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

NCT04495166 | Completed Results DMC

• 2 other identifiers: Motherly1SB-POC-1810-20573
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators developed Motherly 1.0, a smartphone app designed to treat and promote maternal mental health. A 2-arm parallel-randomized controlled clinical trial (RCT) will be conducted to test the efficacy of Motherly in conjunction with brief cognitive-behavioral therapy. 70 pregnant women between 16-40 years old will be recruited. Since all interventions will be conducted online, participants will be recruited from any Brazilian state or municipality. Participants will be randomly assigned to either receive intervention via app consisting of behavioral activation and psychoeducation to promote changes in sleep, nutrition, and physical activity habits, as well as to engage in prenatal care, breastfeeding, and social support, and to stimulate child development, in addition to brief cognitive-behavioral therapy (CBT) (n=35); or to a comparison group receiving an psychoeducational app (active control) with psychoeducational content about gestation, maternal health and mental health, and child development in addition to brief CBT (n=35). Duration of treatment will be eight weeks, during which participants in both groups will be assessed at the beginning (baseline; T0), weeks 3-4 (midpoint; T1), and week 8 (endpoint; T2) in order to evaluate treatment effects. A follow-up postnatal assessment will also be conducted when the child is three months of age (T3).

Conditions

Perinatal Depression

Outcome Measures

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).

  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)

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

• Change in Maternal Prenatal Quality of Life From Baseline to Posttreatment (8 Weeks)

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

• Change in Maternal Prenatal Psychological Well-Being From Baseline to Posttreatment (8 Weeks).

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

• Change in Maternal Physical Activity Levels From Baseline to Posttreatment (8 Weeks).

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

• Change in Maternal Prenatal Perceived Stress From Baseline to Posttreatment (8 Weeks).

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

Study Arms (2)

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.

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.

Behavioral: Brief Psychotherapy; Behavioral: Educational app

Interventions

Motherly 1.0 BEHAVIORAL

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).

Motherly app with brief psychotherapy

Brief Psychotherapy BEHAVIORAL

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 app (Active control); Motherly app with brief psychotherapy

Educational app BEHAVIORAL

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.

Educational app (Active control)

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Daniel Fatori

São Paulo, Brazil

Location

Related Publications (3)

• 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.

  PMID: 21545782 BACKGROUND

• 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.

  PMID: 17549635 BACKGROUND

• 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.

  PMID: 33757591 DERIVED

MeSH Terms

Interventions

Psychotherapy, Brief

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

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.

Results Point of Contact

• Title: Daniel Fatori
• Organization: Medical School of the University of Sao Paulo

daniel.fatori@gmail.com

5511 96162-6183

Study Officials

• Daniel Fatori, PhD

  Medical School, University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 31, 2020
• Study Start: August 3, 2020
• Primary Completion: November 23, 2020
• Study Completion: April 27, 2021
• Last Updated: January 11, 2022
• Results First Posted: January 11, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)