Clinical trial NCT03158649: A Novel Web-based Positive Psychology Intervention Addressed to Pregnant Women
Official title: A Novel Web-based Positive Psychology Intervention Addressed to Pregnant Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Mental Health Wellness 1
Keywords: Pregnancy
Prenatal well-being
Mental maternal prenatal well-being
Positive Psychology
Positive Psychology Intervention
Web-based intervention
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: University of Twente
name: Universidade Federal do Rio Grande do Norte
First posted: 2017-05-18
Enrollment: 164
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Changes in Mental well-being
timeFrame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Secondary outcomes:
measure: Changes in Social support
timeFrame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
measure: Changes in Future directed thinking
timeFrame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
measure: Changes in Affect
timeFrame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
measure: Changes in Depression
timeFrame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
measure: Changes in Pregnancy related anxiety
timeFrame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
measure: Changes in Psychological well-being
timeFrame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
measure: Changes in Self-compassion
timeFrame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
measure: Changes in Satisfaction with life
timeFrame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia
Study officials:
affiliation: University of Valencia
name: Rosa Maria Baños, PhD
role: STUDY_DIRECTOR
References:
citation: 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/
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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.
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. doi: 10.1037/0003-066X.60.5.410.
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.
citation: 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.
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.
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.