Virtual Reality-enhanced Psychotherapy for Perinatal Depression

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Depression During Pregnancy
• Intervention / Treatment: Behavioral: Virtual reality behavioral activation

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients with serious neuropsychiatric illness (bipolar disorder, schizophrenia, epilepsy, or suicidal ideation)
• Known delivery planned within the next 3 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; 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).
Experimental: Virtual-Reality Behavioral Activation; 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.	Behavioral: Virtual reality behavioral activation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At enrollment, then weekly up to a total of 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - dropout rate	Number of participants who withdraw from the study (after enrollment) divided by total enrollment number	Weekly, up to 3 weeks
Feasibility - compliance rate	Percentage of patients who complete VR-BA 4 sessions per week (total of 12).	Weekly, up to 3 weeks
Feasibility - adverse event rate	Occurrence of any of the following during the study: nausea, falls, seizure, suicidal ideation.	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".	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".	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".	Weekly, up to 3 weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Danielle M Panelli, MD MS, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: depression; pregnancy; virtual reality; maternal mental health; high risk pregnancy; antepartum hospitalization
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: 79808

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No