MOCHA: Embedded Inpatient Mental Health Care for High-Risk Perinatal Patients

Официальное название

MOCHA Protocol: Embedded Inpatient Mental Health Care for High-Risk Perinatal Patients

Обзор

Pregnant and postpartum patients hospitalized for medical complications experience high rates of depression, anxiety, and trauma-related symptoms, yet access to timely psychiatric care during obstetric hospitalization is limited. Project MOCHA integrates early mental health screening, trauma-informed psychotherapy, and structured follow-up into routine inpatient maternity care for individuals at elevated clinical risk. This single-arm implementation study examines the feasibility, acceptability, and fidelity of delivering a Collaborative Mental Health Care Program within a high-risk obstetric inpatient setting. The program includes brief inpatient psychotherapy, symptom monitoring, and post-discharge follow-up over three months. Preliminary changes in depression, anxiety, attention-deficit hyperactivity disorder, and posttraumatic stress symptoms will be assessed to inform future effectiveness trials and broader health system integration.

Подробное описание

Project MOCHA is a low-risk study that investigates how well a collaborative mental health care program can be delivered to pregnant and postpartum patients who are hospitalized for medical complications. The program is offered on a high-risk obstetric unit at the Riley Maternity Tower and is designed to support emotional well-being during and after hospitalization.

Before joining the study, all patients receive their usual medical care. This includes evaluation in the Emergency Department and routine psychosocial assessments completed by hospital staff. These activities are part of standard care and not part of the research study. Study activities begin only after a patient is admitted to the high-risk obstetric unit, eligibility is confirmed through chart review, and informed consent is obtained.

After enrollment, participants complete a brief mental health questionnaire using a secure electronic system. Participants may then receive individual therapy sessions during their hospital stay. Therapy sessions are brief and adjusted to each patient's medical condition and length of stay. The sessions use trauma-informed approaches to help patients manage stress, mood symptoms, anxiety, and trauma-related concerns. After each therapy session, participants complete a short symptom check. Some participants may also be offered telehealth sessions between in-person visits if additional support is needed.

About three months after leaving the hospital, participants are contacted to complete a follow-up check-in that lasts about 15 to 20 minutes. This follow-up is done by phone or telehealth and includes questions about mental health symptoms and overall well-being. Participants may choose to continue therapy after discharge as part of routine clinical care for up to one year, but continued therapy is not required to take part in the study.

To better understand how the program compares to care before it was available, the study will also review records from patients who received individual therapy on the inpatient obstetric unit before Project MOCHA began. Some of these former patients may be contacted three to six months after discharge to complete a brief symptom check and interview. Medical record information will be reviewed for descriptive comparison only.

The main goal of the study is to understand whether this program can be carried out as planned in a hospital setting and whether patients find it useful and acceptable. The study also examines changes in symptoms such as depression, anxiety, attention-deficit hyperactivity disorder, and trauma-related stress over time. Information from this study will help improve mental health care for hospitalized obstetric patients and guide future research.

Вмешательства

• Поведенческое Collaborative Mental Health Care Program (CMHCP)
  The CMHCP intervention provides mental health support to pregnant and postpartum patients hospitalized for medical complications on a high-risk obstetric unit. After enrollment, participants complete a brief mental health questionnaire. During their hospital stay, participants may receive brief individual therapy sessions delivered in person and adapted to medical needs and length of stay. Therapy uses trauma-informed strategies to support emotional well-being. Participants complete short sympto

Первичные конечные точки

• Change in depressive symptoms measured by the Edinburgh Postnatal Depression Scale (EPDS) [Срок оценки: From baseline (hospital admission) to 3 months post-discharge]
• Change in anxiety symptoms measured by the Generalized Anxiety Disorder 7 (GAD-7) [Срок оценки: From baseline (hospital admission) to 3 months post-discharge]
• Change in posttraumatic stress symptoms measured by the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) [Срок оценки: From baseline (hospital admission) to 3 months post-discharge]
• Feasibility of weekly symptom screening during hospitalization [Срок оценки: During hospitalization (from admission to discharge)]
• Acceptability of psychotherapy sessions measured by the Session Rating Scale (SRS) [Срок оценки: During hospitalization (from admission to discharge)]
• Fidelity to psychotherapy protocol: percentage of scheduled sessions delivered [Срок оценки: During hospitalization (from admission to discharge)]
• Acceptability of the MOCHA program measured by the Client Satisfaction Questionnaire (CSQ-8) [Срок оценки: 3 months post-discharge]
• Change in symptoms of Attention Deficit Hyperactivity Disorder as measured by Adult ADHD Self-Report Scale [Срок оценки: From baseline (hospital admission) to 3 months post-discharge]

Вторичные конечные точки (4)

• Change in pregnancy-related stress measured by the Prenatal Maternal Stress Scale (PMSS) [Срок оценки: From baseline (hospital admission) to hospital discharge]
• Stress symptoms measured by the Perceived Stress Scale (PSS) [Срок оценки: 3 months post-discharge]
• Exposure and appraisal of stressful life events measured by the Perinatal Life Events Checklist (PLEC) [Срок оценки: Baseline (hospital admission)]
• Change in perinatal obsessive-compulsive symptoms measured by the Perinatal Obsessive-Compulsive Scale (POCS) [Срок оценки: Baseline to 3 months post-discharge]

Критерии участия

Критерии включения

• 18 years old or older
• Pregnant (or recently have given birth) at any gestational age
• Must have experienced at least one adverse pregnancy outcome
• Admitted for an extended inpatient stay
• English speaking

Критерии исключения

• Under 18 years old
• Not currently pregnant or past one year postpartum
• Not experienced at least one adverse pregnancy outcome
• Not admitted for an extended inpatient stay at RMT

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Riley Hospital for Children at Indiana University Health — Indianapolis

Идентификаторы

NCT: NCT07540585 · MOCHA-IMP-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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