Feasibility of M-health Version of "What Were We Thinking" Intervention to Promote Maternal Postpartum Mental Health

NCT04847076 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-05-12

No results posted yet for this study

Summary

The purpose of this study is to assess the feasibility, acceptability and preliminary effectiveness of "What Were We Thinking" (WWWT) a psychoeducational intervention -delivered remotely via communication technologies- to prevent symptoms of postpartum depression and anxiety in new mothers; which has been shown to be effective in primary health settings. WWWT was developed in Australia and has been culturally adapted to be used in Chile. The m-health version of the Chilean adaptation of WWWT for the current study includes: Psychoeducational modules on issues relevant to mothers during the post-partum period; contact with the program facilitator through instant messaging services available on mobile phones and a virtual group meeting.

This pilot study will use a mixed design. The quantitative component will consist of a before-after design with control group including 90 adult mothers of child aged 6-8 weeks who receive health care in a primary health centers in Santiago, Chile. Mothers will be randomized into the experimental (EG) or control groups (CG) in a rate of 1:1. Both EG and CG will receive usual treatment provided by primary health centers (TAU), and only de EG will receive the m-health adapted version of the WWWT.

The qualitative component considers 12 users semi-structured interviews. The maximum variation sampling strategy will be used according to the completion of m-health version of WWWT. An open coding of Grounded Theory will be used to data analysis.

The feasibility of m-health version of WWWT intervention will be evaluated in terms of eligibility rates, recruitment rates and reasons for study refusals, feasibility to deliver the three components of the intervention, data attrition and follow-up rates by treatment condition. Their acceptability considers participant completion of the intervention rates, and a qualitative assessment of the users' acceptability of and satisfaction. Secondary outcomes will include changes on maternal levels of depressive and anxiety symptoms, maternal self-efficacy and perceived social support. And differences in mother-infant quality of interaction between intervention and control groups.

Conditions

  • Depression, Postpartum
  • Anxiety Disorders and Symptoms
  • Maternal Behavior

Interventions

BEHAVIORAL

m-health version of WWWT intervention

m-health version of Chilean adaptation of WWWT intervention: a) Psychoeducational information for understanding and managing infant behavior and on parenting. b) Contact with the program facilitator. c) A virtual group meeting

OTHER

Treatment as usual

TAU for children under one year of age include routine health checks by health professionals (nurse or doctor), every month from 0 to 4 months of age, and at 6, 8 and 12 months of age

Sponsors & Collaborators

  • Instituto Milenio para Investigación en Depresión y Personalidad

    collaborator OTHER
  • Peñalolén County Corporation, Chile

    collaborator UNKNOWN
  • Universidad del Desarrollo

    lead OTHER

Principal Investigators

  • Soledad Coo · Universidad del Desarrollo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-03
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04847076 on ClinicalTrials.gov