Behavioral Treatments for Acute Stress Disorder In Firefighters

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

Tracking Information

• First Submitted Date: September 13, 2005
• First Posted Date: September 16, 2005
• Last Update Posted Date: December 14, 2015
• Study Start Date: Not Provided
• Actual Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (submitted: September 13, 2005): ASD symptoms
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Behavioral Treatments for Acute Stress Disorder In Firefighters
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Stress Disorders, Post-Traumatic

Intervention

• 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

• Experimental: 1 Cognitive behavioral therapy
  Intervention: Behavioral: Cognitive behavioral therapy
• Experimental: 2 Psychoeducation
  Intervention: Behavioral: Psychoeducation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 5, 2010): 169
• Original Enrollment (submitted: September 13, 2005): 200
• Actual Study Completion Date: May 2009
• Actual Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 21 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00183508
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Rose T. Zimering, PhD, Boston Veterans Healthcare System
• Study Sponsor: Boston University
• Collaborators: National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Rose T. Zimering, PhD; Boston Veterans Healthcare System

• PRS Account: Boston University
• Verification Date: December 2015