Clinical trial NCT05225025: A Pilot Trial of the Reach Out, Stay Strong, Essentials for Mothers of Newborns (ROSE) Postpartum Depression Prevention Intervention in Pregnant Patients Admitted to Strong Hospital
Official title: A Pilot Trial of the ROSE Postpartum Depression Prevention Intervention in Antepartum Patients Admitted to High-risk Obstetrics Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Postpartum Anxiety
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Mae Stone Goode Foundation
First posted: 2022-02-04
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a pilot, single-center, randomized controlled trial. It will

1. determine feasibility and acceptability of an evidence-based intervention for prevention of postpartum depression with antepartum patients on a high-risk obstetric unit,
2. determine what adaptations may be needed for an inpatient population
3. determine what retention strategies are most successful and acceptable for this patient population
4. estimate the effect size of an intervention for in-hospital distress, anxiety and depression
5. estimate the effect size of an intervention to reduce the risk of a post-partum depression diagnosis or depressive symptoms.


Eligibility criteria: Inclusion Criteria:

* Viable pregnancy between 20 weeks 0 days and 35 weeks 0 days gestation at the time of enrollment
* Anticipated admission to the hospital for \>5 days due to pregnancy complication requiring hospital observation
* Age \> 18 years
* Planned hospitalization at Strong Memorial Hospital through the duration of antepartum course
* Planned delivery at Strong Memorial Hospital

Exclusion Criteria:

* Fetal demise in utero
* Inability to give informed consent secondary to intellectual capacity
* English is not primary language used to communicate
* Currently incarcerated
* Age \< 18 years
* Planned antepartum hospitalization at another institution
* Planned delivery at another institution
* Actively suicidal or in need of acute psychiatric care

Primary outcomes:
measure: Subject-reported in-hospital distress
timeFrame: 14 days
measure: Subject-reported depressive symptom severity
timeFrame: 6 weeks postpartum
measure: Subject-reported anxiety symptom severity
timeFrame: 6 weeks postpartum
measure: Clinical diagnosis of depression
timeFrame: 6 weeks postpartum
Secondary outcomes:
Other outcomes:
measure: satisfaction with ROSE behavioral health intervention
timeFrame: 14 days and 6 weeks postpartum
measure: self-reported mother-infant bonding
timeFrame: 6 weeks postpartum
measure: self-reported functional status
timeFrame: 6 weeks postpartum
measure: percentage of eligible subjects who enrolled in the study
timeFrame: baseline
measure: percentage of enrolled subjects who completed all inpatient study activities
timeFrame: 14 days
measure: percentage of enrolled subjects who completed all inpatient plus outpatient study activities
timeFrame: 6 weeks postpartum
Locations:
city: Rochester
country: United States
facility: Strong Hospital
state: New York
Study officials:
References: