Treatment for Women With Post-Traumatic Stress Disorder R... | NCT00069381

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

NCT00069381

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Mar 29, 2013Estimated

Enrollment

144Actual

Phase

Not Applicable

Conditions

Stress Disorders, Post-Traumatic

Interventions

Psychotherapy treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01MH062347	U.S. NIH Grant/Contract		View source
DSIR 83-ATAS

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2002

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Sep 24, 2003

First Submission Date that Met QC Criteria

Sep 24, 2003

First Posted Date

Sep 25, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2013

Last Update Posted Date

Mar 29, 2013Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

144Actual

Label	Type	Description	Intervention Names
study arm	Experimental		Behavioral: Psychotherapy treatment

Name	Type	Description	Arm Group Labels	Other Names
Psychotherapy treatment	Behavioral		study arm

Measure	Description	Time Frame
outcome		within study timeframe

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NYU Child Study Center Institute for Trauma and Stress		New York	New York	10016	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20595411	Derived	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.

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders