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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07540585
Status
Not Yet Recruiting

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Conditions

  • ADHD - Attention Deficit Disorder With Hyperactivity
  • Anxiety Disorders
  • Depressive Disorder, Major
  • Pregnancy Complications
  • Pregnancy, High Risk
  • Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Collaborative Mental Health Care Program (CMHCP) — BEHAVIORAL
    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 symptom check-ins during hospitalization, and some may receive optional telehealth sessions if additional support is needed. Participants are contacted about three months after discharge for follow-up to assess mental health symptoms and well-being.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Prospective MOCHA Cohort
    Perinatal patients admitted to the Riley Maternity Tower for medically complex pregnancies who receive the Collaborative Mental Health Care Program (CMHCP). Participants are followed prospectively from inpatient admission through 3-month post-discharge follow-up.

Primary Outcome Measure

Change in depressive symptoms measured by the Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: From baseline (hospital admission) to 3 months post-discharge ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Riley Hospital for Children at Indiana University HealthIndianapolisIndiana46202
Tiffany R Williams, PhD
317-963-7300

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