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

NCT07540585 | Not Yet Recruiting

• 1 other identifier: MOCHA-IMP-2026
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Collaborative Mental Health Care Program; Inpatient high-risk pregnancy support; MOCHA; High-risk pregnancy mental health; Perinatal psychotherapy; Trauma-informed therapy

Outcome Measures

Primary Outcomes (8)

• 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.

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

• 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.

  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)

  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.

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

• 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.

  During hospitalization (from admission to discharge)

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

  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.

  During hospitalization (from admission to discharge)

• Fidelity to psychotherapy protocol: percentage of scheduled sessions delivered

  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.

  During hospitalization (from admission to discharge)

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

  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.

  3 months post-discharge

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

  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.

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

Secondary Outcomes (4)

• Change in pregnancy-related stress measured by the Prenatal Maternal Stress Scale (PMSS)

  From baseline (hospital admission) to hospital discharge

• Stress symptoms measured by the Perceived Stress Scale (PSS)

  3 months post-discharge

• Exposure and appraisal of stressful life events measured by the Perinatal Life Events Checklist (PLEC)

  Baseline (hospital admission)

• Change in perinatal obsessive-compulsive symptoms measured by the Perinatal Obsessive-Compulsive Scale (POCS)

  Baseline to 3 months post-discharge

Other Outcomes (2)

• Perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS)

  3 months post-discharge

• Perceived self-mastery measured by the Pearlin Self-Mastery Scale (PSMS)

  3 months post-discharge

Study Arms (1)

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.

Behavioral: Collaborative Mental Health Care Program (CMHCP)

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.

Prospective MOCHA Cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Post-Traumatic; Depressive Disorder, Major; Pregnancy Complications; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Depressive Disorder; Mood Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Study Officials

• Tiffany R Williams, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany R Williams, PhD

CONTACT

317-963-7300; tw84@iu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Profressor

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)