Treatment for Women With Post-Traumatic Stress Disorder Related to Childhood Abuse
Primary Purpose
Stress Disorders, Post-Traumatic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychotherapy treatment
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic
Eligibility 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
Sites / Locations
- NYU Child Study Center Institute for Trauma and Stress
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
study arm
Arm Description
Outcomes
Primary Outcome Measures
outcome
Secondary Outcome Measures
Full Information
NCT ID
NCT00069381
First Posted
September 24, 2003
Last Updated
March 27, 2013
Sponsor
NYU Langone Health
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00069381
Brief Title
Treatment for Women With Post-Traumatic Stress Disorder Related to Childhood Abuse
Official Title
Skills Training, Exposure, and Their Combination in Childhood Abuse PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief Summary
This study will compare one- and two-component treatments in women with post-traumatic stress disorder (PTSD).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study arm
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy treatment
Primary Outcome Measure Information:
Title
outcome
Time Frame
within study timeframe
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
NYU Child Study Center Institute for Trauma and Stress
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20595411
Citation
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.
Results Reference
derived
Links:
URL
http://www.AboutOurKids.org
Description
Related Info
Learn more about this trial
Treatment for Women With Post-Traumatic Stress Disorder Related to Childhood Abuse
We'll reach out to this number within 24 hrs