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Anxiety Reduction Treatment for Acute Trauma

NYU Langone Health logo

NYU Langone Health

Status

Terminated

Conditions

Anxiety

Treatments

Behavioral: ARTAT
Behavioral: TAU

Study type

Interventional

Funder types

Other

Identifiers

NCT02315378
10-01334
W81XWH-08-1-0412 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 2 patient groups

ARTAT
Other group
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:
Behavioral: ARTAT
TAU
Other group
Description:
Treatment as Usual
Treatment:
Behavioral: TAU

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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