Clinical trial NCT02315378: Anxiety Reduction Treatment for Acute Trauma
Official title: Anxiety Reduction Treatment for Acute Trauma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety
Keywords: Anxiety, Acute Trauma
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Acute Stress Disorder (ASD) Interview
timeFrame: up to one month
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: up to three-month follow-up
measure: Structured Clinical Interview for DSM-IV
timeFrame: one-month to determine life history of PTSD
measure: Event Severity Rating Scale (ESR)
timeFrame: Baseline
measure: Mini-Mental status Exam (MMSE)
timeFrame: Screen
Secondary outcomes:
measure: Beck Anxiety Inventory (BA1)
timeFrame: Baseline, post-treatment, one-month and three month follow-up
measure: Peritraumatic Dissociative Experiences Questionnaire (PDEQ)
timeFrame: Baseline
measure: Peritraumatic Distress Inventory (PDI)
timeFrame: Baseline
measure: Life Stressor Checklist - Revised (LSC-R)
timeFrame: one-month follow-up
measure: Posttraumatic Stress Disorder Checklist - Specific Stressor Version (PCL-S)
timeFrame: one-month and three-month follow-ups
Other outcomes:
Locations:
Study officials:
affiliation: NYU School of Medicine
name: Charles R Marmar, MD
role: PRINCIPAL_INVESTIGATOR
References: