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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00069381
First received: September 24, 2003
Last updated: March 27, 2013
Last verified: March 2013

September 24, 2003
March 27, 2013
April 2002
July 2009   (final data collection date for primary outcome measure)
outcome [ Time Frame: within study timeframe ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00069381 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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. Epub 2010 Jul 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
144
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
Female
22 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00069381
R01 MH62347, R01MH062347, DSIR 83-ATAS
Not Provided
New York University School of Medicine
New York University School of Medicine
National Institute of Mental Health (NIMH)
Not Provided
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