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Life sciences · Interventional Study
ClinicalTrials.gov · November 9, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07925762). This is a study registration, not published results. Lead sponsor: University of Sao Paulo. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 104 participants (ESTIMATED). Conditions: Postpartum Depression, Depression, Postpartum. Interventions: BEHAVIORAL: Smartphone-Assisted Single-Session Psychotherapy Intervention. Primary outcome measures: Depressive symptoms (clinician-rated) , Week 4 (post-treatment, T3). Brief summary: Our goal is to learn whether a single session of online psychotherapy, followed by four weeks of support from a smartphone app (Motherly), reduces depressive symptoms in women with postpartum depression. Specifically, we want to see if mothers receiving this care show greater improvement-as evaluated by a healthcare professional-than those waiting to start treatment. We will compare the intervention with a waitlist control. Women in the waitlist group receive the same intervention after 4 weeks. Participants will: * Attend one online psychotherapy session of about 90 minutes, based mainly on behavioral activation; * Use the Motherly app on their own for 4 weeks to implement behavioral strategies learned during the therapy session and access psychoeducational content; * Complete remote clinical interviews and questionnaires at weeks 1, 2, 4 and 8 The study also explores which participant characteristics predict benefit (moderators), whether changes in behavioral activation and access to rewarding activities explain the effect (mediators), and how therapeutic alliance and app engagement relate to outcomes.