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CompletedNCT04495166Updated Jan 11, 2022Results posted

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

An interventional study of Motherly 1.0 and Brief Psychotherapy in Perinatal Depression, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to female participants aged 16 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-01-11.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
16 Years to 40 Years
Sex
Female
01

Study 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).

02

Conditions studied

  • Perinatal Depression
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 81 is close to the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 40 Years
Sexes eligible
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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
81 participants (actual)

Study arms

  • 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 · Behavioral: Brief Psychotherapy

  • 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 · Behavioral: Educational app

Interventions

  • BehavioralMotherly 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).

  • BehavioralBrief 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.

  • BehavioralEducational 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.

06

What researchers measure

Primary outcomes

  1. 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).

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

Secondary outcomes

  1. 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).

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

  2. 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).

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

  3. 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).

    Time frame: Baseline (T0), Week 8 (Posttreatment, T2).

  4. 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).

    Time frame: Baseline (T0), Week 8 (Posttreatment, T2).

  5. 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).

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

  6. 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).

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

  7. 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).

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

  8. 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).

    Time frame: When the infant is two months of age (Follow-up, T3).

  9. 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).

    Time frame: When the infant is two months of age (Follow-up, T3).

  10. 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).

    Time frame: Baseline (T0), when the infant is two months of age (Follow-up, T3).

  11. 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).

    Time frame: Baseline (T0), when the infant is two months of age (Follow-up, T3).

  12. 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).

    Time frame: Baseline (T0), when the infant is two months of age (Follow-up, T3).

  13. 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).

    Time frame: Baseline (T0), when the infant is two months of age (Follow-up, T3).

  14. 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).

    Time frame: Baseline (T0), when the infant is two months of age (Follow-up, T3).

  15. 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).

    Time frame: Baseline (T0), when the infant is two months of age (Follow-up, T3).

  16. 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).

    Time frame: Baseline (T0), when the infant is two months of age (Follow-up, T3).

07

Results

Posted Jan 11, 2022
Limitations and 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.

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.

Participant flow — Overall Study
MilestoneMotherly App With Brief PsychotherapyEducational App (Active Control)
Started3744
Completed3041
Not completed73

Outcome measures

PrimaryChange 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).

Time frame:
Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
Reported as:
Mean · score on EPDS
Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks)
score on EPDSMotherly App With Brief PsychotherapyEducational App (Active Control)
T017.3 (15.8 to 18.8)16.8 (15.5 to 18.1)
T112.5 (10.8 to 14.2)12.1 (10.5 to 13.6)
T211.1 (9.3 to 13.0)10.8 (9.1 to 12.4)
Statistical analysis
  • Motherly App With Brief Psychotherapy vs Educational App (Active Control) · t-test, 2 sided · p = 0.757 (Statistical tests were 2-sided and p values \<0.05 were considered statistically significant)To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.
SecondaryChange 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).

Time frame:
Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
Reported as:
Mean · Score on the GAD-7
Change in Maternal Prenatal Anxiety From Baseline to Posttreatment (8 Weeks)
Score on the GAD-7Motherly App With Brief PsychotherapyEducational App (Active Control)
T014.0 (12.8 to 15.3)13.5 (11.9 to 15.0)
T111.1 (9.4 to 12.8)10.9 (9.3 to 12.6)
T29.8 (7.8 to 11.8)9.7 (7.9 to 11.5)
Statistical analysis
  • Motherly App With Brief Psychotherapy vs Educational App (Active Control) · t-test, 2 sided · p = 0.910 (Statistical tests were 2-sided and p values \<0.05 were considered statistically significant)To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.
SecondaryChange 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).

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

No measurements were reported for this outcome.

SecondaryChange 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).

Time frame:
Baseline (T0), Week 8 (Posttreatment, T2).
Reported as:
Mean · Score on the PWB
Change in Maternal Prenatal Psychological Well-Being From Baseline to Posttreatment (8 Weeks).
Score on the PWBMotherly App With Brief PsychotherapyEducational App (Active Control)
T0149.7 (142.6 to 156.7)140.4 (133.1 to 147.7)
T1157.6 (149.7 to 165.4)153.0 (144.6 to 161.4)
Statistical analysis
  • Motherly App With Brief Psychotherapy vs Educational App (Active Control) · t-test, 2 sided · p = 0.442 (Statistical tests were 2-sided and p values \<0.05 were considered statistically significant)To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.
SecondaryChange 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).

Time frame:
Baseline (T0), Week 8 (Posttreatment, T2).
Reported as:
Mean · MET-min per week
Change in Maternal Physical Activity Levels From Baseline to Posttreatment (8 Weeks).
MET-min per weekMotherly App With Brief PsychotherapyEducational App (Active Control)
T01626.0 (845.1 to 2407.0)2160.1 (1355.4 to 2964.8)
T22770.0 (682.4 to 4859.0)1540.1 (1040.7 to 2039.5)
Statistical analysis
  • Motherly App With Brief Psychotherapy vs Educational App (Active Control) · t-test, 2 sided · p = 0.223 (Statistical tests were 2-sided and p values \<0.05 were considered statistically significant)To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.
SecondaryChange 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).

Time frame:
Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
Reported as:
Mean · Score on the PSS
Change in Maternal Prenatal Perceived Stress From Baseline to Posttreatment (8 Weeks).
Score on the PSSMotherly App With Brief PsychotherapyEducational App (Active Control)
T026.5 (24.7 to 28.3)26.6 (24.6 to 28.6)
T125.6 (23.5 to 27.7)25.0 (22.9 to 27.2)
T223.9 (21.5 to 26.4)22.9 (20.6 to 25.2)
Statistical analysis
  • Motherly App With Brief Psychotherapy vs Educational App (Active Control) · t-test, 2 sided · p = 0.540 (Statistical tests were 2-sided and p values \<0.05 were considered statistically significant)To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.
SecondaryChange 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).

Time frame:
Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
Reported as:
Number · Proportion (in percentage)
Change in Maternal Prenatal Depression Severity From Baseline to Posttreatment (8 Weeks).
Proportion (in percentage)Motherly App With Brief PsychotherapyEducational App (Active Control)
T163 (45 to 80)73 (59 to 87)
T280 (65 to 94)80 (66 to 93)
Statistical analysis
  • Motherly App With Brief Psychotherapy vs Educational App (Active Control) · t-test, 2 sided · p = 0.901 (Statistical tests were 2-sided and p values \<0.05 were considered statistically significant)To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.
SecondaryChange 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).

Time frame:
Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
Reported as:
Mean · Score on SQA
Change in Maternal Prenatal Sleep Quality From Baseline to Posttreatment (8 Weeks).
Score on SQAMotherly App With Brief PsychotherapyEducational App (Active Control)
T04.6 (4.0 to 5.2)4.6 (4.0 to 5.2)
T15.6 (4.8 to 6.4)5.0 (4.3 to 5.8)
T25.6 (4.7 to 6.5)5.4 (4.7 to 6.1)
Statistical analysis
  • Motherly App With Brief Psychotherapy vs Educational App (Active Control) · t-test, 2 sided · p = 0.748 (Statistical tests were 2-sided and p values \<0.05 were considered statistically significant)To include participants that were not assessed in post-baseline assessments we used multiple imputation by chained equations with 100 imputations.
SecondaryInfant 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).

Time frame:
When the infant is two months of age (Follow-up, T3).

Results for this outcome have not been posted.

SecondaryInfant 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).

Time frame:
When the infant is two months of age (Follow-up, T3).

Results for this outcome have not been posted.

SecondaryChange 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).

Time frame:
Baseline (T0), when the infant is two months of age (Follow-up, T3).

Results for this outcome have not been posted.

SecondaryChange 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).

Time frame:
Baseline (T0), when the infant is two months of age (Follow-up, T3).

Results for this outcome have not been posted.

SecondaryChange 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).

Time frame:
Baseline (T0), when the infant is two months of age (Follow-up, T3).

Results for this outcome have not been posted.

SecondaryChange 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).

Time frame:
Baseline (T0), when the infant is two months of age (Follow-up, T3).

Results for this outcome have not been posted.

SecondaryChange 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).

Time frame:
Baseline (T0), when the infant is two months of age (Follow-up, T3).

Results for this outcome have not been posted.

SecondaryChange 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).

Time frame:
Baseline (T0), when the infant is two months of age (Follow-up, T3).

Results for this outcome have not been posted.

SecondaryChange 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).

Time frame:
Baseline (T0), when the infant is two months of age (Follow-up, T3).

Results for this outcome have not been posted.

Adverse events

Collected over 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).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Motherly App With Brief Psychotherapy0/37 (0%)0/37 (0%)0/37 (0%)
Educational App (Active Control)0/44 (0%)0/44 (0%)0/44 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Motherly App With Brief PsychotherapyEducational App (Active Control)Total
Mean32.8 ± 4.632.3 ± 4.932.5 ± 2.9
Sex: Female, Male
Sex: Female, Male(Participants)Motherly App With Brief PsychotherapyEducational App (Active Control)Total
Female374481
Male000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Motherly App With Brief PsychotherapyEducational App (Active Control)Total
White252651
Non-white121830
Number of people in the house
Number of people in the house(people in the house)Motherly App With Brief PsychotherapyEducational App (Active Control)Total
Mean3.0 ± 1.22.8 ± 1.22.9 ± 1.2
Participant has college degree or higher
Participant has college degree or higher(Participants)Motherly App With Brief PsychotherapyEducational App (Active Control)Total
Count of participants223052
Participant is working for pay
Participant is working for pay(Participants)Motherly App With Brief PsychotherapyEducational App (Active Control)Total
Count of participants233053
Family income in Brazilian Real
Family income in Brazilian Real(Brazilian Reais (R$))Motherly App With Brief PsychotherapyEducational App (Active Control)Total
Mean5108.8 ± 4434.74214.8 ± 3179.34623.1 ± 3805.8
Participant is studying
Participant is studying(Participants)Motherly App With Brief PsychotherapyEducational App (Active Control)Total
Count of participants121628

8 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Daniel Fatori
    São Paulo, Brazil
09

References and documents

Publications

  • 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. PubMed 21545782 ↗
  • 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. doi: 10.1007/s11121-007-0070-9. Epub 2007 Jun 5. PubMed 17549635 ↗
  • Zuccolo PF, Xavier MO, Matijasevich A, Polanczyk G, Fatori D. A smartphone-assisted brief online cognitive-behavioral intervention for pregnant women with depression: a study protocol of a randomized controlled trial. Trials. 2021 Mar 23;22(1):227. doi: 10.1186/s13063-021-05179-8. PubMed 33757591 ↗

Study documents

  • Protocol, analysis plan and consent form · Jul 31, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04495166
Lead sponsor
University of Sao Paulo
Collaborators
Grand Challenges Canada, Fundação Maria Cecilia Souto Vidigal
Responsible party
Guilherme Vanoni Polanczyk, MD PhD (Professor, University of Sao Paulo) — Principal investigator
First posted
Jul 31, 2020
Start date
Aug 3, 2020
Primary completion
Nov 23, 2020
Completion
Apr 27, 2021
Results posted
Jan 11, 2022
Last update
Jan 11, 2022

Study contacts

Daniel Fatori, PhD
principal investigator · Medical School, University of Sao Paulo

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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