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

NCT03158649 | Unknown

• 1 other identifier: H1429002403332
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Mental Health Wellness 1

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Changes in Social support

  Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)

• Changes in Future directed thinking

  Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)

• Changes in Affect

  Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)

• Changes in Depression

  Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)

• Changes in Pregnancy related anxiety

  Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)

Study Arms (2)

Positive Psychology Internet-based Intervention condition

EXPERIMENTAL

Internet-based positive psychology training

Other: "Embarazo y Bienestar"

Waiting List condition

NO INTERVENTION

Waiting List control condition

Interventions

"Embarazo y Bienestar" 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.

Positive Psychology Internet-based Intervention condition

Eligibility Criteria

• Age: 11 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• being pregnant
• have regular access to Internet
• decided to be the mother of the baby
• Spanish-speaker

Sponsors & Collaborators

• University of Valencia: lead
• University of Twente: collaborator
• Universidade Federal do Rio Grande do Norte: collaborator

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

Related Publications (9)

• 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/

  PMID: 28079998 BACKGROUND

• 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.

  PMID: 23567594 BACKGROUND

• 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.

  PMID: 27914182 BACKGROUND

• 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.

  PMID: 24119939 BACKGROUND

• 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.

  PMID: 16045394 BACKGROUND

• 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.

  PMID: 27810284 BACKGROUND

• 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.

  PMID: 26991368 BACKGROUND

• 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.

  PMID: 26928898 BACKGROUND

• 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.

  BACKGROUND

Study Officials

• Rosa Maria Baños, PhD

  University of Valencia

  STUDY DIRECTOR

Central Study Contacts

Giulia Corno

CONTACT

0034963864412; giulia.me.corno@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: May 18, 2017
• Study Start: June 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 27, 2017

Record last verified: 2017-11

Locations

ES (1)