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Attention Control Treatment for Post Traumatic Stress Disorder ׂ(PTSD)

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ClinicalTrials.gov Identifier: NCT02945709
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Yair Bar-Haim, Tel Aviv University

Brief Summary:

The purpose of this study is to explore the efficacy of Attention Control Training for Post Traumatic Stress Disorder (PTSD).

ACT was found to be effective in decreasing attention bias variability and PTSD symptoms in combat veterans (Badura-Brack, et al., 2015). It is now important to continue the examination of ACT's efficacy in additional populations of patients with PTSD. Such extension of treatment to other traumatic experiences raises the question of whether the threatening content of the training material could be personalized for each patient.


Condition or disease Intervention/treatment Phase
PTSD Behavioral: Personalized Attention control training (ACT) Behavioral: Non-personalized Attention control training (ACT) Behavioral: Control training. Not Applicable

Detailed Description:

The aim of this study is to explore the efficacy of Attention Control Training for Post Traumatic Stress Disorder (PTSD).

ACT was found to be effective in decreasing attention bias variability and PTSD symptoms in combat veterans (Badura-Brack, et al., 2015). It is now important to continue the examination of ACT's efficacy in additional populations of patients with PTSD. Such extension of treatment to other traumatic experiences raises the question of whether the threatening content of the training material could be personalized for each patient.

For this purpose, we will recruit participants that are diagnosed with PTSD and will be randomly assigned to one of three conditions: personalized ACT, non-personalized ACT, or control training We expect that personalized ACT will produce greater reduction in PTSD symptoms relative to a non-personalized ACT, and that both these conditions will be more effective in symptoms reduction than a control condition not designed to affect attention or expose patients to threat stimuli. We also expect the ACT conditions to reduce attention bias variability relative to the control condition.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Attention Control Treatment for Post Traumatic Stress Disorder
Study Start Date : October 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Personalized ACT
The personalized attention control training (ACT), comprised of six computerized sessions, in purpose of modulate biases in attention for personalized threat stimuli.
Behavioral: Personalized Attention control training (ACT)
In this intervention, participants will be trained with a personalized Dot-Probe task. Each participant will perform the task with the set of words that he or she ranked as the most threatening according to a Word Ranking Task.

Active Comparator: Non personalized ACT
The Non-personalized attention control training (ACT), comprised of six sessions, in purpose of modulate biases in attention for non-personalized threat stimuli.
Behavioral: Non-personalized Attention control training (ACT)
In this intervention, participants will be trained with the same Dot-Probe task as in the personalized condition, except that the word stimuli will be randomly fit for each participant. It should be noted that 25% out of the words in this condition will be high ranked words according to each patient's word ranking. The aim of this is to enhance similarity to a generic ACT intervention (see Badura-Brack et al., 2015), where there is some degree of exposure to what one may consider "personalized" stimuli (i.e., threat words that were randomly included by the researchers), although it is not deliberately set to idiosyncratic preferences.

Placebo Comparator: Control training
Computerized control training, comprised of six sessions with a variation of the dot-probe task with neutral stimuli
Behavioral: Control training.
In this intervention, participants will perform a computerized task, similar to the Dot-Probe task. In each trial, one neutral word will be presented at the center of the screen and participants will respond to a probe ('E' or 'f') presented following the removal of the words display. This version does not include the essential ingredients thought to reduce PTSD symptoms in the other dot-probe tasks: exposure to threat content and competition on attentional resources. Thus, this control version provides a control condition for the ACT interventions.




Primary Outcome Measures :
  1. A diagnosis of PTSD and a total score of severity symptoms, as driven from the CAPS-5 interview [ Time Frame: 40 minutes ]
    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).


Secondary Outcome Measures :
  1. Total score of the PTSD Checklist (PCL-5). [ Time Frame: 10 minutes ]
    The PCL-5, is a 20-item National Center for PTSD Checklist of the Department of Veterans Affairs. Scores can range from 0 to 80, with higher scores reflecting more symptoms of PTSD (Weathers, Litz, Keane, Palmieri, Marx, & Schnurr, 2013).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Meeting a current diagnosis of Post-Traumatic Stress Disorder (PTSD) according to DSM-V (American Psychiatric Association, 2013);

Exclusion Criteria:

  1. A diagnosis of psychotic or bipolar disorders.
  2. A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
  3. Suicidal ideation.
  4. Drugs drugs or alcohol abuse.
  5. Non-fluent Hebrew.
  6. A pharmacological or psychotherapy treatment that is not stabilized in the past 3 months (a stable treatment will not be a reason for exclusion from the study).
  7. Pregnancy. -

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): NCT02945709


Contacts
Contact: Yair Bar-Haim, Prof. yair1@post.tau.ac.il
Contact: Adva Segal, ma

Locations
Israel
Tel Aviv University Recruiting
Tel Aviv, Israel, 69978
Principal Investigator: Yair Bar-Haim, PhD         
Sponsors and Collaborators
Tel Aviv University
Investigators
Principal Investigator: Yair Bar-Haim, Prof. Tel Aviv University

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

Responsible Party: Yair Bar-Haim, Professor Yair Bar-Haim, Tel Aviv University
ClinicalTrials.gov Identifier: NCT02945709     History of Changes
Other Study ID Numbers: TAUPTSD
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yair Bar-Haim, Tel Aviv University:
PTSD
attention training
cognitive bias modification

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders