Clinical trial NCT05756205: E-health Intervention for Improving Mental Health During Pregnancy Using Virtual Reality
Official title: A Randomized Controlled Low-intensity E-health Intervention by Midwives for Improving Mental Health in Pregnant Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Depression
Pregnancy Related
Keywords: Pregnancy
Anxiety
Depression
Virtual Reality
Midwifery
Lead sponsor: Hospital Mutua de Terrassa
Sponsor class: OTHER
Collaborators: name: University of Barcelona
First posted: 2023-03-06
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a two-arm prospective, randomized, parallel-controlled clinical trial. 150 women will be recruited and screened during their pregnancy
Primary purpose: TREATMENT

Brief summary: Pregnancy-related anxiety and depression has received considerable attention worldwide. Mental health problems in pregnant women already since early weeks of gestation may have important consequences for the fetus. Current literature recommends the use of interventions based on new technologies for the treatment of mood disorders, already during the prenatal period. Adult pregnant women (weeks 12-14 of gestation) will be recruited and screened from different primary care centres in Catalonia, Spain. Women who pass the initial mental screening will be randomly allocated to the relaxation virtual reality intervention or control group. The intervention aims to improve mental state of pregnant women during pregnancy, work through breathing, mindfulness and muscle relaxation techniques.

Detailed description: Background: Pregnancy-related anxiety and depression has received considerable attention worldwide. Mental health problems in pregnant women already since early weeks of gestation may have important consequences for the fetus. The necessity for more effective health care pathways, including some early interventions that reduce the overall burden of the childbearing situation, appears a key factor for a successful birth and care of the baby. The few studies focalized in interventions, are focused on delivery and post-partum, without taking into account the whole maternity process. Current literature recommends the use of interventions based on new technologies for the treatment of mood disorders, already during the prenatal period. There have been scarce well-designed intervention studies that test technological low-intensity interventions by midwives to address pregnant women's mental health, diminishing anxiety and depression during pregnancy.

Methods/design: Adult pregnant women (weeks 12-14 of gestation) will be recruited and screened from different primary care centres in Catalonia, Spain. Women who pass the initial mental screening will be randomly allocated to the relaxation virtual reality intervention or control group. The intervention aims to improve mental state of pregnant women during pregnancy, work through breathing, mindfulness and muscle relaxation techniques. Women in the control group will receive standard care offered by the public funded maternity services in Catalonia. The primary outcome measures will include the Edinburg Postnatal Depression (EPDS), State Trait Anxiety Inventory (STAI), Symptom Checklist-90 (SCL-90), and the Cambridge Worry Scale (CWS) instruments. Secondary outcome measures will include the Temperament and Character Inventory-Revised (TCI-R) and the Whooley and Generalized Anxiety Disorder-2 (GAD-2) questions. Routinely, pregnancy monitoring measures will also be evaluated.

Discussion: This study aims to test the efficacy of a low-intensity, midwife-led e-health intervention based on new technologies to work on women's anxiety and depression during pregnancy. The hypothesis is that that low-intensity mental health intervention during pregnancy, using an e-health (virtual reality) as a support tool, will be effective in reducing of anxiety, depressive symptoms, and improving satisfaction with pregnancy follow-up.

Eligibility criteria: Inclusion Criteria:

* All women who control their pregnancy in the primary care centers of the Sexual and Reproductive Health Care (ASSIR; Atención a la Salut Sexual i Reproductiva) of Mutua Terrassa, Barcelona (Spain)
* The women must present a positive value in the mental health screening performed at the beginning of the pregnancy (weeks 12-14 of gestation).
* Verbal and written literacy understanding of Spanish
* ≥18 years old.

Exclusion Criteria:

* Women with diagnosed psychiatric pathology who are already being followed by the mental health team
* Women victims of gender-based violence who tested positive in the partner violence screen

Primary outcomes:
measure: Depression in pregnand women
timeFrame: 6 weeks
measure: Anxiety in pregnand women
timeFrame: 6 weeks
Secondary outcomes:
measure: Symptom checklist -90-R
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Fundació Assitencial Mutua Terrassa
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua Terrassa
state: Barcelona
Study officials:
affiliation: Fundació Assistencial Mutua Terrassa
name: Marta Jimenez Barragan, RN, RM
role: PRINCIPAL_INVESTIGATOR
References: