Müller ◽

Lina Maria Matthies ◽

Maren Goetz ◽

Harald Abele ◽

Sara Yvonne Brucker ◽

...

Keyword(s):

Mental Health ◽

Cost Effectiveness ◽

Pregnant Women ◽

Edinburgh Postnatal Depression Scale ◽

Maternal Mental Health ◽

Depression Scale ◽

Mental Illnesses ◽

Randomized Controlled ◽

Peripartum Period ◽

Anxiety Questionnaire

Abstract Background Mental disorders are common during the peripartum period and may have far-reaching consequences for both mother and child. Unfortunately, most antenatal care systems do not provide any structured screening for maternal mental health. As a consequence, mental illnesses are often overlooked and not treated adequately. If correctly diagnosed, cognitive behavioral therapy is currently the treatment of choice for mental illnesses. In addition, mindfulness-based interventions (MBIs) seem to represent a promising treatment option for anxiety and depression during the peripartum period. Considering the internet’s increasing omnipresence, MBIs can also be offered electronically via a (tablet) computer or smartphone (electronically based MBI = eMBI). Objective The current study aims to examine the clinical effectiveness and cost-effectiveness of an eMBI (the mindmom application) developed by an interdisciplinary team of gynecologists, psychologists, and midwives, teaching pregnant women how to deal with stress, pregnancy-related anxiety, and depressive symptoms. The study sample consists of pregnant women in their third trimester who screened positive for emotional distress. The mindmom study is a bicentric prospective randomized controlled trial (RCT), which is currently conducted at the University women’s hospitals of Heidelberg and Tübingen, Germany. Methods Within the scope of the routine prenatal care, pregnant women attending routine pregnancy care in Baden-Wuerttemberg, Germany, are invited to participate in a screening for mental distress based on the Edinburgh Postnatal Depression Scale (EPDS). Women with an EPDS screening result > 9 will be referred to one of the mindmom coordinating study centers and are offered counseling either face-to-face or via videotelephony. After an initial psychological counseling, women are invited to participate in an eMBI in their last pregnancy trimester. The study will enroll N = 280 study participants (N = 140 per group), who are randomized 1:1 into the intervention (IG) or control group (treatment as usual = TAU). All participants are requested to complete a total of 7 digital assessments (5 visits pre- and 2 follow-up visits postpartum), involving self-report questionnaires, sociodemographic and medical data, physiological measures, and morning cortisol profiles. The primary outcome will be depressive and anxiety symptoms, measured by the Edinburgh Postnatal Depression Scale, the State Trait Anxiety Questionnaire, and the Pregnancy-Related Anxiety Questionnaire. Secondary outcomes include mindfulness, satisfaction with birth, quality of life, fetal attachment, bonding, mode of delivery, and cost-effectiveness. Discussion This is the first German RCT to examine the (cost-)effectiveness of an eMBI on maternal mental health during pregnancy. If successful, the mindmom app represents a low-threshold and cost-effective help for psychologically distressed women during pregnancy, thereby reducing the negative impact on perinatal health outcome. Trial registration Deutsches Register Klinischer Studien, German Clinical Trials Register DRKS00017210. Registered on 13 January 2020. Retrospectively registered.

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An Integrated Approach to Improve Maternal Mental Health and Well-Being During the COVID-19 Crisis

Frontiers in Psychiatry ◽

10.3389/fpsyt.2020.598746 ◽

2020 ◽

Vol 11 ◽

Author(s):

Rahul Shidhaye ◽

Purnima Madhivanan ◽

Pallavi Shidhaye ◽

Karl Krupp

Keyword(s):

Mental Health ◽

Social Support ◽

Pregnant Women ◽

Maternal Mental Health ◽

Integrated Approach ◽

Well Being ◽

Mitigation Strategies ◽

Increased Risk ◽

The Impact ◽

Health And Well Being

The ongoing COVID-19 pandemic has led to disruption of normal life across the globe, severely affecting the already vulnerable populations such as the pregnant women. Maternal mental health and well-being is a public health priority and the evidence about the impact of COVID-19 on mental health status of pregnant women is gradually emerging. The findings of the recently published studies suggest that increased risk perception about contracting COVID-19, reduced social support, increase in domestic violence, disruption of antenatal care, and economic consequences of COVID-19 mitigation strategies can lead to adverse mental health outcomes in antenatal period. There is a significant increase in antenatal depression and anxiety since the onset of COVID-19 and social determinants of health (e.g., younger age, lower education, lower income) are associated with these poor outcomes. In this paper, we propose an integrated approach to improve the mental health and well-being of pregnant women. Physical activity and/or mind-body interventions like yoga can be practiced as self-care interventions by pregnant women. Despite social distancing being the current norm, efforts should be made to strengthen social support. Evidence-based interventions for perinatal depression should be integrated within the health system and stepped, collaborative care using non-specialist health workers as key human resource be utilized to improve access to mental health services. Use of digital platforms and smartphone enabled delivery of services has huge potential to further improve the access to care. Most importantly, the COVID-19 related policy guidelines should categorically include maternal mental health and well-being as a priority area.

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