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

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).

Official Title
-----------------
Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression

Conditions
-----------------
Perinatal Depression

Intervention / Treatment
-----------------
* Behavioral: Motherly 1.0
* Behavioral: Brief Psychotherapy
* Behavioral: Educational app


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motherly app with brief psychotherapy<br>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. | Behavioral: Motherly 1.0<br>* A mobile app designed to promote life habits that have been shown to improve physical and mental health in pregnant women. The app consists of a package of specific and customized interventions defined by eight different modules: 1) Mental Health; 2) Sleep; 3) Nutrition; 4) Physical activity; 5) Social support; 6) Prenatal support; 7) Postnatal support, and 8) Library of pre and postnatal content. The app relies on extensive psychoeducational content delivered as tutorials, brief messages, and available as a library that can be read at the users' discretion; behavior monitoring using schedules, checklists, and notifications to help participants keep track of their health care visits, and schedule behavior activation activities; and gaming elements such as changes in background appearance to reflect participant's mood assessment and ratings of activities, and graphical and easy-to-use questionnaires for obtaining information (mood, nutrition habits).<br>Behavioral: Brief Psychotherapy<br>* Brief Cognitive-Behavioral Therapy (CBT) with a focus on behavioral activation (BA). Participants will be guided by psychotherapists to plan, schedule, and engage in positively reinforcing activities, and will be aided to develop problem-solving strategies for circumventing barriers to completing scheduled activities. Implementation of these techniques will be conducted with the aid of the Motherly 1.0 for participants in the experimental arm; for participants in the control arm, BA will be implemented without the aid of Motherly 1.0. Throughout the four sessions, psychotherapists will monitor participants' adherence, answering questions about the strategies and providing support for solving problems or CBT techniques, such as cognitive restructuring, relaxation techniques, sleep hygiene, stress and anxiety management, among other evidence-based techniques might be used if appropriate to the case.<br>|
| Active Comparator: Educational app (Active control)<br>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. | Behavioral: Brief Psychotherapy<br>* Brief Cognitive-Behavioral Therapy (CBT) with a focus on behavioral activation (BA). Participants will be guided by psychotherapists to plan, schedule, and engage in positively reinforcing activities, and will be aided to develop problem-solving strategies for circumventing barriers to completing scheduled activities. Implementation of these techniques will be conducted with the aid of the Motherly 1.0 for participants in the experimental arm; for participants in the control arm, BA will be implemented without the aid of Motherly 1.0. Throughout the four sessions, psychotherapists will monitor participants' adherence, answering questions about the strategies and providing support for solving problems or CBT techniques, such as cognitive restructuring, relaxation techniques, sleep hygiene, stress and anxiety management, among other evidence-based techniques might be used if appropriate to the case.<br>Behavioral: Educational app<br>* A simplified version of the Motherly 1.0 app consisting of psychoeducational content about various aspects of pregnancy, maternal physical and mental health, and child development. Active intervention functionalities, such as behavioral activation, activity scheduling, sleep hygiene, among others, are NOT present in this simplified version of the app.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks) | 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). | Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Maternal Prenatal Anxiety From Baseline to Posttreatment (8 Weeks) | 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). | Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2). | 
| Change in Maternal Prenatal Quality of Life From Baseline to Posttreatment (8 Weeks) | 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). | Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2). | 
| Change in Maternal Prenatal Psychological Well-Being From Baseline to Posttreatment (8 Weeks). | 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). | Baseline (T0), Week 8 (Posttreatment, T2). | 
| Change in Maternal Physical Activity Levels From Baseline to Posttreatment (8 Weeks). | 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). | Baseline (T0), Week 8 (Posttreatment, T2). | 
| Change in Maternal Prenatal Perceived Stress From Baseline to Posttreatment (8 Weeks). | 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). | Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2). | 
| Change in Maternal Prenatal Depression Severity From Baseline to Posttreatment (8 Weeks). | 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). | Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2). | 
| Change in Maternal Prenatal Sleep Quality From Baseline to Posttreatment (8 Weeks). | 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). | Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2). | 
| Infant Developmental Milestones at 2 Months of Age. | 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). | When the infant is two months of age (Follow-up, T3). | 
| Infant Social/Emotional Problems at 2 Months of Age. | 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). | When the infant is two months of age (Follow-up, T3). | 
| Change in Maternal Prenatal Depression From Baseline to Follow-up. | 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). | Baseline (T0), when the infant is two months of age (Follow-up, T3). | 
| Change in Maternal Prenatal Anxiety From Baseline to to Follow-up. | 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). | 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. | 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). | 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. | 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). | Baseline (T0), when the infant is two months of age (Follow-up, T3). | 
| Change in Maternal Prenatal Perceived Stress From Baseline to Follow-up. | 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). | Baseline (T0), when the infant is two months of age (Follow-up, T3). | 
| Change in Maternal Prenatal Depression Severity From Baseline to Follow-up. | 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). | Baseline (T0), when the infant is two months of age (Follow-up, T3). | 
| Change in Maternal Prenatal Sleep Quality From Baseline to Follow-up. | 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). | Baseline (T0), when the infant is two months of age (Follow-up, T3). |