NCT00656344

Brief Summary

This study is exploring the use of an intervention designed to treat PTSD in individuals with comorbid PTSD and substance abuse resulting from the attacks of September 11 or from military service in Iraq. A cognitive behavioral treatment protocol will be used to treat PTSD. The exposure component of the protocol will be enhanced with the use of virtual reality in which the client will view a virtual environment while describing their trauma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2006

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

October 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2008

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 10, 2013

Status Verified

December 1, 2013

Enrollment Period

7.2 years

First QC Date

April 7, 2008

Last Update Submit

December 6, 2013

Conditions

Keywords

PTSDSubstance AbuseWTC attacksIraq War

Outcome Measures

Primary Outcomes (1)

  • posttraumatic stress symptomatology

    prior to treatment, during the treatment, immediately following treatment and 6 months after the completion of treatment

Secondary Outcomes (1)

  • substance use symptomatology

    prior to treatment, during treatment, immediately following treatment, and 6 months after the completion of treatment

Interventions

A cognitive behavioral protocol with cognitive and behavioral techniques will be used to treat symptoms. The exposure part of the treatment will be enhanced with the use of a virtual environment.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking
  • Between the ages of 18 and 70
  • Exposed to the WTC Attacks (were in towers or in the immediate area) or veterans of the Iraq War
  • Diagnosed with PTSD symptoms
  • Current substance abuse disorder or history of substance abuse disorder

You may not qualify if:

  • Presence of current organic mental disorder
  • Presence or history of schizophrenia, bipolar disorder or depression with psychotic features, delusional disorder
  • Active suicidal ideation, intent, or plan
  • Active homicidal ideation, intent, or plan
  • Use of pacemaker
  • Medically unstable
  • History of seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersChemically-Induced Disorders

Study Officials

  • JoAnn Difede

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology in Psychiatry

Study Record Dates

First Submitted

April 7, 2008

First Posted

April 11, 2008

Study Start

October 1, 2006

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 10, 2013

Record last verified: 2013-12

Locations