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

Not Applicable

Completed

Conditions: Perinatal Depression

Interventions: Behavioral: Motherly 1.0
Behavioral: Educational app
Behavioral: Brief Psychotherapy

Registration Number: NCT04495166

Lead Sponsor: University of Sao Paulo

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 81

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational app (Active control)	Educational app	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.
Motherly app with brief psychotherapy	Motherly 1.0	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.
Motherly app with brief psychotherapy	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.
Educational app (Active control)	Brief Psychotherapy	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.

Primary Outcome Measures

Name	Time	Method
Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks)	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 Outcome Measures

Name	Time	Method
Change in Maternal Prenatal Anxiety From Baseline to Posttreatment (8 Weeks)	Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).	Participants will be assessed with the Generalized Anxiety Disorder 7 (GAD-7) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (GAD-7 max-min scores=0-21, higher scores=worse outcome).
Change in Maternal Prenatal Quality of Life From Baseline to Posttreatment (8 Weeks)	Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).	Participants will be assessed with the 12-item health survey (SF-12) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (SF-12 max-min scores=12-50, higher scores=worse outcome).
Change in Maternal Prenatal Psychological Well-Being From Baseline to Posttreatment (8 Weeks).	Baseline (T0), Week 8 (Posttreatment, T2).	Participants were assessed with the Ryff's Psychological Well-Being Scale at baseline and at 8 weeks (posttreatment). (Ryff's Psychological Well-Being Scale max-min Total scores=36-216; higher scores=better outcome).
Change in Maternal Prenatal Perceived Stress From Baseline to Follow-up.	Baseline (T0), when the infant is two months of age (Follow-up, T3).	Participants will be assessed with the Perceived Stress Scale (PSS) at baseline and when the infant is two months of age (Follow-up, T3). (PSS max-min scores=0-40, higher scores=worse outcome).
Change in Maternal Prenatal Depression Severity From Baseline to Follow-up.	Baseline (T0), when the infant is two months of age (Follow-up, T3).	Participants will be assessed with the Clinical Global Impressions Scale-Improvement (CGI-I) when the infant is two months of age (Follow-up, T3). (CGI-I, min-max=0-7, higher scores=worst outcome).
Change in Maternal Prenatal Perceived Stress From Baseline to Posttreatment (8 Weeks).	Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).	Participants were assessed with the Perceived Stress Scale (PSS) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (PSS max-min scores=0-40, higher scores=worse outcome).
Change in Maternal Prenatal Sleep Quality From Baseline to Posttreatment (8 Weeks).	Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).	Participants were assessed with the Single-item Sleep Quality Scale (SIMP) at baseline, at 4 weeks, and at 8 weeks (posttreatment). (SIMP max-min scores=0-10, higher scores=better outcome).
Infant Social/Emotional Problems at 2 Months of Age.	When the infant is two months of age (Follow-up, T3).	Infants will be assessed with the Baby Pediatric Symptom Checklist (BPSC) at 2 months of the child's age. (BPSC min-max=0-24, higher scores=worse outcome).
Change in Maternal Physical Activity Levels From Baseline to Posttreatment (8 Weeks).	Baseline (T0), Week 8 (Posttreatment, T2).	Participants were assessed with the International Physical Activity Questionnaire (IPAQ) at baseline and at 8 weeks (posttreatment). (IPAQ measures Total Metabolic Equivalent of Task (MET) minutes per week (MET-min per week), higher MET-min per week=better outcome).
Change in Maternal Prenatal Depression Severity From Baseline to Posttreatment (8 Weeks).	Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).	Participants were assessed with the Clinical Global Impressions Scale-Improvement (CGI-I). (scores in this scale are: 1=very much improved, 2= much improved, 3= minimally improved, 4 = no change, 5 = minimally worse, 6= much worse, 7= very much worse; scores were recoded as binary variable: improved (1, 2, 3) vs not-improved (4, 5, 6, 7).
Infant Developmental Milestones at 2 Months of Age.	When the infant is two months of age (Follow-up, T3).	Child developmental milestones will be assessed with the Survey of Well-being of Young Children (SWYC) at 2 months of the child's age. (SWYC min-max=0-20, higher scores=better outcome).
Change in Maternal Prenatal Depression From Baseline to Follow-up.	Baseline (T0), when the infant is two months of age (Follow-up, T3).	Participants will be assessed with the Edinburgh Postnatal Depression Scale (EPDS) at baseline and when the infant is two months of age (Follow-up, T3). (EPDS max-min scores=0-30, higher scores=worse outcome).
Change in Maternal Prenatal Anxiety From Baseline to to Follow-up.	Baseline (T0), when the infant is two months of age (Follow-up, T3).	Participants will be assessed with the Generalized Anxiety Disorder 7 (GAD-7) at baseline and when the infant is two months of age (Follow-up, T3). (GAD-7 max-min scores=0-21, higher scores=worse outcome).
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).	Participants will be assessed with the 12-item health survey (SF-12) at baseline and when the infant is two months of age (Follow-up, T3). (SF-12 max-min scores=12-50, higher scores=worse outcome).
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).	Participants will be assessed with the Ryff's Psychological Well-Being Scale at baseline and when the infant is two months of age (Follow-up, T3). (Ryff's Psychological Well-Being Scale max-min scores=6-36, higher scores=better outcome).
Change in Maternal Prenatal Sleep Quality From Baseline to Follow-up.	Baseline (T0), when the infant is two months of age (Follow-up, T3).	Participants will be assessed with the Single-item Sleep Quality Scale (SIMP) at baseline and when the infant is two months of age (Follow-up, T3). (SIMP max-min scores=0-10, higher scores=better outcome).