A Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression

University of Sao Paulo

Status: Completed

Conditions: Perinatal Depression

Treatments: Behavioral: Educational app; Behavioral: Brief Psychotherapy; Behavioral: Motherly 1.0

Study type: Interventional

Funder types: Other

Identifiers

NCT04495166

SB-POC-1810-20573

Motherly1

Details and patient eligibility

About

Investigators developed Motherly 1.0, a smartphone app designed to treat and promote maternal mental health. A 2-arm parallel-randomized controlled clinical trial (RCT) will be conducted to test the efficacy of Motherly in conjunction with brief cognitive-behavioral therapy. 70 pregnant women between 16-40 years old will be recruited. Since all interventions will be conducted online, participants will be recruited from any Brazilian state or municipality. Participants will be randomly assigned to either receive intervention via app consisting of behavioral activation and psychoeducation to promote changes in sleep, nutrition, and physical activity habits, as well as to engage in prenatal care, breastfeeding, and social support, and to stimulate child development, in addition to brief cognitive-behavioral therapy (CBT) (n=35); or to a comparison group receiving an psychoeducational app (active control) with psychoeducational content about gestation, maternal health and mental health, and child development in addition to brief CBT (n=35). Duration of treatment will be eight weeks, during which participants in both groups will be assessed at the beginning (baseline; T0), weeks 3-4 (midpoint; T1), and week 8 (endpoint; T2) in order to evaluate treatment effects. A follow-up postnatal assessment will also be conducted when the child is three months of age (T3).

Enrollment: 81 patients

Sex: Female

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women aged between 16-40 years;
• having a score of >7 on the Edinburgh Postnatal Depression Scale (EPDS);
• gestational age between 17-26 weeks;
• being literate;
• owning a functional smartphone with Android for personal use.

Exclusion criteria

• pregnancies classified as being at risk, fetal malformation, or congenital disease;
• visual, auditory or intellectual disabilities, or chronic diseases associated with fetal development alterations;
• severe and/or chronic mental disorder (e.g., schizophrenia, bipolar disorder, etc).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 2 patient groups

Motherly app with brief psychotherapy

Experimental group

Description:

Participants in this arm will receive intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition will undergo brief Cognitive-Behavioral Therapy (CBT) with a focus on behavioral activation.

Treatment:

Behavioral: Brief Psychotherapy

Behavioral: Motherly 1.0

Educational app (Active control)

Active Comparator group

Description:

Participants in this arm will have access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they will undergo will undergo brief Cognitive-Behavioral Therapy (CBT) with a focus on behavioral activation.

Treatment:

Behavioral: Educational app

Behavioral: Brief Psychotherapy