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A Novel Web-based Positive Psychology Intervention Addressed to Pregnant Women

NCT ID: NCT03158649

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-12-31

Brief Summary

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The identification and treatment of the disorders connected to the perinatal period has traditionally catalyzed the researchers' attention. Nevertheless, since the World Health Organization has recently coined the concept of positive pregnancy experience, which includes not only treatment of diseases, but also health education, and health promotion, research on antenatal care has expanded to a salutogenic perspective. In the wake of this perspective, a growing number of research have been examining the potential benefits of positive aspects and protective factors on maternal prenatal well-bein. This salutogenic perspective is supported by the emerging field of Positive Psychology. Evidence from Positive Psychology studies has shown that it is possible to build and enhance personal strengths, sense of meaning and positive feelings by practicing some brief positive exercises, called Positive Psychology Interventions (PPIs). Recently, researchers have started to investigate the effects of a PPI on women's prenatal well-being, reporting promising findings in terms of potential direct effects of the positive intervention on women's prenatal stress in comparison to a treatment-as-usual control condition. In the past decade, many web-based delivered interventions have been designed and documented to be effective for the promotion of mental health and for the prevention and treatment of different disorders. Indeed, recent systematic reviews provides preliminary evidence that web-based interventions can be a promising and advisable form of intervention during the perinatal period. PPIs have been translated also in the online format. Preliminary evidence suggests that online positive psychology interventions can effectively enhance well-being and reduce depressive symptoms.

The research team have developed the protocol for a web-based positive psychology programme addressed to promote and enhance women's prenatal well-being. This intervention programme will last five weeks and will be completely self-administered. It is intend to study the effect of the intervention on levels of mental well-being, depression, pregnancy related anxiety and other relevant variables, and the results will be compared to a waiting list control group.

Detailed Description

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Objective: The aim of this study is to examine the effectiveness of a positive psychology online-based intervention on indices of prenatal wellbeing. Hypotheses: Specifically, the primary hypothesis is that women that would participate to the intervention would report higher levels of mental well-being comparing to the ones reported by women assigned to the control group (i.e., waiting list, WL). Secondly, it is expected that women that would be involve in the positive intervention would report higher levels of positive affect, perceived social support, positive future thinking, and self-acceptance, comparing to the ones reported by the WL group. Moreover it is expected that participants assigned to the intervention condition would report lower levels of negative affect, depression symptoms, pregnancy related anxiety and negative future thinking, comparing to the ones reported by the WL group.

Conditions

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Pregnancy Mental Health Wellness 1

Keywords

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Pregnancy Prenatal well-being Mental maternal prenatal well-being Positive Psychology Positive Psychology Intervention Web-based intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Positive Psychology Internet-based Intervention condition

Internet-based positive psychology training

Group Type EXPERIMENTAL

"Embarazo y Bienestar"

Intervention Type OTHER

The intervention programme is called "Embarazo y Bienestar" ("Pregnancy and Well-being"). Embarazo y Bienestar is a modular, self-placed program mainly designed to foster women's prenatal well-being by practicing some positive psychology-based exercises. The intervention programme consist of four modules of intervention, one welcome module, and a final resume page.

Waiting List condition

Waiting List control condition

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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"Embarazo y Bienestar"

The intervention programme is called "Embarazo y Bienestar" ("Pregnancy and Well-being"). Embarazo y Bienestar is a modular, self-placed program mainly designed to foster women's prenatal well-being by practicing some positive psychology-based exercises. The intervention programme consist of four modules of intervention, one welcome module, and a final resume page.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* being pregnant
* have regular access to Internet
* decided to be the mother of the baby
* Spanish-speaker
Minimum Eligible Age

11 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Twente

OTHER

Sponsor Role collaborator

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role collaborator

University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Rosa María Baños Rivera

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rosa Maria Baños, PhD

Role: STUDY_DIRECTOR

University of Valencia

Locations

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University of Valencia

Valencia, , Spain

Site Status

Countries

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Spain

Central Contacts

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Giulia Corno

Role: CONTACT

Phone: 0034963864412

Email: [email protected]

Facility Contacts

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Giulia Corno

Role: primary

References

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WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK409108/

Reference Type BACKGROUND
PMID: 28079998 (View on PubMed)

Bos SC, Macedo A, Marques M, Pereira AT, Maia BR, Soares MJ, Valente J, Gomes AA, Azevedo MH. Is positive affect in pregnancy protective of postpartum depression? Braz J Psychiatry. 2013 Mar;35(1):5-12. doi: 10.1016/j.rbp.2011.11.002.

Reference Type BACKGROUND
PMID: 23567594 (View on PubMed)

McManus MA, Khalessi AA, Lin J, Ashraf J, Reich SM. Positive feelings during pregnancy, early feeding practices, and infant health. Pediatr Int. 2017 May;59(5):593-599. doi: 10.1111/ped.13209. Epub 2017 Feb 14.

Reference Type BACKGROUND
PMID: 27914182 (View on PubMed)

Voellmin A, Entringer S, Moog N, Wadhwa PD, Buss C. Maternal positive affect over the course of pregnancy is associated with the length of gestation and reduced risk of preterm delivery. J Psychosom Res. 2013 Oct;75(4):336-40. doi: 10.1016/j.jpsychores.2013.06.031. Epub 2013 Jul 9.

Reference Type BACKGROUND
PMID: 24119939 (View on PubMed)

Seligman ME, Steen TA, Park N, Peterson C. Positive psychology progress: empirical validation of interventions. Am Psychol. 2005 Jul-Aug;60(5):410-21. doi: 10.1037/0003-066X.60.5.410.

Reference Type BACKGROUND
PMID: 16045394 (View on PubMed)

Matvienko-Sikar K, Dockray S. Effects of a novel positive psychological intervention on prenatal stress and well-being: A pilot randomised controlled trial. Women Birth. 2017 Apr;30(2):e111-e118. doi: 10.1016/j.wombi.2016.10.003. Epub 2016 Oct 31.

Reference Type BACKGROUND
PMID: 27810284 (View on PubMed)

Ashford MT, Olander EK, Ayers S. Computer- or web-based interventions for perinatal mental health: A systematic review. J Affect Disord. 2016 Jun;197:134-46. doi: 10.1016/j.jad.2016.02.057. Epub 2016 Mar 9.

Reference Type BACKGROUND
PMID: 26991368 (View on PubMed)

Lee EW, Denison FC, Hor K, Reynolds RM. Web-based interventions for prevention and treatment of perinatal mood disorders: a systematic review. BMC Pregnancy Childbirth. 2016 Feb 29;16:38. doi: 10.1186/s12884-016-0831-1.

Reference Type BACKGROUND
PMID: 26928898 (View on PubMed)

Bolier L, Abello KM. Online positive psychological interventions: State of the art and future directions. In Parks AC, Schueller SM editors. The Wiley Blackwell handbook of positive psychological interventions. Chichester, UK: John Wiley & Sons, Ltd; 2014. p. 286-309.

Reference Type BACKGROUND

Other Identifiers

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H1429002403332

Identifier Type: -

Identifier Source: org_study_id