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Anxiety Reduction Treatment for Acute Trauma

Primary Purpose

Anxiety

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TAU
ARTAT
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Acute Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    ARTAT

    TAU

    Arm 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 as Usual

    Outcomes

    Primary Outcome Measures

    Acute Stress Disorder (ASD) Interview
    Structured clinical interview that is based on the DSM-IV criteria for acute stress disorder.
    Clinician Administered PTSD Scale (CAPS)
    Structured clinical interview used to determine PTSD diagnosis.
    Structured Clinical Interview for DSM-IV
    Interview to determine the presence of current or past DSM-IV Axis I disorders.
    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.
    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.

    Secondary Outcome Measures

    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
    Peritraumatic Dissociative Experiences Questionnaire (PDEQ)
    A 10 item measure of dissociative symptoms
    Peritraumatic Distress Inventory (PDI)
    Assesses respondents' emotional and physical reactions experienced during or immediately after a traumatic event.
    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.
    Posttraumatic Stress Disorder Checklist - Specific Stressor Version (PCL-S)
    Assesses PTSD symptomatology and severity in response to respondents' traumatic event.

    Full Information

    First Posted
    December 5, 2014
    Last Updated
    June 12, 2023
    Sponsor
    NYU Langone Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02315378
    Brief Title
    Anxiety Reduction Treatment for Acute Trauma
    Official Title
    Anxiety Reduction Treatment for Acute Trauma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Terminated
    Why Stopped
    The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.
    Study Start Date
    June 2008 (undefined)
    Primary Completion Date
    October 2010 (Actual)
    Study Completion Date
    August 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NYU Langone Health

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety
    Keywords
    Anxiety, Acute Trauma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ARTAT
    Arm Type
    Other
    Arm 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.
    Arm Title
    TAU
    Arm Type
    Other
    Arm Description
    Treatment as Usual
    Intervention Type
    Behavioral
    Intervention Name(s)
    TAU
    Other Intervention Name(s)
    Treatment as Usual
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    ARTAT
    Other Intervention Name(s)
    Anxiety Reduction Treatment for Acute Trauma
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Acute Stress Disorder (ASD) Interview
    Description
    Structured clinical interview that is based on the DSM-IV criteria for acute stress disorder.
    Time Frame
    up to one month
    Title
    Clinician Administered PTSD Scale (CAPS)
    Description
    Structured clinical interview used to determine PTSD diagnosis.
    Time Frame
    up to three-month follow-up
    Title
    Structured Clinical Interview for DSM-IV
    Description
    Interview to determine the presence of current or past DSM-IV Axis I disorders.
    Time Frame
    one-month to determine life history of PTSD
    Title
    Event Severity Rating Scale (ESR)
    Description
    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.
    Time Frame
    Baseline
    Title
    Mini-Mental status Exam (MMSE)
    Description
    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.
    Time Frame
    Screen
    Secondary Outcome Measure Information:
    Title
    Beck Anxiety Inventory (BA1)
    Description
    A 21 item measure that assesses the severity of the subjects anxiety, addressing both the physiological and cognitive components of anxiety
    Time Frame
    Baseline, post-treatment, one-month and three month follow-up
    Title
    Peritraumatic Dissociative Experiences Questionnaire (PDEQ)
    Description
    A 10 item measure of dissociative symptoms
    Time Frame
    Baseline
    Title
    Peritraumatic Distress Inventory (PDI)
    Description
    Assesses respondents' emotional and physical reactions experienced during or immediately after a traumatic event.
    Time Frame
    Baseline
    Title
    Life Stressor Checklist - Revised (LSC-R)
    Description
    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.
    Time Frame
    one-month follow-up
    Title
    Posttraumatic Stress Disorder Checklist - Specific Stressor Version (PCL-S)
    Description
    Assesses PTSD symptomatology and severity in response to respondents' traumatic event.
    Time Frame
    one-month and three-month follow-ups

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles R Marmar, MD
    Organizational Affiliation
    NYU School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Anxiety Reduction Treatment for Acute Trauma

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