Behavioral Treatments for Acute Stress Disorder In Firefighters

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

Developing Group Treatments for Acute Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00183508
• Other study ID #: R21MH064584
• Secondary ID: R21MH064584DATR
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: December 11, 2015
• Est. completion date: May 2009

Study information

• Verified date: December 2015
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: May 2009
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Stress Disorders, Traumatic, Acute

Intervention

Behavioral:
• Cognitive behavioral therapy
Participants will learn cognitive behavioral strategies for symptom reduction
• Psychoeducation
Participants will receive psychoeducation regarding common reactions to traumatic events

Locations

Country	Name	City	State
United States	Boston Veterans Healthcare System	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accute stress disorder symptoms		Measured pre- and post-treatment and at follow-up assessments 1 and 3 months after the intervention	No