Anxiety DepressionNCT05756205
E-health Intervention for Improving Mental Health During Pregnancy Using Virtual Reality
A study testing Immersive Virtual Reality (IVR) in people with Anxiety Depression and Pregnancy Related, run by Hospital Mutua de Terrassa at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety Depression, Pregnancy Related
- What is being tested?
- Immersive Virtual Reality (IVR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Dec 2022to 30 Dec 2024
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Fundació Assitencial Mutua Terrassa
Terrassa, Barcelona, 08221
Marta Jimenez-Barragan, MA, +34686698651, mjimenezb@mutuaterrassa.cat
Marta Jimenez Barragan, MA
- Recruiting
Hospital Universitari Mútua Terrassa
Terrassa, Barcelona, 08221
Marta Jimenez-Barragan, MA, +34686698651, mjimenezb@mutuaterrassa.cat
Marta Jimenez Barragan, MA
About this study
Official title: A Randomized Controlled Low-intensity E-health Intervention by Midwives for Improving Mental Health in Pregnant Women
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.
Read the 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.
- Conditions
- Anxiety Depression, Pregnancy Related
- Being tested
- Immersive Virtual Reality (IVR)
- Keywords
- Pregnancy, Anxiety, Depression, Virtual Reality, Midwifery
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality (IVR)Device
The intervention will consist of an Immersive Virtual Reality (IVR) application with virtual reality goggles Oculus GO, to reduce anxiety during pregnancy. This application lasts 14 minutes by the use of mindfulness techniques based on breathing, mindfulness and passive muscle relaxation. It consists of three modules that can be chosen completely or separately.
The aspects that conform this intervention will be: information about, the most common perinatal mental health problems, exercises based on attention to breathing (mindfulness-relaxation), 6 weeks of duration, for 14 minutes a day, knowledge from involved personnel of the number of times the woman has connected and the time she has done the exercise, satisfaction questions to pregnant women after pregnancy, alerts to notify the principal investigator if there is a problem with e-health, and, finally, an email address to contact the principal investigator.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | The intervention will consist of an Immersive Virtual Reality (IVR) application with virtual reality goggles Oculus GO, to reduce anxiety during pregnancy. This application lasts 14 minutes by the use of mindfulness techniques based on breathing, mindfulness and passive muscle relaxation. Receives: Device: Immersive Virtual Reality (IVR) |
| Routine care | No intervention | The control group will receive the usual follow-up pregnancy monitoring, without the e-health intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression in pregnand women
Edingburg depression Scale (>9)
Measured: 6 weeks
Anxiety in pregnand women
State trait anxiety inventory (>75%)
Measured: 6 weeks
Secondary outcomes (1)
Symptom checklist -90-R
Anxiety symptoms (>60%)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Dec 2022
- Primary completion1 Feb 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a two-arm prospective, randomized, parallel-controlled clinical trial. 150 women will be recruited and screened during their pregnancy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Barcelona
- Responsible party
- Sponsor
- Investigators
- Marta Jimenez Barragan, RN, RM, Principal investigator, Fundació Assistencial Mutua Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756205
- Sponsor's protocol ID
- 02/2018
- Status last verified
- Nov 2022
- First submitted
- 8 Feb 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jimenez-Barragan M, Del Pino Gutierrez A, Sauch Valmana G, Monistrol O, Monge Marcet C, Pallarols Badia M, Garrido I, Carmona Ruiz A, Porta Roda O, Esquinas C, Falguera Puig G. Immersive Virtual Reality eHealth Intervention to Reduce Anxiety and Depression in Pregnant Women: Randomized Controlled Trial. JMIR Hum Factors. 2025 Apr 30;12:e71708. doi: 10.2196/71708.
PubMed 40306641Jimenez-Barragan M, Del Pino Gutierrez A, Garcia JC, Monistrol-Ruano O, Coll-Navarro E, Porta-Roda O, Falguera-Puig G. Study protocol for improving mental health during pregnancy: a randomized controlled low-intensity m-health intervention by midwives at primary care centers. BMC Nurs. 2023 Sep 7;22(1):309. doi: 10.1186/s12912-023-01440-4.
PubMed 37674184
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Low-intensity E-health Intervention by Midwives for Improving Mental Health in Pregnant Women
- ClinicalTrials.gov ID
- NCT05756205
- Acronym / sponsor ID
- 02/2018
- Conditions
- Anxiety Depression, Pregnancy Related
- Keywords
- Pregnancy, Anxiety, Depression, Virtual Reality, Midwifery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Collaborators
- University of Barcelona
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 6 Mar 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This will be a two-arm prospective, randomized, parallel-controlled clinical trial. 150 women will be recruited and screened during their pregnancy
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: Immersive Virtual Reality (IVR)The intervention will consist of an Immersive Virtual Reality (IVR) application with virtual reality goggles Oculus GO, to reduce anxiety during pregnancy. This application lasts 14 minutes by the use of mindfulness techniques based on breathing, mindfulness and passive muscle relaxation. |
| Routine care | No intervention | –The control group will receive the usual follow-up pregnancy monitoring, without the e-health intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Immersive Virtual Reality (IVR)The intervention will consist of an Immersive Virtual Reality (IVR) application with virtual reality goggles Oculus GO, to reduce anxiety during pregnancy. This application lasts 14 minutes by the use of mindfulness techniques based on breathing, mindfulness and passive muscle relaxation. It consists of three modules that can be chosen completely or separately. The aspects that conform this intervention will be: information about, the most common perinatal mental health problems, exercises based on attention to breathing (mindfulness-relaxation), 6 weeks of duration, for 14 minutes a day, knowledge from involved personnel of the number of times the woman has connected and the time she has done the exercise, satisfaction questions to pregnant women after pregnancy, alerts to notify the principal investigator if there is a problem with e-health, and, finally, an email address to contact the principal investigator. | Device | Virtual Reality |
Primary outcome
Depression in pregnand women
Time frame: 6 weeks
Edingburg depression Scale (>9)
Anxiety in pregnand women
Time frame: 6 weeks
State trait anxiety inventory (>75%)
1 secondary outcome
Symptom checklist -90-R
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Derived from this study: PubMed 40306641Jimenez-Barragan M, Del Pino Gutierrez A, Sauch Valmana G, Monistrol O, Monge Marcet C, Pallarols Badia M, Garrido I, Carmona Ruiz A, Porta Roda O, Esquinas C, Falguera Puig G. Immersive Virtual Reality eHealth Intervention to Reduce Anxiety and Depression in Pregnant Women: Randomized Controlled Trial. JMIR Hum Factors. 2025 Apr 30;12:e71708. doi: 10.2196/71708.
- Derived from this study: PubMed 37674184Jimenez-Barragan M, Del Pino Gutierrez A, Garcia JC, Monistrol-Ruano O, Coll-Navarro E, Porta-Roda O, Falguera-Puig G. Study protocol for improving mental health during pregnancy: a randomized controlled low-intensity m-health intervention by midwives at primary care centers. BMC Nurs. 2023 Sep 7;22(1):309. doi: 10.1186/s12912-023-01440-4.
- Individual participant dataSharing planned: No
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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.
Marta Jimenez Barragan, RN, RM principal investigator
Fundació Assistencial Mutua Terrassa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality (IVR) in people with Anxiety Depression and Pregnancy Related, run by Hospital Mutua de Terrassa at 2 sites 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 2 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 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Marta Jimenez Barragan, RN, RM (+34937365050 ext. 41707, mjimenezb@mutuaterrassa.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression in pregnand women (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 NCT05756205, which also lists 2 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 6 Mar 2023.