Clinical trial NCT05055674: The Effects of Motherly on Postpartum Depression
Official title: Randomized Controlled Trial Testing the Effects of Motherly: a Standalone Smartphone Application Treatment for Women With Postpartum Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Depression
Keywords: postpartum depression
smartphone application
digital technology
maternal depression
mental health
mental disorder
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 264
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of two groups: a) intervention, which will have access to the Motherly app; or b) active control, which will be given access to COMVC, a smartphone app that delivers only psychoeducational content.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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).

Primary outcomes:
measure: Depression symptoms
timeFrame: Posttreatment (T1) 1 month after baseline
Secondary outcomes:
measure: Depression symptoms
timeFrame: Follow-up (T2) 2 months after baseline
measure: Anxiety symptoms
timeFrame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
measure: Sleep quality
timeFrame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
measure: Quality of Life: Physical Health
timeFrame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
measure: Quality of Life: Mental Health
timeFrame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
measure: Parenting stress
timeFrame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
measure: Parental Distress
timeFrame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
measure: Parent-child Dysfunctional Interaction
timeFrame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
measure: Difficult Child
timeFrame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
measure: Attachment
timeFrame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
measure: Parenting Competence
timeFrame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Other outcomes:
measure: Activation and avoidance behaviors
timeFrame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
measure: Reinforcement probability and environmental suppression
timeFrame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
measure: Response to treatment
timeFrame: Posttreatment (T1) 1 month after baseline and Follow-up (T2) 2 months after baseline
Locations:
Study officials:
affiliation: Professor
name: Guilherme V Polanczyk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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