- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03158649
A Novel Web-based Positive Psychology Intervention Addressed to Pregnant Women
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Giulia Corno
- Phone Number: 0034963864412
- Email: giulia.me.corno@gmail.com
Study Locations
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Valencia, Spain, 46010
- University of Valencia
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Contact:
- Giulia Corno
- Email: giulia.me.corno@gmail.com
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Sub-Investigator:
- Giulia Corno
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- being pregnant
- have regular access to Internet
- decided to be the mother of the baby
- Spanish-speaker
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Positive Psychology Internet-based Intervention condition
Internet-based positive psychology training
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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.
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No Intervention: Waiting List condition
Waiting List control condition
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Mental well-being
Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Warwick-Edinburgh Mental Well-Being Scale (WEMWBS; Tennant et al., 2007)
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Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Social support
Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al., 1988)
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Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Changes in Future directed thinking
Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Subjective Probability Task (SPT; MacLeod et al., 1996)
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Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Changes in Affect
Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Scale of Positive and Negative Experience (SPANE; Diener et al., 2010)
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Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Changes in Depression
Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Patient Health Questionnaire-9 (PHQ-9; Kroenke, & Spitzer, 2002)
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Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Changes in Pregnancy related anxiety
Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Pregnancy Related Anxiety Scale (PRAS; Rini et al., 1999)
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Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Changes in Psychological well-being
Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Psychological Well-Being Scale (PWBS-29; Ryff, 1989)
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Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Changes in Self-compassion
Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Self-Compassion Scale -Short Form (SCS-SF; Raes et al., 2011)
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Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Changes in Satisfaction with life
Time Frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Satisfaction With Life Scale (SWLS; Diener, et al., 1985)
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Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Rosa Maria Baños, PhD, University of Valencia
Publications and helpful links
General Publications
- 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.
- 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/
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H1429002403332
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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