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

This study has been completed.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00069381
  Purpose

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


Condition Intervention
Stress Disorders, Post-Traumatic
Behavioral: Psychotherapy treatment

MedlinePlus related topics:   Post-Traumatic Stress Disorder    Stress   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Skills Training, Exposure, and Their Combination in Childhood Abuse PTSD

Further study details as provided by National Institute of Mental Health (NIMH):

Estimated Enrollment:   144
Study Start Date:   April 2002

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.

  Eligibility
Ages Eligible for Study:   22 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069381

Locations
United States, New York
NYU Child Study Center Institute for Trauma and Stress    
      New York, New York, United States, 10016

Sponsors and Collaborators
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   R01 MH62347, DSIR 83-ATAS
First Received:   September 24, 2003
Last Updated:   October 15, 2008
ClinicalTrials.gov Identifier:   NCT00069381
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on October 31, 2008




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