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Not yet recruiting NCT07540585

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

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

Sponsor: Indiana University

trial.available_in: БГ
Overview
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.
Description
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.
Who can participate
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Interventions
Collaborative Mental Health Care Program (CMHCP)
BEHAVIORAL
Locations 1
United States (1)
Riley Hospital for Children at Indiana University Health
Indianapolis , Indiana
Tiffany R Williams, PhD
Technical details
Status
Not yet recruiting
Study type
OBSERVATIONAL
Sex
Female only
Minimum age
18 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
01.06.2026
Completion date
01.06.2027
Registry ID
NCT07540585
Source
clinicaltrials.gov
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