About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
This study includes perinatal patients admitted to the Riley Maternity Tower for medically complex pregnancies or birth-related complications. Participants may be pregnant or recently postpartum and require an extended inpatient hospital stay due to one or more obstetric risk factors or adverse pregnancy outcomes. Patients who give birth during hospitalization and remain admitted are also eligible to participate. All participants must be at least 18 years old, English-speaking, and able to complete study questionnaires during hospitalization and again approximately three months after discharge. Therapy sessions take place in the inpatient setting. To complete follow-up assessments, participants must have access to a smartphone or computer with internet service, a webcam or phone, and a private space for a brief phone or telehealth interview.
Trial design
Cohort
Prospective
Treatments tested in this trial
Collaborative Mental Health Care Program (CMHCP)
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in depressive symptoms measured by the Edinburgh Postnatal Depression Scale (EPDS)
The Edinburgh Postnatal Depression Scale (EPDS) is a validated 10-item self-report questionnaire assessing depressive symptoms. Total scores range from 0 to 30, with higher scores indicating more severe depressive symptoms. The outcome is defined as the change in EPDS total score.
Change in anxiety symptoms measured by the Generalized Anxiety Disorder 7 (GAD-7)
The Generalized Anxiety Disorder 7 (GAD-7) is a validated 7-item self-report questionnaire assessing anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater anxiety. The outcome is defined as the change in GAD-7 total score.
Change in posttraumatic stress symptoms measured by the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5)
The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) is a validated 5-item yes/no self-report screening tool assessing posttraumatic stress symptoms. Higher scores indicate greater likelihood of clinically significant PTSD symptoms. The outcome is defined as the change in PC-PTSD-5 total score.
Feasibility of weekly symptom screening during hospitalization
Feasibility will be assessed as the percentage of enrolled participants who complete at least one weekly symptom mini-screen during hospitalization. Weekly mini-screens include abbreviated versions of the EPDS, GAD-7, and PC-PTSD-5 administered via REDCap. A participant will be considered compliant if all items within a given mini-screen are completed.
Secondary outcomes
Change in pregnancy-related stress measured by the Prenatal Maternal Stress Scale (PMSS)
The Prenatal Maternal Stress Scale (PMSS) is a 15-item self-report measure assessing pregnancy-specific stress, with total scores ranging from 0 to 45. Higher scores indicate greater pregnancy-related stress. The outcome is defined as the change in PMSS total score.
Stress symptoms measured by the Perceived Stress Scale (PSS)
The Perceived Stress Scale (PSS) is a 10-item self-report measure assessing perceived stress, with total scores ranging from 0 to 40. Higher scores indicate greater perceived stress. The outcome is defined as the PSS total score.
Exposure and appraisal of stressful life events measured by the Perinatal Life Events Checklist (PLEC)
The Perinatal Life Events Checklist (PLEC) is a self-report checklist assessing exposure to stressful or difficult life events during pregnancy or the postpartum period. Participants indicate whether each event occurred and rate how stressful it was at the time. A summary score is calculated based on the number of endorsed events and/or severity ratings, depending on scoring rules, with higher scores indicating greater exposure to stressful life events.
Change in perinatal obsessive-compulsive symptoms measured by the Perinatal Obsessive-Compulsive Scale (POCS)
The Perinatal Obsessive-Compulsive Scale (POCS) is a 33-item self-report measure assessing perinatal-specific obsessions and compulsions. Total scores range from 0 to 40, with higher scores indicating greater symptom severity. The outcome is defined as the change in POCS total score.
Other outcomes
Perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS)
The Multidimensional Scale of Perceived Social Support (MSPSS) is a 12-item self-report measure assessing perceived support from family, friends, and a significant other. Total scores range from 12 to 84, with higher scores indicating greater perceived social support.
Perceived self-mastery measured by the Pearlin Self-Mastery Scale (PSMS)
The Pearlin Self-Mastery Scale (PSMS) is a 7-item self-report measure assessing perceived control and coping ability. Total scores range from 7 to 28, with higher scores indicating greater perceived self-mastery.
Sponsors and contacts
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