- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Valencia, Spanien, 46010
- University of Valencia
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- being pregnant
- have regular access to Internet
- decided to be the mother of the baby
- Spanish-speaker
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Positive Psychology Internet-based Intervention condition
Internet-based positive psychology training
|
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.
|
|
Inget ingripande: Waiting List condition
Waiting List control condition
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in Mental well-being
Tidsram: 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)
|
Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in Social support
Tidsram: 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)
|
Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
|
|
Changes in Future directed thinking
Tidsram: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
|
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
Tidsram: 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)
|
Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
|
|
Changes in Depression
Tidsram: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
|
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
Tidsram: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
|
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
Tidsram: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
|
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
Tidsram: 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)
|
Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
|
|
Changes in Satisfaction with life
Tidsram: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
|
Satisfaction With Life Scale (SWLS; Diener, et al., 1985)
|
Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Rosa Maria Baños, PhD, University of Valencia
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- H1429002403332
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Graviditet
-
Habil HamdouniFaculty of Medicine, SousseAvslutadLumbopelvic Range of Motion in Second-Trimester PregnancyTunisien
-
King's College Hospital NHS TrustEuropean Association for the Study of the LiverRekryteringCirros, lever | HELLP syndrom | Intrahepatisk kolestas av graviditet | Graviditetssjukdom | AFLP - Acute Fatty Lever of PregnancyStorbritannien
Kliniska prövningar på "Embarazo y Bienestar"
-
Beijing Tiantan HospitalNeurodawn Pharmaceutical Co., Ltd.RekryteringFriska vuxna manliga och kvinnliga volontärerKina
-
Arkansas Colleges of Health EducationRekrytering
-
Aurion BiotechRekryteringHornhinnan ödem | Hornhinnan endotel dysfunktion | Fuchs endotelial korneadysfunktion | Pseudofakisk bullös keratopati (PBK)Förenta staterna
-
Beijing Tiantan HospitalNeurodawn Pharmaceutical Co., Ltd.AvslutadAkut ischemisk strokeKina
-
Kochi UniversityOkändBukspottskörtelcancerJapan
-
CelltrionAvslutad
-
Jilin UniversityOkänd
-
Prof. Dr. Cemil Tascıoglu Education and Research...Health Institutes of TurkeyHar inte rekryterat ännuIcke-småcellig lungcancer | Metastaserande lungkarcinomTurkiet (Türkiye)
-
CHU de ReimsRekryteringFöräldrars ångest efter för tidig födselFrankrike