Postpartum Anxiety, Postpartum Depression
Conditions
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.
Interventions
BEHAVIORALROSE
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.
OTHERStandard of Care
Usual hospital care with no behavioral intervention
Sponsors
Mae Stone Goode Foundation
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject-reported in-hospital distress | 14 days | 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. |
| Subject-reported depressive symptom severity | 6 weeks postpartum | 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. |
| Subject-reported anxiety symptom severity | 6 weeks postpartum | 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. |
| Clinical diagnosis of depression | 6 weeks postpartum | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| percentage of enrolled subjects who completed all inpatient study activities | 14 days | — |
| satisfaction with ROSE behavioral health intervention | 14 days and 6 weeks postpartum | 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. |
| percentage of enrolled subjects who completed all inpatient plus outpatient study activities | 6 weeks postpartum | — |
| self-reported mother-infant bonding | 6 weeks postpartum | 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. |
| self-reported functional status | 6 weeks postpartum | 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. |
| percentage of eligible subjects who enrolled in the study | baseline | — |
Countries
United States
Outcome results
None listed