Virtual Reality-enhanced Psychotherapy for Perinatal Depression

NCT07279311 | Not Yet Recruiting

• 1 other identifier: 79808
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

pregnancy; high risk pregnancy; antepartum hospitalization; depression; maternal mental health; virtual reality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Feasibility - dropout rate

  Weekly, up to 3 weeks

• Feasibility - compliance rate

  Weekly, up to 3 weeks

• Feasibility - adverse event rate

  3 weeks

• Acceptability - Presence Questionnaire

  Weekly, up to 3 weeks

• Acceptability - Technology Acceptance Model

  Weekly, up to 3 weeks

Study Arms (2)

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.

Behavioral: Virtual reality behavioral activation

Interventions

Virtual reality behavioral activation BEHAVIORAL

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.

Virtual-Reality Behavioral Activation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Danielle M Panelli, MD MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Obstetrics & Gynecology - Maternal Fetal Medicine, Principal Investigator

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 12, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)