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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

Skills Training, Exposure, and Their Combination in Childhood Abuse PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069381
• Other study ID #: R01MH062347
• Secondary ID: R01MH062347DSIR
• Status: Completed
• Phase: N/A
• First received: September 24, 2003
• Last updated: March 27, 2013
• Start date: April 2002
• Est. completion date: July 2009

Study information

• Verified date: March 2013
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Psychotherapy treatment

Locations

Country	Name	City	State
United States	NYU Child Study Center Institute for Trauma and Stress	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	outcome		within study timeframe	No

External Links

•   Link