- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04495166
A Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression
November 10, 2021 updated by: Guilherme Vanoni Polanczyk, MD PhD, University of Sao Paulo
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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São Paulo, Brazil
- Daniel Fatori
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 38 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
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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 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.
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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.
|
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks)
Time Frame: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
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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).
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Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Maternal Prenatal Anxiety From Baseline to Posttreatment (8 Weeks)
Time Frame: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
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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).
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Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
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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).
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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).
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Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
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Change in Maternal Prenatal Psychological Well-Being From Baseline to Posttreatment (8 Weeks).
Time Frame: Baseline (T0), Week 8 (Posttreatment, T2).
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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).
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Baseline (T0), Week 8 (Posttreatment, T2).
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Change in Maternal Physical Activity Levels From Baseline to Posttreatment (8 Weeks).
Time Frame: Baseline (T0), Week 8 (Posttreatment, T2).
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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).
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Baseline (T0), Week 8 (Posttreatment, T2).
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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).
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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).
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Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
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Change in Maternal Prenatal Depression Severity From Baseline to Posttreatment (8 Weeks).
Time Frame: Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
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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).
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Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
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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).
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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).
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Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
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Infant Developmental Milestones at 2 Months of Age.
Time Frame: When the infant is two months of age (Follow-up, T3).
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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).
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When the infant is two months of age (Follow-up, T3).
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Infant Social/Emotional Problems at 2 Months of Age.
Time Frame: When the infant is two months of age (Follow-up, T3).
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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).
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When the infant is two months of age (Follow-up, T3).
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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).
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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).
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Baseline (T0), when the infant is two months of age (Follow-up, T3).
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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).
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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).
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Baseline (T0), when the infant is two months of age (Follow-up, T3).
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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).
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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).
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Baseline (T0), when the infant is two months of age (Follow-up, T3).
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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).
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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).
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Baseline (T0), when the infant is two months of age (Follow-up, T3).
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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).
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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).
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Baseline (T0), when the infant is two months of age (Follow-up, T3).
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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).
|
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).
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Baseline (T0), when the infant is two months of age (Follow-up, T3).
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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).
|
Participants will be assessed with the Single-item Sleep Quality Scale (SIMP) at baseline and when the infant is two months of age (Follow-up, T3).
(SIMP max-min scores=0-10, higher scores=better outcome).
|
Baseline (T0), when the infant is two months of age (Follow-up, T3).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel Fatori, PhD, Medical School, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1007/s11121-007-0070-9. 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 3, 2020
Primary Completion (Actual)
November 23, 2020
Study Completion (Actual)
April 27, 2021
Study Registration Dates
First Submitted
July 23, 2020
First Submitted That Met QC Criteria
July 29, 2020
First Posted (Actual)
July 31, 2020
Study Record Updates
Last Update Posted (Actual)
January 11, 2022
Last Update Submitted That Met QC Criteria
November 10, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Motherly1
- SB-POC-1810-20573 (Grand Challenge Canada)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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