Expired Study
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Boston, Massachusetts 02114


Purpose:

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).


Study summary:

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.


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


Study is Available At:


Original ID:

R21MH064584


NCT ID:

NCT00183508


Secondary ID:

R21MH064584


Study Acronym:


Brief Title:

Behavioral Treatments for Acute Stress Disorder In Firefighters


Official Title:

Developing Group Treatments for Acute Stress Disorder


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Boston University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

169


Enrollment Type:

Actual


Overall Contact Information

Official Name:Rose T. Zimering, PhD
Principal Investigator
Boston Veterans Healthcare System

Study Dates

Completion Date:May 2009
Completion Type:Actual
Primary Completion Date:December 2005
Primary Completion Type:Actual
Verification Date:December 2015
Last Changed Date:December 11, 2015
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Accute stress disorder symptoms
Time Frame:Measured pre- and post-treatment and at follow-up assessments 1 and 3 months after the intervention
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Cognitive behavioral therapy
Description:Participants will learn cognitive behavioral strategies for symptom reduction
Arm Name:1 Cognitive behavioral therapy
Intervention Type:Behavioral
Name:Psychoeducation
Description:Participants will receive psychoeducation regarding common reactions to traumatic events
Arm Name:2 Psychoeducation

Study Arms

Study Arm Type:Experimental
Arm Name:2 Psychoeducation
Study Arm Type:Experimental
Arm Name:1 Cognitive behavioral therapy

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Boston University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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