Brief Cognitive-Behavioral Treatment for Victims of Mass Violence

This study has been completed.
Sponsor:
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00495027
First received: June 28, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

June 28, 2007
June 28, 2007
March 2002
Not Provided
PTSD Symptom Scale [ Time Frame: 6 months ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Brief Cognitive-Behavioral Treatment for Victims of Mass Violence
Brief Cognitive-Behavioral Treatment for Victims of Mass Violence

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Post-Traumatic Stress Disorder
Behavioral: Internet-delivered Stress Innoculation Training
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
August 2005
Not Provided

Inclusion Criteria:

  1. 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)
  2. At least one re-experiencing symptom rated as “severe” on the Post Traumatic Stress Disorder Checklist (PCL)

Exclusion Criteria:

  1. Substance dependent
  2. Current suicidal ideation
  3. History of psychotic disorder
  4. Inadequate comprehension of English
  5. Evidence of PTSD or depression immediately prior to the attack
  6. Currently receiving psychological/psychiatric treatment.
  7. Marked dissociative presentation.
  8. Grossly inadequate social supports
  9. Mental retardation and cognitive impairment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00495027
R01-MH066589-02
No
Not Provided
Boston University
Not Provided
Principal Investigator: Brett T Litz, Ph.D. Boston University
Boston University
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP