NCT00495027

Brief Summary

The objective of this randomized control trial is to compare the effectiveness of Stress Inoculation Training (SIT), a well researched psychological treatment for Post Traumatic Stress Disorder (PTSD), to that of the non-specific standard care provided in primary care settings, called Supportive Counseling (SC), on individuals who were exposed to the September 11, 2001 terrorist attack on the Pentagon, or the immediate aftermath of this attack. Both SIT and SC interventions will each be provided in one 2-hour session with eight weeks of daily systematic web-based follow up to promote self-help. The primary hypothesis of this study is that SIT will reduce the level of PTSD in participants relative to SCand to the pre-treatment levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2002

Typical duration for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2007

Completed
Last Updated

July 2, 2007

Status Verified

June 1, 2007

First QC Date

June 28, 2007

Last Update Submit

June 28, 2007

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSDpreventionWorld Wide WebBehavior Therapy

Outcome Measures

Primary Outcomes (1)

  • PTSD Symptom Scale

    6 months

Interventions

Internet-delivered Stress Innoculation TrainingBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Sufficient proximity to the September 11, 2001 Pentagon attack and its aftermath, including rescue and clean-up activities (at least two items endorsed on the exposure checklist, see the checklist on page 6 of the attached Rapid protocol)
  • At least one re-experiencing symptom rated as "severe" on the Post Traumatic Stress Disorder Checklist (PCL)

You may not qualify if:

  • Substance dependent
  • Current suicidal ideation
  • History of psychotic disorder
  • Inadequate comprehension of English
  • Evidence of PTSD or depression immediately prior to the attack
  • Currently receiving psychological/psychiatric treatment.
  • Marked dissociative presentation.
  • Grossly inadequate social supports
  • Mental retardation and cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Brett T Litz, Ph.D.

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 28, 2007

First Posted

July 2, 2007

Study Start

March 1, 2002

Study Completion

August 1, 2005

Last Updated

July 2, 2007

Record last verified: 2007-06

Locations

US(1)