- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07587177
mHealth Intervention to Prevent Postpartum Depression and Anxiety in Chilean Women (WWWT)
WHAT WERE WE THINKING" (WWWT) PROGRAM: A DIGITAL INTERVENTION TO PREVENT POSTPARTUM DEPRESSION AND ANXIETY IN CHILEAN WOMEN
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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Postpartum depression and anxiety are common mental health conditions that affect women during the transition to motherhood and have significant consequences for maternal well-being, parenting, and infant development. In Chile, a substantial proportion of women report elevated depressive and anxiety symptoms during the postpartum period. Despite the implementation of universal screening strategies in primary health care, access to mental health treatment remains limited, as many women identified as at risk do not engage in or receive appropriate care. This gap highlights the need for preventive interventions that can be delivered early and at scale.
Preventive psychosocial interventions targeting modifiable risk factors, such as maternal self-efficacy and perceived social support, have shown effectiveness in reducing the risk of developing postpartum mental health difficulties. However, engagement in face-to-face interventions is often low. In this context, digital health (e-mental health) and mobile health (mHealth) interventions offer a promising alternative, particularly in settings with high mobile phone access and limited mental health resources. Guided digital interventions that include human support have demonstrated higher adherence and effectiveness compared to unguided formats.
"What Were We Thinking" (WWWT) is a psychoeducational, preventive intervention originally developed in Australia to reduce the risk of postpartum depression and anxiety among first-time mothers. The intervention targets key modifiable risk factors, including maternal self-efficacy in infant care and the quality of partner support. The program has been culturally adapted for use in Chile and further adapted to an mHealth format to facilitate delivery through mobile phones.
The Chilean mHealth version of WWWT includes three main components: (1) fourteen brief psychoeducational video modules (3-5 minutes each) delivered via text messaging over a period of 4 to 5 weeks, each accompanied by reflective prompts; (2) asynchronous communication with a trained facilitator through text messaging to provide guidance, answer questions, and support engagement; and (3) one virtual group session with other participating mothers led by the facilitator. The intervention is delivered between 4 and 10 weeks postpartum. Facilitators are trained health professionals (e.g., psychologists, midwives, nurses) with knowledge in perinatal mental health, and they are also responsible for referring participants to primary care services when needed.
A previous feasibility study conducted in Chile demonstrated high acceptability and feasibility of the mHealth WWWT intervention, as well as positive perceptions among participants regarding its usefulness for maternal well-being and partner involvement. Preliminary findings suggested that the intervention may be particularly beneficial for women presenting with mild symptoms at baseline, consistent with its preventive focus. However, no significant differences were found between intervention and control groups in overall symptom levels, possibly due to elevated baseline distress during the COVID-19 pandemic. Therefore, further research is needed to evaluate the effectiveness of the intervention under non-crisis conditions and in a larger sample.
The present study is a randomized controlled trial with two parallel arms (intervention and control) designed to evaluate the effectiveness of the WWWT intervention in preventing postpartum depression and anxiety symptoms. Participants are first-time mothers with infants younger than two months receiving care in primary health centers in Chile. After baseline assessment, participants are randomly assigned (1:1) to either the intervention group, which receives the full WWWT program, or the control group, which receives usual care. Follow-up assessments are conducted 3 months after completion of the intervention.
Primary outcomes include depressive and anxiety symptoms. Secondary outcomes include maternal self-efficacy, perceived social support, and coparenting relationship quality. Outcomes are assessed using validated self-report measures administered online at baseline and follow-up.
This study will provide rigorous evidence on the effectiveness of a scalable, culturally adapted digital preventive intervention for postpartum mental health in a Latin American context. Findings may inform the integration of mHealth interventions into primary health care services and contribute to improving maternal mental health and early child development outcomes.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Soledad Coo, PhD
- Telefonní číslo: +56 9 9075 3976
- E-mail: scoo@udd.cl
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: WWWT Intervention
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.
|
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.
|
|
Žádný zásah: Usual Care
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Postpartum depressive symptoms
Časové okno: Baseline and 3 months after completion of the intervention
|
Depressive symptoms assessed using the Edinburgh Postnatal Depression Scale (EPDS)
|
Baseline and 3 months after completion of the intervention
|
|
Postpartum anxiety symptoms
Časové okno: Baseline and 3 months after completion of the intervention
|
Anxiety symptoms assessed using the Depression, Anxiety and Stress Scales (DASS-21)
|
Baseline and 3 months after completion of the intervention
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Maternal self-efficacy
Časové okno: Baseline and 3 months after completion of the intervention
|
Maternal self-efficacy assessed using the Escala de Evaluación Parental (EEP)
|
Baseline and 3 months after completion of the intervention
|
|
Perceived social support
Časové okno: Baseline and 3 months after completion of the intervention
|
Perceived social support assessed using the Multidimensional Scale of Perceived Social Support (MSPSS)
|
Baseline and 3 months after completion of the intervention
|
|
Satisfaction with coparenting
Časové okno: Baseline and 3 months after completion of the intervention
|
Satisfaction with coparenting assessed using the Escala de Evaluación Parental (EEP)
|
Baseline and 3 months after completion of the intervention
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- COO-2026
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .