NCT00183508

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

First QC Date

September 13, 2005

Last Update Submit

December 11, 2015

Conditions

Stress Disorders, Post-Traumatic

Keywords

PTSDOccupational HealthTraumaJobCBT

Outcome Measures

Primary Outcomes (1)

  • Accute stress disorder symptoms

    Measured pre- and post-treatment and at follow-up assessments 1 and 3 months after the intervention

Study Arms (2)

1 Cognitive behavioral therapy

EXPERIMENTAL
Behavioral: Cognitive behavioral therapy

2 Psychoeducation

EXPERIMENTAL
Behavioral: Psychoeducation

Interventions

Cognitive behavioral therapyBEHAVIORAL

Participants will learn cognitive behavioral strategies for symptom reduction

1 Cognitive behavioral therapy
PsychoeducationBEHAVIORAL

Participants will receive psychoeducation regarding common reactions to traumatic events

2 Psychoeducation

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Veterans Healthcare System

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and Injuries

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Rose T. Zimering, PhD

    Boston Veterans Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Primary Completion

December 1, 2005

Study Completion

May 1, 2009

Last Updated

December 14, 2015

Record last verified: 2015-12

Locations

US(1)