Interpersonal Treatment Program to Prevent Depression and Post-Traumatic Stress Disorder in Low-Income Pregnant Women With Partner Abuse

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Butler Hospital
ClinicalTrials.gov Identifier:
NCT00602732
First received: January 22, 2008
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

This study will evaluate the effectiveness of an interpersonally oriented treatment program called Reach Out for a Safe Environment in preventing depression and post-traumatic stress disorder in low-income pregnant women who have experienced recent partner abuse.


Condition Intervention Phase
Depression, Postpartum
Depression
Behavioral: The Reach Out for a Safe Environment (ROSE) program
Behavioral: Enhanced care as usual (ECU)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intervention for Low-income Pregnant Women With Partner Abuse

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Longitudinal Interval Follow-up Examination (LIFE) [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Revised Conflict Tactic Scale (CTS2) [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Edinburgh Postnatal Depression Scale [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • The Davidson Trauma Scale [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • The Arizona Social Support Interview Schedule [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
  • Parenting Stress Index [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2005
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants assigned to the ROSE program
Behavioral: The Reach Out for a Safe Environment (ROSE) program
Participants in the ROSE program will receive a course on managing stress and negative feelings and will learn how to access resources for help. The ROSE program involves four 90-minute group sessions over a 4-week period prior to delivery. Participants will also attend one 50-minute booster session within 4 weeks prior to delivery of their babies.
Other Name: Reach Out Stay Strong: Essentials for New Mothers
Active Comparator: 2
Participants assigned to enhanced care as usual
Behavioral: Enhanced care as usual (ECU)
Participants in ECU will receive the usual medical care provided for pregnant women at their prenatal clinic. Participants will also receive educational material and a list of treatment resources for depression.

Detailed Description:

Each year, approximately 324,000 pregnant women experience partner abuse (PA). With the emotional highs and lows that accompany new motherhood, pregnancy is often a challenging process for many women. Experiencing PA, while already going through a vulnerable time during pregnancy, may have harmful effects on the well-being of the woman and her infant. Women affected by PA are at an increased risk for certain physical and psychological problems, including depression and post-traumatic stress disorder (PTSD). Furthermore, the emotional distress from PA may impair a woman's ability to seek out the necessary support to ensure the safety of herself and her children. There have been few research efforts to develop an effective treatment to reduce the psychological impact of PA on pregnant women and even fewer efforts that target low-income women, who make up a large portion of affected women. The Reach Out for a Safe Environment (ROSE) program is an interpersonally oriented treatment developed to address factors that may contribute to postpartum mental health difficulties associated with PA. This study will evaluate the effectiveness of the ROSE program in preventing depression and PTSD in low-income pregnant women who have experienced recent PA.

Participation in this single-blind study will last approximately 29 weeks. All potential participants will answer an initial questionnaire concerning their history of physical, sexual, or emotional abuse in the past year. Selected participants will then undergo an interview about symptoms of depression, reactions to trauma, emotional difficulties, and alcohol and drug use. Participants invited to continue in the study will then be randomly assigned to the ROSE program or enhanced care as usual (ECU). Participants assigned to the ROSE program will attend four weekly 90-minute group sessions prior to delivery and one individual 50-minute booster session within 4 weeks of delivery. During these sessions, participants will learn ways to manage stress and negative feelings and how to access helpful resources. Participants will also complete two questionnaires about emotional difficulties per week for the duration of the program. Participants assigned to ECU will receive the usual medical care provided for pregnant women and will receive educational material on depression.

All participants will complete questionnaires and interviews about their emotional difficulties, relationships with others, and use of services for these difficulties prior to treatment assignment, 4 weeks after treatment assignment, 4 weeks after delivery, and 3 months after delivery. Participants in the ROSE program will additionally complete a questionnaire about their perceptions of the program after the fourth treatment session and after the booster session.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to speak and read English sufficiently to complete the study procedures
  • Willing and able to receive public assistance
  • Identified as having experienced physical assault based on responses to CTS2 within 1 year prior to study entry
  • 35 weeks or less gestation

Exclusion Criteria:

  • Meets current criteria for major depressive disorder or post-traumatic stress disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602732

Locations
United States, Rhode Island
Memorial Hospital
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Butler Hospital
Investigators
Principal Investigator: Caron Zlotnick, PhD Butler Hospital
  More Information

No publications provided

Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT00602732     History of Changes
Other Study ID Numbers: R34 MH075013, R34MH075013, DSIR 83-ATP
Study First Received: January 22, 2008
Last Updated: March 27, 2014
Health Authority: United States: Federal Government

Keywords provided by Butler Hospital:
Partner Abuse
Preventive Intervention
Postpartum Depression
Postpartum PTSD

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Stress Disorders, Traumatic
Anxiety Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on September 29, 2014