Evidence map›Paper›PMID 40590604›Full record

ArticleJMIR research protocols2025

A Chatbot-Based Version of a World Health Organization-Validated Intervention (Self-Help Plus) for Stress Management in Pregnant Women: Protocol for a Usability Study.

Silvia Rizzi, Valentina Fietta, Lorenzo Gios, Stefania Poggianella, Maria Chiara Pavesi, Chiara De Luca, Debora Marroni, Claudia Paoli, Anna Gianatti, Barbara Burlon and 11 more

Abstract read
In one paragraph

Article in JMIR research protocols, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Silvia Rizzi *Digital Health Research, Centre for Digital Health & Wellbeing, Fondazione Bruno Kessler, Trento, Italy.ORCID 0000-0002-8610-2432
Valentina Fietta *Digital Health Research, Centre for Digital Health & Wellbeing, Fondazione Bruno Kessler, Trento, Italy.ORCID 0000-0001-8524-8432
Lorenzo Gios *Digital Health Research, Centre for Digital Health & Wellbeing, Fondazione Bruno Kessler, Trento, Italy.ORCID 0000-0003-2981-0851
Stefania Poggianella *Digital Health Research, Centre for Digital Health & Wellbeing, Fondazione Bruno Kessler, Trento, Italy.ORCID 0000-0001-6271-6037
Maria Chiara Pavesi *Istituto Pavoniano Artigianelli, Trento, Italy.ORCID 0009-0002-1240-8508
Chiara De Luca *Istituto Pavoniano Artigianelli, Trento, Italy.ORCID 0009-0007-5689-7987
Debora Marroni *Operating Unit of Psychology, Healthcare Trust of the Autonomous Province of Trento, Trento, Italy.ORCID 0009-0001-3756-4518
Claudia Paoli *Transmural Obstetric Gynecological Department, Healthcare Trust of the Autonomous Province of Trento, Trento, Italy.ORCID 0009-0003-9668-5234
Anna Gianatti *Transmural Obstetric Gynecological Department, Healthcare Trust of the Autonomous Province of Trento, Trento, Italy.ORCID 0009-0006-2747-5745
Barbara Burlon *Transmural Obstetric Gynecological Department, Healthcare Trust of the Autonomous Province of Trento, Trento, Italy.ORCID 0009-0005-4402-8675
Vanda Chiodega *Transmural Obstetric Gynecological Department, Healthcare Trust of the Autonomous Province of Trento, Trento, Italy.ORCID 0009-0005-7620-9200
Barbara Endrizzi *Transmural Obstetric Gynecological Department, Healthcare Trust of the Autonomous Province of Trento, Trento, Italy.ORCID 0009-0002-5922-2647
Angela Giordano *Transmural Obstetric Gynecological Department, Healthcare Trust of the Autonomous Province of Trento, Trento, Italy.ORCID 0009-0002-5582-0287
Francesca Biagioli *Transmural Obstetric Gynecological Department, Healthcare Trust of the Autonomous Province of Trento, Trento, Italy.ORCID 0009-0009-5139-3784
Veronica Albertini *Transmural Obstetric Gynecological Department, Healthcare Trust of the Autonomous Province of Trento, Trento, Italy.ORCID 0009-0009-8720-691X
Marianna Purgato *World Health Organization Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neurosciences, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.ORCID 0000-0002-3783-8195
Corrado Barbui *World Health Organization Collaborating Centre for Research and Training in Mental Health and Service Evaluation, Department of Neurosciences, Biomedicine and Movement Sciences, Section of Psychiatry, University of Verona, Verona, Italy.ORCID 0000-0003-1073-9282
Chiara Guella *Operating Unit of Psychology, Healthcare Trust of the Autonomous Province of Trento, Trento, Italy.ORCID 0009-0008-8788-1504
Erik Gadotti *Istituto Pavoniano Artigianelli, Trento, Italy.ORCID 0009-0003-1506-4728
Stefano Forti *Digital Health Research, Centre for Digital Health & Wellbeing, Fondazione Bruno Kessler, Trento, Italy.ORCID 0000-0003-3471-2033
Fabrizio TaddeiTransmural Obstetric Gynecological Department, Healthcare Trust of the Autonomous Province of Trento, Trento, Italy.ORCID 0009-0002-0279-6594

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPregnancy is a complex period involving significant physical, mental, and social changes in a woman's life, affecting her psychological well-being. According to the literature, anxiety, stress, and depression are common symptoms among pregnant women. Promoting a healthy lifestyle with a focus on mental health is essential. In this context, digital solutions such as coaches on smartphones are emerging as valuable tools to support the psychological well-being of pregnant women without existing disorders.

objectiveThis study aims to present the research protocol of a pilot study designed as a proof-of-concept investigation. The study evaluates the feasibility, acceptability, and utility of an acceptance and commitment therapy-based stress management mobile app. The primary objective is to explore the feasibility of using a coach, ALBA (A Well-Being Assistant), developed within the TreC Ricerca app, to promote women's psychological well-being during pregnancy through 5 sessions based on acceptance and commitment therapy. The pre- and postintervention effects on psychological well-being will also be explored as a secondary objective, serving as a proxy for the potential impact of the intervention.

methodsThe study serves as a proof-of-concept investigation, where a small sample size (N=50) is deemed adequate to fulfill the study's objectives. Participant recruitment will be conducted among pregnant women affiliated with the pregnancy care services of the Azienda Provinciale per i Servizi Sanitari di Trento, using a convenience sampling approach. ALBA will interact with the participating women for 6 weeks, between the 14th and 26th weeks of gestation. Specifically, there will be 1 session per week, which the woman can choose, to allow more flexibility regarding her needs, supplemented by ALBA-supported exercises to be performed between sessions. This study adopts a mixed methods approach, combining quantitative and qualitative data collection and analysis. Usability and engagement are assessed using the System Usability Scale, Chatbot Usability Questionnaire, User Engagement Scale-Short Form, and the User Mobile Rating Scale. Moreover, other quantitative outcome measures include levels of stress, anxiety, depression, emotional regulation, psychological flexibility, coping strategies, self-efficacy, and overall well-being, along with qualitative data from semistructured interviews. Finally, the analysis of the data gathered in this study will primarily adopt descriptive statistics and a text mining approach, focused on evaluating the attainment of the study objectives and changes over experimental time.

resultsThe psychoeducational approach aims to yield notable outcomes regarding the usability and engagement of women with ALBA. Furthermore, an anticipated enhancement in psychological well-being and quality of life is expected.

conclusionsExisting literature indicates a preference among women in the perinatal period for online support, highlighting the potential of digital interventions to address barriers related to social stigma and seeking assistance. In this context, ALBA emerges as a valuable resource, providing consistent psychoeducational support for women throughout pregnancy. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53891.

Indexed as

Acceptance and Commitment TherapyMobile ApplicationsPregnant PeopleStress, PsychologicalAdultFeasibility StudiesFemaleGenerative Artificial IntelligenceHumansPilot ProjectsPregnancyProof of Concept Studychatbotdevelopmentdigital solutionseHealthhealthy lifestylemHealthmobile appsmobile healthmultifacetedpregnancypromoting well-beingpsychologicalpsychological healthstress managementtransformationsusabilityuser-centered designwell-beingwoman

Identifiers

PMID40590604
PMCPMC12357124

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.