跳至主要内容
临床试验/NCT07279311
NCT07279311Enrolling By Invitation不适用

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

Stanford University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2026年3月31日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
44
试验地点
1
主要终点
Depressive symptoms scale score using Edinburgh Postnatal Depression Scale (EPDS)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: Virtual reality behavioral activation (Behavioral)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Feasibility - dropout rate(Weekly, up to 3 weeks)
  • Feasibility - compliance rate(Weekly, up to 3 weeks)
  • Feasibility - adverse event rate(3 weeks)
  • Acceptability - Technology Acceptance Model(Weekly, up to 3 weeks)
  • Acceptability - Presence Questionnaire(Weekly, up to 3 weeks)
  • Tolerability - Simulator Sickness Questionnaire(Weekly, up to 3 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Danielle Panelli

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

Stanford University

研究点 (1)

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