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. Identifier: NCT00069381
Recruitment Status : Completed
First Posted : September 25, 2003
Last Update Posted : March 29, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York University School of Medicine

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

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Behavioral: Psychotherapy treatment Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Skills Training, Exposure, and Their Combination in Childhood Abuse PTSD
Study Start Date : April 2002
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: study arm Behavioral: Psychotherapy treatment

Primary Outcome Measures :
  1. outcome [ Time Frame: within study timeframe ]

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00069381

United States, New York
NYU Child Study Center Institute for Trauma and Stress
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
National Institute of Mental Health (NIMH)

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: New York University School of Medicine Identifier: NCT00069381     History of Changes
Other Study ID Numbers: R01MH062347 ( U.S. NIH Grant/Contract )
R01MH062347 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2003    Key Record Dates
Last Update Posted: March 29, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders