NCT07587177

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of a digital psychoeducational intervention, "What Were We Thinking" (WWWT), to prevent the development of postpartum depression and anxiety symptoms in first-time mothers in Chile. The study includes adult women with a healthy, full-term infant younger than two months who are receiving care in primary health centers. The main questions it aims to answer are:

  • Does participation in the WWWT intervention reduce depressive and anxiety symptoms at 3 months after the end of the intervention compared to usual care?
  • Does participation in the intervention improve maternal self-efficacy, perceived social support, and coparenting relationship quality compared to usual care? Researchers will compare an experimental group receiving the full WWWT intervention with a control group receiving usual care to determine the effectiveness of the intervention. Participants will:
  • Complete self-report questionnaires assessing depressive symptoms, anxiety symptoms, maternal self-efficacy, perceived social support, and coparenting at baseline and at 3-month follow-up
  • Be randomly assigned to either the intervention group or the control group
  • Receive the WWWT intervention between 4 and 10 weeks postpartum (intervention group), including:
  • Fourteen psychoeducational video modules (3-5 minutes each) delivered via text messaging over 4-5 weeks
  • Individual contact with a trained facilitator through text messaging
  • One virtual group session with other mothers and a facilitator
  • Continue receiving usual care in primary health services (control group) and receive a shortened version of the intervention after the follow-up assessment

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
May 2026Aug 2026

Study Start

First participant enrolled

May 1, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

May 14, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

May 8, 2026

Last Update Submit

May 8, 2026

Conditions

Keywords

Postpartum depression preventionPostpartum anxiety preventionPerinatal mental healthFirst-time mothersmHealth interventionRandomized controlled trialChileWhat Were We Thinking (WWWT)

Outcome Measures

Primary Outcomes (2)

  • Postpartum depressive symptoms

    Depressive symptoms assessed using the Edinburgh Postnatal Depression Scale (EPDS)

    Baseline and 3 months after completion of the intervention

  • Postpartum anxiety symptoms

    Anxiety symptoms assessed using the Depression, Anxiety and Stress Scales (DASS-21)

    Baseline and 3 months after completion of the intervention

Secondary Outcomes (3)

  • Maternal self-efficacy

    Baseline and 3 months after completion of the intervention

  • Perceived social support

    Baseline and 3 months after completion of the intervention

  • Satisfaction with coparenting

    Baseline and 3 months after completion of the intervention

Study Arms (2)

WWWT Intervention

EXPERIMENTAL

Participants receive the full "What Were We Thinking" (WWWT) mHealth intervention between 4 and 10 weeks postpartum. The intervention includes 14 psychoeducational video modules delivered via text messaging over 4-5 weeks, asynchronous support from a trained facilitator via text messages, and one virtual group session. Participants also continue receiving usual primary health care.

Behavioral: What Were We Thinking (WWWT) mHealth Intervention

Usual Care

NO INTERVENTION

Participants receive usual care provided by primary health services. They do not receive the WWWT intervention during the study period. After completion of the follow-up assessment, participants are offered a shortened version of the intervention.

Interventions

The "What Were We Thinking" (WWWT) is a psychoeducational, preventive mHealth intervention designed for first-time mothers to reduce the risk of postpartum depression and anxiety. The intervention targets modifiable risk factors, including maternal self-efficacy in infant care and perceived social support. It is delivered between 4 and 10 weeks postpartum and includes three components: (1) fourteen psychoeducational video modules (3-5 minutes each) delivered via text messaging over 4-5 weeks, accompanied by reflective prompts; (2) asynchronous support from a trained facilitator via text messaging; and (3) one virtual group session led by the facilitator. Facilitators are trained health professionals and can refer participants to primary care services when needed.

WWWT Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First-time mothers (primiparous women)
  • Aged 18 years or older
  • Having a healthy, full-term infant younger than 2 months of age
  • Receiving prenatal or postnatal care at participating primary health centers in Chile
  • Having access to a mobile phone capable of receiving calls and text messages
  • Able to understand and communicate in Spanish

You may not qualify if:

  • Severe symptoms of depression or anxiety at baseline requiring immediate specialized mental health treatment
  • Severe psychosocial problems (e.g., substance abuse, domestic violence, significant cognitive impairment)
  • Infant born preterm or with severe medical conditions (e.g., genetic disorders or serious neonatal complications)
  • Inability to provide informed consent or participate in study procedures due to language or cognitive barriers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Coo S, Garcia MI, Perez JC, Aldoney D, Olhaberry M, Fernandez O, Alamo N, Franco P, Perez F, Fernandez S, Fisher J, Rowe H. Online Intervention Targeting Postnatal Depression and Anxiety in Chilean First-Time Mothers: Feasibility Trial. J Pediatr Psychol. 2024 Apr 15;49(4):266-278. doi: 10.1093/jpepsy/jsad086.

    PMID: 38070171BACKGROUND
  • Coo S, Garcia MI, Awad N, Rowe H, Fisher J. Cultural adaptation of an intervention to prevent postnatal depression and anxiety in Chilean new mothers. J Reprod Infant Psychol. 2021 Jul;39(3):276-287. doi: 10.1080/02646838.2019.1705264. Epub 2019 Dec 17.

    PMID: 31847567BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Central Study Contacts

Soledad Coo, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

May 8, 2026

First Posted

May 14, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

May 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) will be shared upon reasonable request after publication of the primary study results. Data that may be shared include participant-level outcome data, baseline characteristics, and study-related variables. Identifiable information will be removed to ensure confidentiality. Requests for data access will require approval by the principal investigator and may be subject to a data sharing agreement. Data will be made available for academic research purposes only.