AnxietyNCT02315378
Anxiety Reduction Treatment for Acute Trauma
A study testing TAU and ARTAT in people with Anxiety, run by NYU Langone Health.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- TAU and ARTAT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- TAU, ARTAT
- Keywords
- Anxiety, Acute Trauma
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAUBehavioural
Also called Treatment as Usual
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.
ARTATBehavioural
Also called Anxiety Reduction Treatment for Acute Trauma
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ARTAT |
| TAU | Other | Treatment as Usual Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Stress Disorder (ASD) Interview
Structured clinical interview that is based on the DSM-IV criteria for acute stress disorder.
Measured: up to one month
Clinician Administered PTSD Scale (CAPS)
Structured clinical interview used to determine PTSD diagnosis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Screen
Secondary outcomes (5)
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
Measured: Baseline, post-treatment, one-month and three month follow-up
Peritraumatic Dissociative Experiences Questionnaire (PDEQ)
A 10 item measure of dissociative symptoms
Measured: Baseline
Peritraumatic Distress Inventory (PDI)
Assesses respondents' emotional and physical reactions experienced during or immediately after a traumatic event.
Measured: Baseline
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.
Measured: one-month follow-up
Posttraumatic Stress Disorder Checklist - Specific Stressor Version (PCL-S)
Assesses PTSD symptomatology and severity in response to respondents' traumatic event.
Measured: one-month and three-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startJun 2008
- Primary completionOct 2010
- Study completionAug 2013
Why it stopped: The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles R Marmar, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315378
- Sponsor's protocol ID
- 10-01334
- Other IDs
- W81XWH-08-1-0412
- Status last verified
- Aug 2016
- First submitted
- 5 Dec 2014
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety Reduction Treatment for Acute Trauma
- ClinicalTrials.gov ID
- NCT02315378
- Acronym / sponsor ID
- 10-01334
- Conditions
- Anxiety
- Keywords
- Anxiety, Acute Trauma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARTAT | Other | Behavioral: ARTATA 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. |
| TAU | Other | Behavioral: TAUTreatment as Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAUAlso: Treatment as UsualTreatment 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. | Behavioural | TAU |
| ARTATAlso: Anxiety Reduction Treatment for Acute TraumaA 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. | Behavioural | ARTAT |
Primary outcome
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.
Clinician Administered PTSD Scale (CAPS)
Time frame: up to three-month follow-up
Structured clinical interview used to determine PTSD diagnosis.
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.
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.
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.
5 secondary outcomes
Beck Anxiety Inventory (BA1)
Time frame: Baseline, post-treatment, one-month and three month follow-up
Peritraumatic Dissociative Experiences Questionnaire (PDEQ)
Time frame: Baseline
Peritraumatic Distress Inventory (PDI)
Time frame: Baseline
Life Stressor Checklist - Revised (LSC-R)
Time frame: one-month follow-up
Posttraumatic Stress Disorder Checklist - Specific Stressor Version (PCL-S)
Time frame: one-month and three-month follow-ups
Results and safety
The study was stopped early (reason given: The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles R Marmar, MD principal investigator
NYU School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing TAU and ARTAT in people with Anxiety, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Stress Disorder (ASD) Interview (time frame: up to one month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.