Smartphone-Assisted Single-Session Psychotherapy Intervention for Postpartum Depression (Motherly Plus)

Motherly Plus: Randomized Controlled Trial Evaluating a Smartphone-Assisted Single-Session Psychotherapy Intervention for Postpartum Depression

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Postpartum Depression; Postpartum
• Intervention / Treatment: Behavioral: Smartphone-Assisted Single-Session Psychotherapy Intervention

Detailed Description

Background. Postpartum depression (PPD) affects about 17% of women worldwide and carries risks of chronicity, suicidality and impaired child development. Psychotherapy is effective, but access is limited in low- and middle-income countries by workforce shortages and unequal distribution of services. Tele-mental health, smartphone apps and single-session psychotherapy are scalable alternatives. Evidence for single-session psychotherapy in PPD is limited to two trials of multi-hour group workshops, and no trial has combined an individual single session with digital support.

Design. Parallel-group, two-arm randomized controlled trial with masked outcome assessment, conducted remotely in Brazil. A total of 104 women aged 18-40 years, up to 12 months postpartum, with a DSM-5-TR diagnosis of major depressive disorder will be randomized to (1) smartphone app-supported single-session psychotherapy or (2) waitlist control. Assessments occur at T1 (week 1, baseline), T2 (week 2, mid-treatment), T3 (week 4, post-treatment) and T4 (week 8, follow-up). A pilot study to test procedures was completed before the start of recruitment.

Recruitment and screening. Participants are recruited through social media and the project website. Stage 1 is an online eligibility form. Stage 2 is a telephone or video interview to confirm criteria and a diagnostic assessment with the Mini-International Neuropsychiatric Interview (MINI). Eligible women sign an electronic informed consent form before randomization.

Intervention. One online single-session psychotherapy of about 90 minutes, based primarily on behavioral activation (BA). Components: pre-session questionnaire; rapport and assessment of daily routine, reinforcers and support networks; psychoeducation on the behavioral model of depression; collaborative scheduling of achievable, value-aligned activities and problem-solving of barriers and avoidance; training in the Motherly app; session closing and commitment. Optional components (stress management, emotion regulation, cognitive restructuring, sleep hygiene) are used according to clinical judgment. Participants then use the Motherly app independently for 4 weeks. The app includes modules on behavioral activation, emotion regulation, stress management, cognitive restructuring, sleep hygiene and relaxation, and mindfulness, plus activity scheduling, symptom tracking and an educational library. Therapists are psychologists who receive 10 hours of training and are supervised by senior researchers.

Control. Waitlist with no intervention for 4 weeks after randomization, after which participants receive the same intervention. Women with current suicidal ideation with intent or plan, a recent suicide attempt, or treatment-resistant depression are excluded because a waitlist is not appropriate for them.

Randomization and masking. The randomization list is generated by an independent statistician in R and allocation is automated through the REDCap randomization module, ensuring concealment. Outcome assessors are masked and have no role in recruitment, allocation notification, intervention delivery or fidelity assessment. Measures that could reveal allocation are collected online after the clinician-rated assessment. Access to allocation data in REDCap is restricted by role. At post-treatment, assessors guess each participant's allocation and rate their confidence, and masking success is reported with 95% confidence intervals. The main analysis is run with a pre-specified R script on a dataset with masked group labels.

Sample size. A meta-analysis of eight RCTs of single-session interventions for adult depression (Metapsy database, version 24.0.2) gave g = 0.60. With two-sided alpha of 5%, 80% power and 15% attrition, 104 participants are required (G*Power 3.1.9.4).

Statistical analysis. Primary and secondary outcomes will be analyzed with generalized estimating equations (GEE) with an AR(1) working correlation structure and robust sandwich variance estimator, in the intention-to-treat sample. Each model includes the outcome as dependent variable and group, time (categorical) and the group-by-time interaction as predictors. Marginal means will be compared with pairwise comparisons. Missing data will be handled with multiple imputation by chained equations under a missing-at-random assumption. Standardized effect sizes (Cohen's d) will be computed from marginal means and observed standard deviations. Sensitivity analyses will compare results with completers only, and baseline predictors of dropout will be examined. Significance level is p < 0.05 with 95% confidence intervals.

Moderators (exploratory). Interaction models will test maternal age, skin color/ethnicity, education, family income, number of previous children, relationship with the father, perceived social support (MSPSS), baby's age, time spent with the child, number of pediatric and prenatal consultations, baseline depression (QIDS-SR16, QIDS-C16), baseline severity (CGI-S) and functioning (SDS). The trial is not powered for these analyses.

Mediators (exploratory). Behavioral activation and avoidance (modified BADS-SF, two-week recall) and environmental reward (Reward Probability Index) are assessed at T1 and T2. Parallel mediation models will test whether they mediate the effect on depressive symptoms at T3, adjusting for baseline levels of symptoms and mediators. Depressive symptoms at T2 will also be considered to account for early change.

Treatment-specific processes (intervention arm). Therapeutic alliance (WAI-SR, client and therapist versions, at T2) and seven app engagement indicators will be related to clinical outcomes with regression models.

Fidelity. An independent rater will assess adherence from audio recordings of the sessions, using a checklist adapted from a previous behavioral activation study.

Safety. Adverse events are recorded at post-treatment and follow-up. Clinical worsening is defined as an increase of 30% or more in the QIDS-16 total score (clinician-rated or self-report) relative to baseline. Serious adverse events include death, life-threatening events, hospitalization, significant disability and suicide risk (score of 2 or more on QIDS-16 item 12). REDCap sends automatic alerts to the investigators. Participants with emerging suicidal ideation receive a written safety plan and are referred for psychiatric evaluation; domestic violence is addressed with referrals to specialized services. Participants without remission at the end of the study are referred to specialized care.

Ethics. Approved by CAPPesq, HC-FMUSP (CAAE 97532226.8.0000.0068; approval 8.574.338). Conducted in accordance with the Declaration of Helsinki.

Registration note. The protocol was submitted to the Brazilian Clinical Trials Registry (ReBEC; UTN U1111-1345-9666) on [PREENCHER data], before the start of recruitment, but was not published by that registry. This ClinicalTrials.gov record was created after the first participants were enrolled. No changes to outcomes or analyses were made.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Fatori, PhD; Phone Number: +55 11 2661-792; Email: daniel.fatori@usp.br
• Study Contact Backup: Name: Pedro Zuccolo, PhD; Phone Number: +55 11 995047489; Email: pedrozuccolo@usp.br

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05403-903
      • Recruiting
      • Instituto de Psiquiatria, Hospital das Clinicas, Faculdade de Medicina da Universidade de Sao Paulo
      • Contact: Julia Nicolella, Psychologist; Phone Number: +55 11 2661-7922; Email: junicolella@hotmail.com
      • Sub-Investigator: Pedro Zuccolo, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-session psychotherapy + Motherly app; 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.	Behavioral: Smartphone-Assisted Single-Session Psychotherapy Intervention; A single online psychotherapy session (about 90 minutes) based primarily on behavioral activation: psychoeducation on the behavioral model of depression, identification of reinforcers and avoidance, collaborative scheduling of achievable value-aligned activities, problem-solving of barriers, and training in the Motherly app. Optional components (stress management, emotion regulation, cognitive restructuring, sleep hygiene) are used according to clinical judgment. A pre-session questionnaire tailors the session. Participants then use the Motherly app for 4 weeks to schedule and track activities, monitor symptoms and access modules on behavioral activation, emotion regulation, stress management, cognitive restructuring, sleep hygiene and mindfulness. The intervention is delivered by psychologists with 10 hours of training and senior supervision.
No Intervention: Waitlist control; Waitlist control: no intervention for 4 weeks after randomization. Participants then receive the same app-supported single-session psychotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms (clinician-rated)	Total score on the Quick Inventory of Depressive Symptomatology, Clinician-Rated (QIDS-C16), administered by masked assessors. Range 0-27; higher scores indicate more severe depression.	Week 4 (post-treatment, T3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptoms (self-report)	Total score on the Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR16). Range 0-27; higher scores indicate more severe depression.	Week 4 (T3) and week 8 (T4)
Anxiety Symptoms	Total score on the Generalized Anxiety Disorder 7-item scale (GAD-7). Range 0-21; higher scores indicate more severe anxiety.	Week 4 (T3) and week 8 (T4)
Sleep problems	Global score on the Pittsburgh Sleep Quality Index (PSQI). Range 0-21; higher scores indicate worse sleep quality.	Week 4 (T3) and week 8 (T4)
Parental distress	Parental Distress subscale of the Parenting Stress Index Short Form (PSI-SF). Range 12-60; higher scores indicate more stress.	Week 4 (T3) and week 8 (T4)
Parent-child dysfunctional interaction	Parent-Child Dysfunctional Interaction subscale of the PSI-SF. Range 12-60; higher scores indicate more stress.	Week 4 (T3) and week 8 (T4)
Parenting stress	Total score of the PSI-SF. Range 36-180; higher scores indicate more stress.	Week 4 (T3) and week 8 (T4)
Functional impairment	Total score on the Sheehan Disability Scale (SDS), covering work/school, social life and family life. Range 0-30; higher scores indicate more impairment.	Week 4 (T3) and week 8 (T4)
Change in depression severity and functional impairment relative to baseline	Clinical Global Impression - Improvement (CGI-I), rated by masked assessors relative to baseline (T1). Range 1 (very much improved) to 7 (very much worse).	Week 4 (T3)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postnatal depressive symptoms (EPDS)	Total score on the Edinburgh Postnatal Depression Scale. Range 0-30; higher scores indicate more symptoms. Used for comparison with the PPD literature.	Week 4 (T3), week 8 (T4)

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Daniel Fatori, PhD, University of Sao Paulo

Publications and helpful links

Helpful Links

• <p>Study website</p>

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 3, 2026
• First Submitted That Met QC Criteria: November 3, 2026
• First Posted (Actual): November 9, 2026

Study Record Updates

• Last Update Posted (Actual): November 9, 2026
• Last Update Submitted That Met QC Criteria: November 3, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Mobile health; telehealth; Perinatal depression; Smartphone application; Maternal depression; Behavioral activation; Digital mental health; Single-session therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Behavioral Symptoms; Mood Disorders; Puerperal Disorders; Depressive Disorder; Behavior; Depression; Depression, Postpartum
• Other Study ID Numbers: 97532226.8.0000.0068; 21/12901-9 (Other Grant/Funding Number: FAPESP); 408132/2025-6 (Other Grant/Funding Number: CNPq); U1111-1345-9666 (Other Identifier: WHO Universal Trial Number (UTN)); 97532226.8.0000.0068 (Other Identifier: CAAE, Plataforma Brasil (Brazilian ethics submission number))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified individual participant data underlying the published results will be shared upon reasonable request to the principal investigator.

IPD Sharing Time Frame

After publication of the main findings.

IPD Sharing Access Criteria

Reasonable request to the principal investigator (daniel.fatori@usp.br), subject to approval by the investigators.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No