Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks)
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to 40 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Motherly app with brief psychotherapy
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.
Intervention: Motherly 1.0 (Behavioral)
Motherly app with brief psychotherapy
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.
Intervention: Brief Psychotherapy (Behavioral)
Educational app (Active control)
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.
Intervention: Brief Psychotherapy (Behavioral)
Educational app (Active control)
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.
Intervention: Educational app (Behavioral)
Outcomes
Primary Outcomes
Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks)
Time Frame: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
Participants were assessed with the Edinburgh Postnatal Depression Scale (EPDS) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (EPDS max-min scores=0-30, higher scores=worse outcome).
Secondary Outcomes
- Change in Maternal Prenatal Quality of Life From Baseline to Posttreatment (8 Weeks)(Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).)
- Change in Maternal Prenatal Psychological Well-Being From Baseline to Posttreatment (8 Weeks).(Baseline (T0), Week 8 (Posttreatment, T2).)
- Change in Maternal Prenatal Sleep Quality From Baseline to Posttreatment (8 Weeks).(Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).)
- Change in Maternal Prenatal Anxiety From Baseline to Posttreatment (8 Weeks)(Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).)
- Change in Maternal Prenatal Perceived Stress From Baseline to Follow-up.(Baseline (T0), when the infant is two months of age (Follow-up, T3).)
- Change in Maternal Prenatal Depression Severity From Baseline to Follow-up.(Baseline (T0), when the infant is two months of age (Follow-up, T3).)
- Change in Maternal Prenatal Perceived Stress From Baseline to Posttreatment (8 Weeks).(Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).)
- Infant Social/Emotional Problems at 2 Months of Age.(When the infant is two months of age (Follow-up, T3).)
- Change in Maternal Physical Activity Levels From Baseline to Posttreatment (8 Weeks).(Baseline (T0), Week 8 (Posttreatment, T2).)
- Change in Maternal Prenatal Depression Severity From Baseline to Posttreatment (8 Weeks).(Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).)
- Infant Developmental Milestones at 2 Months of Age.(When the infant is two months of age (Follow-up, T3).)
- Change in Maternal Prenatal Depression From Baseline to Follow-up.(Baseline (T0), when the infant is two months of age (Follow-up, T3).)
- Change in Maternal Prenatal Anxiety From Baseline to to Follow-up.(Baseline (T0), when the infant is two months of age (Follow-up, T3).)
- Change in Maternal Prenatal Quality of Life From Baseline to to Follow-up.(Baseline (T0), when the infant is two months of age (Follow-up, T3).)
- Change in Maternal Prenatal Psychological Well-Being From Baseline to Follow-up.(Baseline (T0), when the infant is two months of age (Follow-up, T3).)
- Change in Maternal Prenatal Sleep Quality From Baseline to Follow-up.(Baseline (T0), when the infant is two months of age (Follow-up, T3).)
Investigators
Guilherme Vanoni Polanczyk, MD PhD
Professor
University of Sao Paulo