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Enrolling by Invitation

NCT Number: NCT07279311

Virtual Reality-enhanced Psychotherapy for Perinatal Depression

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.

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Key information

Conditions

Depression During Pregnancy Behavior Behavioral Symptoms Depression

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Depressive symptoms scale score using Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: At enrollment, then weekly up to a total of 3 weeks

    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.

Secondary outcomes

  1. Feasibility - dropout rate

    Time frame: Weekly, up to 3 weeks

    Number of participants who withdraw from the study (after enrollment) divided by total enrollment number

  2. Feasibility - compliance rate

    Time frame: Weekly, up to 3 weeks

    Percentage of patients who complete VR-BA 4 sessions per week (total of 12).

  3. Feasibility - adverse event rate

    Time frame: 3 weeks

    Occurrence of any of the following during the study: nausea, falls, seizure, suicidal ideation.

  4. Acceptability - Presence Questionnaire

    Time frame: Weekly, up to 3 weeks

    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".

  5. Acceptability - Technology Acceptance Model

    Time frame: Weekly, up to 3 weeks

    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".

  6. Tolerability - Simulator Sickness Questionnaire

    Time frame: Weekly, up to 3 weeks

    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".

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 12, 2025
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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