Anxiety Clinical Trial
Official title:
Anxiety Reduction Treatment for Acute Trauma
Verified date | August 2016 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 36 |
Est. completion date | August 2013 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute Stress Disorder (ASD) Interview | Structured clinical interview that is based on the DSM-IV criteria for acute stress disorder. | up to one month | |
Primary | Clinician Administered PTSD Scale (CAPS) | Structured clinical interview used to determine PTSD diagnosis. | up to three-month follow-up | |
Primary | Structured Clinical Interview for DSM-IV | Interview to determine the presence of current or past DSM-IV Axis I disorders. | one-month to determine life history of PTSD | |
Primary | 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. | Baseline | |
Primary | 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. | Screen | |
Secondary | 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 | Baseline, post-treatment, one-month and three month follow-up | |
Secondary | Peritraumatic Dissociative Experiences Questionnaire (PDEQ) | A 10 item measure of dissociative symptoms | Baseline | |
Secondary | Peritraumatic Distress Inventory (PDI) | Assesses respondents' emotional and physical reactions experienced during or immediately after a traumatic event. | Baseline | |
Secondary | 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. | one-month follow-up | |
Secondary | Posttraumatic Stress Disorder Checklist - Specific Stressor Version (PCL-S) | Assesses PTSD symptomatology and severity in response to respondents' traumatic event. | one-month and three-month follow-ups |
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