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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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Skills Training, Exposure, and Their Combination in Childhood Abuse PTSD

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • outcome [ Time Frame: within study timeframe ] [ Designated as safety issue: No ]

Enrollment: 144
Study Start Date: April 2002
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: study arm Behavioral: Psychotherapy treatment

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
New York University School of Medicine
  More Information

Additional Information:
No publications provided by New York University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00069381     History of Changes
Other Study ID Numbers: R01 MH62347, R01MH062347, DSIR 83-ATAS
Study First Received: September 24, 2003
Last Updated: March 27, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014