Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00495027
Status:
COMPLETED
Last Update Posted:
2007-07-02
First Post:
2007-06-28
Brief Title:
Brief Cognitive-Behavioral Treatment for Victims of Mass Violence
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
Brief Cognitive-Behavioral Treatment for Victims of Mass Violence
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 selfstress-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 911 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
The major aim of this project is to evaluate an abbreviated format of SIT that aims to provide effective selfstress-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 911 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None