Virtual Reality-enhanced Psychotherapy for Perinatal Depression

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07279311
Status
Enrolling By Invitation

Conditions

  • Depression During Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lucile Packard Children's HospitalPalo AltoCalifornia94304-

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