Anxiety Reduction Treatment for Acute Trauma
Primary Purpose
Anxiety
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TAU
ARTAT
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Acute Trauma
Eligibility Criteria
Inclusion Criteria:
- Adults who have experienced an acute psychologically traumatic event within the last 8 hours
- Resting hear rate of 80 BPM or greater upon ED presentation
Exclusion Criteria:
- Attending physician does not concur with enrolling subject in study
- Traumatic event occurred more than 8 hours before ED arrival
- Physical injury that contraindicates participation
- Significant head injury
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
ARTAT
TAU
Arm Description
A one-session intervention targeting at-risk individuals (those continuing to experience peritraumatic panic following a trauma) and designed to reduce peritraumatic anxiety and enhance self-efficacy.
Treatment as Usual
Outcomes
Primary Outcome Measures
Acute Stress Disorder (ASD) Interview
Structured clinical interview that is based on the DSM-IV criteria for acute stress disorder.
Clinician Administered PTSD Scale (CAPS)
Structured clinical interview used to determine PTSD diagnosis.
Structured Clinical Interview for DSM-IV
Interview to determine the presence of current or past DSM-IV Axis I disorders.
Event Severity Rating Scale (ESR)
Questionnaire that includes 6 items assessing the intensity of experiences during the event, including extent of injury, life threat to self or loved ones, witnessing injury or death, exposure to horrifying scenes, and an overall how sever the event was.
Mini-Mental status Exam (MMSE)
This is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language with a maximum score of 30.
Secondary Outcome Measures
Beck Anxiety Inventory (BA1)
A 21 item measure that assesses the severity of the subjects anxiety, addressing both the physiological and cognitive components of anxiety
Peritraumatic Dissociative Experiences Questionnaire (PDEQ)
A 10 item measure of dissociative symptoms
Peritraumatic Distress Inventory (PDI)
Assesses respondents' emotional and physical reactions experienced during or immediately after a traumatic event.
Life Stressor Checklist - Revised (LSC-R)
This is a 30-item screening measure of exposure to stressful events across the lifespan, including events such as a physical assault, sexual assault, being robbed or mugged, and the catastrophic death of a loved one.
Posttraumatic Stress Disorder Checklist - Specific Stressor Version (PCL-S)
Assesses PTSD symptomatology and severity in response to respondents' traumatic event.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02315378
Brief Title
Anxiety Reduction Treatment for Acute Trauma
Official Title
Anxiety Reduction Treatment for Acute Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a randomized controlled trial to investigate the feasibility and effectiveness of a brief Anxiety Reduction Treatment for Acute Trauma (ARTAT) with adults (over age 18) showing signs of peritraumatic anxiety in the Emergency Department of Bellevue Hospital, New York in the hours following a psychologically traumatic event. Thirty-six participants will be enrolled over a 12-month period: 18 receiving ARTAT and 18 receiving Treatment As Usual (TAU). The study will target anxious arousal in patients immediately (1 to 8 hours) following a trauma. Participants will be recruited from among patients who present in the Emergency Department at Bellevue Hospital for treatment of an injury sustained in a traumatic event (accident, assault) as long as injuries do not preclude participation. Participants included in the study will have experienced a trauma within 8 hours and presenting with signs of a strong risk factor for PTSD: peritraumatic panic (severe psychological and physiological anxiety symptoms such as fear of dying, fear of losing emotional control, tachycardia, sweating, shaking and dissociation symptoms such as derealisation and depersonalization that occur during and immediately following a trauma. Following the initial assessment, eligible participants will be randomized to receive the one-hour anxiety-reduction intervention designed to reduce anxiety and panic symptoms through education and anxiety y management skills or TAU. The clinician administered and self-report assessments will be conducted at screening, baseline, post-treatment, weekly, and at a one-month and three-month follow-up.
Detailed Description
The purpose of the proposed research is to pilot a behavioral intervention specifically designed to reduce the symptoms of peritraumatic panic, in order to reduce the likelihood of subsequent PTSD. The investigators have developed the Anxiety Reduction Treatment for Acute Trauma (ARTAT), a one-session intervention targeting at-risk individuals (those continuing to experience peritraumatic panic following a trauma) and enhance self-efficacy. The intervention provides education about common responses to trauma in order to normalize symptoms and teaches individuals anxiety management techniques such as deep breathing and muscle relaxation. ARTAT specifically avoids encouraging people to process the trauma (given evidence that this may enhance arousal).
This study is a randomized controlled trial of a single session 60- minute Anxiety Reduction Treatment for Acute Trauma (ARTAT) administered during Emergency Department (ED) admission to patients presenting with anxiety following traumatic exposure. Thirty-six participants will be enrolled over a 12-month period (18 receiving ARTAT and 18 receiving TAU). The study will target anxious arousal in patients immediately (1 to 8 hours) following a trauma. Participants will be recruited from among patients who present in the Bellevue Emergency Department for treatment of an injury sustained in a traumatic event (accident, assault) as long as injuries do not preclude participation. Participants included in the study will have experienced a trauma within 8 hours and presenting with signs of a strong risk factor for PTSD: peritraumatic panic (severe psychological and physiological anxiety symptoms such as fear of dying, fear of losing emotional control, tachycardia, sweating, shaking and dissociation symptoms such as derealisation and depersonalization that occur during and immediately following a trauma. Following the initial assessment, eligible participants will be randomized to receive the one-hour anxiety-reduction intervention designed to reduce anxiety and panic symptoms through education and anxiety y management skills or the TAU. The clinician administered and self-report assessments will be conducted at screening, baseline, post-treatment, and at a one-month and three-month follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Anxiety, Acute Trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARTAT
Arm Type
Other
Arm Description
A one-session intervention targeting at-risk individuals (those continuing to experience peritraumatic panic following a trauma) and designed to reduce peritraumatic anxiety and enhance self-efficacy.
Arm Title
TAU
Arm Type
Other
Arm Description
Treatment as Usual
Intervention Type
Behavioral
Intervention Name(s)
TAU
Other Intervention Name(s)
Treatment as Usual
Intervention Description
Treatment as Usual for patients presenting after accidents and assaults as it pertains to mental health, is a brief intervention that varies in length depending on the patient's needs. If the patient is highly distressed, the social worked will provide brief crisis management support. The social worker also performs case management functions such as attempting to get in touch with family, contacting shelter or hotel if the patient is homeless, contacting other social service agencies if needed, and providing the patient referrals for mental health services in the community. A psychiatrist will also be called to assess the patient only if he or she appears to be a threat to self (suicidal) or others, and exclusion criteria for this study.
Intervention Type
Behavioral
Intervention Name(s)
ARTAT
Other Intervention Name(s)
Anxiety Reduction Treatment for Acute Trauma
Intervention Description
A one-session intervention targeting at-risk individuals (those continuing to experience peritraumatic panic following a trauma) and designed to reduce peritraumatic anxiety and enhance self-efficacy.
Primary Outcome Measure Information:
Title
Acute Stress Disorder (ASD) Interview
Description
Structured clinical interview that is based on the DSM-IV criteria for acute stress disorder.
Time Frame
up to one month
Title
Clinician Administered PTSD Scale (CAPS)
Description
Structured clinical interview used to determine PTSD diagnosis.
Time Frame
up to three-month follow-up
Title
Structured Clinical Interview for DSM-IV
Description
Interview to determine the presence of current or past DSM-IV Axis I disorders.
Time Frame
one-month to determine life history of PTSD
Title
Event Severity Rating Scale (ESR)
Description
Questionnaire that includes 6 items assessing the intensity of experiences during the event, including extent of injury, life threat to self or loved ones, witnessing injury or death, exposure to horrifying scenes, and an overall how sever the event was.
Time Frame
Baseline
Title
Mini-Mental status Exam (MMSE)
Description
This is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language with a maximum score of 30.
Time Frame
Screen
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory (BA1)
Description
A 21 item measure that assesses the severity of the subjects anxiety, addressing both the physiological and cognitive components of anxiety
Time Frame
Baseline, post-treatment, one-month and three month follow-up
Title
Peritraumatic Dissociative Experiences Questionnaire (PDEQ)
Description
A 10 item measure of dissociative symptoms
Time Frame
Baseline
Title
Peritraumatic Distress Inventory (PDI)
Description
Assesses respondents' emotional and physical reactions experienced during or immediately after a traumatic event.
Time Frame
Baseline
Title
Life Stressor Checklist - Revised (LSC-R)
Description
This is a 30-item screening measure of exposure to stressful events across the lifespan, including events such as a physical assault, sexual assault, being robbed or mugged, and the catastrophic death of a loved one.
Time Frame
one-month follow-up
Title
Posttraumatic Stress Disorder Checklist - Specific Stressor Version (PCL-S)
Description
Assesses PTSD symptomatology and severity in response to respondents' traumatic event.
Time Frame
one-month and three-month follow-ups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults who have experienced an acute psychologically traumatic event within the last 8 hours
Resting hear rate of 80 BPM or greater upon ED presentation
Exclusion Criteria:
Attending physician does not concur with enrolling subject in study
Traumatic event occurred more than 8 hours before ED arrival
Physical injury that contraindicates participation
Significant head injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles R Marmar, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Anxiety Reduction Treatment for Acute Trauma
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