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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:
ClinicalTrials.gov Identifier:
NCT00602732
First Posted: January 28, 2008
Last Update Posted: March 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Butler Hospital
  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 (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 ]

Secondary Outcome Measures:
  • Revised Conflict Tactic Scale (CTS2) [ Time Frame: Measured at Year 1 ]
  • Edinburgh Postnatal Depression Scale [ Time Frame: Measured at Year 1 ]
  • The Davidson Trauma Scale [ Time Frame: Measured at Year 1 ]
  • The Arizona Social Support Interview Schedule [ Time Frame: Measured at Year 1 ]
  • Parenting Stress Index [ Time Frame: Measured at Year 1 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602732


Locations
United States, Rhode Island
Memorial Hospital
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Butler Hospital
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Caron Zlotnick, PhD Butler Hospital
  More Information

Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT00602732     History of Changes
Other Study ID Numbers: R34MH075013 ( U.S. NIH Grant/Contract )
DSIR 83-ATP
First Submitted: January 22, 2008
First Posted: January 28, 2008
Last Update Posted: March 28, 2014
Last Verified: March 2014

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications