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

Postpartum Depression Clinical Trial

Official title:

A Pilot Trial of the ROSE Postpartum Depression Prevention Intervention in Antepartum Patients Admitted to High-risk Obstetrics Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05225025
• Other study ID #: STUDY00005941
• Status: Completed
• Phase: N/A
• Start date: July 5, 2021
• Est. completion date: May 2, 2022

Study information

• Verified date: June 2022
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2, 2022
• Est. primary completion date: May 2, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Anxiety
• Postpartum Depression

Intervention

Behavioral:
• ROSE
The ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) program is an evidence-based intervention that has been proven to reduce cases of post-partum depression among low-income and racially and ethnically diverse women. ROSE is administered to pregnant women in small group settings, typically in the same location that prenatal care is being provided (in this study, a hospital setting). It is divided into four 90-minute group sessions and teaches interpersonal psychotherapy-based skills that mitigate identified risk factors for PPD such as social support, stress management skills and communication. ROSE curriculum will be implemented using groups in a continuous cycle, with patients entering into the intervention curriculum at the time of their enrollment and continuing through until all 4 total sessions have been accomplished.

Other:
• Standard of Care
Usual hospital care with no behavioral intervention

Locations

Country	Name	City	State
United States	Strong Hospital	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Mae Stone Goode Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	satisfaction with ROSE behavioral health intervention	Satisfaction score will be measured using the Client Satisfaction Questionnaire-8 (CSQ-8). The scores range from 8-32, with greater satisfaction indicated by higher scores.	14 days and 6 weeks postpartum
Other	self-reported mother-infant bonding	Mother-infant bonding will be assessed over four domains by the Postpartum Bonding Questionnaire (PBQ). Scores range from 0-125, with worse outcome indicated by higher scores.	6 weeks postpartum
Other	self-reported functional status	Functional status will be assessed using the Inventory of Functional Status After Childbirth (IFSAC) measure. Scores range from 36-144, with higher scores indicating better outcome.	6 weeks postpartum
Other	percentage of eligible subjects who enrolled in the study		baseline
Other	percentage of enrolled subjects who completed all inpatient study activities		14 days
Other	percentage of enrolled subjects who completed all inpatient plus outpatient study activities		6 weeks postpartum
Primary	Subject-reported in-hospital distress	Hospital distress will be measured using the Depression, Anxiety and Stress Scale-21 (DASS-21) Stress subscale. Stress subscale ranges from 0 to 42 with higher scores indicating worse outcome.	14 days
Primary	Subject-reported depressive symptom severity	Depressive symptom severity will be measured using the Edinburgh Postnatal Depression Scale (EPDS). The scale ranges from 0-30 with higher scores indicating worse outcome.	6 weeks postpartum
Primary	Subject-reported anxiety symptom severity	Anxiety symptom severity will be measured using the General Anxiety Disorder-7 (GAD-7) measurement scale. The scale ranges from 0 to 21 with higher scores indicating worse outcome.	6 weeks postpartum
Primary	Clinical diagnosis of depression	Diagnosis of depression will be made using the Mini International Neuropsychiatric Interview (M.I.N.I) brief structured diagnostic interview which explores, in a standardized way, the main psychiatric disorders of Axis I of the DSM-IV TR. Only modules A and B (Major depressive episode and dysthymia) will be used. This structured interview contains questions with binary answers, with Yes indicating worse outcome.	6 weeks postpartum