Virtual Reality-enhanced Psychotherapy for Perinatal Depression

NCT ID: NCT07279311

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Virtual reality behavioral activation

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Danielle Panelli

Instructor in Obstetrics & Gynecology - Maternal Fetal Medicine, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Danielle M Panelli, MD MS

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Lucile Packard Children's Hospital

Palo Alto, California, United States

Countries

United States

Other Identifiers

79808

Identifier Type: -

Identifier Source: org_study_id