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Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention to improve maternal mental health in the peripartum: study protocol for a randomised controlled trial.

Trials
January 1, 1970
Grace Branjerdporn et al. (12 authors)
Clinical Trial ProtocolJournal ArticleHuman StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate the effectiveness of a mindfulness mobile app in improving mental health outcomes (postnatal depression, mother-infant bonding, and quality of life) in perinatal women.

Results Summary

The study suggests mindfulness interventions can reduce stress, anxiety, depression, and sleep disturbances in prenatal populations, with low risks and potential benefits for women facing barriers to face-to-face care.

Population

Perinatal women aged 18 years and over attending maternity clinics at Mater Mothers' Hospital.

Effective Dosage

Not specified

Duration

11 months

Interactions

None mentioned

Extracted Claims (5)
InterventionDirectionEndpointPopulationDosageImpactClaim #
mobile application teaching mindfulness
increase
women's mental health
perinatal women
-
improve
#1
mindfulness interventions
decrease
stress
prenatal population
-
reduce
#2
mindfulness interventions
decrease
anxiety
prenatal population
-
reduce
#3
mindfulness interventions
decrease
depression
prenatal population
-
reduce
#4
mindfulness interventions
decrease
sleep disturbances
prenatal population
-
reduce
#5
Abstract

BACKGROUND: Perinatal women are highly vulnerable to developing mental health issues and particularly susceptible to a recurrence of psychiatric illness. Poor mental health during the perinatal period can have long-term impacts on the physical and psychiatric health of both mother and child. A potentially useful strategy to improve women's mental health is through a mobile application teaching mindfulness, an evidence-based technique helping individuals focus on the present moment. METHODS: A mixed method, prospective randomised controlled trial. The study group comprise women aged 18 years and over, who are attending the public and private maternity clinics at Mater Mothers' Hospital. A sample of 360 prenatal women will be randomised into the intervention group (with the use of the mindfulness app) or usual care. Participants will remain in the study for 11 months and will be assessed at four timepoints for changes in postnatal depression, mother-infant bonding, and quality of life. A cost-effectiveness evaluation will also be conducted using quality-adjusted life year (QALY) calculations. A random selection of intervention participants will be invited to attend focus groups to give feedback on the mindfulness app. DISCUSSION: Previous studies have found mindfulness interventions can reduce stress, anxiety, depression, and sleep disturbances in a prenatal population. The risks of the intervention are low, but could be of significant benefit for women who are unable to attend face-to-face appointments due to geographical, financial, or time barriers; during endemic or pandemic scenarios; or due to health or mobility issues. TRIAL REGISTRATION: This study was approved by the Mater Misericordiae Human Research Ethics Committee (83,589). Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12622001581752 ( https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385107&isReview=true ). Registered on 22 Dec. 2022.

Medical Subject Headings (MeSH)
AdolescentAdultFemaleHumansPregnancyAustraliaCost-Benefit AnalysisMental HealthMindfulnessPeripartum PeriodProspective StudiesQuality of LifeRandomized Controlled Trials as TopicInfant, Newborn
Study Links
Quality Scores
Safety85
Efficacy75/10
Quality90/10
0
Research Impact Scores
APT Score0.05
Weight Score1.44
Normalized Score0.82
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