PregnancyNCT03158649
A Novel Web-based Positive Psychology Intervention Addressed to Pregnant Women
A study testing "Embarazo y Bienestar" in people with Pregnancy and Mental Health Wellness 1, run by University of Valencia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Mental Health Wellness 1
- What is being tested?
- "Embarazo y Bienestar"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2020to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- being pregnant
- have regular access to Internet
- decided to be the mother of the baby
- Spanish-speaker
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Valencia
Valencia, 46010
Giulia Corno, giulia.me.corno@gmail.com
Giulia Corno
About this study
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.
Read the 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.
- Conditions
- Pregnancy, Mental Health Wellness 1
- Being tested
- "Embarazo y Bienestar"
- Keywords
- Pregnancy, Prenatal well-being, Mental maternal prenatal well-being, Positive Psychology, Positive Psychology Intervention, Web-based intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Embarazo y Bienestar"Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychology Internet-based Intervention condition | Experimental | Internet-based positive psychology training Receives: Other: "Embarazo y Bienestar" |
| Waiting List condition | No intervention | Waiting List control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Mental well-being
Warwick-Edinburgh Mental Well-Being Scale (WEMWBS; Tennant et al., 2007)
Measured: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Secondary outcomes (8)
Changes in Social support
Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al., 1988)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study startJun 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente, Universidade Federal do Rio Grande do Norte
- Responsible party
- Principal investigator, Rosa María Baños Rivera, University of Valencia
- Investigators
- Rosa Maria Baños, PhD, Study director, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158649
- Sponsor's protocol ID
- H1429002403332
- Status last verified
- Nov 2017
- First submitted
- 2 Jul 2015
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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/
PubMed 28079998Bos 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.
PubMed 23567594McManus 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.
PubMed 27914182Voellmin 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.
PubMed 24119939Seligman 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.
PubMed 16045394Matvienko-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.
PubMed 27810284Ashford 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.
PubMed 26991368Lee 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.
PubMed 26928898Bolier 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 at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Web-based Positive Psychology Intervention Addressed to Pregnant Women
- ClinicalTrials.gov ID
- NCT03158649
- Acronym / sponsor ID
- H1429002403332
- Conditions
- Pregnancy, Mental Health Wellness 1
- Keywords
- Pregnancy, Prenatal well-being, Mental maternal prenatal well-being, Positive Psychology, Positive Psychology Intervention, Web-based intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- University of Twente, Universidade Federal do Rio Grande do Norte
- Study start
- Jun 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Psychology Internet-based Intervention condition | Experimental | Other: "Embarazo y Bienestar"Internet-based positive psychology training |
| Waiting List condition | No intervention | –Waiting List control condition |
Who may qualify
- Ages
- 11 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- being pregnant
- have regular access to Internet
- decided to be the mother of the baby
- Spanish-speaker
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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. | Other | Positive Psychology Internet-based Intervention condition |
Primary outcome
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)
8 secondary outcomes
Changes in Social support
Time frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Changes in Future directed thinking
Time frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Changes in Affect
Time frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Changes in Depression
Time frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Changes in Pregnancy related anxiety
Time frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Changes in Psychological well-being
Time frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Changes in Self-compassion
Time frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Changes in Satisfaction with life
Time frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Background: PubMed 28079998WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK409108/
- Background: PubMed 23567594Bos 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.
- Background: PubMed 27914182McManus 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.
- Background: PubMed 24119939Voellmin 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.
- Background: PubMed 16045394Seligman 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.
- Background: PubMed 27810284Matvienko-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.
- Background: PubMed 26991368Ashford 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.
- Background: PubMed 26928898Lee 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.
- BackgroundBolier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosa Maria Baños, PhD study director
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Embarazo y Bienestar" in people with Pregnancy and Mental Health Wellness 1, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giulia Corno (0034963864412, giulia.me.corno@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Mental well-being (time frame: Baseline, post- training (5-weeks) and at follow-up (5-weeks after post-training)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03158649, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.