Randomized Controlled Trial Testing the Effects of Motherly: a Standalone Smartphone Application Treatment for Women With Postpartum Depression
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Sao Paulo
- Enrollment
- 264
- Primary Endpoint
- Depression symptoms
Study Overview
Brief Summary
Investigators will be test the efficacy of Motherly, a smartphone application (app) to treat depression in women with postpartum Depression. The Motherly app offers psychoeducation, mood and anxiety monitoring, several well-established psychological techniques (behavioral activation, cognitive restructuring, emotion regulation, stress management techniques, mindfulness and meditation, sleep hygiene), and helps mothers organize their medical appointments and keep track of their childrens' development. The efficacy of the Motherly app will be tested in a parallel two-arm randomized controlled trial. Participants will be randomly allocated to receive the Motherly app (intervention), or COMVC (active control), a smartphone app that delivers only psychoeducational content related to general mental health.
Detailed Description
The postpartum period is strongly associated with increased risk for depression, with estimates of approximately 19% of women affected by the disorder. Psychosocial interventions such as home visiting programs and well-established psychological therapies are efficient to treat this condition but require a significant number of qualified trained professionals. However, financial and human resources to meet these demands are scarce in developing countries such as Brazil. Therefore, interventions delivered via electronic devices such as smartphones might fill this gap. Our objective is to test the efficacy of Motherly, a smartphone application (app) to treat depression in women with postpartum Depression. The Motherly app offers psychoeducation, mood and anxiety monitoring, several well-established psychological techniques (behavioral activation, cognitive restructuring, emotion regulation, stress management techniques, mindfulness and meditation, sleep hygiene), and helps mothers organize their medical appointments and keep track of their childrens' development. The efficacy of the Motherly app will be tested in a parallel two-arm randomized controlled trial. Two-hundred and sixty-four (N=264) 18-40-years-old women with postpartum depression will be to one of two groups: (1) intervention, which will have access to the Motherly app; or (2) active control, which will be given access to COMVC, a smartphone app that delivers only psychoeducational content on general mental health (COMVC means "With You" in Brazilian Portuguese). Duration of treatment will be four weeks, during which participants in both groups will be assessed at the beginning (baseline; T0), end (post treatment, T1), and 1 month after treatment completion (follow-up, T2).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Participants will be aware of the intervention received, as well as investigators and professionals responsible for monitoring app usage during the study. The Outcome assessor will be blind to randomization status.
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women who had given birth to a live baby in the past 12 months;
- •Age between 18-40 years;
- •Edinburgh Postnatal Depression Scale (EPDS) total score ≥ 10;
- •Depression symptoms present in the past 2 weeks;
- •Being literate;
- •Owing an Android or iPhone smartphone for personal use.
Exclusion Criteria
- •Intellectual, visual, or auditory deficiency;
- •Chronic diseases that prevent using smartphones or understanding how to use the apps;
- •Severe and/or chronic mental health diagnosis (schizophrenia or bipolar disorder).
Arms & Interventions
Motherly App
Participants in this arm will have access to Motherly, a smartphone app that is designed to promote life habits that have been shown to improve depression and mental health in mothers.
Intervention: Motherly app (Behavioral)
COMVC App
Participants in this arm will have access to COMVC, a smartphone app designed to deliver only psychoeducational content and mental health monitoring.
Intervention: COMVC app (Behavioral)
Outcomes
Primary Outcomes
Depression symptoms
Time Frame: Posttreatment (T1) 1 month after baseline
Change in mean total scores between intervention and control groups in the Edinburgh Postnatal Depression Scale (EPDS) at Posttreatment (T1)
Secondary Outcomes
- Parental Distress(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
- Attachment(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
- Anxiety symptoms(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
- Sleep quality(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
- Parenting stress(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
- Parenting Competence(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
- Depression symptoms(Follow-up (T2) 2 months after baseline)
- Quality of Life: Physical Health(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
- Quality of Life: Mental Health(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
- Parent-child Dysfunctional Interaction(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
- Difficult Child(Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline)
Investigators
Guilherme Vanoni Polanczyk, MD PhD
Associate Professor
University of Sao Paulo
