Virtual Reality-enhanced Psychotherapy for Perinatal Depression

Official title

Virtual Reality-enhanced Psychotherapy as a Mental Health Intervention During Antepartum Hospitalization: A Pilot Randomized Controlled Trial

Overview

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.

Interventions

• 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.

Primary outcome measures

• Depressive symptoms scale score using Edinburgh Postnatal Depression Scale (EPDS) [Time frame: At enrollment, then weekly up to a total of 3 weeks]

Secondary outcome measures (6)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Lucile Packard Children's Hospital — Palo Alto

Identifiers

NCT: NCT07279311 · 79808

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗