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

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT04495166
• Collaborator: Grand Challenges Canada (Other), Fundação Maria Cecilia Souto Vidigal (Other)
• Enrollment: 81
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.8
• Patients Per Site Per Month: 9.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Perinatal Depression	Behavioral: Motherly 1.0; Behavioral: Brief Psychotherapy; Behavioral: Educational app	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression
• Actual Study Start Date: Aug 3, 2020
• Actual Primary Completion Date: Nov 23, 2020
• Actual Study Completion Date: Apr 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Motherly 1.0; 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).; Behavioral: Brief Psychotherapy; 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.
Active Comparator: 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.	Behavioral: Brief Psychotherapy; 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.; Behavioral: Educational app; 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. 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).

3. 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).

4. 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).

5. 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).

6. 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).

7. 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).

8. 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).

9. 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).

10. 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).

11. 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).

12. 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).

13. 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).

14. 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).

15. 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).

16. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 40 Years
• Sexes Eligible for Study: 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Daniel Fatori	São Paulo		Brazil

Sponsors and Collaborators

• University of Sao Paulo
• Grand Challenges Canada
• Fundação Maria Cecilia Souto Vidigal

Investigators

• Principal Investigator: Daniel Fatori, PhD, Medical School, University of Sao Paulo

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jul 31, 2020

More Information

Publications

• Graham JW, Olchowski AE, Gilreath TD. How many imputations are really needed? Some practical clarifications of multiple imputation theory. Prev Sci. 2007 Sep;8(3):206-13. Epub 2007 Jun 5.
• Sockol LE, Epperson CN, Barber JP. A meta-analysis of treatments for perinatal depression. Clin Psychol Rev. 2011 Jul;31(5):839-49. doi: 10.1016/j.cpr.2011.03.009. Epub 2011 Mar 27.

• Responsible Party: Guilherme Vanoni Polanczyk, MD PhD, Professor, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT04495166
• Other Study ID Numbers: Motherly1; SB-POC-1810-20573
• First Posted: Jul 31, 2020
• Last Update Posted: Jan 11, 2022
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

Participant Flow

Recruitment Details

Participants were recruited via social media advertisements from August to September 2020. After demonstrating interest in the study, potential participants were referred to a website page where they were informed of the study's aims, procedures, assessments, and nature of the interventions. They responded to an online survey assessing eligibility criteria. Eligible participants were invited to a baseline assessment conducted via internet or telephone.

Pre-assignment Detail

Three hundred and twenty (320) women registered online, but 188 did not meet eligibility criteria and one had a duplicated registration. Thirty-six (36) women were excluded in a brief telephone because they did not meet eligibility criteria or declined to participate in the study. Ninety-five (95) women were scheduled for baseline assessment, but 14 cancelled or missed the appointment. Eighty one (81) participants were enrolled and randomized to intervention (N=37) or active control (N=44).

Arm/Group Title	Motherly App With Brief Psychotherapy	Educational App (Active Control)
Arm/Group Description	Participants in this arm received 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, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.	Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
Period Title: Overall Study
STARTED	37	44
COMPLETED	30	41
NOT COMPLETED	7	3

Baseline Characteristics

Arm/Group Title	Motherly App With Brief Psychotherapy	Educational App (Active Control)	Total
Arm/Group Description	Participants in this arm received 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 they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.	Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.	Total of all reporting groups
Overall Participants	37	44	81
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.8 (4.6)	32.3 (4.9)	32.5 (2.9)
Sex: Female, Male (Count of Participants)
Female	37 100%	44 100%	81 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	25 67.6%	26 59.1%	51 63%
Non-white	12 32.4%	18 40.9%	30 37%
Number of people in the house (people in the house) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [people in the house]	3.0 (1.2)	2.8 (1.2)	2.9 (1.2)
Participant has college degree or higher (Count of Participants)
Count of Participants [Participants]	22 59.5%	30 68.2%	52 64.2%
Participant is working for pay (Count of Participants)
Count of Participants [Participants]	23 62.2%	30 68.2%	53 65.4%
Family income in Brazilian Real (Brazilian Reais (R$)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Brazilian Reais (R$)]	5108.8 (4434.7)	4214.8 (3179.3)	4623.1 (3805.8)
Participant is studying (Count of Participants)
Count of Participants [Participants]	12 32.4%	16 36.4%	28 34.6%
Participant is married or in a stable relationship (Count of Participants)
Count of Participants [Participants]	33 89.2%	38 86.4%	71 87.7%
Number of prenatal visits (prenatal visits) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [prenatal visits]	3.8 (1.6)	4.6 (1.8)	4.3 (1.7)
Gestational age in weeks (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	18.7 (2.8)	19.9 (3.3)	19.4 (3.1)
Participant diagnosed with high-risk pregnancy (Count of Participants)
Count of Participants [Participants]	13 35.1%	7 15.9%	20 24.7%
Participant is receiving mental health treatment (Count of Participants)
Count of Participants [Participants]	10 27%	8 18.2%	18 22.2%
Participant used alcohol during gestation (Count of Participants)
Count of Participants [Participants]	7 18.9%	3 6.8%	10 12.3%
Participant used tobacco during gestation (Count of Participants)
Count of Participants [Participants]	3 8.1%	3 6.8%	6 7.4%
Participant used cannabis during gestation (Count of Participants)
Count of Participants [Participants]	1 2.7%	1 2.3%	2 2.5%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.

Arm/Group Title	Motherly App With Brief Psychotherapy	Educational App (Active Control)
Arm/Group Description	Participants in this arm received 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 they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.	Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
Measure Participants	37	44
T0	17.3	16.8
T1	12.5	12.1
T2	11.1	10.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Motherly App With Brief Psychotherapy, Educational App (Active Control)
	Comments	The sample size was calculated based on an effect size of 0.65 on depression, which is based on a previous meta-analysis (Sockol et al., 2011). Sample size calculation considered a difference in means between two independent groups, probability of type I error of 5%, statistical power of 80%, a two-tailed test, and a dropout rate of 15%.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.757
	Comments	Statistical tests were 2-sided and p values <0.05 were considered statistically significant
	Method	t-test, 2 sided
	Comments	To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.

2. Secondary Outcome

Title	Change in Maternal Prenatal Anxiety From Baseline to Posttreatment (8 Weeks)
Description	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).
Time Frame	Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).

Outcome Measure Data

Analysis Population Description

In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.

Arm/Group Title	Motherly App With Brief Psychotherapy	Educational App (Active Control)
Arm/Group Description	Participants in this arm received 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 they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.	Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
Measure Participants	37	44
T0	14.0	13.5
T1	11.1	10.9
T2	9.8	9.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Motherly App With Brief Psychotherapy, Educational App (Active Control)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.910
	Comments	Statistical tests were 2-sided and p values <0.05 were considered statistically significant
	Method	t-test, 2 sided
	Comments	To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.

3. Secondary Outcome

Title	Change in Maternal Prenatal Quality of Life From Baseline to Posttreatment (8 Weeks)
Description	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).
Time Frame	Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).

Outcome Measure Data

Analysis Population Description

This measure was not collected during all RCT due to logistics and the need to reduce data collection time.

Arm/Group Title	Motherly App With Brief Psychotherapy	Educational App (Active Control)
Arm/Group Description	Participants in this arm received 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 they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.	Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
Measure Participants	0	0

4. Secondary Outcome

Title	Change in Maternal Prenatal Psychological Well-Being From Baseline to Posttreatment (8 Weeks).
Description	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).
Time Frame	Baseline (T0), Week 8 (Posttreatment, T2).

Outcome Measure Data

Analysis Population Description

In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.

Arm/Group Title	Motherly App With Brief Psychotherapy	Educational App (Active Control)
Arm/Group Description	Participants in this arm received 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 they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.	Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
Measure Participants	37	44
T0	149.7	140.4
T1	157.6	153.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Motherly App With Brief Psychotherapy, Educational App (Active Control)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.442
	Comments	Statistical tests were 2-sided and p values <0.05 were considered statistically significant
	Method	t-test, 2 sided
	Comments	To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.

5. Secondary Outcome

Title	Change in Maternal Physical Activity Levels From Baseline to Posttreatment (8 Weeks).
Description	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).
Time Frame	Baseline (T0), Week 8 (Posttreatment, T2).

Outcome Measure Data

Analysis Population Description

In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.

Arm/Group Title	Motherly App With Brief Psychotherapy	Educational App (Active Control)
Arm/Group Description	Participants in this arm received 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 they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.	Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
Measure Participants	37	44
T0	1626.0	2160.1
T2	2770.0	1540.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Motherly App With Brief Psychotherapy, Educational App (Active Control)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.223
	Comments	Statistical tests were 2-sided and p values <0.05 were considered statistically significant
	Method	t-test, 2 sided
	Comments	To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.

6. Secondary Outcome

Title	Change in Maternal Prenatal Perceived Stress From Baseline to Posttreatment (8 Weeks).
Description	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).
Time Frame	Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).

Outcome Measure Data

Analysis Population Description

In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.

Arm/Group Title	Motherly App With Brief Psychotherapy	Educational App (Active Control)
Arm/Group Description	Participants in this arm received 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 they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.	Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
Measure Participants	37	44
T0	26.5	26.6
T1	25.6	25.0
T2	23.9	22.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Motherly App With Brief Psychotherapy, Educational App (Active Control)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.540
	Comments	Statistical tests were 2-sided and p values <0.05 were considered statistically significant
	Method	t-test, 2 sided
	Comments	To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.

7. Secondary Outcome

Title	Change in Maternal Prenatal Depression Severity From Baseline to Posttreatment (8 Weeks).
Description	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).
Time Frame	Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).

Outcome Measure Data

Analysis Population Description

In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.

Arm/Group Title	Motherly App With Brief Psychotherapy	Educational App (Active Control)
Arm/Group Description	Participants in this arm received 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 they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.	Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
Measure Participants	37	44
T1	63	73
T2	80	80

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Motherly App With Brief Psychotherapy, Educational App (Active Control)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.901
	Comments	Statistical tests were 2-sided and p values <0.05 were considered statistically significant
	Method	t-test, 2 sided
	Comments	To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.

8. Secondary Outcome

Title	Change in Maternal Prenatal Sleep Quality From Baseline to Posttreatment (8 Weeks).
Description	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).
Time Frame	Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).

Outcome Measure Data

Analysis Population Description

In order to include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations (MICE) with 100 imputations (Graham et al., 2007). MICE models included information from all outcomes at T1, T2, and T3, as well as key baseline characteristics.

Arm/Group Title	Motherly App With Brief Psychotherapy	Educational App (Active Control)
Arm/Group Description	Participants in this arm received 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 they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.	Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
Measure Participants	37	44
T0	4.6	4.6
T1	5.6	5.0
T2	5.6	5.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Motherly App With Brief Psychotherapy, Educational App (Active Control)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.748
	Comments	Statistical tests were 2-sided and p values <0.05 were considered statistically significant
	Method	t-test, 2 sided
	Comments	To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.

9. Secondary Outcome

Title	Infant Developmental Milestones at 2 Months of Age.
Description	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).
Time Frame	When the infant is two months of age (Follow-up, T3).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	Infant Social/Emotional Problems at 2 Months of Age.
Description	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).
Time Frame	When the infant is two months of age (Follow-up, T3).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Secondary Outcome

Title	Change in Maternal Prenatal Depression From Baseline to Follow-up.
Description	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).
Time Frame	Baseline (T0), when the infant is two months of age (Follow-up, T3).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	Change in Maternal Prenatal Anxiety From Baseline to to Follow-up.
Description	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).
Time Frame	Baseline (T0), when the infant is two months of age (Follow-up, T3).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

13. Secondary Outcome

Title	Change in Maternal Prenatal Quality of Life From Baseline to to Follow-up.
Description	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).
Time Frame	Baseline (T0), when the infant is two months of age (Follow-up, T3).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

14. Secondary Outcome

Title	Change in Maternal Prenatal Psychological Well-Being From Baseline to Follow-up.
Description	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).
Time Frame	Baseline (T0), when the infant is two months of age (Follow-up, T3).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

15. Secondary Outcome

Title	Change in Maternal Prenatal Perceived Stress From Baseline to Follow-up.
Description	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).
Time Frame	Baseline (T0), when the infant is two months of age (Follow-up, T3).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

16. Secondary Outcome

Title	Change in Maternal Prenatal Depression Severity From Baseline to Follow-up.
Description	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).
Time Frame	Baseline (T0), when the infant is two months of age (Follow-up, T3).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

17. Secondary Outcome

Title	Change in Maternal Prenatal Sleep Quality From Baseline to Follow-up.
Description	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).
Time Frame	Baseline (T0), when the infant is two months of age (Follow-up, T3).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Adverse events were collected throughout the trial by psychotherapist during their sessions with participants. Moreover, assessors collected information on adverse events during the assessments at baseline (T0), mid-treatment (T1), posttreatment (T3).
Adverse Event Reporting Description	Given that the intervention in this study is non-invasive, with a very low risk for participants of serious adverse events and mortality, then adverse events were collected qualitatively throughout the trial by the assessors, who asked participants about psychological distress and discomfort from the interventions.
Arm/Group Title	Motherly App With Brief Psychotherapy		Educational App (Active Control)
Arm/Group Description	Participants in this arm received 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 they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.		Participants in this arm had access to a psychoeducational app (active control) which delivers content about gestation, maternal health and mental health, and child development. In addition, they underwent a brief Cognitive-Behavioral Therapy (CBT) protocol with a focus on behavioral activation.
All Cause Mortality
	Motherly App With Brief Psychotherapy		Educational App (Active Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/44 (0%)
Serious Adverse Events
	Motherly App With Brief Psychotherapy		Educational App (Active Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/44 (0%)
Other (Not Including Serious) Adverse Events
	Motherly App With Brief Psychotherapy		Educational App (Active Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/44 (0%)

Limitations/Caveats

sample was primarily composed of highly educated women with high family income. Therefore, considering Brazil is a LMIC with inequality and widespread poverty, it is difficult to generalize our findings to other regions and countries. Study was conducted during the COVID-19 pandemic, which may have impacted participants' mental health.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.