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

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ClinicalTrials.gov Identifier: NCT03158649
Recruitment Status : Not yet recruiting
First Posted : May 18, 2017
Last Update Posted : November 27, 2017
Sponsor:
Collaborators:
University of Twente
Universidade Federal do Rio Grande do Norte
Information provided by (Responsible Party):
Rosa María Baños Rivera, University of Valencia

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.


Condition or disease Intervention/treatment Phase
Pregnancy Mental Health Wellness 1 Other: "Embarazo y Bienestar" Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Novel Web-based Positive Psychology Intervention Addressed to Pregnant Women
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Positive Psychology Internet-based Intervention condition
Internet-based positive psychology training
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.

No Intervention: Waiting List condition
Waiting List control condition



Primary Outcome Measures :
  1. Changes in Mental well-being [ Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training) ]
    Warwick-Edinburgh Mental Well-Being Scale (WEMWBS; Tennant et al., 2007)


Secondary Outcome Measures :
  1. Changes in Social support [ Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training) ]
    Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al., 1988)

  2. Changes in Future directed thinking [ Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training) ]
    Subjective Probability Task (SPT; MacLeod et al., 1996)

  3. Changes in Affect [ Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training) ]
    Scale of Positive and Negative Experience (SPANE; Diener et al., 2010)

  4. Changes in Depression [ Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training) ]
    Patient Health Questionnaire-9 (PHQ-9; Kroenke, & Spitzer, 2002)

  5. Changes in Pregnancy related anxiety [ Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training) ]
    Pregnancy Related Anxiety Scale (PRAS; Rini et al., 1999)

  6. Changes in Psychological well-being [ Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training) ]
    Psychological Well-Being Scale (PWBS-29; Ryff, 1989)

  7. Changes in Self-compassion [ Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training) ]
    Self-Compassion Scale -Short Form (SCS-SF; Raes et al., 2011)

  8. Changes in Satisfaction with life [ Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training) ]
    Satisfaction With Life Scale (SWLS; Diener, et al., 1985)



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158649


Contacts
Contact: Giulia Corno 0034963864412 giulia.me.corno@gmail.com

Locations
Spain
University of Valencia Recruiting
Valencia, Spain, 46010
Contact: Giulia Corno       giulia.me.corno@gmail.com   
Sub-Investigator: Giulia Corno         
Sponsors and Collaborators
University of Valencia
University of Twente
Universidade Federal do Rio Grande do Norte
Investigators
Study Director: Rosa Maria Baños, PhD University of Valencia

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

Responsible Party: Rosa María Baños Rivera, PhD, University of Valencia
ClinicalTrials.gov Identifier: NCT03158649     History of Changes
Other Study ID Numbers: H1429002403332
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rosa María Baños Rivera, University of Valencia:
Pregnancy
Prenatal well-being
Mental maternal prenatal well-being
Positive Psychology
Positive Psychology Intervention
Web-based intervention