Virtual Reality-enhanced Psychotherapy as a Mental Health Intervention During Antepartum Hospitalization: A Pilot Randomized Controlled Trial
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
- 否
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
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
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
Danielle Panelli
Instructor in Obstetrics & Gynecology - Maternal Fetal Medicine, Principal Investigator
Stanford University
