NCT00069381

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2003

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

7.3 years

First QC Date

September 24, 2003

Last Update Submit

March 27, 2013

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

  • outcome

    within study timeframe

Study Arms (1)

study arm

EXPERIMENTAL
Behavioral: Psychotherapy treatment

Interventions

Psychotherapy treatmentBEHAVIORAL
study arm

Eligibility Criteria

Age22 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Bipolar Disorder
  • Eating Disorder
  • Borderline Personality Disorder
  • Active substance abuse or dependence
  • Living with the abuser
  • Self mutilation
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Child Study Center Institute for Trauma and Stress

New York, New York, 10016, United States

Location

Related Publications (1)

  • 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.

    PMID: 20595411DERIVED

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2003

First Posted

September 25, 2003

Study Start

April 1, 2002

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations

US(1)