Trial Outcomes & Findings for A Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression (NCT NCT04495166)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

81 participants

Primary outcome timeframe

Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).

Results posted on

2022-01-11

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	Motherly App With Brief Psychotherapy 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.	Educational App (Active Control) 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.
Overall Study STARTED	37	44
Overall Study COMPLETED	30	41
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Motherly App With Brief Psychotherapy n=37 Participants 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.	Educational App (Active Control) n=44 Participants 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 n=81 Participants Total of all reporting groups
Age, Continuous	32.8 years STANDARD_DEVIATION 4.6 • n=39 Participants	32.3 years STANDARD_DEVIATION 4.9 • n=41 Participants	32.5 years STANDARD_DEVIATION 2.9 • n=35 Participants
Sex: Female, Male Female	37 Participants n=39 Participants	44 Participants n=41 Participants	81 Participants n=35 Participants
Sex: Female, Male Male	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race/Ethnicity, Customized White	25 Participants n=39 Participants	26 Participants n=41 Participants	51 Participants n=35 Participants
Race/Ethnicity, Customized Non-white	12 Participants n=39 Participants	18 Participants n=41 Participants	30 Participants n=35 Participants
Number of people in the house	3.0 people in the house STANDARD_DEVIATION 1.2 • n=39 Participants	2.8 people in the house STANDARD_DEVIATION 1.2 • n=41 Participants	2.9 people in the house STANDARD_DEVIATION 1.2 • n=35 Participants
Participant has college degree or higher	22 Participants n=39 Participants	30 Participants n=41 Participants	52 Participants n=35 Participants
Participant is working for pay	23 Participants n=39 Participants	30 Participants n=41 Participants	53 Participants n=35 Participants
Family income in Brazilian Real	5108.8 Brazilian Reais (R$) STANDARD_DEVIATION 4434.7 • n=39 Participants	4214.8 Brazilian Reais (R$) STANDARD_DEVIATION 3179.3 • n=41 Participants	4623.1 Brazilian Reais (R$) STANDARD_DEVIATION 3805.8 • n=35 Participants
Participant is studying	12 Participants n=39 Participants	16 Participants n=41 Participants	28 Participants n=35 Participants
Participant is married or in a stable relationship	33 Participants n=39 Participants	38 Participants n=41 Participants	71 Participants n=35 Participants
Number of prenatal visits	3.8 prenatal visits STANDARD_DEVIATION 1.6 • n=39 Participants	4.6 prenatal visits STANDARD_DEVIATION 1.8 • n=41 Participants	4.3 prenatal visits STANDARD_DEVIATION 1.7 • n=35 Participants
Gestational age in weeks	18.7 weeks STANDARD_DEVIATION 2.8 • n=39 Participants	19.9 weeks STANDARD_DEVIATION 3.3 • n=41 Participants	19.4 weeks STANDARD_DEVIATION 3.1 • n=35 Participants
Participant diagnosed with high-risk pregnancy	13 Participants n=39 Participants	7 Participants n=41 Participants	20 Participants n=35 Participants
Participant is receiving mental health treatment	10 Participants n=39 Participants	8 Participants n=41 Participants	18 Participants n=35 Participants
Participant used alcohol during gestation	7 Participants n=39 Participants	3 Participants n=41 Participants	10 Participants n=35 Participants
Participant used tobacco during gestation	3 Participants n=39 Participants	3 Participants n=41 Participants	6 Participants n=35 Participants
Participant used cannabis during gestation	1 Participants n=39 Participants	1 Participants n=41 Participants	2 Participants n=35 Participants

PRIMARY outcome

Timeframe: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Motherly App With Brief Psychotherapy n=37 Participants 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.	Educational App (Active Control) n=44 Participants 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.
Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks) T1	12.5 score on EPDS Interval 10.8 to 14.2	12.1 score on EPDS Interval 10.5 to 13.6
Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks) T2	11.1 score on EPDS Interval 9.3 to 13.0	10.8 score on EPDS Interval 9.1 to 12.4
Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks) T0	17.3 score on EPDS Interval 15.8 to 18.8	16.8 score on EPDS Interval 15.5 to 18.1

SECONDARY outcome

Timeframe: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Motherly App With Brief Psychotherapy n=37 Participants 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.	Educational App (Active Control) n=44 Participants 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.
Change in Maternal Prenatal Anxiety From Baseline to Posttreatment (8 Weeks) T0	14.0 Score on the GAD-7 Interval 12.8 to 15.3	13.5 Score on the GAD-7 Interval 11.9 to 15.0
Change in Maternal Prenatal Anxiety From Baseline to Posttreatment (8 Weeks) T1	11.1 Score on the GAD-7 Interval 9.4 to 12.8	10.9 Score on the GAD-7 Interval 9.3 to 12.6
Change in Maternal Prenatal Anxiety From Baseline to Posttreatment (8 Weeks) T2	9.8 Score on the GAD-7 Interval 7.8 to 11.8	9.7 Score on the GAD-7 Interval 7.9 to 11.5

SECONDARY outcome

Timeframe: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).

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

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (T0), Week 8 (Posttreatment, T2).

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Motherly App With Brief Psychotherapy n=37 Participants 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.	Educational App (Active Control) n=44 Participants 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.
Change in Maternal Prenatal Psychological Well-Being From Baseline to Posttreatment (8 Weeks). T0	149.7 Score on the PWB Interval 142.6 to 156.7	140.4 Score on the PWB Interval 133.1 to 147.7
Change in Maternal Prenatal Psychological Well-Being From Baseline to Posttreatment (8 Weeks). T1	157.6 Score on the PWB Interval 149.7 to 165.4	153.0 Score on the PWB Interval 144.6 to 161.4

SECONDARY outcome

Timeframe: Baseline (T0), Week 8 (Posttreatment, T2).

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Motherly App With Brief Psychotherapy n=37 Participants 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.	Educational App (Active Control) n=44 Participants 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.
Change in Maternal Physical Activity Levels From Baseline to Posttreatment (8 Weeks). T0	1626.0 MET-min per week Interval 845.1 to 2407.0	2160.1 MET-min per week Interval 1355.4 to 2964.8
Change in Maternal Physical Activity Levels From Baseline to Posttreatment (8 Weeks). T2	2770.0 MET-min per week Interval 682.4 to 4859.0	1540.1 MET-min per week Interval 1040.7 to 2039.5

SECONDARY outcome

Timeframe: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Motherly App With Brief Psychotherapy n=37 Participants 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.	Educational App (Active Control) n=44 Participants 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.
Change in Maternal Prenatal Perceived Stress From Baseline to Posttreatment (8 Weeks). T2	23.9 Score on the PSS Interval 21.5 to 26.4	22.9 Score on the PSS Interval 20.6 to 25.2
Change in Maternal Prenatal Perceived Stress From Baseline to Posttreatment (8 Weeks). T0	26.5 Score on the PSS Interval 24.7 to 28.3	26.6 Score on the PSS Interval 24.6 to 28.6
Change in Maternal Prenatal Perceived Stress From Baseline to Posttreatment (8 Weeks). T1	25.6 Score on the PSS Interval 23.5 to 27.7	25.0 Score on the PSS Interval 22.9 to 27.2

SECONDARY outcome

Timeframe: Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Motherly App With Brief Psychotherapy n=37 Participants 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.	Educational App (Active Control) n=44 Participants 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.
Change in Maternal Prenatal Depression Severity From Baseline to Posttreatment (8 Weeks). T1	63 Proportion (in percentage) Interval 45.0 to 80.0	73 Proportion (in percentage) Interval 59.0 to 87.0
Change in Maternal Prenatal Depression Severity From Baseline to Posttreatment (8 Weeks). T2	80 Proportion (in percentage) Interval 65.0 to 94.0	80 Proportion (in percentage) Interval 66.0 to 93.0

SECONDARY outcome

Timeframe: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Motherly App With Brief Psychotherapy n=37 Participants 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.	Educational App (Active Control) n=44 Participants 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.
Change in Maternal Prenatal Sleep Quality From Baseline to Posttreatment (8 Weeks). T0	4.6 Score on SQA Interval 4.0 to 5.2	4.6 Score on SQA Interval 4.0 to 5.2
Change in Maternal Prenatal Sleep Quality From Baseline to Posttreatment (8 Weeks). T1	5.6 Score on SQA Interval 4.8 to 6.4	5.0 Score on SQA Interval 4.3 to 5.8
Change in Maternal Prenatal Sleep Quality From Baseline to Posttreatment (8 Weeks). T2	5.6 Score on SQA Interval 4.7 to 6.5	5.4 Score on SQA Interval 4.7 to 6.1

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).