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Smartphone-Assisted Single-Session Psychotherapy Intervention for Postpartum Depression

Key facts

Who runs it
University of Sao Paulo
Where
Brazil1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
104 people, planned
Started
9 Sept 2026
Expected to end
1 Jul 2027
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Smartphone-Assisted Single-Session Psychotherapy Intervention
Record updated
9 November 2026

Who can take part

Age
18 years to 40 years
Sex
Women only
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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

Who cannot take part

  • Current suicidal ideation with intent or plan, or suicide attempt in the previous week
  • Treatment-resistant depression (nonresponse to at least 2 adequate previous evidence-based treatments)
  • Pharmacological treatment or psychotherapy in the previous 4 weeks
  • 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)
  • Gestational loss (miscarriage) or early neonatal death in the index pregnancy

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 40 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • Single-session psychotherapy + Motherly appTreatment being tested

    Smartphone-Assisted Single-Session Psychotherapy Intervention: one online psychotherapy session of about 90 minutes based primarily on behavioral activation, delivered by a trained psychologist, followed by 4 weeks of self-guided use of the Motherly app.

    Treatment: Smartphone-Assisted Single-Session Psychotherapy Intervention

  • Waitlist controlNo study treatment, for comparison

    Waitlist control: no intervention for 4 weeks after randomization. Participants then receive the same app-supported single-session psychotherapy.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Motherly Plus: Randomized Controlled Trial Evaluating a Smartphone-Assisted Single-Session Psychotherapy Intervention for Postpartum Depression
Fit questions
Built from NCT07925762, who can take part
Record updated
9 November 2026