Brief Cognitive-Behavioral Treatment for Victims of Mass Violence
Primary Purpose
Post-Traumatic Stress Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Internet-delivered Stress Innoculation Training
Sponsored by
About this trial
This is an interventional prevention trial for Post-Traumatic Stress Disorder focused on measuring PTSD, prevention, World Wide Web, Behavior Therapy
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Walter Reed Army Medical Center
Outcomes
Primary Outcome Measures
PTSD Symptom Scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00495027
Brief Title
Brief Cognitive-Behavioral Treatment for Victims of Mass Violence
Official Title
Brief Cognitive-Behavioral Treatment for Victims of Mass Violence
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boston University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Because resources are often scarce in the aftermath of disasters, a useful mental health intervention is one that is effective, feasible, rapidly available, and efficiently delivered to the largest proportion of affected individuals possible. In terms of treating PTSD in other trauma contexts, there is considerable evidence that cognitive-behavioral therapy (CBT) procedures are effective at reducing the array of PTSD symptoms. Overall, the available evidence points to the theoretical and empirical justification for using Prolonged Exposure (PE) and Stress Inoculation Training (SIT), two components of CBT, with patients presenting with PTSD. A practical limitation of available studies is that they are limited to individually administered therapy contexts that typically require between 8 and 12 sessions delivered in a specialty mental health care-setting. The labor-intensive nature of these therapies represents a significant obstacle to provision of therapy to potentially thousands of individuals suffering PTSD in the context of mass violence events.
The major aim of this project is to evaluate an abbreviated format of SIT that aims to provide effective self/stress-management skills to individuals with PTSD. The rationale behind this intervention is that with appropriate and intensive therapist input during a single session of therapy, supplemented systematically with self-paced and self-directed homework, promoted, prompted, and monitored via a specialized web-site and augmented by therapist feedback and guidance delivered via the web, primary care patients with PTSD stemming from mass violence can benefit from the strategies that have demonstrated efficacy in reducing PTSD symptoms. Survivors of the Pentagon attack on 9/11 who present at primary care clinics that serve the Pengaton are randomly assigned to SIT or a supportive counseling control group. Patients' compliance and symptoms are monitored on the web and via clinical interview.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
PTSD, prevention, World Wide Web, Behavior Therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered Stress Innoculation Training
Primary Outcome Measure Information:
Title
PTSD Symptom Scale
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett T Litz, Ph.D.
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Brief Cognitive-Behavioral Treatment for Victims of Mass Violence
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