Smartphone-supported single-session psychotherapy for postpartum depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial in Brazil compares a smartphone-assisted single-session psychotherapy focused on behavioral activation to a waitlist control. Participants receive one 90-minute online session and four weeks of guided app use via the Motherly app to apply strategies and access psychoeducation, with assessments at weeks 1, 2, 4 and 8. The study seeks to identify moderators of benefit and changes in behavioral activation as possible mediators of improvement. Eligible participants are 18–40 years old, up to 12 months postpartum, with DSM-5-TR major depressive disorder and a QIDS-SR16 score ≥13, and must own an Android smartphone. All outcomes are assessed remotely with masked evaluation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 18 to 40 years
* Up to 12 months postpartum
* Score of 13 or higher on the Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR16)
* Meets DSM-5-TR criteria for major depressive disorder, confirmed with the Mini-International Neuropsychiatric Interview (MINI)
* Able to read and write in Brazilian Portuguese
* Owns a personal Android smartphone with internet access

Exclusion Criteria:

* Intellectual, visual or hearing impairments, or chronic diseases that preclude smartphone use or comprehension of the intervention
* Current or lifetime diagnosis of severe and/or chronic mental disorders (e.g., schizophrenia, bipolar disorder)
* Current suicidal ideation with intent or plan, or suicide attempt in the previous week
* Gestational loss (miscarriage) or early neonatal death in the index pregnancy
* Treatment-resistant depression (nonresponse to at least 2 adequate previous evidence-based treatments)
* Pharmacological treatment or psychotherapy in the previous 4 weeks

Where it's running

• Instituto de Psiquiatria, Hospital das Clinicas, Faculdade de Medicina da Universidade de Sao Paulo
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Daniel Fatori, PhD — University of Sao Paulo
• Study coordinator: Daniel Fatori, PhD
• Email: daniel.fatori@usp.br
• Phone: +55 11 2661-792

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.