Stress Disorders, Post-TraumaticNCT00183508
Behavioral Treatments for Acute Stress Disorder In Firefighters
A study testing Cognitive behavioral therapy and Psychoeducation in people with Stress Disorders, Post-Traumatic, run by Boston University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Cognitive behavioral therapy and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently an active duty, nonofficer member of a Boston area fire department
- Willing and able to comply with all study requirements
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Veterans Healthcare System
Boston, Massachusetts, 02114
About this study
Official title: Developing Group Treatments for Acute Stress Disorder
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).
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Cognitive behavioral therapy, Psychoeducation
- Keywords
- PTSD, Occupational Health, Trauma, Job, CBT
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
Participants will learn cognitive behavioral strategies for symptom reduction
PsychoeducationBehavioural
Participants will receive psychoeducation regarding common reactions to traumatic events
| Study group | Role | What they receive |
|---|---|---|
| 1 Cognitive behavioral therapy | Experimental | Not described Receives: Behavioral: Cognitive behavioral therapy |
| 2 Psychoeducation | Experimental | Not described Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accute stress disorder symptoms
Measured: Measured pre- and post-treatment and at follow-up assessments 1 and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Primary completionDec 2005
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Rose T. Zimering, PhD, Principal investigator, Boston Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183508
- Sponsor's protocol ID
- R21MH064584
- Other IDs
- R21MH064584, DATR AD-TS
- Status last verified
- Dec 2015
- First submitted
- 13 Sep 2005
- Last updated
- 14 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Group Treatments for Acute Stress Disorder
- ClinicalTrials.gov ID
- NCT00183508
- Acronym / sponsor ID
- R21MH064584
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- PTSD, Occupational Health, Trauma, Job, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Primary completion
- Dec 2005 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Cognitive behavioral therapy | Experimental | Behavioral: Cognitive behavioral therapy |
| 2 Psychoeducation | Experimental | Behavioral: Psychoeducation |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently an active duty, nonofficer member of a Boston area fire department
- Willing and able to comply with all study requirements
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral therapyParticipants will learn cognitive behavioral strategies for symptom reduction | Behavioural | 1 Cognitive behavioral therapy |
| PsychoeducationParticipants will receive psychoeducation regarding common reactions to traumatic events | Behavioural | 2 Psychoeducation |
Primary outcome
Accute stress disorder symptoms
Time frame: Measured pre- and post-treatment and at follow-up assessments 1 and 3 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rose T. Zimering, PhD principal investigator
Boston Veterans Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy and Psychoeducation in people with Stress Disorders, Post-Traumatic, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.