Depression During Pregnancy
Conditions
Keywords
pregnancy, high risk pregnancy, antepartum hospitalization, depression, maternal mental health, virtual reality
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.
Interventions
BEHAVIORALVirtual 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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms scale score using Edinburgh Postnatal Depression Scale (EPDS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - dropout rate | Weekly, up to 3 weeks | Number of participants who withdraw from the study (after enrollment) divided by total enrollment number |
| Feasibility - compliance rate | Weekly, up to 3 weeks | Percentage of patients who complete VR-BA 4 sessions per week (total of 12). |
| Feasibility - adverse event rate | 3 weeks | Occurrence of any of the following during the study: nausea, falls, seizure, suicidal ideation. |
| Acceptability - Presence Questionnaire | 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". |
| Acceptability - Technology Acceptance Model | 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". |
| Tolerability - Simulator Sickness Questionnaire | 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". |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDanielle M Panelli, MD MS
Stanford University
Outcome results
None listed