Anxiety Reduction Treatment for Acute Trauma

NCT02315378 | Terminated

• 2 other identifiers: 10-01334W81XWH-08-1-0412
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety

Keywords

Anxiety, Acute Trauma

Outcome Measures

Primary Outcomes (5)

• Acute Stress Disorder (ASD) Interview

  Structured clinical interview that is based on the DSM-IV criteria for acute stress disorder.

  up to one month

• Clinician Administered PTSD Scale (CAPS)

  Structured clinical interview used to determine PTSD diagnosis.

  up to three-month follow-up

• 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

• 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

• 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 Outcomes (5)

• Beck Anxiety Inventory (BA1)

  Baseline, post-treatment, one-month and three month follow-up

• Peritraumatic Dissociative Experiences Questionnaire (PDEQ)

  Baseline

• Peritraumatic Distress Inventory (PDI)

  Baseline

• Life Stressor Checklist - Revised (LSC-R)

  one-month follow-up

• Posttraumatic Stress Disorder Checklist - Specific Stressor Version (PCL-S)

  one-month and three-month follow-ups

Study Arms (2)

ARTAT

OTHER

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.

Behavioral: ARTAT

TAU

OTHER

Treatment as Usual

Behavioral: TAU

Interventions

TAU BEHAVIORAL

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.

Also known as: Treatment as Usual

TAU

ARTAT BEHAVIORAL

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.

Also known as: Anxiety Reduction Treatment for Acute Trauma

ARTAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Charles R Marmar, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 11, 2014
• Study Start: June 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: August 1, 2013
• Last Updated: June 15, 2023

Record last verified: 2016-08