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NCT Number: NCT07540585

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

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.

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Key information

Conditions

Anxiety Disorders ADHD - Attention Deficit Disorder With Hyperactivity Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Depressive Disorder Depressive Disorder, Major Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Neurodevelopmental Disorders Pregnancy Complications Pregnancy, High Risk Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Urogenital Diseases

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, 46202, United States

Location contact

Tiffany R Williams, PhD

CONTACT

[email protected]

317-963-7300

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

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

    Time frame: From baseline (hospital admission) to hospital discharge

    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.

  2. Stress symptoms measured by the Perceived Stress Scale (PSS)

    Time frame: 3 months post-discharge

    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.

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

    Time frame: Baseline (hospital admission)

    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.

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

    Time frame: Baseline to 3 months post-discharge

    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

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

    Time frame: 3 months post-discharge

    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.

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

    Time frame: 3 months post-discharge

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tiffany R Williams, PhD

CONTACT

[email protected]

317-963-7300

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Acronym: MOCHA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 20, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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