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

NCT00602732 | Completed Phase 1 DMC

• 2 other identifiers: R34MH075013DSIR 83-ATP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression, Postpartum; Depression

Keywords

Partner Abuse; Preventive Intervention; Postpartum Depression; Postpartum PTSD

Outcome Measures

Primary Outcomes (1)

• Longitudinal Interval Follow-up Examination (LIFE)

  Measured at Year 1

Secondary Outcomes (5)

• Revised Conflict Tactic Scale (CTS2)

  Measured at Year 1

• Edinburgh Postnatal Depression Scale

  Measured at Year 1

• The Davidson Trauma Scale

  Measured at Year 1

• The Arizona Social Support Interview Schedule

  Measured at Year 1

• Parenting Stress Index

  Measured at Year 1

Study Arms (2)

1

EXPERIMENTAL

Participants assigned to the ROSE program

Behavioral: The Reach Out for a Safe Environment (ROSE) program

2

ACTIVE COMPARATOR

Participants assigned to enhanced care as usual

Behavioral: Enhanced care as usual (ECU)

Interventions

The Reach Out for a Safe Environment (ROSE) program BEHAVIORAL

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.

Also known as: Reach Out Stay Strong: Essentials for New Mothers

1

Enhanced care as usual (ECU) BEHAVIORAL

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.

2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• weeks or less gestation

You may not qualify if:

• Meets current criteria for major depressive disorder or post-traumatic stress disorder

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Memorial Hospital

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Depression, Postpartum; Depression

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Caron Zlotnick, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: January 28, 2008
• Study Start: September 1, 2005
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 28, 2014

Record last verified: 2014-03

Locations

US (1)