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

BEHAVIORAL

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 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.

Change in depressive symptoms measured by the Edinburgh Postnatal Depression Scale (EPDS)

Time frame: From baseline (hospital admission) to 3 months post-discharge

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)

Time frame: From baseline (hospital admission) to 3 months post-discharge

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)

Time frame: From baseline (hospital admission) to 3 months post-discharge

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

Time frame: During hospitalization (from admission to discharge)

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.

Acceptability of psychotherapy sessions measured by the Session Rating Scale (SRS)

Time frame: During hospitalization (from admission to discharge)

The Session Rating Scale (SRS) is a 4-item visual analogue scale (0-10 per item), with total scores ranging from 0 to 40. Higher scores indicate stronger therapeutic alliance and greater acceptability. The outcome is defined as the change in SRS total score.

Fidelity to psychotherapy protocol: percentage of scheduled sessions delivered

Time frame: During hospitalization (from admission to discharge)

Fidelity will be assessed as the percentage of scheduled psychotherapy sessions that are delivered according to the study protocol. Protocol-adherent sessions are defined as CBT- or DBT-informed psychotherapy sessions lasting 45-60 minutes and documented by clinicians. The numerator will be the number of sessions delivered per protocol, and the denominator will be the total number of scheduled sessions during hospitalization.

Acceptability of the MOCHA program measured by the Client Satisfaction Questionnaire (CSQ-8)

Time frame: 3 months post-discharge

The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report measure assessing overall satisfaction with the MOCHA program. Total scores range from 8 to 32, with higher scores indicating greater satisfaction. The outcome is defined as the change in CSQ-8 total score.

Change in symptoms of Attention Deficit Hyperactivity Disorder as measured by Adult ADHD Self-Report Scale

Time frame: From baseline (hospital admission) to 3 months post-discharge

The Adult ADHD Self-Report Scale (ASRS) is a validated self-report questionnaire assessing symptoms of attention-deficit/hyperactivity disorder (ADHD) in adults. The scale includes items assessing inattentive and hyperactive-impulsive symptoms, with higher scores indicating greater ADHD symptom severity. The outcome is defined as the change in PMSS total score.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.