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

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.
ClinicalTrials.gov Identifier: NCT00069381
Recruitment Status : Completed
First Posted : September 25, 2003
Last Update Posted : March 29, 2013
Information provided by (Responsible Party):

September 24, 2003
September 25, 2003
March 29, 2013
April 2002
July 2009   (Final data collection date for primary outcome measure)
outcome [ Time Frame: within study timeframe ]
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Complete list of historical versions of study NCT00069381 on ClinicalTrials.gov Archive Site
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Treatment for Women With Post-Traumatic Stress Disorder Related to Childhood Abuse
Skills Training, Exposure, and Their Combination in Childhood Abuse PTSD
This study will compare one- and two-component treatments in women with post-traumatic stress disorder (PTSD).

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.

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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Stress Disorders, Post-Traumatic
Behavioral: Psychotherapy treatment
Experimental: study arm
Intervention: Behavioral: Psychotherapy treatment
Cloitre M, Stovall-McClough KC, Nooner K, Zorbas P, Cherry S, Jackson CL, Gan W, Petkova E. Treatment for PTSD related to childhood abuse: a randomized controlled trial. Am J Psychiatry. 2010 Aug;167(8):915-24. doi: 10.1176/appi.ajp.2010.09081247. Epub 2010 Jul 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2009
July 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
22 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R01MH062347( U.S. NIH Grant/Contract )
R01MH062347 ( U.S. NIH Grant/Contract )
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New York University School of Medicine
New York University School of Medicine
National Institute of Mental Health (NIMH)
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New York University School of Medicine
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP