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

Study Overview
=================
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.

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

Conditions
-----------------
Pregnancy, Mental Health Wellness 1

Intervention / Treatment
-----------------
* Other: Embarazo y Bienestar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being pregnant have regular access to Internet decided to be the mother of the baby Spanish-speaker

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive Psychology Internet-based Intervention condition<br>Internet-based positive psychology training | Other: Embarazo y Bienestar<br>* 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.<br>|
| No Intervention: Waiting List condition<br>Waiting List control condition | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Prenatal well-being, Mental maternal prenatal well-being, Positive Psychology, Positive Psychology Intervention, Web-based intervention