Recruiting

Collaborative Mental Health

Sponsor:

Indiana University

Code:

NCT07540585

Conditions

Anxiety Disorders

Stress Disorders, Post-Traumatic

Pregnancy, High Risk

Depressive Disorder, Major

Pregnancy Complications

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Collaborative Mental Health Care Program (CMHCP)

Study Details

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

Study ID

NCT07540585

Start date

Jul 15, 2026

Status verified date

Sep, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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 ]
  • Change in anxiety symptoms measured by the Generalized Anxiety Disorder 7 (GAD-7) [ Time Frame: 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) [ Time Frame: From baseline (hospital admission) to 3 months post-discharge ]
  • Feasibility of weekly symptom screening during hospitalization [ Time Frame: During hospitalization (from admission to discharge) ]
  • Acceptability of psychotherapy sessions measured by the Session Rating Scale (SRS) [ Time Frame: During hospitalization (from admission to discharge) ]
  • Fidelity to psychotherapy protocol: percentage of scheduled sessions delivered [ Time Frame: During hospitalization (from admission to discharge) ]
  • Acceptability of the MOCHA program measured by the Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: 3 months post-discharge ]
  • 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 ]

Central Contacts and Locations

Central contacts

Tiffany R Williams, PhD

317-963-7300tw84@iu.edu

Locations

Riley Hospital for Children at Indiana University Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Tiffany R Williams, PhD

317-963-7300tw84@iu.edu

Angela G Campbell, PhD

anggcamp@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Indiana University on 2026-09-08.