NCT02591485

Brief Summary

The purpose of this study is to explore the efficacy of Attention Control Training in preventing the development of Post Traumatic Stress Disorder (PTSD), during the period near after a traumatic event and before PTSD is develop. Individuals who underwent a traumatic event in the past two weeks will be randomly assigned to either Attention Control Training (ACT), designed to normalize threat-related attention biases or a control conditions: without intervention at all. Outcome measures will be a diagnosed of PTSD and the level of severity of symptoms derived from the Clinician Administered PTSD Scale (CAPS-5), after 3 month since the traumatic event had occurred. The investigators expected to find lower ratios of PTSD symptoms in the ACT condition relative to the control condition in which no symptomatic relief is expected.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

3 years

First QC Date

October 28, 2015

Last Update Submit

November 21, 2019

Conditions

PTSD

Keywords

PTSD preventionAcute stress disorderAttention trainingCognitive bias modification

Outcome Measures

Primary Outcomes (1)

  • A diagnosis of PTSD and a total score of severity symptoms, as driven from the CAPS-5 interview.

    The Clinician Administered PTSD Scale (CAPS-5), is a structured interview that will be used to make a diagnosis of PTSD according to the DSM-V criteria. This interview is consists of 30 items regarding the frequency and intensity of PTSD symptoms and a total score of severity is been rated (Weathers, Blake, Schnurr, Kaloupek, Marx, \& Keane, 2013).

    40 minutes

Other Outcomes (3)

  • Total score of the PTSD Checklist (PCL-5).

    10 minutes

  • Total score of depression (PHQ-9).

    10 minutes

  • The Sheehan Disabilities Scale(SDS)

    5 minutes

Study Arms (2)

Attention Control Training

EXPERIMENTAL

Computerized attention modification training, comprised of six sessions that delivered by internet, in purpose of modulate biases in attention for threat stimuli.

Behavioral: Attention Control Training

Follow-up only

NO INTERVENTION

In this condition, a follow-up interviews will be conducted 3 months since the traumatic event had occurred.

Interventions

Attention Control TrainingBEHAVIORAL

In the ACT, participants perform six computerized attention training sessions, 10 minutes per training session over six weeks. In each session the dot-probe task is administered. This task is consisted of 160 trials. Each trial began with a centrally-presented fixation cross that then replaced by a pair of words presented. Following that, a target probe appeared in the location previously occupied by one of the words, and participants are requested to discriminate the probe type via button press. Targets appear with equal probability at the location of threat and neutral stimuli, in order to modify the fluctuations in attention allocation.

Attention Control Training

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The occurrence of a traumatic event (criteria A of PTSD from the DSM-5) in the period of less than a month from the beginning of the study.
  • An ASD diagnosis (score 7 and above in the ASDI).

You may not qualify if:

  • A previous traumatic event in the period of three month or less before the current event.
  • Chronic PTSD.
  • A diagnosis of psychotic or bipolar disorders.
  • A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
  • Suicidal ideation.
  • Drugs or alcohol abuse.
  • Another psychotherapeutic treatment.
  • Poor judgment capacity (i.e., special populations).
  • Pregnant women.
  • Disagreement to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel-Aviv University

Tel Aviv, Israel

Location

Related Publications (8)

  • Weathers, F., Blake, D., Schnurr, P., Kaloupek, D., Marx, B., & Keane, T., The clinician-administered PTSD scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD at www. ptsd. va. gov, 2013.

    BACKGROUND

  • Weathers, F., B. Litz, T. Keane, P. Palmieri, B. Marx, & P. Schnurr, The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www. ptsd. va. gov, 2013.

    BACKGROUND

  • American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders (DSM-5). 2013: American Psychiatric Pub.

    BACKGROUND

  • Harvey AG, Bryant RA. The relationship between acute stress disorder and posttraumatic stress disorder: a prospective evaluation of motor vehicle accident survivors. J Consult Clin Psychol. 1998 Jun;66(3):507-12. doi: 10.1037//0022-006x.66.3.507.

    PMID: 9642889BACKGROUND

  • Iacoviello BM, Wu G, Abend R, Murrough JW, Feder A, Fruchter E, Levinstein Y, Wald I, Bailey CR, Pine DS, Neumeister A, Bar-Haim Y, Charney DS. Attention bias variability and symptoms of posttraumatic stress disorder. J Trauma Stress. 2014 Apr;27(2):232-239. doi: 10.1002/jts.21899. Epub 2014 Mar 6.

    PMID: 24604631BACKGROUND

  • Badura-Brack AS, Naim R, Ryan TJ, Levy O, Abend R, Khanna MM, McDermott TJ, Pine DS, Bar-Haim Y. Effect of Attention Training on Attention Bias Variability and PTSD Symptoms: Randomized Controlled Trials in Israeli and U.S. Combat Veterans. Am J Psychiatry. 2015 Dec;172(12):1233-41. doi: 10.1176/appi.ajp.2015.14121578. Epub 2015 Jul 24.

    PMID: 26206075BACKGROUND

  • Naim R, Abend R, Wald I, Eldar S, Levi O, Fruchter E, Ginat K, Halpern P, Sipos ML, Adler AB, Bliese PD, Quartana PJ, Pine DS, Bar-Haim Y. Threat-Related Attention Bias Variability and Posttraumatic Stress. Am J Psychiatry. 2015 Dec;172(12):1242-50. doi: 10.1176/appi.ajp.2015.14121579. Epub 2015 Jul 24.

    PMID: 26206076BACKGROUND

  • Bryant, R. A., Harvey, A., G., Dang, S., T., & Sackville, T., Assessing acute stress disorder: Psychometric properties of a structured clinical interview. Psychological Assessment, 1998. 10(3): p. 215.

    BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticStress Disorders, Traumatic, Acute

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Yair Bar-Haim, Prof.

    Tel Aviv University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Yair Bar-Haim

Study Record Dates

First Submitted

October 28, 2015

First Posted

October 29, 2015

Study Start

February 1, 2016

Primary Completion

February 1, 2019

Study Completion

March 1, 2019

Last Updated

November 25, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)