Anxiety Reduction Treatment for Acute Trauma

Anxiety Clinical Trial

Official title:

Anxiety Reduction Treatment for Acute Trauma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02315378
• Other study ID #: 10-01334
• Secondary ID: W81XWH-08-1-0412
• Status: Terminated
• Phase: N/A
• Start date: June 2008
• Est. completion date: August 2013

Study information

• Verified date: August 2016
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• TAU
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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Outcome

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