- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00183508
Behavioral Treatments for Acute Stress Disorder In Firefighters
Developing Group Treatments for Acute Stress Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02114
- Boston Veterans Healthcare System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 Cognitive behavioral therapy
|
Participants will learn cognitive behavioral strategies for symptom reduction
|
Experimental: 2 Psychoeducation
|
Participants will receive psychoeducation regarding common reactions to traumatic events
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Accute stress disorder symptoms
Time Frame: Measured pre- and post-treatment and at follow-up assessments 1 and 3 months after the intervention
|
Measured pre- and post-treatment and at follow-up assessments 1 and 3 months after the intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rose T. Zimering, PhD, Boston Veterans Healthcare System
Study record dates
Study Major Dates
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21MH064584 (U.S. NIH Grant/Contract)
- DATR AD-TS (Other Identifier: Other)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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