Anxiety Reduction Treatment for Acute Trauma

Not Applicable

Terminated

• Conditions: Anxiety
• Interventions: Behavioral: TAU; Behavioral: ARTAT

• Registration Number: NCT02315378
• Lead Sponsor: NYU Langone Health

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2010-10
• Study Completion: 2013-08
• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-11
• Status Verified: 2016-08
• Last Update Submitted: 2023-06-12
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAU	TAU	Treatment as Usual
ARTAT	ARTAT	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 Measures

Name	Time	Method
Structured Clinical Interview for DSM-IV	one-month to determine life history of PTSD	Interview to determine the presence of current or past DSM-IV Axis I disorders.
Acute Stress Disorder (ASD) Interview	up to one month	Structured clinical interview that is based on the DSM-IV criteria for acute stress disorder.
Mini-Mental status Exam (MMSE)	Screen	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.
Clinician Administered PTSD Scale (CAPS)	up to three-month follow-up	Structured clinical interview used to determine PTSD diagnosis.
Event Severity Rating Scale (ESR)	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Peritraumatic Dissociative Experiences Questionnaire (PDEQ)	Baseline	A 10 item measure of dissociative symptoms
Peritraumatic Distress Inventory (PDI)	Baseline	Assesses respondents' emotional and physical reactions experienced during or immediately after a traumatic event.
Posttraumatic Stress Disorder Checklist - Specific Stressor Version (PCL-S)	one-month and three-month follow-ups	Assesses PTSD symptomatology and severity in response to respondents' traumatic event.
Beck Anxiety Inventory (BA1)	Baseline, post-treatment, one-month and three month follow-up	A 21 item measure that assesses the severity of the subjects anxiety, addressing both the physiological and cognitive components of anxiety
Life Stressor Checklist - Revised (LSC-R)	one-month follow-up	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.