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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03158649
• Other study ID #: H1429002403332
• Status: Not yet recruiting
• Phase: N/A
• First received: July 2, 2015
• Last updated: November 22, 2017
• Start date: June 2020
• Est. completion date: December 2020

Study information

• Verified date: November 2017
• Source: University of Valencia
• Contact: Giulia Corno
• Phone: 0034963864412
• Email: giulia.me.corno[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 164
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 11 Years to 45 Years

Eligibility

Inclusion Criteria:

• being pregnant

• have regular access to Internet

• decided to be the mother of the baby

• Spanish-speaker

Related Conditions & MeSH terms

• Mental Health Wellness 1
• Pregnancy

Intervention

Other:
• "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.

Locations

Country	Name	City	State
Spain	University of Valencia	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
University of Valencia	Universidade Federal do Rio Grande do Norte, University of Twente

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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. Review. — View Citation

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.

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? Rev Bras Psiquiatr. 2013 Mar;35(1):5-12. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Seligman ME, Steen TA, Park N, Peterson C. Positive psychology progress: empirical validation of interventions. Am Psychol. 2005 Jul-Aug;60(5):410-21. — View Citation

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. — View Citation

World health Organization. (2016). WHO recommendations on antenatal care for a positive pregnancy experience.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Mental well-being	Warwick-Edinburgh Mental Well-Being Scale (WEMWBS; Tennant et al., 2007)	Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Secondary	Changes in Social support	Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al., 1988)	Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Secondary	Changes in Future directed thinking	Subjective Probability Task (SPT; MacLeod et al., 1996)	Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Secondary	Changes in Affect	Scale of Positive and Negative Experience (SPANE; Diener et al., 2010)	Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Secondary	Changes in Depression	Patient Health Questionnaire-9 (PHQ-9; Kroenke, & Spitzer, 2002)	Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Secondary	Changes in Pregnancy related anxiety	Pregnancy Related Anxiety Scale (PRAS; Rini et al., 1999)	Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Secondary	Changes in Psychological well-being	Psychological Well-Being Scale (PWBS-29; Ryff, 1989)	Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Secondary	Changes in Self-compassion	Self-Compassion Scale -Short Form (SCS-SF; Raes et al., 2011)	Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Secondary	Changes in Satisfaction with life	Satisfaction With Life Scale (SWLS; Diener, et al., 1985)	Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)