Smartphone-assisted online brief cognitive behavioral therapy to treat maternal depression: findings of a randomized controlled trial

Objective: To test the efficacy of smartphone-assisted online brief cognitive behavioral therapy (b-CBT) to treat maternal depression compared to online brief CBT plus an active control app. Methods: A randomized controlled trial was conducted. Assessments were performed at baseline (T0), midpoint (T1, week 4-5), post-treatment (T2, week 8), and follow-up (T3, 2-month postnatal follow-up) by blinded interviewers. The primary outcome was depression measured by the Edinburgh Postnatal Depression Scale (EPDS) at T2. We also assessed anxiety, stress, sleep quality, well-being, physical activity, treatment response, and offspring child behavior problems. Results: Eighty-one participants were randomized to the intervention (n=37) or active control (n=44) groups. Seventy-one participants completed the post-treatment assessment or reported primary outcome data. No differences were found between the intervention and active control groups regarding maternal depression or other mental health outcomes. Overall, we found large within-group effect sizes, with 80% of the total sample responding to treatment. Conclusions: Our data showed no difference between the groups, suggesting that adding apps to psychotherapy treatment may not enhance treatment effects on prenatal depression. A within-groups analysis showed that most participants with depression responded to treatment; however, future studies are needed to confirm whether this effect is related to factors other than the intervention.

Smartphone-assisted online brief cognitive behavioral therapy to treat maternal depression: findings of a randomized controlled trial.

OBJECTIVE: To test the efficacy of smartphone-assisted online brief cognitive behavioral therapy (b-CBT) to treat maternal depression compared to online brief CBT plus an active control app. METHODS: A randomized controlled trial was conducted. Assessments were performed at baseline (T0), midpoint (T1, week 4-5), post-treatment (T2, week 8), and follow-up (T3, 2-month postnatal follow-up) by blinded interviewers. The primary outcome was depression measured by the Edinburgh Postnatal Depression Scale (EPDS) at T2. We also assessed anxiety, stress, sleep quality, well-being, physical activity, treatment response, and offspring child behavior problems. RESULTS: Eighty-one participants were randomized to the intervention (n=37) or active control (n=44) groups. Seventy-one participants completed the post-treatment assessment or reported primary outcome data. No differences were found between the intervention and active control groups regarding maternal depression or other mental health outcomes. Overall, we found large within-group effect sizes, with 80% of the total sample responding to treatment. CONCLUSIONS: Our data showed no difference between the groups, suggesting that adding apps to psychotherapy treatment may not enhance treatment effects on prenatal depression. A within-groups analysis showed that most participants with depression responded to treatment; however, future studies are needed to confirm whether this effect is related to factors other than the intervention.

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 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.

Why Brazilian women suffer more from depression and suicidal ideation: a mediation analysis of the role of violence.

OBJECTIVE: We aimed to investigate the mediating effect of violence by a family member or acquaintance on biological sex, depression and suicidal ideation. METHODS: We used data from the 2013 Brazilian National Health Survey, a cross-sectional nationwide survey. Major depressive episode and suicidal ideation were evaluated with the Patient Health Questionnaire. Violence victimization and other sociodemographic variables were self-reported. We used logistic regression to estimate the OR, 95%CI and G-computation to calculate the natural direct and indirect effects. RESULTS: A total of 60,202 individuals were evaluated. Women had higher prevalences of major depressive episode (OR = 2.36; 95%CI 2.03-2.74), suicidal ideation (OR = 2.02; 95%CI 1.73-2.36) and violence victimization (OR = 1.73; 95%CI 1.45-2.06). The mediation analysis showed that 10.6% of the association between sex and major depressive episode and 8.0% of the association between sex and suicidal ideation is explained by violence. CONCLUSIONS: Women in Brazil have an increased risk of major depressive episode and suicidal ideation, and this association is mediated, in part, by the fact that they suffer more violence from family members or acquaintances.

Validity of the Brief Infant Sleep Questionnaire (BISQ) in Brazilian children.

OBJECTIVE: To investigate the validity of the Brief Infant Sleep Questionnaire (BISQ), in assessing sleep quality in childhood. METHODS: This was a validation study with children from the Pelotas 2015 Birth Cohort. BISQ was applied to mothers when their children were 3, 6, 12, and 24 months of age. The poor sleep indicators analysed, as defined by BISQ, were >3 wakings per night, nocturnal wakefulness >1 h and total sleep duration <9/24 h, compared to number of wakings per night and nocturnal and total sleep duration defined by actigraphy taken as the gold standard. The Actiwatch wGT3X-BT device was used by the child consecutively during five days at three and six months and for three days at 12 and 24 months. At each age the prevalence, sensitivity, specificity, accuracy, and positive (PPV) and negative predictive values (NPV) of each sleep indicator was calculated. RESULTS: A total of 586 children were enrolled in the study. Nocturnal wakefulness >1 h was the most frequent indicator at all ages, with higher sensitivity (varying from 27.5% at six months to 54.8% at three) and lower specificity (53.4% at three months to 79.4% at six months), in comparison to the other sleep indicators. Specificity for >3 wakings and total sleep duration <9 h was greater than 85.0% at all the ages. Higher accuracies were observed for total sleep <9 h at 3 (85.6%), 6 (88.2%) and 12 months (73.6%) and for > 3 wakings at 24 months (84.5%). The sensitivity for the presence of at least one indicator decreased with age from 56.0% at three months to 35.8% at 24 months, whereas the specificity increased from 50.6% at three months to 63.8% at 24 months. CONCLUSION: The high specificity of the BISQ sleep parameters supports the validity of parents' reports on sleep-related problems in childhood for use in epidemiological studies.