Anxiety DisordersMOCHANCT07540585
MOCHA: Embedded Inpatient Mental Health Care for High-Risk Perinatal Patients
An observational study of Anxiety Disorders and Stress Disorders, Post-Traumatic, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Anxiety Disorders, Stress Disorders, Post-Traumatic, Pregnancy, High Risk
- What is being tested?
- Collaborative Mental Health Care Program (CMHCP)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to 1 Sep 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202
Tiffany R Williams, PhD, 317-963-7300, tw84@iu.edu
Angela G Campbell, PhD, anggcamp@iu.edu
About this study
Official title: MOCHA Protocol: 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.
Read the detailed description
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.
- Conditions
- Anxiety Disorders, Stress Disorders, Post-Traumatic, Pregnancy, High Risk, Depressive Disorder, Major, Pregnancy Complications, ADHD - Attention Deficit Disorder With Hyperactivity
- Being tested
- Collaborative Mental Health Care Program (CMHCP)
- Keywords
- Collaborative Mental Health Care Program, Inpatient high-risk pregnancy support, MOCHA, High-risk pregnancy mental health, Perinatal psychotherapy, Trauma-informed therapy
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic, Depressive Disorder, Major, Pregnancy Complications, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Mental Health Care Program (CMHCP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Collaborative Mental Health Care Program (CMHCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: From baseline (hospital admission) to hospital discharge
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.
Measured: 3 months post-discharge
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.
Measured: Baseline (hospital admission)
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.
Measured: Baseline to 3 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start15 Jul 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiffany R. Williams, Indiana University
- Investigators
- Tiffany R Williams, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540585
- Sponsor's protocol ID
- MOCHA-IMP-2026
- Acronym
- MOCHA
- Status last verified
- Sep 2026
- First submitted
- 16 Mar 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual level data will be shared; de identified aggregate results will be reported.