Depression During PregnancyNCT07279311
Virtual Reality-enhanced Psychotherapy for Perinatal Depression
A study testing Virtual reality behavioral activation in people with Depression During Pregnancy, run by Stanford University at 1 site in United States.
Trial summary
Perinatal depression is a growing public health crisis in the United States, affecting one in five individuals during pregnancy or postpartum. Mental health conditions contribute to 23% of maternal deaths, underscoring the urgent need for innovative interventions. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression During Pregnancy
- What is being tested?
- Virtual reality behavioral activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to Stanford Children's Hospital antepartum unit for obstetric indications that are likely to warrant >3 weeks of hospitalization (such as vasa previa, preterm premature rupture of membranes, severe preeclampsia).
- Able to read and write in English or Spanish
- Baseline EPDS score on admission >=10 on routine screening
- Admitted >24 hours prior to enrollment
Who cannot join
- Patients with serious neuropsychiatric illness (bipolar disorder, schizophrenia, epilepsy, or suicidal ideation)
- Known delivery planned within the next 3 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Lucile Packard Children's Hospital
Palo Alto, California, 94304
About this study
Official title: Virtual Reality-enhanced Psychotherapy as a Mental Health Intervention During Antepartum Hospitalization: A Pilot Randomized Controlled Trial
Perinatal depression is a growing public health crisis in the United States, affecting one in five individuals during pregnancy or postpartum. Mental health conditions contribute to 23% of maternal deaths, underscoring the urgent need for innovative interventions. Obstetric patients who experience complications requiring prolonged hospitalization are particularly vulnerable to mental health deterioration. Virtual reality (VR) has shown promise for expanding access, reducing barriers, and enhancing first-line depression treatment when paired with evidence-based psychotherapies such as behavioral activation (BA). However, traditional BA is not feasible for inpatients, as their hospitalization prevents participation in conventional in-person, mood-boosting activities; VR-enhanced BA (VR-BA) presents a novel opportunity to address this gap.
The goal of the study is to compare a 3-week VR-BA protocol to standard therapy (social work consultation) for hospitalized pregnant individuals with depressive symptoms. The objectives are to assess 1) whether VR-BA is acceptable, tolerable, and feasible in this population and 2) whether it leads to greater reductions in depressive symptoms compared to standard therapy.
- Conditions
- Depression During Pregnancy
- Being tested
- Virtual reality behavioral activation
- Keywords
- pregnancy, high risk pregnancy, antepartum hospitalization, depression, maternal mental health, virtual reality
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality behavioral activationBehavioural
The available VR-BA sessions include immersive 360° videos using headsets. The content encompasses a wide range of categories, including but not limited to animals; sports, dance, or arts; adrenaline; travel; and hiking or the outdoors. The patient will select activities which align most with their values and interests, with guidance during the telehealth sessions. The videos range from 1 minute to 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Participants will receive standard therapy during their antepartum hospitalization, which will include consultations with social workers and psychiatry physicians (if recommended by the social worker). |
| Virtual-Reality Behavioral Activation | Experimental | Participants will receive the 3-week VR-BA psychotherapy. The VR-BA consists of 4 self-guided VR sessions per week and a weekly telemedicine guided BA session with a trained study team member via ZOOM (and Spanish interpreter, if required) lasting 30-50 minutes. This will be a total of 3 telemedicine-guided BA sessions and 12 self-guided VR sessions over the course of the study. Receives: Behavioral: Virtual reality behavioral activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms scale score using Edinburgh Postnatal Depression Scale (EPDS)
Edinburgh Postnatal Depression Scale (EPDS) scores will be compared at the end of the 3 week intervention between groups. The EPDS is a 10-item questionnaire, with total score 0-30. Higher scores are consistent with greater levels of depressive symptoms.
Measured: At enrollment, then weekly up to a total of 3 weeks
Secondary outcomes (6)
Feasibility - dropout rate
Number of participants who withdraw from the study (after enrollment) divided by total enrollment number
Measured: Weekly, up to 3 weeks
Feasibility - compliance rate
Percentage of patients who complete VR-BA 4 sessions per week (total of 12).
Measured: Weekly, up to 3 weeks
Feasibility - adverse event rate
Occurrence of any of the following during the study: nausea, falls, seizure, suicidal ideation.
Measured: 3 weeks
Acceptability - Presence Questionnaire
Validated questionnaire (3 questions) asking about perception of the virtual reality experience using the headset and videos. Each response is rated on a Likert scale ranging from 0-4, with 0 being "not at all" and 4 being "very strongly".
Measured: Weekly, up to 3 weeks
Acceptability - Technology Acceptance Model
Validated questionnaire (13 questions) asking participants about perceived usefulness, perceived ease of use, attitudes toward use, intention to use technology. Each response is rated on a Likert scale ranging from 0-4, with 0 being "strongly disagree" and 4 being "strongly agree".
Measured: Weekly, up to 3 weeks
Tolerability - Simulator Sickness Questionnaire
Validated questionnaire (16 questions) asking participants about tolerability of wearing the headset. Each response is rated on a Likert scale ranging from 0-3, with 0 representing "no more than usual" and 3 representing "severely more than usual".
Measured: Weekly, up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start31 Mar 2026
- Primary completionSep 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression During PregnancyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Panelli, Stanford University
- Investigators
- Danielle M Panelli, MD MS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279311
- Sponsor's protocol ID
- 79808
- Status last verified
- Mar 2026
- First submitted
- 1 Dec 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality-enhanced Psychotherapy as a Mental Health Intervention During Antepartum Hospitalization: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07279311
- Acronym / sponsor ID
- 79808
- Conditions
- Depression During Pregnancy
- Keywords
- pregnancy, high risk pregnancy, antepartum hospitalization, depression, maternal mental health, virtual reality
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 12 Dec 2025 (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.
Perinatal depression is a growing public health crisis in the United States, affecting one in five individuals during pregnancy or postpartum. Mental health conditions contribute to 23% of maternal deaths, underscoring the urgent need for innovative interventions. Obstetric patients who experience complications requiring prolonged hospitalization are particularly vulnerable to mental health deterioration. Virtual reality (VR) has shown promise for expanding access, reducing barriers, and enhancing first-line depression treatment when paired with evidence-based psychotherapies such as behavioral activation (BA). However, traditional BA is not feasible for inpatients, as their hospitalization prevents participation in conventional in-person, mood-boosting activities; VR-enhanced BA (VR-BA) presents a novel opportunity to address this gap.
The goal of the study is to compare a 3-week VR-BA protocol to standard therapy (social work consultation) for hospitalized pregnant individuals with depressive symptoms. The objectives are to assess 1) whether VR-BA is acceptable, tolerable, and feasible in this population and 2) whether it leads to greater reductions in depressive symptoms compared to standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Participants will receive standard therapy during their antepartum hospitalization, which will include consultations with social workers and psychiatry physicians (if recommended by the social worker). |
| Virtual-Reality Behavioral Activation | Experimental | Behavioral: Virtual reality behavioral activationParticipants will receive the 3-week VR-BA psychotherapy. The VR-BA consists of 4 self-guided VR sessions per week and a weekly telemedicine guided BA session with a trained study team member via ZOOM (and Spanish interpreter, if required) lasting 30-50 minutes. This will be a total of 3 telemedicine-guided BA sessions and 12 self-guided VR sessions over the course of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients admitted to Stanford Children's Hospital antepartum unit for obstetric indications that are likely to warrant >3 weeks of hospitalization (such as vasa previa, preterm premature rupture of membranes, severe preeclampsia).
- Able to read and write in English or Spanish
- Baseline EPDS score on admission >=10 on routine screening
- Admitted >24 hours prior to enrollment
Key exclusion criteria (2 listed)
- Patients with serious neuropsychiatric illness (bipolar disorder, schizophrenia, epilepsy, or suicidal ideation)
- Known delivery planned within the next 3 weeks
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 |
|---|---|---|
| Virtual reality behavioral activationThe available VR-BA sessions include immersive 360° videos using headsets. The content encompasses a wide range of categories, including but not limited to animals; sports, dance, or arts; adrenaline; travel; and hiking or the outdoors. The patient will select activities which align most with their values and interests, with guidance during the telehealth sessions. The videos range from 1 minute to 10 minutes. | Behavioural | Virtual-Reality Behavioral Activation |
Primary outcome
Depressive symptoms scale score using Edinburgh Postnatal Depression Scale (EPDS)
Time frame: At enrollment, then weekly up to a total of 3 weeks
Edinburgh Postnatal Depression Scale (EPDS) scores will be compared at the end of the 3 week intervention between groups. The EPDS is a 10-item questionnaire, with total score 0-30. Higher scores are consistent with greater levels of depressive symptoms.
6 secondary outcomes
Feasibility - dropout rate
Time frame: Weekly, up to 3 weeks
Feasibility - compliance rate
Time frame: Weekly, up to 3 weeks
Feasibility - adverse event rate
Time frame: 3 weeks
Acceptability - Presence Questionnaire
Time frame: Weekly, up to 3 weeks
Acceptability - Technology Acceptance Model
Time frame: Weekly, up to 3 weeks
Tolerability - Simulator Sickness Questionnaire
Time frame: Weekly, up to 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- 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.
Danielle M Panelli, MD MS principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality behavioral activation in people with Depression During Pregnancy, run by Stanford University at 1 site in United States.
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: enrolling by invitation, as of the sponsor's last update on 6 Apr 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms scale score using Edinburgh Postnatal Depression Scale (EPDS) (time frame: At enrollment, then weekly up to a total of 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2026.