Perinatal DepressionNCT04495166

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

A study testing Motherly 1.0, Brief Psychotherapy and Educational app in people with Perinatal Depression, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 to 40 years, women only
Conditions the study is for: Perinatal Depression
What is being tested?: Motherly 1.0, Brief Psychotherapy and Educational app
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 1 siteBrazil
Study dates: 3 Aug 2020to 27 Apr 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 40 years
Women only
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Daniel Fatori
São Paulo

Other trials in Brazil

About this study

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

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).

Conditions: Perinatal Depression
Being tested: Motherly 1.0, Brief Psychotherapy, Educational app

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Motherly 1.0Behavioural
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).
Brief PsychotherapyBehavioural
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.
Educational appBehavioural
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.

Study groups in NCT04495166
Study group	Role	What they receive
Motherly app with brief psychotherapy	Experimental	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. Receives: Behavioral: Motherly 1.0; Behavioral: Brief Psychotherapy
Educational app (Active control)	Active comparator	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. Receives: Behavioral: Brief Psychotherapy; Behavioral: Educational app

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (16)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Aug 202027 Apr 2021

First posted31 Jul 2020
Study start3 Aug 2020
Primary completion23 Nov 2020
Study completion27 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Perinatal DepressionStudies of the same condition, open and under way.
More trials run by University of Sao PauloThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04495166
Sponsor's protocol ID: Motherly1
Other IDs: SB-POC-1810-20573
Status last verified: Nov 2021
First submitted: 23 Jul 2020
Last updated: 11 Jan 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Perinatal Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression
ClinicalTrials.gov ID: NCT04495166
Acronym / sponsor ID: Motherly1
Conditions: Perinatal Depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: University of Sao PauloUniversity, hospital or other
Collaborators: Grand Challenges Canada, Fundação Maria Cecilia Souto Vidigal
Study start: 3 Aug 2020 (actual)
Primary completion: 23 Nov 2020 (actual)
Study completion: 27 Apr 2021 (actual)
First posted: 31 Jul 2020 (actual)
Results: Posted 11 Jan 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Motherly app with brief psychotherapy	Experimental	Behavioral: Motherly 1.0, Behavioral: Brief PsychotherapyParticipants in this arm will receive intervention via Motherly 1.0, an app that delivers behavioral activation strategies and psychoeducational content to promote changes in sleep, nutrition, and physical activity habits. It has also functionalities that help participants to engage in prenatal care, breastfeeding, and social support, and to stimulate child development. In addition will undergo brief Cognitive-Behavioral Therapy (CBT) with a focus on behavioral activation.
Educational app (Active control)	Active comparator	Behavioral: Brief Psychotherapy, Behavioral: Educational appParticipants 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.

Who may qualify

Ages: 16 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (3 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Motherly 1.0A 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).	Behavioural	Motherly app with brief psychotherapy
Brief PsychotherapyBrief 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.	Behavioural	Educational app (Active control), Motherly app with brief psychotherapy
Educational appA 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.	Behavioural	Educational app (Active control)

Primary outcome

Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks)
Time frame: 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).

16 secondary outcomes

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

Results and safety

Results posted to the registry on 11 Jan 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Motherly App With Brief Psychotherapy	37	30
Educational App (Active Control)	44	41

Primary outcome: Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks)

Time frame: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).. Mean (95% Confidence Interval). Unit: score on EPDS

Measure	Motherly App With Brief Psychotherapy n = 37	Educational App (Active Control) n = 44
T0	17.3 (15.8 to 18.8)	16.8 (15.5 to 18.1)
T1	12.5 (10.8 to 14.2)	12.1 (10.5 to 13.6)
T2	11.1 (9.3 to 13.0)	10.8 (9.1 to 12.4)

Motherly App With Brief Psychotherapy vs Educational App (Active Control): p = 0.757, t-test, 2 sided

Population analysed: 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.

16 secondary outcomes are reported in the full results.

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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Motherly App With Brief Psychotherapy	0 of 37 (0%)	0 of 37 (0%)	0 of 37
Educational App (Active Control)	0 of 44 (0%)	0 of 44 (0%)	0 of 44

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21545782Sockol 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.
Background: PubMed 17549635Graham 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.
Derived from this study: PubMed 33757591Zuccolo 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.
Individual participant dataSharing planned: No

Related trials for Perinatal Depression

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel Fatori, PhD principal investigator

Medical School, University of Sao Paulo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Motherly 1.0, Brief Psychotherapy and Educational app in people with Perinatal Depression, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks) (time frame: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04495166, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.