Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Anxiety Reduction Treatment for Acute Trauma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02315378
Recruitment Status : Terminated (The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.)
First Posted : December 11, 2014
Last Update Posted : August 17, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: TAU Behavioral: ARTAT Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anxiety Reduction Treatment for Acute Trauma
Study Start Date : June 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: 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.
Other Name: Anxiety Reduction Treatment for Acute Trauma

TAU
Treatment as Usual
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.
Other Name: Treatment as Usual




Primary Outcome Measures :
  1. Acute Stress Disorder (ASD) Interview [ Time Frame: up to one month ]
    Structured clinical interview that is based on the DSM-IV criteria for acute stress disorder.

  2. Clinician Administered PTSD Scale (CAPS) [ Time Frame: up to three-month follow-up ]
    Structured clinical interview used to determine PTSD diagnosis.

  3. Structured Clinical Interview for DSM-IV [ Time Frame: one-month to determine life history of PTSD ]
    Interview to determine the presence of current or past DSM-IV Axis I disorders.

  4. Event Severity Rating Scale (ESR) [ Time Frame: 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.

  5. Mini-Mental status Exam (MMSE) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Beck Anxiety Inventory (BA1) [ Time Frame: 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

  2. Peritraumatic Dissociative Experiences Questionnaire (PDEQ) [ Time Frame: Baseline ]
    A 10 item measure of dissociative symptoms

  3. Peritraumatic Distress Inventory (PDI) [ Time Frame: Baseline ]
    Assesses respondents' emotional and physical reactions experienced during or immediately after a traumatic event.

  4. Life Stressor Checklist - Revised (LSC-R) [ Time Frame: 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.

  5. Posttraumatic Stress Disorder Checklist - Specific Stressor Version (PCL-S) [ Time Frame: one-month and three-month follow-ups ]
    Assesses PTSD symptomatology and severity in response to respondents' traumatic event.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315378


Sponsors and Collaborators
NYU Langone Health
Investigators
Layout table for investigator information
Principal Investigator: Charles R Marmar, MD NYU School of Medicine

Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02315378     History of Changes
Other Study ID Numbers: 10-01334
W81XWH-08-1-0412 ( Other Grant/Funding Number: Department of Defense )
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016

Keywords provided by NYU Langone Health:
Anxiety, Acute Trauma

Additional relevant MeSH terms:
Layout table for MeSH terms
Anxiety Disorders
Mental Disorders