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

NCT04847076 | Unknown

• 1 other identifier: MIDAP2020FIP1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Feasibility Studies; Prevention; mHealth

Outcome Measures

Primary Outcomes (5)

• Eligibility rate as feasibility indicator

  Proportion of women who meet inclusion criteria compared with the total number of new mothers registered during the recruitment period in each participating primary health center

  At the baseline assessment during the recruitment period.

• Recruitment rate as feasibility indicator

  Proportion of mothers who accept the invitation to participate in the study respect to those meet eligibility criteria

  At the baseline assessment during the recruitment period.

• Percentage of EG participants who receive the 12 psychoeducational modules, who attend the virtual meeting and who -at least- once established contact with the program facilitator

  The feasibility to deliver the components of the intervention will be measured in terms of the percentage of participants of the EG who receive the 12 psychoeducational modules, who attend the virtual meeting and who -at least- once established contact with the program facilitator.

  At 4-weeks from beginning intervention (when intervention finished)

• Percentage of participants who finished intervention by group as acceptability indicator

  Proportion of participants who finished the intervention compared with a number of participant who began intervention in each group

  At 4-weeks from beginning intervention (when intervention finished).

• Percentage of participant retention at follow-up by group as acceptability indicator

  Proportion of participants who remain in the study at the 12 weeks follow up compared with a number of participant who began intervention in each group

  At 12-weeks after the completion of the intervention (follow-up measurement).

Secondary Outcomes (4)

• Changes in maternal postnatal symptoms of depression, according to mean scores obtained with the Edinburgh Postnatal Depression Scale (EPDS)

  At baseline (a week before the intervention starts) and 12-weeks after the completion of the intervention (follow-up measurement).

• Change in maternal postnatal symptoms of anxiety according to mean scores obtained with the Perinatal Anxiety Screening Scale (PASS)

  At baseline (a week before the intervention starts) and 12-weeks after the completion of the intervention (follow-up measurement).

• Changes on perceived social support according to mean scores obtained with the multidimensional perceived social support scale (MSPSS)

  At baseline (a week before the intervention starts) and 12-weeks after the completion of the intervention (follow-up measurement).

• Change in maternal self-efficacy according to mean scores obtained with the Parental Evaluation Scale (PEE)

  At baseline (a week before the intervention starts) and 12-weeks after the completion of the intervention (follow-up measurement).

Other Outcomes (2)

• Reasons for study refusals as a feasibility indicator

  At the baseline assessment during the recruitment period.

• Acceptability and satisfaction of the intervention from EG mothers' perspective

  During a 12 weeks period following the completion of the intervention

Study Arms (2)

m-health version of WWWT intervention

EXPERIMENTAL

Include: a) Psychoeducational information for understanding and managing infant behavior and on parenting. This information will be delivered through instant messaging service for mobile phones (i.e., Whatsapp) 3 times a week for four-week period. Each module will include a very brief video offering information regarding a specific topic, a proposed personal exercise and the invitation to assess the perceived usefulness of the information received. Some modules include links to external, complementary information from the Chilean Infancy Policy. b) Contact with the program facilitator. It will allow mothers to ask questions that arise from the topics addressed in the psychoeducational videos. The answers seek to promote the understanding and elaboration of the contents, and operate by providing expert support; c) A virtual group meeting.

Behavioral: m-health version of WWWT intervention

TREATMENT AS USUAL

OTHER

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. The objective of the routine health care check is to carry out a comprehensive evaluation of the child's development and growth, guide parents and caregivers regarding child development, health and upbringing of the child. Also, promoting exclusive breastfeeding, healthy mother/child bonding (by detecting relevant alterations in this area) and encouraging paternal participation in upbringing and care of the child. Finally, in the health check-ups at 2 and 6 months of age of the child, Edinburgh Postpartum Depression Scale is used for screening depressive symptoms in mothers. At risk cases are referred for mental health assessment and care.

Other: Treatment as usual

Interventions

m-health version of WWWT intervention BEHAVIORAL

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

m-health version of WWWT intervention

Treatment as usual OTHER

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

TREATMENT AS USUAL

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Women is selected, since only they have the biological capacity to have children
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• First time mothers
• Adult (18 -64 years old)
• Having a healthy infant who is 6-8 weeks age
• Receive medical care in a primary health centers
• Having access to a mobile phone with instant messaging services (i.e., Whatsapp)
• Fluent in Spanish

You may not qualify if:

• Severe mental health problem (i.e. schizophrenia, mood disorder with suicidal ideation)
• Cognitive disability
• Actual substance abuse
• High risk for presenting symptoms of depression (EPDS above cut-off score)
• Severe psychosocial problem (i.e. domestic violence, sexual abuse).

Sponsors & Collaborators

• Universidad del Desarrollo: lead
• Instituto Milenio para Investigación en Depresión y Personalidad: collaborator
• Peñalolén County Corporation, Chile: collaborator

Study Sites (2)

Primary Health Center San Luis

Santiago, RMN, 7931091, Chile

RECRUITING

Primary Health Center Cardenal Silva Henríquez

Santiago, RM, 7910652, Chile

RECRUITING

Related Publications (1)

• Perez JC, Aldoney D, Garcia MI, Olhaberry M, Fernandez O, Alamo N, Franco P, Perez F, Fisher J, Rowe H, Coo S. Online intervention to prevent postnatal depression and anxiety in Chilean new mothers: Protocol for a feasibility trial. Health Informatics J. 2022 Oct-Dec;28(4):14604582221135440. doi: 10.1177/14604582221135440.

  PMID: 36300324 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Soledad Coo

  Universidad del Desarrollo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soledad Coo

CONTACT

56968417262; scoo@udd.cl

Carola Perez

CONTACT

56997051989; janetperez@udd.cl

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: Faculty of Psychology

Model Details: Participants will be randomized to intervention or control groups at a 1:1 ratio.

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 15, 2021
• Study Start: May 3, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: These data will be available to researchers who provide a methodologically sound proposal for the purposes of achieving specific aims outlined in that proposal. Proposals should be directed to Soledad Cood and J. Carola Pérez via email (scoo@udd.cl; janetperez@udd.cl) and will be reviewed by both researchers. Requests to access data to undertake hypothesis-driven research will not be unreasonably withheld. To gain access, data requesters will need to sign a data access agreement and to confirm that data will only be used for the agreed purpose for which access was granted and this these data will be not shared to other people.

Locations

CL (2)