Treatment for Women With Post-Traumatic Stress Disorder Related to Childhood Abuse

Not Applicable

Completed

• Conditions: Stress Disorders, Post-Traumatic
• Interventions: Behavioral: Psychotherapy treatment

• Registration Number: NCT00069381
• Lead Sponsor: NYU Langone Health

Brief Summary

This study will compare one- and two-component treatments in women with post-traumatic stress disorder (PTSD).

Detailed Description

PTSD is a debilitating and often chronic anxiety disorder with serious psychiatric comorbidity. The most common trauma associated with PTSD among women is childhood abuse. PTSD related to childhood abuse may cause problems with emotion regulation and interpersonal functioning. This study will address three domains of PTSD related to childhood abuse: emotion management problems, interpersonal problems, and PTSD symptoms.

Participants in this study will be randomly assigned to 16 sessions of one of three treatments: Skills Training for Affective and Interpersonal Regulation (STAIR), which focuses on helping individuals strengthen and build skills in managing feelings and improving interpersonal relationships; Modified Prolonged Exposure (MPE), which focuses on developing narratives of abuse history and completing an "emotional processing" of the trauma in a safe environment; and a combination of STAIR and MPE. Dropout rates and adverse effects will be measured.

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2003-09-24
• Study First Submitted QC: 2003-09-24
• Study First Posted: 2003-09-25
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-27
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

Inclusion Criteria

• DSM-IV criteria for Post-Traumatic Stress Disorder related to childhood physical and/or sexual abuse by a care-giver
• At least one clear memory of the abuse
• Willing to have all assessments tape recorded and sessions video taped
• Willing to maintain any concurrent treatments for the duration of the study

Exclusion Criteria

• Bipolar Disorder
• Eating Disorder
• Borderline Personality Disorder
• Active substance abuse or dependence
• Living with the abuser
• Self mutilation
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study arm	Psychotherapy treatment	-

Primary Outcome Measures

Name	Time	Method
outcome	within study timeframe

Trial Locations

Locations (1)

NYU Child Study Center Institute for Trauma and Stress; 🇺🇸 New York, New York, United States