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Behavioral Treatments for Acute Stress Disorder In Firefighters

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ClinicalTrials.gov Identifier: NCT00183508
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 14, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Boston University

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date December 14, 2015
Study Start Date  ICMJE Not Provided
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2010)
Accute stress disorder symptoms [ Time Frame: Measured pre- and post-treatment and at follow-up assessments 1 and 3 months after the intervention ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
ASD symptoms
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Behavioral Treatments for Acute Stress Disorder In Firefighters
Official Title  ICMJE Developing Group Treatments for Acute Stress Disorder
Brief Summary This study will develop a treatment for firefighters experiencing symptoms of acute stress disorder (ASD). Effective treatments may reduce immediate symptoms and prevent the development of more chronic conditions, such as post-traumatic stress disorder (PTSD).
Detailed Description

Exposure to traumatic events has reached unprecedented proportions in American society, and the rates of PTSD have risen significantly, particularly among populations with repetitive exposure to critical incidents. The continued threat of attacks against Americans warrants development of preventive interventions to reduce the occurrence of PTSD and its precursor, ASD. This study will determine the effectiveness of a preventive treatment in urban firefighters who have experienced a traumatic event.

Firefighters will undergo an initial assessment that will include an interview and self-report questionnaires to measure depression, anxiety, coping skills, social support, physical health, and work functioning. Following the occurrence of a traumatic work-related event, firefighters will be reassessed. The post-incident assessment will consist of self-report questionnaires that assess ASD symptoms.

Participants who display ASD symptoms will be randomly assigned to one of two groups: the first group will learn cognitive behavioral strategies for symptom reduction, and the second group will receive psychoeducation regarding common reactions to traumatic events. Participants' treatment will last for 12 weeks. Participants will have follow-up assessments 1 and 3 months after the interventional part of the study. Assessments will include clinical scales and interviews.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Stress Disorders, Post-Traumatic
Intervention  ICMJE
  • Behavioral: Cognitive behavioral therapy
    Participants will learn cognitive behavioral strategies for symptom reduction
  • Behavioral: Psychoeducation
    Participants will receive psychoeducation regarding common reactions to traumatic events
Study Arms  ICMJE
  • Experimental: 1 Cognitive behavioral therapy
    Intervention: Behavioral: Cognitive behavioral therapy
  • Experimental: 2 Psychoeducation
    Intervention: Behavioral: Psychoeducation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2010)
169
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
200
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Currently an active duty, nonofficer member of a Boston area fire department
  • Willing and able to comply with all study requirements

Exclusion Criteria:

  • Pregnancy or plan to become pregnant during the study
  • Plan to relocate within 2 months of study entry
  • Psychotic symptoms within 30 days prior to study entry
  • Experiencing severe depression at study entry OR having suicidal thoughts within 30 days prior to study entry
  • Evidence of severe organic impairment that would interfere with participation in the study
  • Current alcohol or substance dependence
  • Currently awaiting outcome of a court case involving exposure to traumatic events through the fire department
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00183508
Other Study ID Numbers  ICMJE R21MH064584( U.S. NIH Grant/Contract )
R21MH064584 ( U.S. NIH Grant/Contract )
DATR AD-TS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rose T. Zimering, PhD, Boston Veterans Healthcare System
Study Sponsor  ICMJE Boston University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Rose T. Zimering, PhD Boston Veterans Healthcare System
PRS Account Boston University
Verification Date December 2015

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