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Completed

NCT Number: 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

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.

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Key information

Conditions

Postpartum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Postpartum Anxiety Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Strong Hospital

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ROSE

Behavioral

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.

Standard of care

Other

Usual hospital care with no behavioral intervention

Primary outcomes

  1. Subject-reported in-hospital distress

    Time frame: 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.

  2. Subject-reported depressive symptom severity

    Time frame: 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.

  3. Subject-reported anxiety symptom severity

    Time frame: 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.

  4. Clinical diagnosis of depression

    Time frame: 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 outcomes

  1. satisfaction with ROSE behavioral health intervention

    Time frame: 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.

  2. self-reported mother-infant bonding

    Time frame: 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.

  3. self-reported functional status

    Time frame: 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.

  4. percentage of eligible subjects who enrolled in the study

    Time frame: baseline

  5. percentage of enrolled subjects who completed all inpatient study activities

    Time frame: 14 days

  6. percentage of enrolled subjects who completed all inpatient plus outpatient study activities

    Time frame: 6 weeks postpartum

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Mae Stone Goode Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 4, 2022
Registry last updated
Jun 13, 2022

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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